2019 Vol. 37, No. 6
Display Method:
2019, 37(6): 481-484.
doi: 10.3969/j.issn.1006-0111.2019.06.001
Abstract:
Malaria is a critical public health problem resulting in substantial morbidity and mortality in developing countries,especially in Africa.Quinoline,dihydrofolate reductase inhibitors and artemisinin drugs are currently the main drugs for the treatment of malaria,and have good clinical application value,but have the disadvantages of poor solubility,low bioavailability and lack of targeting.To overcome these drawbacks,optimizing the anti-malarial drug dosage form has become a research hotspot at present.Various optimized dosage forms for antimalarial drugs,such as solid dispersions,cyclodextrin inclusion complexes,nanoparticles,liposomes,etc.,are now reviewed.
Malaria is a critical public health problem resulting in substantial morbidity and mortality in developing countries,especially in Africa.Quinoline,dihydrofolate reductase inhibitors and artemisinin drugs are currently the main drugs for the treatment of malaria,and have good clinical application value,but have the disadvantages of poor solubility,low bioavailability and lack of targeting.To overcome these drawbacks,optimizing the anti-malarial drug dosage form has become a research hotspot at present.Various optimized dosage forms for antimalarial drugs,such as solid dispersions,cyclodextrin inclusion complexes,nanoparticles,liposomes,etc.,are now reviewed.
2019, 37(6): 485-490.
doi: 10.3969/j.issn.1006-0111.2019.06.002
Abstract:
Rheumatoid arthritis (RA) is a common autoimmune disease characterized by joint damage and synovial inflammation.Two major classes of RA drugs,including small molecule synthetic RA drugs and macromolecular biological RA drugs (TNF inhibitors、B cell inhibitors、T cell inhibitors、IL inhibitors、target RANKL biologics、target GM-CSF biologics) were reviewed in this paper,focusing on the therapeutic mechanisms of these two classes of drugs.In addition the latest therapeutic target for rheumatoid arthritis was also summarized,which provided a potential new direction for the treatment of patients with rheumatoid arthritis.
Rheumatoid arthritis (RA) is a common autoimmune disease characterized by joint damage and synovial inflammation.Two major classes of RA drugs,including small molecule synthetic RA drugs and macromolecular biological RA drugs (TNF inhibitors、B cell inhibitors、T cell inhibitors、IL inhibitors、target RANKL biologics、target GM-CSF biologics) were reviewed in this paper,focusing on the therapeutic mechanisms of these two classes of drugs.In addition the latest therapeutic target for rheumatoid arthritis was also summarized,which provided a potential new direction for the treatment of patients with rheumatoid arthritis.
2019, 37(6): 491-494.
doi: 10.3969/j.issn.1006-0111.2019.06.003
Abstract:
Objective To investigate the low-polarity components from the stems of Schisandra rubriflora (Franch).Rehd.et Wils. Methods Dried and grinded stems of this plant were extracted by 90% ethylalcohol,then the extraction was partitioned by petroleum ether to afford petroleum extract,which was analyzed by GC-MS and elucidated by the comparison with the standard mass spectral data.The relative contents in percentage were calculated by the area normalization method. Results 49 compounds were identified.Of them,β-selinene (12.08%),2-methyl-Z,Z-3,13-octadecadienol (10.3%) were the main components. Conclusion The main components in the low-polarity components of the stems of Schisandra rubriflora (Franch).Rehd.et Wils.were esters (45.94%),fatty acids (19.35%) and sesquiterpenoids (13.94%).
Objective To investigate the low-polarity components from the stems of Schisandra rubriflora (Franch).Rehd.et Wils. Methods Dried and grinded stems of this plant were extracted by 90% ethylalcohol,then the extraction was partitioned by petroleum ether to afford petroleum extract,which was analyzed by GC-MS and elucidated by the comparison with the standard mass spectral data.The relative contents in percentage were calculated by the area normalization method. Results 49 compounds were identified.Of them,β-selinene (12.08%),2-methyl-Z,Z-3,13-octadecadienol (10.3%) were the main components. Conclusion The main components in the low-polarity components of the stems of Schisandra rubriflora (Franch).Rehd.et Wils.were esters (45.94%),fatty acids (19.35%) and sesquiterpenoids (13.94%).
2019, 37(6): 495-497,526.
doi: 10.3969/j.issn.1006-0111.2019.06.004
Abstract:
Objective To compare the content of total flavonoids in Herba Anoectochilus and its adulterants. Methods Rutin was selected as reference substance,the total flavonoids in Herba Anoectochilus and its adulterants were determined by ultraviolet spectrophotometry. Results The contents of total flavonoids in 12 batches of Herba Anoectochilus varied widely,ranging from 3.89 to 15.17 mg/g,which could be noted that the total flavonoids contents of wild A.roxburghii from Guangdong were higher than the other sources.The contents of total flavonoids in 13 batches adulterants ranging from 3.66 to 21.96 mg/g,and Goodyera schlechtendaliana possessed the highest total flavonoids content. Conclusion The contents of total flavonoids in Herba Anoectochilus and its and adulterants were obviously different.
Objective To compare the content of total flavonoids in Herba Anoectochilus and its adulterants. Methods Rutin was selected as reference substance,the total flavonoids in Herba Anoectochilus and its adulterants were determined by ultraviolet spectrophotometry. Results The contents of total flavonoids in 12 batches of Herba Anoectochilus varied widely,ranging from 3.89 to 15.17 mg/g,which could be noted that the total flavonoids contents of wild A.roxburghii from Guangdong were higher than the other sources.The contents of total flavonoids in 13 batches adulterants ranging from 3.66 to 21.96 mg/g,and Goodyera schlechtendaliana possessed the highest total flavonoids content. Conclusion The contents of total flavonoids in Herba Anoectochilus and its and adulterants were obviously different.
2019, 37(6): 498-502.
doi: 10.3969/j.issn.1006-0111.2019.06.005
Abstract:
Objective To study the protective effect and explore the mechanism of monocyte locomotion inhibitor factor(MLIF) on traumatic brain injury (TBI) in rats. Methods The SD rats were randomly divided into five groups:sham operation group,model group and three MLIF groups (0.33 mg/kg,1 mg/kg,3 mg/kg).Rats were made model of brain injury by fluid percussion injury.The tail vein was administered within 30 min after TBI,once every 24 hours,and rats were administered for 7 days.Brain water content,serum levels of SOD and MDA,Hematoxylin-eosin staining and Nissl staining were used to detect the rats brain tissues. Results After rats traumatic brain injury for 24h,the brain water content in rats in three MLIF groups(0.33 mg/kg,1 mg/kg and 3 mg/kg)was significantly lower than that in model group(P<0.01),The effect of MLIF (1 mg/kg) group was the best.Compared to rats traumatic brain injury for 1d and 3d,brain water content in MLIF group (1 mg/kg) was significantly lower than that in model group (P<0.01).SOD content in serum in MLIF (1 mg/kg) group was significantly increased (P <0.01) and MDA content in serum in MLIF (1 mg/kg) group was significantly decreased (P<0.05).HE staining and Nissl staining showed that the pathological changes of brain tissue in model group were obvious,and which in MLIF group were improved in brain tissue. Conclusion MLIF could inhibit oxidative stress and edema reaction of brain injury,which had protective effect on traumatic brain injury.
Objective To study the protective effect and explore the mechanism of monocyte locomotion inhibitor factor(MLIF) on traumatic brain injury (TBI) in rats. Methods The SD rats were randomly divided into five groups:sham operation group,model group and three MLIF groups (0.33 mg/kg,1 mg/kg,3 mg/kg).Rats were made model of brain injury by fluid percussion injury.The tail vein was administered within 30 min after TBI,once every 24 hours,and rats were administered for 7 days.Brain water content,serum levels of SOD and MDA,Hematoxylin-eosin staining and Nissl staining were used to detect the rats brain tissues. Results After rats traumatic brain injury for 24h,the brain water content in rats in three MLIF groups(0.33 mg/kg,1 mg/kg and 3 mg/kg)was significantly lower than that in model group(P<0.01),The effect of MLIF (1 mg/kg) group was the best.Compared to rats traumatic brain injury for 1d and 3d,brain water content in MLIF group (1 mg/kg) was significantly lower than that in model group (P<0.01).SOD content in serum in MLIF (1 mg/kg) group was significantly increased (P <0.01) and MDA content in serum in MLIF (1 mg/kg) group was significantly decreased (P<0.05).HE staining and Nissl staining showed that the pathological changes of brain tissue in model group were obvious,and which in MLIF group were improved in brain tissue. Conclusion MLIF could inhibit oxidative stress and edema reaction of brain injury,which had protective effect on traumatic brain injury.
2019, 37(6): 503-507.
doi: 10.3969/j.issn.1006-0111.2019.06.006
Abstract:
Objective To establish a pharmacokinetic method for simultaneous determination the drug concentration in the skin and blood for transdermal formulations,and to study the absorption and metabolism of matrine gel in vivo. Methods A micro dialysis probe-based skin-blood synchronous micro dialysis system was established.After the probe was implanted into the skin and jugular vein,the matrine gel was administered.The dialysate in the probe was continuously collected for 12 h.The concentration of the drug in the probe dialysate was determined by LC-MS. Results In this study,a two-site synchronous micro dialysis pharmacokinetic evaluation system was successfully established.After given matrine gel,the concentration,AUC and half-life of the drug in skin were significantly higher than that in blood. Conclusion The established micro dialysis system combined with LC-MS could provide a new technology platform for the pharmacokinetic study on transdermal formulations.
Objective To establish a pharmacokinetic method for simultaneous determination the drug concentration in the skin and blood for transdermal formulations,and to study the absorption and metabolism of matrine gel in vivo. Methods A micro dialysis probe-based skin-blood synchronous micro dialysis system was established.After the probe was implanted into the skin and jugular vein,the matrine gel was administered.The dialysate in the probe was continuously collected for 12 h.The concentration of the drug in the probe dialysate was determined by LC-MS. Results In this study,a two-site synchronous micro dialysis pharmacokinetic evaluation system was successfully established.After given matrine gel,the concentration,AUC and half-life of the drug in skin were significantly higher than that in blood. Conclusion The established micro dialysis system combined with LC-MS could provide a new technology platform for the pharmacokinetic study on transdermal formulations.
2019, 37(6): 508-511.
doi: 10.3969/j.issn.1006-0111.2019.06.007
Abstract:
Objective To establish a HPLC method for the simultaneous determination of diphenhydramine hydrochloride,octyl methoxycinnamate and octyl salicylate in multi-effect protective cream. Methods The HPLC condition was as follows.The column was Agilent Extend-C18 (4.6 mm×150 mm,5 μm).The mobile phase was methanol and ammonium acetate buffer solution (20 mmol/L,pH=7.5).Gradient elution.The methanol ratio varies with time as follows:0-10 min,methanol→60%; 10-12 min,methanol 60%→92%;12-20 min,methanol→92%.Acquisition time was 20 minutes.Liquid phase equilibrium time was 10 min.Flow rate was 1 ml/min.UV detection wavelength was 218 nm.Column temperature was 25℃.Injection volume was 15 μl. Results The three components were separated at baseline within 30 min.The methodological verification showed that the standard curves had good linearity (r>0.9995).The inter-day precision were less than 3.0%.The recovery was between 90% and 108%.The RSD% of stability and repeatability were also less than 3.0%.The results showed that the method could meet the requirements of method validation.The contents of the three components in three batches were determined according to the newly established method. Conclusion The method is simple and reliable,can provide a basis for the quality control of multi-effect protective cream,and laid a foundation for its quality standard research.
Objective To establish a HPLC method for the simultaneous determination of diphenhydramine hydrochloride,octyl methoxycinnamate and octyl salicylate in multi-effect protective cream. Methods The HPLC condition was as follows.The column was Agilent Extend-C18 (4.6 mm×150 mm,5 μm).The mobile phase was methanol and ammonium acetate buffer solution (20 mmol/L,pH=7.5).Gradient elution.The methanol ratio varies with time as follows:0-10 min,methanol→60%; 10-12 min,methanol 60%→92%;12-20 min,methanol→92%.Acquisition time was 20 minutes.Liquid phase equilibrium time was 10 min.Flow rate was 1 ml/min.UV detection wavelength was 218 nm.Column temperature was 25℃.Injection volume was 15 μl. Results The three components were separated at baseline within 30 min.The methodological verification showed that the standard curves had good linearity (r>0.9995).The inter-day precision were less than 3.0%.The recovery was between 90% and 108%.The RSD% of stability and repeatability were also less than 3.0%.The results showed that the method could meet the requirements of method validation.The contents of the three components in three batches were determined according to the newly established method. Conclusion The method is simple and reliable,can provide a basis for the quality control of multi-effect protective cream,and laid a foundation for its quality standard research.
2019, 37(6): 512-517.
doi: 10.3969/j.issn.1006-0111.2019.06.008
Abstract:
Objective To study the prototype components and metabolites of Saposhnikoviae Radixin in rats' plasma. Methods UPLC-Q-TOF-MS method was used to identify the components and metabolites of rat plasma.The Eclipse Plus C18 column(150 mm×2.1 mm,1.8 μm,Agilent)was used.The mobile phase was 0.1% acetic acid solution (A)-0.1% acetic acidacetonitrile (B).The gradient elution was used.The flowing rate was 0.3 ml/min.The injection volume was 3 μl. Results An analytical method for the determination of metabolites of Saposhnikoviae Radix in plasma samples after oral administration.A total of 21 compounds,including 10 prototype components and 11 metabolites,were identified by comparison of their retention time,ion fragmentation information with that of the control plasma,herb extract,and reference compounds. Conclusion The metabolic pathway of the main components of Saposhnikoviae Radixin in rats mainly include hydroxylation,demethylation and glucuronidation,etc.This established method is simple and reliable and provide research basis for revealing the bioactive components of Saposhnikoviae Radix.
Objective To study the prototype components and metabolites of Saposhnikoviae Radixin in rats' plasma. Methods UPLC-Q-TOF-MS method was used to identify the components and metabolites of rat plasma.The Eclipse Plus C18 column(150 mm×2.1 mm,1.8 μm,Agilent)was used.The mobile phase was 0.1% acetic acid solution (A)-0.1% acetic acidacetonitrile (B).The gradient elution was used.The flowing rate was 0.3 ml/min.The injection volume was 3 μl. Results An analytical method for the determination of metabolites of Saposhnikoviae Radix in plasma samples after oral administration.A total of 21 compounds,including 10 prototype components and 11 metabolites,were identified by comparison of their retention time,ion fragmentation information with that of the control plasma,herb extract,and reference compounds. Conclusion The metabolic pathway of the main components of Saposhnikoviae Radixin in rats mainly include hydroxylation,demethylation and glucuronidation,etc.This established method is simple and reliable and provide research basis for revealing the bioactive components of Saposhnikoviae Radix.
2019, 37(6): 518-520.
doi: 10.3969/j.issn.1006-0111.2019.06.009
Abstract:
Objective To establish a method for the determination of sodium fluoride in fluoride-containing mouthwash by 19F-NMR technique. Methods The 19F-NMR technique was used to establish the relevant standard curve with trifluoroacetic acid as the internal standard.The 19F-NMR spectrum of the sample was collected at 25℃ using a 300 MHz NMR spectrometer. Results The linear relationship of sodium fluoride was good in the range of 0.1-0.8 mg/ml.The regression equation was A=1.1392C-0.0013,r=0.99995.The average recovery of low,medium and high concentration levels were 99.36%,99.31.% and 99.65%,respectively,and RSD was 0.51%,0.35% and 0.54% respectively.The average content of sodium fluoride in the fluoride mouthwash was 99.30%. Conclusion The method was accurate and precise which could be used to determine the sodium fluoride in fluoride-containing mouthwash.
Objective To establish a method for the determination of sodium fluoride in fluoride-containing mouthwash by 19F-NMR technique. Methods The 19F-NMR technique was used to establish the relevant standard curve with trifluoroacetic acid as the internal standard.The 19F-NMR spectrum of the sample was collected at 25℃ using a 300 MHz NMR spectrometer. Results The linear relationship of sodium fluoride was good in the range of 0.1-0.8 mg/ml.The regression equation was A=1.1392C-0.0013,r=0.99995.The average recovery of low,medium and high concentration levels were 99.36%,99.31.% and 99.65%,respectively,and RSD was 0.51%,0.35% and 0.54% respectively.The average content of sodium fluoride in the fluoride mouthwash was 99.30%. Conclusion The method was accurate and precise which could be used to determine the sodium fluoride in fluoride-containing mouthwash.
2019, 37(6): 521-526.
doi: 10.3969/j.issn.1006-0111.2019.06.010
Abstract:
Objective To study the preparation technology and quality of cefotiam hexetil hydrochloride tablet. Methods The disintegration time limit and dissolution of drug were taken as the main index.The original piece of reference was used to optimize the prescription process and preliminary study on its quality. Results The best prescription was determined by experiments:cefotiam hexetil hydrochloride tablets were prepared by dry granulation with anhydrous citric acid,alpha-cyclodextrin,microcrystalline cellulose,hydroxypropyl cellulose,silica,magnesium stearate and film-coated premix (gastric-soluble).The indexes of cefotiam hexetil hydrochloride tablet conformed to the Japanese Pharmaceutical Bureau Prescription (JPXV) standard. Conclusion The preparation technology of cefotiam hexetil hydrochloride tablet was feasible and the product had good stability.
Objective To study the preparation technology and quality of cefotiam hexetil hydrochloride tablet. Methods The disintegration time limit and dissolution of drug were taken as the main index.The original piece of reference was used to optimize the prescription process and preliminary study on its quality. Results The best prescription was determined by experiments:cefotiam hexetil hydrochloride tablets were prepared by dry granulation with anhydrous citric acid,alpha-cyclodextrin,microcrystalline cellulose,hydroxypropyl cellulose,silica,magnesium stearate and film-coated premix (gastric-soluble).The indexes of cefotiam hexetil hydrochloride tablet conformed to the Japanese Pharmaceutical Bureau Prescription (JPXV) standard. Conclusion The preparation technology of cefotiam hexetil hydrochloride tablet was feasible and the product had good stability.
2019, 37(6): 527-531.
doi: 10.3969/j.issn.1006-0111.2019.06.011
Abstract:
Objective To establish microbial limit test methods for 6 hospital preparations. Methods The tests were carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese pharmacopoeia 2015 edition.Test samples were treated by membrane filtration.Experiments were made on microorganism introduction method,the volume of rinsing solution and dilution ratio of the test solution. Results The method of membrane filtration could eliminate the bacteriostasis of samples.Introduction of validation strains in the sample solution worked for 6 samples in the test of total number of aerobic bacteria,molds and yeasts.The recovery ratios of five tests bacterial were within a range from 0.5 to 2.0.The membrane filtration was used for control bacteria in all preparations,and the control bacteria could be detected. Conclusion The methods met the requirements of Chinese pharmacopoeia(2015 edition),which could be used for routine work of drug quality control.
Objective To establish microbial limit test methods for 6 hospital preparations. Methods The tests were carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese pharmacopoeia 2015 edition.Test samples were treated by membrane filtration.Experiments were made on microorganism introduction method,the volume of rinsing solution and dilution ratio of the test solution. Results The method of membrane filtration could eliminate the bacteriostasis of samples.Introduction of validation strains in the sample solution worked for 6 samples in the test of total number of aerobic bacteria,molds and yeasts.The recovery ratios of five tests bacterial were within a range from 0.5 to 2.0.The membrane filtration was used for control bacteria in all preparations,and the control bacteria could be detected. Conclusion The methods met the requirements of Chinese pharmacopoeia(2015 edition),which could be used for routine work of drug quality control.
2019, 37(6): 532-536.
doi: 10.3969/j.issn.1006-0111.2019.06.012
Abstract:
Objective To revise and improve the quality standard for Shugan Hewei pills. Methods TLC was used for the identification of costustoot、fingered citrona and orange peel.The content of norisoboldine,albiflorin,paeoniflorin,pentagalloylglucose and hesperidin was determined by HPLC. Results Costustoot、fingered citrona and orange peel could be detected by TLC.Norisoboldine,albiflorin,paeoniflorin,pentagalloylglucose and hesperidin were well separated under the chromatographic condition.The average recovery was 98.44%(RSD=1.84%)、100.99%(RSD=1.86%)、99.04%(RSD=1.82%)、100.15%(RSD=1.98%)、101.61%(RSD=1.82%)。 Conclusion The method is simple and accurate,reproducible,and can be used to control the quality of the preparation.
Objective To revise and improve the quality standard for Shugan Hewei pills. Methods TLC was used for the identification of costustoot、fingered citrona and orange peel.The content of norisoboldine,albiflorin,paeoniflorin,pentagalloylglucose and hesperidin was determined by HPLC. Results Costustoot、fingered citrona and orange peel could be detected by TLC.Norisoboldine,albiflorin,paeoniflorin,pentagalloylglucose and hesperidin were well separated under the chromatographic condition.The average recovery was 98.44%(RSD=1.84%)、100.99%(RSD=1.86%)、99.04%(RSD=1.82%)、100.15%(RSD=1.98%)、101.61%(RSD=1.82%)。 Conclusion The method is simple and accurate,reproducible,and can be used to control the quality of the preparation.
2019, 37(6): 537-542.
doi: 10.3969/j.issn.1006-0111.2019.06.013
Abstract:
Objective To screen out the optimal conditions for extraction and purification of total flavonoids from the herb pair of Scutellariae barbatae and Hedyotis diffusa. Methods Single factor and L9(34) orthogonal experiment was designed with the extraction ratio and extract quantity of total flavonoids as indexes,using matching of herb pair,ethanol concentration,solid-liquid ratio,extraction time as inspected elements.The technical process for purification of total flavonoids with the static and dynamic adsorption experiments was screened by adsorption and desorption ratio as targets. Results The optimal process conditions were:ethanol concentration 70%,the matching of herb pair of 4:1,the solid-liquid ratio of 1:25,extraction for 3 times and 2h for each time.The parameters of the purification process were as follows:concentration of sample 63.14 mg/ml and pH value 4.0,which used in the chromatographic column of polyamide resin at a flow velocity of 1.5 ml/min.The chromatographic column was eluted with purified water of 3.1BV,and then eluted with 65% ethanol concentration of 9.3BV at a flow velocity of 3ml/min.The purity of the total flavonoids was 40.39% in the fine product,and the transfer rate was 81.57%. Conclusion The optimal process conditions were reasonable and feasible.The purification technique of polyamide resin was uncomplicated and had a good effect.
Objective To screen out the optimal conditions for extraction and purification of total flavonoids from the herb pair of Scutellariae barbatae and Hedyotis diffusa. Methods Single factor and L9(34) orthogonal experiment was designed with the extraction ratio and extract quantity of total flavonoids as indexes,using matching of herb pair,ethanol concentration,solid-liquid ratio,extraction time as inspected elements.The technical process for purification of total flavonoids with the static and dynamic adsorption experiments was screened by adsorption and desorption ratio as targets. Results The optimal process conditions were:ethanol concentration 70%,the matching of herb pair of 4:1,the solid-liquid ratio of 1:25,extraction for 3 times and 2h for each time.The parameters of the purification process were as follows:concentration of sample 63.14 mg/ml and pH value 4.0,which used in the chromatographic column of polyamide resin at a flow velocity of 1.5 ml/min.The chromatographic column was eluted with purified water of 3.1BV,and then eluted with 65% ethanol concentration of 9.3BV at a flow velocity of 3ml/min.The purity of the total flavonoids was 40.39% in the fine product,and the transfer rate was 81.57%. Conclusion The optimal process conditions were reasonable and feasible.The purification technique of polyamide resin was uncomplicated and had a good effect.
2019, 37(6): 543-547,576.
doi: 10.3969/j.issn.1006-0111.2019.06.014
Abstract:
Objective To establish an ultra-high performance liquid chromatography (UPLC) fingerprint of Shenkang injection and identify the common peaks of Shenkang injection fingerprint. Methods The UPLC method was established by employing ACQUITY UPLC® CSH-C18 column(2.1 mm×100 mm,1.7 μm) with methanol(A) -0.1% formic acid(B) aqueous solution as mobile phase in gradient elution.The detection wavelength was 280 nm.The flow rate was 0.4ml/min.The injection volume was 2 μl and the column temperature was 30℃.Time of flight mass spectrometer was used with negative ion mode scanning. Results The UPLC chromatographic fingerprint of Shenkang injection was established.26 common peaks of shenkang injection were identified by UPLC/ESI-Q-TOF MS.The similarity of 20 batches of shenkang injection was over 0.90,which was evaluated by similarity evaluation system for chromatographic fingerprint of TCM(Version 2012.130723). Conclusion This method is highly sensitive,stable and reliable,and can be used for the quality control of shenkang injection.
Objective To establish an ultra-high performance liquid chromatography (UPLC) fingerprint of Shenkang injection and identify the common peaks of Shenkang injection fingerprint. Methods The UPLC method was established by employing ACQUITY UPLC® CSH-C18 column(2.1 mm×100 mm,1.7 μm) with methanol(A) -0.1% formic acid(B) aqueous solution as mobile phase in gradient elution.The detection wavelength was 280 nm.The flow rate was 0.4ml/min.The injection volume was 2 μl and the column temperature was 30℃.Time of flight mass spectrometer was used with negative ion mode scanning. Results The UPLC chromatographic fingerprint of Shenkang injection was established.26 common peaks of shenkang injection were identified by UPLC/ESI-Q-TOF MS.The similarity of 20 batches of shenkang injection was over 0.90,which was evaluated by similarity evaluation system for chromatographic fingerprint of TCM(Version 2012.130723). Conclusion This method is highly sensitive,stable and reliable,and can be used for the quality control of shenkang injection.
2019, 37(6): 548-551,570.
doi: 10.3969/j.issn.1006-0111.2019.06.015
Abstract:
Objective To reduce the unreasonable medical expenditure and improve the level of clinical rational drug by strengthening the supervision of adjuvant drug use. Methods The regionally integrated medical database and standardized basic drug information database were used.The market share of adjuvant drugs varieties and their clinical consumption of multi-center hospital in certain region were collected and analyzed.The data of 2015 and 2018 after the implementation of supervision were compared. Results The monitoring results of clinical application adjuvant drugs in nearly 200 hospitals of the region were obtained.The selection method of key monitoring drug list based on the medical big data was discussed after expert review.The first batch of 80 drugs in the key monitoring of regional medical institutions was confirmed.Improper use of key clinical monitoring drugs had been improved. Conclusion Through the introduction of relevant policies by the state and the implementation of rectification measures in various regions,the unreasonable use of key monitoring drugs had been improved to some extent.
Objective To reduce the unreasonable medical expenditure and improve the level of clinical rational drug by strengthening the supervision of adjuvant drug use. Methods The regionally integrated medical database and standardized basic drug information database were used.The market share of adjuvant drugs varieties and their clinical consumption of multi-center hospital in certain region were collected and analyzed.The data of 2015 and 2018 after the implementation of supervision were compared. Results The monitoring results of clinical application adjuvant drugs in nearly 200 hospitals of the region were obtained.The selection method of key monitoring drug list based on the medical big data was discussed after expert review.The first batch of 80 drugs in the key monitoring of regional medical institutions was confirmed.Improper use of key clinical monitoring drugs had been improved. Conclusion Through the introduction of relevant policies by the state and the implementation of rectification measures in various regions,the unreasonable use of key monitoring drugs had been improved to some extent.
2019, 37(6): 552-558.
doi: 10.3969/j.issn.1006-0111.2019.06.016
Abstract:
Objective To optimize the formulation and preparation technology of N-acetylcysteine(NAC) injection based on the concept of quality by design(QbD). Methods Using QbD as the guidance,the critical quality attributes affecting the quality of the injection were determined through literature and the critical process parameters were determined by fishbone diagram and failure mode and effects analysis.Minitab was applied to design experiments and analyze results and design space was established. Results The evaluation indexes were the pH changes before and after sterilization and the concent of NAC.The addition of sodium calcium edetate,preparation temperature and sterilization condition were determined as the critical quality attributes by fishbone diagram and FMEA.The results of variance analysis showed that the P value of the established mathematical models of the process parameters and evaluation indexes were less than 0.05,which indicated that the models had good prediction ability.The optimal parameters were the addition amount of calcium edetate was 0.049 192%,the preparation temperature was 60℃,and the sterilization condition was 116℃,40 min. Conclusion The prescription was reasonable,the process was stable and the established design space based on the concept of QbD improved the durability of the process and ensured uniform and controllability of the quality of the injection.
Objective To optimize the formulation and preparation technology of N-acetylcysteine(NAC) injection based on the concept of quality by design(QbD). Methods Using QbD as the guidance,the critical quality attributes affecting the quality of the injection were determined through literature and the critical process parameters were determined by fishbone diagram and failure mode and effects analysis.Minitab was applied to design experiments and analyze results and design space was established. Results The evaluation indexes were the pH changes before and after sterilization and the concent of NAC.The addition of sodium calcium edetate,preparation temperature and sterilization condition were determined as the critical quality attributes by fishbone diagram and FMEA.The results of variance analysis showed that the P value of the established mathematical models of the process parameters and evaluation indexes were less than 0.05,which indicated that the models had good prediction ability.The optimal parameters were the addition amount of calcium edetate was 0.049 192%,the preparation temperature was 60℃,and the sterilization condition was 116℃,40 min. Conclusion The prescription was reasonable,the process was stable and the established design space based on the concept of QbD improved the durability of the process and ensured uniform and controllability of the quality of the injection.
2019, 37(6): 559-562.
doi: 10.3969/j.issn.1006-0111.2019.06.017
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Objective To investigate the role of clinical pharmacists in anti-tumor therapy in patients with advanced rectal neuroendocrine tumors. Methods Clinical pharmacists participated in the pharmacy service of a patient with advanced rectal neuroendocrine tumor.Combined with the actual situation of the patient,the clinical pharmacist provided advice on the efficacy and safety of the medication and conducted full-course pharmaceutical care. Results Everolimus can cause serious adverse reactions of hyperglycemia and should be monitored when using drugs.Apatinib can be used as a choice for posterior chemotherapy in patients with advanced rectal neuroendocrine tumors. Conclusion In the case of monitoring the adverse effects of new anti-tumor drugs and lack of evidence-based pharmacological evidence,how to choose anti-tumor drugs in the posterior line is the entry point for clinical pharmacists' work,which plays an important role for improving the safety and efficacy of the drug use of patients with advanced rectal neuroendocrine tumors.
Objective To investigate the role of clinical pharmacists in anti-tumor therapy in patients with advanced rectal neuroendocrine tumors. Methods Clinical pharmacists participated in the pharmacy service of a patient with advanced rectal neuroendocrine tumor.Combined with the actual situation of the patient,the clinical pharmacist provided advice on the efficacy and safety of the medication and conducted full-course pharmaceutical care. Results Everolimus can cause serious adverse reactions of hyperglycemia and should be monitored when using drugs.Apatinib can be used as a choice for posterior chemotherapy in patients with advanced rectal neuroendocrine tumors. Conclusion In the case of monitoring the adverse effects of new anti-tumor drugs and lack of evidence-based pharmacological evidence,how to choose anti-tumor drugs in the posterior line is the entry point for clinical pharmacists' work,which plays an important role for improving the safety and efficacy of the drug use of patients with advanced rectal neuroendocrine tumors.
2019, 37(6): 563-570.
doi: 10.3969/j.issn.1006-0111.2019.06.018
Abstract:
Objective To investigate the efficacy and safety of S-1 monotherapy or combined with platinum chemotherapy in the treatment of patients with advanced NSCLC. Methods Systematic searches were performed for randomized controlled trials with the CNKI,PubMed,Web of Science and Cochrane Library.S-1 monotherapy or combined with platinum chemotherapy was the observation group.Paclitaxel,docetaxel and gemcitabine monotherapy or combined with platinum chemotherapy were the control group.The Cochrane systematic review method was used for literature quality evaluation and RevMan 5.3.5 software was used for statistical analysis. Results 3977 patients were enrolled in 25 studies.The effective rate and disease control rate in the observation group were similar to those in the control group with no statistical significance[ORR:OR=0.97,95% CI (0.83,1.13),P=0.66; DCR:OR=1.11,95% CI (0.92,1.32) P=0.27].In terms of safety,there were less adverse drug reactions in the observation group compared to the control group with statistical significance (P<0.05). Conclusion S-1 monotherapy or combined with platinum chemotherapy is recommended for patients with advanced NSCLC.
Objective To investigate the efficacy and safety of S-1 monotherapy or combined with platinum chemotherapy in the treatment of patients with advanced NSCLC. Methods Systematic searches were performed for randomized controlled trials with the CNKI,PubMed,Web of Science and Cochrane Library.S-1 monotherapy or combined with platinum chemotherapy was the observation group.Paclitaxel,docetaxel and gemcitabine monotherapy or combined with platinum chemotherapy were the control group.The Cochrane systematic review method was used for literature quality evaluation and RevMan 5.3.5 software was used for statistical analysis. Results 3977 patients were enrolled in 25 studies.The effective rate and disease control rate in the observation group were similar to those in the control group with no statistical significance[ORR:OR=0.97,95% CI (0.83,1.13),P=0.66; DCR:OR=1.11,95% CI (0.92,1.32) P=0.27].In terms of safety,there were less adverse drug reactions in the observation group compared to the control group with statistical significance (P<0.05). Conclusion S-1 monotherapy or combined with platinum chemotherapy is recommended for patients with advanced NSCLC.
2019, 37(6): 571-576.
doi: 10.3969/j.issn.1006-0111.2019.06.019
Abstract:
Objective To explore the general rule of medication usage in retired military personnel in the sanatorium. Methods The SQL statement was used to extract the electronic prescription data of all outpatients of 2015-retired military personnel of a third-A-grade hospital in Shanghai for data cleaning and classification.SPSS 19.0 was used to describe the samples and Kruskal-Wallis nonparametric test.The multiple linear regression analysis of factors related to the amount of prescription was performed. Results In 2015,a total of 383 retired military personnel visited the outpatient clinic of this third-A-grade hospitals,with an average age of 83.99±4.22 years old,with an average of 34.48±22.69 clinic visit times per person,and with 835 type of drugs (including different specifications of the same variety).The expenditure on pharmaceutical consumption was 6.66 million yuan.The per capita consumption was 17394.29±14706.94 yuan; Among them,the consumption of chemical drugs and biological preparations was 47.7 million (accounting for 71.83%).The consumption of proprietary Chinese medicines was 1.876 million (accounting for 28.17%).There is a linear correlation between per capita drug consumption and the retired military personnel's persition leval (X2),branch (X3),and the number of visits (X4).The standardized regression equation is Y=0.458X4+0.422X2+0.252X3. Conclusion The outpatient drug consumption and disease spectrum of retired military personnel is basically consistent.The outpatient drug consumption of retired cadres is not limited to health funding guarantee standard,but,the difference of the retired military personnel's drug consumption between the directly affiliated branch and Joint Logistics Support Force is statistically significant.The average annual outpatient drug consumption of retired military personnel is related to many factors.The problem of long-term over-medication of retired military personnel needs attention.
Objective To explore the general rule of medication usage in retired military personnel in the sanatorium. Methods The SQL statement was used to extract the electronic prescription data of all outpatients of 2015-retired military personnel of a third-A-grade hospital in Shanghai for data cleaning and classification.SPSS 19.0 was used to describe the samples and Kruskal-Wallis nonparametric test.The multiple linear regression analysis of factors related to the amount of prescription was performed. Results In 2015,a total of 383 retired military personnel visited the outpatient clinic of this third-A-grade hospitals,with an average age of 83.99±4.22 years old,with an average of 34.48±22.69 clinic visit times per person,and with 835 type of drugs (including different specifications of the same variety).The expenditure on pharmaceutical consumption was 6.66 million yuan.The per capita consumption was 17394.29±14706.94 yuan; Among them,the consumption of chemical drugs and biological preparations was 47.7 million (accounting for 71.83%).The consumption of proprietary Chinese medicines was 1.876 million (accounting for 28.17%).There is a linear correlation between per capita drug consumption and the retired military personnel's persition leval (X2),branch (X3),and the number of visits (X4).The standardized regression equation is Y=0.458X4+0.422X2+0.252X3. Conclusion The outpatient drug consumption and disease spectrum of retired military personnel is basically consistent.The outpatient drug consumption of retired cadres is not limited to health funding guarantee standard,but,the difference of the retired military personnel's drug consumption between the directly affiliated branch and Joint Logistics Support Force is statistically significant.The average annual outpatient drug consumption of retired military personnel is related to many factors.The problem of long-term over-medication of retired military personnel needs attention.
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