盐酸普萘洛尔乳膏的研制及质量标准研究

苗杰; 王爱武; 杨柳; 霍然; 徐广琪

doi:10.3969/j.issn.1006-0111.2013.06.003

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盐酸普萘洛尔乳膏的研制及质量标准研究

苗杰, 王爱武, 杨柳, 霍然, 徐广琪

文章导航 > 药学实践与服务 > 2013 > 31(6): 409-411,435

苗杰, 王爱武, 杨柳, 霍然, 徐广琪. 盐酸普萘洛尔乳膏的研制及质量标准研究[J]. 药学实践与服务, 2013, 31(6): 409-411,435. doi: 10.3969/j.issn.1006-0111.2013.06.003

引用本文:

苗杰, 王爱武, 杨柳, 霍然, 徐广琪. 盐酸普萘洛尔乳膏的研制及质量标准研究[J]. 药学实践与服务, 2013, 31(6): 409-411,435. doi: 10.3969/j.issn.1006-0111.2013.06.003

MIAO Jie, WANG Ai-wu, YANG Liu, HUO Ran, XU Guang-qi. Preparation and quality control of propranolol hydrochloride cream[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(6): 409-411,435. doi: 10.3969/j.issn.1006-0111.2013.06.003

Citation:

MIAO Jie, WANG Ai-wu, YANG Liu, HUO Ran, XU Guang-qi. Preparation and quality control of propranolol hydrochloride cream[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(6): 409-411,435. doi: 10.3969/j.issn.1006-0111.2013.06.003

盐酸普萘洛尔乳膏的研制及质量标准研究

doi: 10.3969/j.issn.1006-0111.2013.06.003

苗杰¹,
王爱武^2,,
杨柳¹,
霍然³,
徐广琪⁴

1.
山东中医药大学, 山东济南 250355;山东大学附属省立医院药剂科, 山东济南 250021
2.
山东大学附属省立医院药剂科, 山东济南 250021
3.
山东大学附属省立医院烧伤整形科, 山东济南 250021
4.
山东大学附属省立医院烧伤整形科, 山东济南 250021;山东大学医学院, 山东济南 250100

基金项目: 山东省科技发展项目(2012YD18056).

Preparation and quality control of propranolol hydrochloride cream

1.
Shandong Traditional Chinese Medical University, Jinan 250355, China;Department of Pharmacy, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China
2.
Department of Pharmacy, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China
3.
Department of Burn-Plastic Surgery, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China
4.
Department of Burn-Plastic Surgery, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China;School of Medicine, Shandong University, Jinan 250100, China

摘要: 目的优选盐酸普萘洛尔乳膏的最佳基质配方和工艺条件,并对其进行质量控制。方法以乳化温度、硬脂酸、单硬脂酸甘油酯及吐温-80用量为考察因素,采用正交试验优选最佳基质配方和工艺条件;采用HPLC法测定盐酸普萘洛尔的含量,并对其进行质量控制。结果筛选出了最佳基质配方和工艺条件为硬脂酸10%,单硬脂酸甘油酯7.5%,吐温-80.3%,乳化温度70℃,制备的盐酸普萘洛尔乳膏外观及稳定性均良好,质量可靠,平均回收率为98.65%,RSD为0.52%(n=9)。结论盐酸普萘洛尔乳膏制备工艺可行,质量稳定,质控方法简便快速。
- 盐酸普萘洛尔 /
- 乳膏 /
- 正交试验 /
- 制备 /
- HPLC /
- 质量控制
Abstract: Objective To optimize matrix formula and process conditions and control the quality of propranolol hydrochloride cream. Methods Emulsifying temperature, dosages of the stearic acid, glyceryl monostearate and Tween-80 were taken as variable factors and the orthogonal experiment was adopted to optimize matrix formula and process conditions. HPLC was chosen to determine the content of propranolol hydrochloride and control its quality. Results The optimized matrix formula of propranolol hydrochloride cream was composed of 10%of stearic acid, 7.5%of glyceryl monostearate, 3% of Tween-80 and emulsifying temperature was 70℃. The appearance and stability were good and the quality was good. The average recovery rate was 98.65%, RSD was 0.52% (n=9). Conclusion The preparation process of propranolol hydrochloride cream was rational and stable in quality. The quality control method was simple and fast.
- propranolol hydrochloride /
- cream /
- orthogonal experiment /
- preparation /
- HPLC /
- quality control

[1]	Léauté-Labrèze C, Dumas dela Roque E, Hubiche T, et al. Propranolol for severe hemangiomas of infancy[J]. N Engl J Med, 2008, 358(24):2649.
[2]	金英姬,金哲虎,崔笑怡,等.普萘洛尔口服治疗婴幼儿血管瘤的临床观察[J].中国皮肤性病学杂志,2011,9(25):688.
[3]	李喜.普萘洛尔口服治疗婴幼儿血管瘤的效果观察[J].山东医药,2011,51(34):103.
[4]	张健.普萘洛尔在婴幼儿增生期血管瘤治疗中的临床应用[D].山东大学, 2010:9.
[5]	毕殿洲.药剂学[M].4版.北京:人民卫生出版社,2000:369.

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盐酸普萘洛尔乳膏的研制及质量标准研究

doi: 10.3969/j.issn.1006-0111.2013.06.003

1. 山东中医药大学, 山东济南 250355;山东大学附属省立医院药剂科, 山东济南 250021

2. 山东大学附属省立医院药剂科, 山东济南 250021

3. 山东大学附属省立医院烧伤整形科, 山东济南 250021

4. 山东大学附属省立医院烧伤整形科, 山东济南 250021;山东大学医学院, 山东济南 250100

基金项目: 山东省科技发展项目(2012YD18056).

收稿日期: 2013-03-29
修回日期: 2013-09-23

关键词:

盐酸普萘洛尔 /

乳膏 /

正交试验 /

制备 /

HPLC /

质量控制

摘要: 目的优选盐酸普萘洛尔乳膏的最佳基质配方和工艺条件,并对其进行质量控制。方法以乳化温度、硬脂酸、单硬脂酸甘油酯及吐温-80用量为考察因素,采用正交试验优选最佳基质配方和工艺条件;采用HPLC法测定盐酸普萘洛尔的含量,并对其进行质量控制。结果筛选出了最佳基质配方和工艺条件为硬脂酸10%,单硬脂酸甘油酯7.5%,吐温-80.3%,乳化温度70℃,制备的盐酸普萘洛尔乳膏外观及稳定性均良好,质量可靠,平均回收率为98.65%,RSD为0.52%(n=9)。结论盐酸普萘洛尔乳膏制备工艺可行,质量稳定,质控方法简便快速。

English Abstract

Preparation and quality control of propranolol hydrochloride cream

1. Shandong Traditional Chinese Medical University, Jinan 250355, China;Department of Pharmacy, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China

2. Department of Pharmacy, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China

3. Department of Burn-Plastic Surgery, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China

4. Department of Burn-Plastic Surgery, Provincial Hospital Affiliated to Shandong University, Jinan 250021, China;School of Medicine, Shandong University, Jinan 250100, China

Received Date: 2013-03-29
Rev Recd Date: 2013-09-23

Keywords:

Abstract: Objective To optimize matrix formula and process conditions and control the quality of propranolol hydrochloride cream. Methods Emulsifying temperature, dosages of the stearic acid, glyceryl monostearate and Tween-80 were taken as variable factors and the orthogonal experiment was adopted to optimize matrix formula and process conditions. HPLC was chosen to determine the content of propranolol hydrochloride and control its quality. Results The optimized matrix formula of propranolol hydrochloride cream was composed of 10%of stearic acid, 7.5%of glyceryl monostearate, 3% of Tween-80 and emulsifying temperature was 70℃. The appearance and stability were good and the quality was good. The average recovery rate was 98.65%, RSD was 0.52% (n=9). Conclusion The preparation process of propranolol hydrochloride cream was rational and stable in quality. The quality control method was simple and fast.

苗杰, 王爱武, 杨柳, 霍然, 徐广琪. 盐酸普萘洛尔乳膏的研制及质量标准研究[J]. 药学实践与服务, 2013, 31(6): 409-411,435. doi: 10.3969/j.issn.1006-0111.2013.06.003

引用本文:

苗杰, 王爱武, 杨柳, 霍然, 徐广琪. 盐酸普萘洛尔乳膏的研制及质量标准研究[J]. 药学实践与服务, 2013, 31(6): 409-411,435. doi: 10.3969/j.issn.1006-0111.2013.06.003

Citation: