印酬;向红霞;王洪凤;孟小夏;龙厚宁;张敏;高秀丽;
YIN Chou;XIANG Hongxia;WANG Hongfeng;MENG Xiaoxia;LONG Houning;ZHANG Min;GAO Xiuli;College of pharmacy,Guizhou Medical University;

• 1:贵州医科大学药学院

摘要(Abstract)：

目的:完善百草妇炎清栓制备工艺,提升百草妇炎清栓的产品稳定性。方法:以百草妇炎清栓的融变时限和体外耐热温度为考察指标,通过单因素及正交试验考察栓剂基质处方中明胶与甘油比例、溶胶用水量及浸膏含水量等因素对百草妇炎清栓的产品稳定性的影响。结果:3个因素对百草妇炎清栓稳定性影响程度从大到小依次为明胶甘油比例>浸膏含水量>浸泡明胶用水量,最佳处方条件为明胶甘油比例为1∶6,浸膏含水量控制在20%,明胶浸泡用水量与明胶比例为1∶1;依照该配比制备的样品外型光滑,融变时限达到药典标准,体外耐热温度可达44℃。结论:明胶甘油比例为1∶6,浸膏含水量控制在20%,明胶浸泡用水量与明胶比例为1∶1时百草妇炎清栓的稳定性好。
Objective: To improve the preparation process of Baicao Fuyanqing suppository,and to improve the stability of the products of Baicao Fuyanqing suppository. Methods: In Baicao Fu Yan Qing suppository,the melt time and heat-resistant temperature in vitro were taken as the most important indexes. The effect of ratio of gelatin and glycerin,water consumption of soaking gelatin and water content in extract in Baicao Fu Yan Qing suppository on stability of product were studied and analyzed through single factor and orthogonal test. Results: The influencing degree of the three factors for the stability of Baicao Fu Yan Qing suppository followed the below order: ratio of gelatin and glycerin,water content in extract and water quantity of sol. The best prescription was: the ratio of gelatin to glycerin was 1∶ 6,water content in extract was controlled to 20% and the ration of water consumption of soaking gelatin to gelatin was 1 ∶ 1. Following this formula and ratio,the appearance of prepared sample was smooth,and the time limit of melting reached the pharmacopoeia standard,and in vitro heat-resistant temperature reached 44 ℃. Conclusion: The quality and stability of Baicao Fuyanqing suppository is better when following formula and ratio: the ratio of gelatin to glycerin was 1 ∶ 6,water content in extract was controlled to 20% and the ration of water consumption of soaking gelatin to gelatin was 1∶ 1.

关键词(KeyWords)： 百草妇炎清栓;栓剂;工艺学,制药;药物稳定性
Baicao Fuyanqing suppository;suppository;technology;pharmaceutical;drug stability

Abstract:

Keywords:

基金项目(Foundation): 贵州省科技成果转化引导基金项目[黔科合成转字(2015)5213号]

作者(Author): 印酬;向红霞;王洪凤;孟小夏;龙厚宁;张敏;高秀丽;
YIN Chou;XIANG Hongxia;WANG Hongfeng;MENG Xiaoxia;LONG Houning;ZHANG Min;GAO Xiuli;College of pharmacy,Guizhou Medical University;

Email:

DOI: 10.19367/j.cnki.1000-2707.2016.07.010

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