菌毒清胶囊制备工艺及质量研究  

Preparation Technology and Quality Control of Junduqing Capsules

作　　者：李卓亚[1] 李运景[1] 唐蕾[1] 赵伟国[1] 梁镇标 LI Zhuoya;LI Yunjing;TANG Lei;ZHAO Weiguo;LIANG Zhenbiao(Zhongshan Municipal People’s Hospital,Zhongshan,Guangdong,China 528400)

机构地区：[1]广东省中山市人民医院,广东中山528400

出　　处：《中国药业》2021年第14期42-44,共3页China Pharmaceuticals

基　　金：广东省中山市医学科研基金[2016J010];广东省中山市科技计划项目[2017B1087]。

摘　　要：目的探讨菌毒清胶囊的制备工艺及质量控制方法。方法以颗粒外观、吸湿率、休止角和胶囊的崩解时限为考察指标,通过单因素试验和正交试验筛选处方;采用高效液相色谱法测定样品中丹酚酸B的含量。结果菌毒清胶囊最优处方为,菌毒清浸膏22.75%、微晶纤维素68.25%、交联羧甲基纤维素钠5%、滑石粉4%、90%乙醇适量(润湿剂),选用1号胶囊壳进行装填。3批制剂中丹酚酸B的平均含量为0.201 mg/g。结论所选工艺操作简单、方法合理,含量测定方法可为菌毒清胶囊的质量控制提供参考。Objective To investigate the preparation technology and quality control of Junduqing Capsules.Methods The prescription was optimized by the single factor test and the orthogonal test with the appearance,moisture absorption rate,angle of repose of the granules and disintegration time of the capsules as indexes.The content of salvianolic acid B in the sample was determined by the high-performance liquid chromatography(HPLC)method.Results The optimal formulation of Junduqing Capsules was as follows:22.75%of Junduqing extraction,68.25%of microcrystalline cellulose,5%of croscarmellose sodium,4%of talcum powder,appropriate amount of 90%ethanol as the wetting agent,and 1~#capsule shell was selected and filled.The average content of salvianolic acid B in the three batches of preparations was 0.201 mg/g.Conclusion The technology is simple and the method is reasonable.The method for content determination can provide a reference for the quality control of Junduqing Capsules.

关 键 词：菌毒清 胶囊 制备工艺 质量控制 正交试验 高效液相色谱法 

分 类 号：R932[医药卫生—生药学] TQ460.6[医药卫生—药学]