摘要
目的建立穿心莲软胶囊的生产工艺以及质量控制方法。方法按《中国药典》2010年版中穿心莲片项规定制备穿心莲提取物;单因素考察软胶囊内容物处方及囊壳材料。采用HPLC法测定穿心莲软胶囊中脱水穿心莲内酯的量及其溶出特征。结果穿心莲软胶囊内容物处方(1 000粒)为穿心莲1 000 g,司盘80 5.5 g、蜂蜡27.5 g、大豆油422 g,软胶囊囊壳处方为明胶-甘油-水(100∶40∶100);所制备的穿心莲软胶囊符合《中国药典》规定。不同批次穿心莲软胶囊中脱水穿心莲内酯的量及溶出特性无明显差异。结论优化后的穿心莲软胶囊处方合理、工艺可行;所建立定量方法操作简便、稳定可靠,可用于穿心莲软胶囊的质量控制。
Objective To establish the preparation technology and a method for the quality control of Chuanxinlian Soft Capsule. Methods According to the Andrographis Herba Tablets item in Chinese Pharmacopoeia 2010, the Chuanxinlian extracts were prepared; The contents of capsule and capsule shell were evaluated by single factor. The content of dehydroandrographolide and the dissolution of Chuanxinlian Soft Capsule were determined by HPLC. Results The best formulation of Chuanxinlian Soft Capsule content （1 000 capsules） was determined as follows： Chuanxinlian 1 000 g, span 80 5.5 g, beeswax 27.5 g, and soybean oil 422 g. The final formulation of capsule shell was fixed as gelatin-glycerin-water （100 ： 40 ： 100）. The prepared Chuanxinlian Soft Capsule was in accordance with the regulation in Chinese Pharmacopoeia. The content and dissolution of dehydroandrographolide had no significant difference among different batches of Chuanxinlian Soft Capsule. Conclusion This prescription of Chuanxinlian Soft Capsule is reasonable and effective; The method is simple and accurate and can be used for the quality control of Chuanxinlian Soft Capsule.
出处
《中草药》
CAS
CSCD
北大核心
2014年第12期1722-1725,共4页
Chinese Traditional and Herbal Drugs
