Preparation technology and quality control of Chuanxinlian Soft Capsule / 中草药

ABSTRACT

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 (10040100). 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.