复方鲨鱼软骨素胶囊的制备与质量控制标准

Preparation technique and quality standards of complex shark cartilage capsules

目的：研究复方鲨鱼软骨素胶囊的制备与质量控制标准。方法：采用多次分离法提取鲨鱼软骨素与中草药有效部位制成复方鲨鱼软骨素胶囊，并依据药典及其他有关标准制定制剂的质量控制标准。结果与结论：制备的胶囊剂符合医院制剂相关的质量控制标准，制备工艺可行，产品质量稳定。

OBJECTIVE: To determine the preparation technique and quality standards of complex shark cartilage capsules. METHODS: The compositions of the complex shark cartilage capsules were extracted repeatedly with different solvent from shark cartilage and chinese herbal medicines respectively. The quality standards of the capsule were established according to the Pharmacopoeia of the Peoples Republic of China( 1995 ad. ) and other related criterions. RESULTS and CONCLUSIONS: The complex shark cartilage capsule is up to the standards of hospital preparations. The preparation technique is practicable and quality of the capsule is stable.