刺五加软胶囊的制备及稳定性考察

目的:制备刺五加软胶囊并对其稳定性进行加速及长期考察。方法:乙醇提取刺五加制备浸膏,通过合适辅料,并对不同助悬剂用量进行考察,制备成刺五加混悬液,再通过制备合适的软胶囊将混悬液进行包裹,利用高效液相法测定软胶囊含量,考察加速和长期稳定性。结果:通过将合适材料的软胶囊包裹刺五加混悬液,得到了浅红色具光泽的稳定性良好的软胶囊,经过长期和加速试验,制备的刺五加软胶囊含量稳定,重新分散性、崩解度、装量差异等均达到2005年版《中国药典》标准。结论:所得到的软胶囊具有长期稳定性,可为工业化生产提供理论依据。

Preparation and Stability of Acanthopanax Senticosi Soft Capsule

OBJECTIVE: To prepare Acanthopanax senticosi soft capsule and investigate their accelerated and long-term stability. METHODS:Acanthopanax senticosi was extracted by alcohol to be prepared into extract, then into suspension by adding suitable adjuvant and optimizing the dosage of the suspending agent, and the suspension was encapsulated to prepare soft capsule with the content determined by HPLC. The accelerated and long-term experiments of the capsule were carried out. RESULTS: Reddish vernicose soft capsule with good stability were obtained by encapsulating Acanthopanax senticosi suspension with suitable substance. The Acanthopanax senticosi soft capsule showed high stability in long-term and accelerated experiments, with redispersibility, disintegration and content uniformity all coincided with the China Pharmacopeia (2005 Edition). CONCLUSION:Acanthopanax senticosi soft capsule are of permanent stability, and this result serves as a theoretic basis for the industrial production of Acanthopanax senticosi soft capsule.