Pharmaceutical Research Of Tianshu Soft Capsule

Tianshu soft capsule come from the ancient prescription of Dachuanxiongwang, and it included Rhizoma Chuanxiong and Rhizoma Gastrodiae. It it has the effect of promoting blood circulation to remove blood stasis and alleviating pain by calming endogenous wind. Tianshu soft capsule has been proved to be an effective formula in treating Migraine clinically.Based on the original recipe, the research designed and prepared Tianshu soft capsule to improve the formulation process based on the original formula, so as to increase its bioavailability and be taked more conveniently.The pharmaceutical research consist of pharmaceutical technology research, quality control standard research, stability research and profile-effect on quality control of Tianshu soft capsule.The research on extraction process: The ultimate extracting processes were determined as follows: The medicinal materials was extracted with 6-fold 60% alcohol for 2h by refluxing, and repeated for 2 times. The ultimate refining processes were determined as follows: Butyl alcohol countercurrent extraction was used to refine the extracting solutionThe research on formation technology: According to the characterstic of the soft capsules,the research choose the supplementary material of the contents.The research on pilot project: In order to prove the rationality of the technological conditions. The results show the all the three groups of products accord with the demands the ratio of product retrieval is 95%.The research on quality standard:The modern analysis methods were carried out to study on the charaeters, TLC, gross deviation, disintegration and determination of the Tianshu soft capsule systematically, set the perfect quality standard. It gives the reliable basis to the internal quality control of the preparation.The research on stability: Adopted the accelerated test and ambient-temperature test to study the preliminary stability about three batches samples in pilot test of the Tianshu soft capsule in six months. According to the detection of each index in quality standard, the results are accord with relevant regulations. It shows that this herb species has a good stability.The research on pharmacodynamics: Pharmacological experiments were done to compare the drug efficacy between Tianshu soft capsule and Dachuanxiongwan. The fingerprint pharmacodynamics of TCM: To find corresponding relationship between the fingerprint of Tianshu soft capule from different factories and their effect. It has made commendable attempt in the research of the modernization of traditional Chinese medicine.