Governance The Zhengjia Capsule Preparation Process And Quality Standards

Objective: Preinvasive liver cancer (liver cancer) is one of the familiar cancer in our nation. Its mortality lies in the third place in the malignant tumour, just after stomach cancer and esophagus cancer. Owing to active materials widely distributing among herbal medicines and plant medicines, TCM plays an important role in restraining or killing tumour cell, regulating body immunity function, ameliorating syndrome and symptome, alleviating toxin and side-effect of radiodiagnosis and chemotherapy, as well as taking good care of tumorous patients. Chinese empirical prescription Zhijiafang, which can not only clear away heat and moisture, but also dispel bruise and ease pain, is made of Salvia miltiorrhiza Bge, Buthus martensii kansch> Scolopendra subspinipes multilans L.Koch, Paeonia lactiflora Pall and Panaxnoto-ginseny.Methods: (1) Study on process technology: From the view of the content of danshentong IIA, danfensuan B and shaoyaogan, the optimum extraction conditions were determined by the orthogonal trials. Imitating assimilation process of the body by bionic extraction, the optimum processing of Quanxie and Wugong, such as the temperature, time, and the ratio of enzyme to substrate were determined by the orthogonal trials. Kjeldahl nitrogen method was developed for the hydrolysis ratio. And the extractions of enzymatic hydrolyzed were proved to be effective by the anti-tumour experiments. Capsules were made after the processing of combinating above dry powders, crushing, sifting out, adding the extractions of total Saponins of Panaxnoto-ginseny and some lactose, mixing, cranking out granule, evaporating and packing. (2) The study on quality specification: By using HPLC we have made quantitative analysis on danshentong IIA and danfensuan B; By using TLC we have made qualitative analysis on Salvia miltiorrhiza Bge, Paeonia lactiflora Pall and total Saponins of Panaxnoto-ginseny.Conclusion: The effective materials of Chinese empirical prescription Zhijiafang were extracted and made into capsule. The study on quality specification of the preparation were made to make sure the quality that the clinical medicine required. It supplies as valuable medicine which the curative effect was confirmed and the quality was controllable for the medicinal market and has some learning meaning.