The Preparation Process And Quality Control Of Jinze Capsule

Jinze Capsule, a medicine made from several traditional Chinese drugs, can beused in treating alcoholic liver disease, fatty liver and hepatic fibrosis. It is effective indispersing the stagnated liver-energy, regulating the middle warmer, activating bloodcirculation to dissipate blood stasis, dampness-dispersing, blood-activating and stasis-dissolving. In the thesis, a systematic study was carried out to investigate thepreparation technology, quality standards of Jinze Capsule. The results will provide apharmaceutical and preparing technological basis for producing a new medicine.The drugs, such as radix glycyrrhizae, radix puerariae, rhizoma alismatis,pericarpium citri reticulatae, were extracted with water because they were founded tohave good solubility in water. The optimum process was determined by a L9(34)orthogonal test with extraction rate of glycyrrhizic acid and paste-forming rate asdetermination markers. The results indicated the optimal water-extraction process wasas follows: the water amount was 8 times of the traditional Chinese drugs, it wasdecocted 3 times and each time was sustained for 2 hours.The purification process was investigated to remove the foreign matter. Anethanol deposition method was applied in the experiment to select the suitablepurification conditions. The factors we considered included yield's density, ethanolconcentration and deposit time. The suitable processes was determined by a L9(34)orthogonal test with transfer rate of glycyrrhizic acid and paste-forming rate asdetermination markers. The results indicated the suitable ethanol-deposition processwas as follows: the relative density of the solution was concentrated to 1.15, theethanol concentration was adjusted to 70% by adding ethanol, the solution wasdeposited for 12 hours.In the experiment of quality standards, we determined the active compositioncontents by HPLC in radix glycyrrhizae and radix puerariae. The limited contents ofglycyrrhizic acid and puerarin in Jinze Capsule were fixed by analyzing the differentsamples. In addition, we identified the six drugs by TLC, which are radix puerariae,radix bupleuri, radix glycyrrhizae, rhizoma alismatis, pericarpium citri reticulataeand radix salviae miltiorrhizae. Moreover, we checked the moisture, weight variationand time limit for disintegration of Jinze Capsule.