Study On The Preparation Technology And Quality Standards For Bawei Jianyi Capsule

Objective:The Subject would establish a method to research the preparation process and quality control of Bawei jianyi capsule. The study can make the capsule standardization and mass production of standardized.Methods:1. To study the extraction process of this capsule, taking bibulous rate as an indicator, to preferably optimal soaking time.2. Because the prescription is mainly contain flavonoids, polysaccharides, phenolic acids and other ingredients, so choose water extraction using orthogonal experiment design method, the amount of water, extraction times, reflux time, to preferably the best water extraction process.3. To verify the best water extraction process, taking dry extract yield to evaluate whether the process is reasonable, stable and practical.4. To study the experimental drying process of water extract, selecting mode of atmospheric or vacuum drying at 70℃ temperature, taking corresponding indicators to evaluate, to preferably optimal drying process.5.To study the granulation process of preparation, investigate particles’ liquidity thr ough determination of particles’ angle of repose, determine the added accessories and a dding excipient through examining fluidity and hygroscopicity of the particle, thus getti ng the priority of the best granulating process.6. Using the reference and reference drug as a reference, Astragalus membranaceus,Dioscorea opposita, Salvia miltiorrhiza, Pueraria lobata, Coix lacrymajobi were identified by thin layer chromatography.7. We used HPLC to determine the content of salvianic acid A sodium, we were carrying out the appropriate method validation.8.Preliminary stability test for eight jianyi capsule to find the effect of high temper ature, high humidity and strong light irradiation on eight jianyi capsule.Results:1.The best extraction process was as follows:adding 2 times volume of water and soaking 0.5 h.2. The optimal water extraction technology was as follows: adding 10 times volume of water and boiling with 1.5h for the first time, then adding 8 times volume of water and boiling 2 times with 1.0h for each time.3. The best water extraction process was verified and the process is reasonable,stable and practical.4. Through experimental research, selecting the drying process was that the extract was dried under vacuum at 70℃.5. The optimum granulating process of preparation is as follows: after crushing,sieving and mixing the ratio of 1:3 of baweijiangyi capsule of dry extract powder and dextrin, then adding proper amount of 80% ethanol and stirring to granulation, then drying, whole grain, sieving, and loading in capsules.6. The methods of qualitative identification were established. Astragalus membranaceus, Dioscorea opposita, Salvia miltiorrhiza, Pueraria lobata, Coix lacrymajobi were identificated.The separation of the stains is apparent, and the negative contrast showed no disturbed. Identification method was highly selectivity.7. The assay methods of the content of salvianic acid A sodium was established.The methods were reproducible, sufficiently simple, sensitive and reproducible.8. Capsule was stable high temperature and light conditions, but it was easy to moisture absorption weight gain in high humidity conditions because of the drug moisture absorption is strong.Conclusion:The preparation of Bawei jianyi capsule was reasonable and feasible. The specificity and reproducibility of quality control methods were better.