Study On The Preparation And Quality Standard Of Antioxidant Liuweidihuang Biological Tablets

Object: In this study, the preferred photosynthetic bacteria was chosen tometabolism the Liuweidihuang decoction. Then we prepare a new-type and efficientLiuweidihuang metabolized by photosynthetic bacteria(LW-PSB). On the basis ofprevious studies, in order to improve the stability of the preparation and medicationcompliance of patients, we use Liuweidihuang metabolized by photosynthetic bacteriadeveloped into coated tablet.Methods:1、Study on preformulation and prepare the LW-PSB freeze-driedpowder To inspect the powder properties of the LW-PSB freeze-dried powder toprovide experimental basis for further study.2、Study on preparation formula andproduction process For the mobility of the powder properties of the LW-PSBfreeze-dried powder,For LW-PSB lyophilized powder learning mobility, taking avariety of fillers, disintegrating agents, adhesives, lubricants as initial screening.According to the result of single factor experiments, the composition and the optimumprocess condition of the core tablets were chosen.3、Study on coating preparation Theinlet air temperature, tablet bed temperature,spray solution rate, atomization pressure,gun-bed distance, coating pan speed, inventory, curing temperature were chosen bysingle factor experiments. Taking disintegration and coating pass rate as theevaluation index, the hardness of the tablet core, the coating concentration, the watercontent of the granule were investigated by orthogonal design test.4、Study on thequality standards Detecting Paeonol and β-carotene content in Liuweidihuangbiological coated tablets by HPLC and ultraviolet spectrophotometry. And theinspection items such as the appearance, properties, qualitative, differences in weightwere included in the tablet quality standards.5、Investigation on the initial stabilityUsing the means of accelerated testing and long-term stability testing to examine thestability of preparation.6、Study on the draft quality standard for the coated tablets. Results:1、Study on preformulation LW-PSB freeze-dried powder was sensitiveto moisture. In the process of preparation, should control the ambient humidity, atthe same time should be added to adjuvant which can improve the problem ofabsorbent.2、Study on preparation formula and production process The composition ofcore tablets was as follows: LW-PSB freeze-dried powder157.5mg per film, MCC252.9mg per film,CMS-Na36mg per film, Magnesium state3.6mg per film,75%alcohol solution just the right amount.3、Study on coating preparation The coatingpreparation were the inlet air temperature50-55℃, tablet bed temperature40-45℃,atomization pressure3-4bar, gun-bed distance10-15cm, coating pan speed50-60rpm,inventory300g, curing temperature45℃, curing time6h.The result of orthogonal testshow the optimal preparation of coating were the hardness of the tablet core75N,the coating concentration2%, the water content of the granule4-6%.4、Study on thequality standards Establish the method to detect Paeonol and β-carotene content inLiuweidihuang biological coated tablets by HPLC and ultraviolet spectrophotometry.5、Investigation on the initial stability Liuweidihuang biological coated tablets werestability in high humidity, high temperature and strong light environment. The resultsof accelerate test and long-term stability test showed that the indicators were all metthe requirements.6、Establish the draft quality standard for the coated tablets.Conclusion: The best prescription and preparation technology of Liuweidihuangbiological coated tablets were reasonable, simple, effective, repeatable, can meet withdemand of preparation. The Liuweidihuang biological coated tablets was initiallyestablished and the methods had good sensitivity, accuracy and reproducibility. Theresults of stability study shows that the quality of Liuweidihuang biological coatedtablets is stabled.