Study On The Preparation And Quality Standard Of Liuweidihuang Photosynthetic Bacteria Coated Tablets

Objective： To introduce preferred strains into classic prescriptionLiuweidihuang decoction and metabolism by photosynthetic bacteria. Through the useof nutritional value of photosynthetic bacteria and biotransformation,we prepare anew-type and efficient traditional Chinese medicine biological agents.Its functions ofanti-aging, enhance immunity, and regulating endocrine are better than LiuweiDihuang decoction and also have the significant effect of cold-tolerance,oxygendeficit-tolerance and anti-fatigue. In order to improve the stability of the praeparatumand medication compliance of patients, we use Liuweidihuang metabolized byphotosynthetic bacteria developed into coated tablet.Methods：①Study on preformulation To inspect the powder properties ofthe the LW-PSB freeze-dried powder to provide experimental basis for further study.②Study on preparation formula and production process Taking soft materialviscosity, particle appearance, angle of repose, tablet appearance, compressibility,hardness and disintegration as evaluation index, the composition and the optimumprocess condition of the core tablets were chosen by single factor experiments.③Study on coating preparation The inlet air temperature, atomizing speed, atomizingpressure, gun-bed distance, coating pan speed, inventory,curing temperature, coatingweight gain rate and coating solution concentration were chosen by single factorexperiments.Taking coating pass rate as an evaluation index, the optimum processconditions of film coating was investigated by orthogonal design test.④Study on thequality standards Detectmining Paeonol and CP-7-1in Liuweidihuang photosynthetic bacteria coated tablets by HPLC and potentiometric titration. And theinspection items such as the appearance, properties, qualitative, differences in weightwere included in the tablet quality standards.⑤Investigation on the initial stabilityUsing the means of accelerated testing and long-term stability testing to examine thestability of preparation.Results：①Study on preformulation LW-PSB freeze-dried powderwas poor fluidity and sensitive to moisture. In the process of preparation, shouldcontrol the ambient humidity, at the same time should be added to adjuvant whichcan improve the problem of absorbent.②Study on preparation formula andproduction process The composition of core tablets was as follows: LW-PSBfreeze-dried powder75mg per film, MCC:Silicon dioxide（48.3:1）123.25mg perfilm, CMS-Na50mg per film,5%PVP alcohol solution just the right amount,Magnesium sterate1.75mg per film. The experimental results show that the particlemobility and hygroscopicity was improved after granulating.The critical relativehumidity was73.9%.③Study on coating preparation The coating preparation wereinlet air temperature45~50℃, atomizing speed2~3mL/min, atomizing pressure2~3bar, gun-bed distance10cm, coating pan speed30~40rpm, inventory600g andcuring temperature40℃. The result of orthogonal test show the optimal preparationof coating were coating weight gain rate3%, coating solution concentration18%andtablet hardness70N.④Study on the quality standards Establish the method todetectmine the Paeonol and CP-7-1in Liuweidihuang photosynthetic bacteria coatedtablets with HPLC and potentiometric titration. And study out the draftquality standard for the coated tablets.⑤Investigation on the initial stabilityLiuweidihuang photosynthetic bacteria coated tablets were stability in hightemperature, high humidity and strong light environment.The accelerate test andlong-term stability test showed that the indicators were all met the requirements andthe active ingredient did not change significantly.Conclusion:The optimal prescription and preparation of Liuweidihuangphotosynthetic bacteria coated tablets have been filtered out. And it shows rational,stable and simple. The draft quality standard of Liuweidihuang photosynthetic bacteria coated tablets is created. It’s proved sensitive, accurate, reproducible andspecific. The preliminary stability tests show the quality of Liuweidihuangphotosynthetic bacteria coated tablets is stable. And the period of validity of theLiuweidihuang photosynthetic bacteria coated tablets is1year.