Study On Process And Standards Of SheHuang Gel

Purpose: The development of Chinese compound gel for the treatment of gynecologicalvaginal inflammation, To optimize the production process of the SheHuang gel and toestablish the quality standards of preparation. and study the stability test and the packagingmaterial compatibility.Method: Using orthogonal design method, in order to optimize the best technologicalconditions on herbs of SheHuang gel by extraction process which weight of extract and theextract contains osthole and berberine hydrochloride as indicator; Select a suitable matrix andexcipient, To optimize the forming process of gel. Conduct quality inspection to finishedproduct of SheHuang gel, including PH Value, weight difference between the inspection, theinspection of the microbial limits, the inspection of heavy metals and arsenic salt limits and soon; Thin-layer chromatography was used for qualitative identification of herbs inpreparations; A high performance liquid chromatographic method of osthole in preparationsfor the content determination, formulate the quality standard of the gel. and conduct the studyof stability test.Result: The best extraction process for SheHuang gel is add10times the amount60%ethanol refluxing extraction three times, each1.5hours; The ideal amount of preparation onexcipient is carboxyl methyl cellulose3%,10%glycerol, polysorbate80to35percent. TheTLC identification of three Chinese Herbs which included in the standard spots clear, strongspecificity; This product per gram Cnidium to osthole prime meter, shall not be less than5.0mg. The stability results showed that this preparation stored for12months is basicallystable, packaging materials on the adsorption capacity of osthole in80ppm or less, have littleeffect on the content of the finished product, far below the amount of the Osthol naturalattenuation.Conclusion: The optimized production process of preparation is reasonably practicable,the quality of finished product is stable and controllable. and the choice of packagingmaterials is appropriate.