| As the best choice for the treatment of Parkinson, Levodopa and benserazidehydrochloride has a broad market prospect. Nowadays, conventional tablets andcapsules of levodopa and benserazide hydrochloride are common on the market. Theaim of this paper is to achieve a new dosage form of levodopa and benserazidehydrochloride, and to explore the best prescription and preparation technique to lay afoundation for future industrial production.At first, we choose high performance liquid chromatography as the assay methodand study its methodological validation. The results suggest that this method is reliable,accurate, and able to meet the analysis needs. According to the compatibility of themain drug and excipients, we choose excipients used in the formulation. And then wecarry on research on prescription and preparation technique. As a result, we get thebest prescription which consists of20%of levodopa,5.7%of benserazidehydrochloride,23.3%of microcrystalline cellulose,25%of mannitol,6%of sodiumcarboxymethyl starch,5%of crosslinked polyvinylpyrrolidone,1%of silica powder,1%of magnesium stearate,2%of sodium cyclamate,6%of anhydrous citric acid,5%of sodium bicarbonate. And by direct powder compression method, we prepare theorally disintegrating tablet. Furthermore, we use three batches of tablets to study itsquality. We find its weight variation less than±7.5%, disintegration in the mouth lessthan30s and the dissolution rate of main drugs in45min greater than90%. At the sametime, it has good taste and no sense of gravel. The main drug content is90%to110%of the labeled amount. All the results show that the quality of these three batches of theformulation can meet Pharmacopoeia requirements.Our research can provide some experience for the development of orally disintegrating tablets. As a special dosage form, it difficult to guarantee the quality ofstability of orally disintegrating tablets. In the future, it necessary to enlargeexperiments to further optimize its prescription and preparation technique and conducta comprehensive study of its stability to ensure the production of high-quality drugs. Clonostachys rosea is an ideal bio-fungicide with high disinfection efficiency,strong specificity and long-term biological control activity. But there are manyproblems in production and application which have been restricting its furtherdevelopment. Our goal is to prepare Clonostachys rosea spores wettable powderswhich is a new fungal microbial pesticide. And then we study its quality to provide thebasis for the future production.At first, we carry on research on how to prepare the wettable powder, includingmethods to obtain Clonostachys rosea spores, research on compatibility of carrier andadjuvants with Clonostachys rosea spores, screening and optimization the formulationof the wettable powder. In the process of optimizing the formula, we use the responsesurface method. At last, we get the best formula which consists of23%of spores,61%of diatomite,1.5%of sodium dodecyl benzene sulfonate,14%of ligninsulfonate,0.5%of sodium carboxymethyl cellulose. Then we prepare wettable powders according tothe formula and investigate its quality, including the wettability, suspension rate,fineness and other indicators. And we also preliminary study its storage stability. Theresults show that all the indicators of the wettable powder can satisfy the nationalstandards.Our research belongs to laboratory study. It will lay a foundation for futureexperiments and industrial production. We find that it can improve the yield of sporesby soaking fermentation products. And it is necessary to carry on more research on thecondition of soaking. In addition, the storage stability of the wettable powder needs toextend the storage time in further study. |
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