| Ivabradine Hydrochloride is a first inhibitor which has selectivity and specificity for adjusting heart rate, which has an selective effect on atrionector but has no effect on heart conduction, myocardial contractility or ventricular repolarization. This product is different from angina therapy drugs which were named β receptor blockers and widely used, they have no effect on sexual desire, and don’t result in respiratory tract constriction, spasm, bradycardia or other adverse effects, and open up a promising new way for angina treatment. The paper is on the basis of documentation research, according to modern research on the situation, referring to the same drug in the research status and other drug formulations of the same dosage forms, the development prescriptions and making their preparation technical study, using HPLC treat and so on analysis technique, established the preparation of the quality standard inspection method, layed quality standards, and made a investigation of the stability of a preliminary study,that is the experimental basis for future research and large-scale production of new drugs mentioned.For preparation process, specifications of5mg (calculated by C27H36N2O5) is designed for formula. The appropriate film coating material is selected, which can ensure that appearance and hardness of tablet is qualified, as well as disintegration time qualified. The preparation of product is prepared by process. Granulating situation, the liquidity of particle, compressibility, disintegration situation are conducted to study. Starch, dextrin, microcrystalline cellulose, carboxymethyl methyl starch sodium, ethanol, PVPK30, magnesium stearate are primarily selected as auxiliary material of tablet. Coating material named Opadry (YS-1-7027) is used by studying the coating thickness influencing on appearance and disintegration of tablet.Coating operation is conducted under general process conditions, the thickness of coating is1%of weight gain. On the base of small scale experiment, middle scale production and the validation were carried on the workshop.For quality standard,relevant research of quality standards, traits, identification, related substances, isomers, dissolution, content uniformity, assay, microbial limit of three batches test products were carried out.According to the results of the findings combined with the stability to formulate the quality standards.of clindamycin phosphate for injection.Preliminary stability test:the product by the10days light of this (45001x), under high temperature (60℃), under high humidity test, in which the color samples under10days high temperature gradually deepened.Related substance of sample is increased slightly, other indicators were little changed. Each indicator is little changed under the condition of Light (46001x), high humidity (25℃RH92.5%),which indicates that Ivabradine Hydrochloride is stable under light and high humidity, but is slightly worse stability under high temperature.Package of Ivabradine Hydrochloride is simulated commercial package. Related substance of sample is increased slightly under accelerated condition located for6months (temperature40℃±2℃, relative humidity75%±5%), other indicators were little changed other indicators were little changed and other indicators were little changed complies with quality standard. Result shows that the product is well stable under temperature40℃±2℃, relative humidity75%±5%.The test certificated:the Preparation process is feasible, the quality standard is controled, the product quality standard is qualified... |
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