| Flibanserin is a drug for the treatment of female sexual dysfunction,which can effectively treat Hypoactive Sexual Desire Disorder(HSDD).MI(the company’s trial secret,referred to by its code name)is a blood-pressure-raising drug that can be effective in small doses.Compatibility of flubancerin and MI can not only effectively exert the efficacy of flubancerin,but also reduce the adverse reactions caused by the single use of flubancerin and improve the safety of medication.In this project,the compound flubancerin film coating tablet was successfully prepared,the qualified quality standard was established,and its stability was verified.1.Compatibility study of compound flibaserin tablets:the test method of stability test was adopted,and the samples were taken out at 0 and 10 days for determination.The results showed that the changes of main drug and impurity were in reasonable range.Excipients can be used in prescriptions.2.Prescription technology research on preparation of compound flibaserin tablet core:the best prescription and prescription technology were screened out through single factor investigation and orthogonal test:flibanserin 10.00 g,MI 0.25 g,after passing through 80 mesh sieve,fully mixed and recorded as material 1.Mix 17.10 g of lactose monohydrate with 3.33 g of microcrystalline cellulose M-101 and 0.85 g of hydroxypropyl methylcellulose E15 and record it as material 2.Mix material 1 and material 2 thoroughly and grind for 5 min.Add 85%ethanol to the soft material,grind it through a 40-mesh sieve,and then dry it at 60℃ for 10 min,and then pass it through a 20-mesh sieve for granulation.Adding 0.17 g of magnesium stearate and 2,55 g of microcrystalline cellulose M-101,mixing for 5 minutes,and compressing the tablets can successfully prepare compound flibanserin tablet cores through the process here.3.Coating technology research of compound flibaserin tablets:through single factor investigation and orthogonal test on common coating indexes,the optimal coating technology was determined:The coating solution concentration is 14%,the inlet temperature is 60℃,the spray quantity of the spray gun is 160mL/min,the rotating speed is 5r/min,the sheet bed temperature is 40℃,the atomizing pressure is 0.4MPa,and the coating weight gain is 2%.Compound flibanserin films can be successfully prepared by this technology.4.Study on the quality standard of compound flibaserin tablets:The appearance shape,weight difference and fragility indexes of the tablets were all qualified according to the 2015 edition of the pharmacopoeia.The main drug content of the three batches of compound flubancerin tablets was more than 98%,the maximum single impurity was not more than 0.2%,and the total impurity was not more than 0.5%.In the medium of hydrochloric acid and acetic acid,the cumulative percentage dissolution of the two main drugs reached more than 90%in 60min.The method established in this chapter can be used for the detection of the product,reasonable and scientific,and the quality of the tablet is qualified.5.Stability test:Under three batches of Compound Flibaserin Tablets influencing factors test,accelerated test and long-term test lofting conditions,the content changes of main drug and impurities were determined.The results showed that the impurities of compound flibaserin tablets did not change significantly under the conditions of high temperature,high humidity and light compared with 0 days,and remained relatively stable.Under the condition of accelerated test and long-term test,the changes of impurity and content of the three batches of compound flibanserin in 3 months were all within the required range,which proved that the stability of compound flibanserin tablets was qualified. |
