Research On The Quality Of Solid Pharmaceutical Preparations

The stability of pharmaceutical preparations refers to the speed and degree of quality changes that occur during the development,production,transportation,storage,and pre-clinical application of pharmaceutical preparations.The stability of pharmaceutical preparations can keep them safe and effective.Therefore,it is very important to study the stability of the pharmaceutical preparation.Hospital has great advantages that study the new drugs.And it is considered to be the cradle of new drugs.However,most hospital preparation departments have a lack of R&D personnel and funds,and long development cycle and high risk.Therefore,they can only focus on the production of preparations,and lack investment in preparation R&D.Under the new situation of medical reform,preparation for the production should be combined the research the medical.And we should make full use of the equipment of the hospital preparation room and give full play to its role.So it can research the new drugs.And the hospital preparations departments should change that from production and supply to technical research.It is an unprecedented opportunity and a challenge.We choose 3 drug preparations in the hospital,hydrocortisone butyrate,nicotinamide gel,and miconazole nitrate as the research objects.And we established drug analysis methodologies by high-performance liquid chromatography to analyse the Specificity,the linearity,the repeatability,the stability,recovery rate.We also study the stability of pharmaceutical preparations.For the above three kinds of pharmaceutical preparations,they are tested by means of high performance liquid chromatography.And the specific experimental methods of each pharmaceutical preparation are as follows:the mobile phase of hydrocortisone butyrate is water and acetonitrile and glacial acetic acid,and the proportion is fifty-five to forty-five to zero point five.And flow rate is 1.0 mL/min,column temperature is 40℃,detection wavelength is 240 nm,injection volume is 20μL.The mobile phase of nicotinamide gel is methanol and water,and the proportion is thirty to seventy.And the flow rate is 1.0 mL/min,column temperature is 40℃,detection wavelength is 230 nm,injection volume is 20 μL.The mobile phase of Miconazole nitrate is methanol and water.And the proportion is ninety to ten.And the flow rate is 1.0 mL/min,column temperature is 40℃,detection wavelength is 230 nm,injection volume is 10 μL.At the same time,the three batch samples of each drug were placed under the conditions of temperature 25℃±2℃ and relative humidity 60%± 10%to conduct long-term stability experiments.Intervals are 3 months,6 months,9 months and 12 months.The three batches of samples are placed under the conditions of 30℃±2℃ and relative humidity of 65%± 5%,the accelerated stability experiments were conducted at intervals of 1 month,2 months,3 months,and 6 months.Through the research of the above detection methods,three pharmaceutical preparations satisfy the requirements of drug stability.In the paper,we also selected the ondansetron drug to study the crystal form of the drug.And we expanded the crystal form research of the chiral drugs ondansetron and ondansetron hydrochloride.Ondansetron hydrochloride is a highly selective 5-HT3 receptor antagonist.And the drug puts on the international market by Glaxo in the 1990s.Our laboratory regard ondansetron hydrochloride,R-ondansetron hydrochloride,S-ondansetron hydrochloride as the research objects,and put them in methanol,ethanol,isopropanol,ethyl acetate,acetone and acetonitrile and tetrahydrofuran and water to research.Since ondansetron is an intermediate for preparing optically pure ondansetron hydrochloride,so we also choose ondansetron,R-ondansetron,and S-ondansetron as research objects.And we use methanol,ethanol,isopropanol,ethyl acetate,acetone,dimethyl formamide,tetrahydrofuran and water as solvents to prepare crystal.Analyze and study its crystal form.Studies have shown that different crystals can be formed in different solvents.Ondansetron hydrochloride crystal and ondansetron crystal through powder ray diffraction to test their crystal.Study shown crystal formed by a single configuration has high degree of crystallization.At the same time,when using tetrahydrofuran and water as solvents,it shows good crystallinity that compared to other solvents.