Compound Kushen Antibacterial Gel Pharmaceutical Research And Determination Of Residual Solvent Of Raw Medicine In Ibuprofen Injection

Compound sophora antibacterial gel is composed of Sophora flavescens extracts, Isomaltooligosaccharide and chitosan. This paper describes the bacterial vaginosis(BV) of the definition, characteristics and pathogenesis,and analyzes sophora antibacterial gel of the rationality and necessity of compound and its application in clinical. In the experiment, using the pharmaceutical technology screening prescription and preparation technology and establishing the quality standard and stability study and investigation on it.Study on Compound sophora antibacterial gel is divided into three parts:The first part is mainly to study the design and process of the prescription.The prescription design mainly including the selection of materials and the single factor investigation.Compound sophora antibacterial gel using 0.26% of Sophora extract, 1% and 1% Isomaltooligosaccharide chitosan ratio, resulting pale yellow, fragrance, semi-solid gel, p H value between 4.0~6.0. In the prescription screening at the same time, the dissolving problem of HPMC and chitosan and prescription of each component in the join sequence was investigated, and examines the different process conditions on the quality of the preparation, the preparation technology was feasible.The second part is mainly to study the quality standard of compound sophora antibacterial gel. This section examines the character, identification,inspection, content determination and other projects of compound sophora antibacterial gel,and develop their corresponding quality standards.The third part is compound sophora antibacterial gel stability study.After stress testing, accelerated testing and long-term test for this product for the stability study, the results show that the product of sunlight, high humidity,high temperatures are relatively stable; accelerated testing this product for six months, there were no significant changes in indicators; long term experiment showed that the product is stable at room temperature.Ibuprofen injection is composed of Ibuprofen, arginine, injection water,activated carbon, sodium hydroxide and other components, this paper describes Ibuprofen injection as the dosage form of rationality, clinical effect and clinical application in the clinical prospects, as well as residual solvent summary of existing research methods, and the determination of ibuprofen injection of two raw materials(ibuprofen and arginine) in the organic residual solvent content.In this paper, the determination of residual solvents in two raw material drug of ibuprofen injection is divided into two parts.The first part of the analysis using GC-MS technique, for the first time on a qualitative analysis of petroleum ether, and the establishment of a mixture of types of ibuprofen in solvent petroleum ether(90~120 ℃) of automatic sampling-gas chromatography method. The type of chromatography column,column temperature, carrier gas flow rate, split ratio and inlet temperature and so on were screened, with petroleum ether organic solvent hexane,heptane, hexane, 2-methyl, 3-methyl-hexyl dioxane, 2,4-dimethyl hexane,2-methyl heptane, 3-methyl-heptane, n-octane chromatographic peak of the eight kinds of ingredients such as response as the object, has carried on the research methodology,the eight kinds of components within the scope of their concentration showed a good linear relationship(r = 0.9977 ~ 0.9996, n= 5), the minimum detection limit of the range of 1.50 ~ 3.10ng·ml-1; the average recoveries of the three spiked concentration of 95.85 % ~ 105.3%.The precision, reproducibility of RSD was less than 5%.The second part has been established the automatic sampling-gas chromatography method for determination of ibuprofen residual organic solvents ethanol for the first time. The type of chromatography column,column temperature, carrier gas flow rate, split ratio and inlet temperature and so on were screened with peaks in response to ethanol as the object, has carried on the research methodology,in 0.049 ~ 0.882 mg · ml- 1concentration range, there was a good linear relationship between peak area and concentration of ethanol,linear regression correlation coefficient of0.9999, the average recovery was 99.84%, RSD was 2.24%(n = 9), the average recoveries of the three spiked concentration of 99.84%.The precision,reproducibility of RSD was less than 5%.