Studies On Preparation Of Chuan Dan Shuang Ye Dropping Pills And Quality Standard

Angiocardiopathy and cerebrovascular disease is the first killer of heathy for mamkind. They mainly contain coronary heart disease, apoplexy, hypertension and so on. The diseases not only influence the life of patients and bring harmfulness to patients,their family and society but also damage some important organa containing heart, brain, kidney as well.With the development of society and people's living standards, the incidence of coronary heart disease in the elderly population have increased year by year and the onset of angina pectoris, myocardial infarction have serious threat to these patients lives.Recently,with the development of dosage form of Chinese drugs,dropping pills have attracted more and more attention.The preparation formulation can improve the bioavailability of some insoluble drugs and have the merits of convenient operating,less procedure,short periodicity and so on.lt is believed that droping pill of Chuan Dan Shuang Ye is the ideal dosage form prior to the tablet of it.Thus we have systematically developed the process of preparation of Chuan Dan Shuang Ye dropping pill which treat coronary heart disease, heartstroke and apoplexy.The process of extracting and refinery is that crude drugs of salvia miltiorrhiza are pulverised into coarse powder, and be decocted three times with 10 times as much 95% ethanol as the weight of raw drugs for three hours one time, then are filtrated. The filtrate is combined and concentrated into the sample solution. After alcohol extraction, decocting two times with 10 times as much water as the weight of the dregs for 90min every time, then are filtrated. The filtrate is combined and concentrated drying into extract.The preparation process of Rhizoma Chuanxiong is as followed:crude drugs of Rhizoma Chuanxiong are pulverised into coarse powder, and be decocted three times with 12 times as much 80% ethanol as the weight of raw drugs for one and a half hours every time, then are filtrated. The filtrate is combined and concentrated into the sample solution.Extract of Ginkgo biloba leaves (EGb) is gained according to the procedure below. The pulverised Ginkgo biloba leaves are firstly extracted under reflux with 8 times as much 50% ethanol as the weight of crude drugs for two hour,is secondly extracted under reflux with 6 times as much 50% ethanol as the weight of crude drugs for an hour.The extracting solution is combined and concentrated to 1:1.5,is added ethanol to the solution containing 75% ethanol.The supernate is decompressed and concentrated to 1:4,is added ethanol to the solution containing 80% ethanol again.After stewing for 48 hour,the pH of supernate is adjusted to 8.8～9.0 and it was centrifugally filtrated and decompressed and concentrated to the solution containing no ethanol.Then it was dissolved to 6 times and adjusted pH to 6.8-7.0 with hydrochloric acid. Place equivalent D-101 resin and polyamide resin in the column.The extration solution of Gingko leaves is passed through the column.Firstly elute the column with 10 times as much water as the volume of the resin column in order to remove the soluble impurity,secondly with 10 times as much 70% ethanol as the volume of the resin column.Collect the ethanol eluent and concentrate it. The finish product is gained.The preparation process of Chinese hawthorn leaves is as followed:crude drugs of Chinese hawthorn leaves are pulverised into coarse powder, and be decocted three times with 8 times as much 60% ethanol as the weight of raw drugs for two hours every time, then are filtrated.The filtrate is combined and concentrated into the sample solution.The finish product of Chinese hawthorn leaves sample is gained.Using orthogonal desin we have optimized the preparation process of Chuan Dan Shuang Ye dropping pill that the mixture of extraction is placed into fused host containing equivalent PEG4000 and PEG6000 at the ratio of 1:3,mixed and decanted into dropping pill machine at 85℃,then is dropped into fluid wax at the dropping distance of 5 cm. Cool and solidify into pills.Salvia miltiorrhiza,the extraction of Gingko biloba leaves,Chinese hawthorn leaves and Rhizoma Chuanxiong are qualitatively identified by thin-layer chromatography.High efficiency performance liquid chromatography is applied to quantitative analysis and methodological evaluation of salviolⅡA in Salvia miltiorrhiza and ferulaic acid in Rhizoma Chuanxiong. According to it the quality standard is made.The stability measurement have suggested the dropping pills has good stability.