Study On The Preparation Technology And Quality Standard Of Tongmai Drop Pills

Angiocardiopathy and cerebrovascular diseases, including coronary heart disease, apoplexy, hypertension, have been becoming"the first killer"for human health. With the development of society and people's living standards, the incidence of coronary heart disease in the elderly population have increased quickly year by year. And the onset of angina pectoris, myocardial infarction have seriously threatened these patients'lives.The prescription of Tongmai medicine is made from three traditional Chinese medicinal materials, which are Radix Puerariae Lobatae, Radix et Rhizoma Salviae Miltiorrhizae and Rhizoma Chuanxiong. As an important patent medicine, Tongmai oral solution was embodied by Chinese traditional patent formulation (NO.20, standard code WS3-B-3980-98). Furthermore, with the development of dosage form of Chinese drugs, dropping pills have attracted much more attentions with its particular advantages, such as improving the bioavailability of some insoluble drugs, shortening periodicity, etc. It is believed that dropping pills will be an ideal dosage form prior to the oral solutuion for Tongmai medicine. Thus, the preparation process and quality standard of Tongmai dropping pills had been systematically researched in this dissertation.First,the extraction process of Tongmai dropping pills was studied and optimized. In this thesis, the optimal extraction conition of Radix Puerariae and Radix Salviae Miltiorrhizae was determined by L9(34) orthogonal test, in which course, puerarin and salvianolic acid B were used as evaluating indicators. The extration conditions were as following: 50% ethanol as solvent, steeping three times, 5 times of ethanol amount and 24h each time. Similarly, we determined the best extraction parameter of Rhizoma Chuanxiong by L9(34) orthogonal test, in which course, ferulic acid was used as evaluating indicator. The determined parameters were as following: 75% ethanol as solvent, steeping three times, 3 times of ethanol amount and 24h each time. The method was simple and realizable.Second,the effective components in Radix Puerariae and Radix Salviae Miltiorrhizae were enriched and purified with macroporous adsorption resins. In this process, elution parameters were investigated using the content of puerarin and salvianolic acid B as markers,which are detected by HPLC. Results showed that AB-8 was the optimal type of the resin. The optimized purification conditions of Radix Puerariae and Radix Salviae Miltiorrhizae were summarized as follows:the capacity of AB-8 macroporous adsorptive resin was as much as 2 times of the sample load(φ:h=1:7),the flow rate of sample was 1 BV/h,amount of distilled Hydrochloric acid solution(pH4)used for washing the resin 5BV,and amount of 50% ethanol as desorption solvent 3BV. This method is simple and feasible with good effect of separation.Third, the preparation technology of Tongmai dropping pills was optimized by orthogonal test, appearance quality as the evaluating indicator. The optimum molding parameters were as follows: the ratio of drug and matrix was 1∶2, matrix was the PEG6000, dropping temperature was 70℃, the cooling fluid temperature was 10℃. The optimization of the molding process is simple, high-yield, and good reproducible and operable.Forth, we established the quality standard of Tongmai dropping pills. TLC method was used to qualitatively identify Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong in the product. The spots of material in TLC chromatogram were clear without interference of negative samples. HPLC method was used to quantatively determine the content of Puerarin. The method is simply operable, accurate and highly sensitive. In addition, the quality stability experiments of Tongmai dropping pills were also achieved. Results showed that Tongmai dropping pills can be stored 6 months in room temperature and in acceleration condition. The data of appearance, properties, identification, determination of three groups of preparation were qualified.As a result, Tongmai dropping pills has satisfactory effects with reasonable and stable preparation technology and controllable quality standard. The quality control methods have many effects with convenience, accuratissime, repetition, and so on.