Study On The Preparation And Quality Standard Of Shuxinjiangya Granule

Shuxinjiangya granule is a new modem compound preparation of Chinese medicine based on a clinically experienced prescription of Traditional Chinese Medicine, which contains the tuber of Panax notoginseng,Curcuma Louga L, Radix salviae miltiorrhizae, Radix Angelica Sinensis.According to "regulator regime of new medicine register" and requirement of the No.6 class of new Chinese medicines,and under the function and indication of the formula and the properties of its chemical components, as well as their pharmacology function, the route of preparative procedure and index components were ascertained. Guided by the contents of index components, which were curcumine, saponins and volatile oil, the extract rate and so on, the research used orthogonal experiment design or signal factor method to optimum conditions of preparation, which included Conbined enzymolysis extraction, refluxing extraction, water decocting extraction, purification, steam distillation, packing procedure, condensing and drying process, granulation.The reduplicate experiments and feasible analysis were conducted.under optimum operating condition. Moreover, the formula were identified by TLC, at the same time, curcumin and Panax saponin Rg₁ were determined, so that the research establish the main quality control of patent medicine.The content of effective component kept stable in all kinds of extraction means. The Panax saponin Rg₁ and curcumin content in the granule is 1.495mg/g_granule, 1.033mg/g_granule which showed that the preparation technology was stable, reasonable and practical.In the identifying materials of all kinds of medicinal materials by TLC, materials and sample had many same, clearly colorific speckles at the corresponding place without interferes of negative contrasts, and the separation effect was fine; HPLC methods being used to determine the Panax saponins Rg₁ and curcumin content, negative contrasts also were not interferential, the recovery of the components arrived at 98.1%, 98.2%. The results showed that these methods controlling quality were selectively, accurate and stable.