Study On Preparation Technology Of Jiang Tanghuayu Capsules

Objective: Diabetes is a common endocrine and metabolic disease .Along with the change of life style and the acceleration of the aging process, the rate of diabetes trends are rising rapidly in china, which become another illness seriously endanger people's lives and health after cardio-cerebral vascular diseases and tumors. The acute and chronic complications, in particular , the chronic disease involving multiple organs, the disabled, and the high death rate, which has seriously affected the physical and mental health of patients with diabetes and has placed a heavy burden to individuals, families and society. At present, compare with Western medicine, Chinese medicine has low intensity and speed of hypoglycemia. But to the integrated control of vascular disease and other chronic complications and overall adjustment of metabolic disorders related to diabetes, it has demonstrated its good prospects. The research of the preparation of Jiang Tanghuayu capsules aims to establish water extraction process of the capsule and to study preparation, quality control standard and the stability of preparation. It not only provides a safe and effective preparation for the clinical treatment but also provides a new idea for the realization of the modernization of Chinese medicine.Method: Herbal medicine treatment: Panax ginseng is precious medicinal materials, smashing ginseng with Advanced Micro Devices; Tuckahoe and radices paeoniae alba with more carbohydrate coy good powder amposition, play a good role in the anti-moisture absorption after crushing; Two medicinal materials were crushed into powder, were sieved by 80 mesh and reserved.Extraction of medicines: The effective ingredients of the drugs are water-soluble. In order to extract the greatest possible number of active ingredients, water extraction was used. Danshen is jun medicine, Its chemical composition, that is salvianolic acid B, has the strongest and highest levels in medicine. Salvianolic acid B is the main objective. The dry extract is another objective for inspection. Objectives were evaluated comprehensively. Extraction process was optimized by L₉(3⁴) orthogonal test.Preparation of particles:Filtrated fluids will be concentrated to thick paste, the poeder of Panax ginseng, tuckahoe and radices paeoniae Alba were mixed .Appropriate matrix was selected. Soft material was prepared. Particles were made.The quality control standards of Capsules:â‘ qualitative identification of the capsule.â‘¡quantitative identification: ginsenosides content in the ginseng and salvianolic acid B in the Dan-shen were determined as an indicator.The stability of three batches of homemade Hypoglycemic Capsules was studied with salvianolic acid B content as an indicator.Results: In the part of extraction, factor C, that is the number of decocting, are significantly affected and factors A (to add water), factors B( decocting time ) are not significantly affected. The order of salvianolic acid B content is: C₃>C₂>C₁,B₂>B₃>B₁,A₂>A₃>A₁ ,So reparation technology condition is A₂B₂C₃. The order of dry extract yield is: C₃> C₂> C₁, B₃> B₂> B₁, A₁> A₃> A₂. Its reparation technology condition is A₁ B₃ C₃. Salvianolic acid B is the main objective. The dry extract is another objective for inspection. And comprehensive evaluation should be made from economic point of view. A₂ B₂ C₃ is identified for the optimization process, which is to add water eight times, to decoct three times, each time one hour.Preparation of the capsule: one tablet's weight is 0.5g and 6-10% accessory Cyclodextrin is filler. In the three batches of Jiang Tanghuayu Capsules, the minimum content of acid B is 5.6 mg.g^-1, the minimum content of ginsenosides is 2.6 mg.g^-1.Through the inspection process of stability, the capsule should avoid high-temperature, high humidity in the store process. The temperature has a greater impact to the active ingredients in the capsule. Conclusion: Hypoglycemic decoction would be replaced by capsules for clinical patients. It provides facilities of to carry and to take medicine. Moreover, it avoid detrimental effect that bring about by decoction time and decoction water number. American ginseng use AMD technology to smash. Capsule content directly contact with solvents and would be dissolved because medicinal herbs membrane have been broken after the smash with advanced micro devices. All of these increased utilization of medicinal and therapeutic effect. In this study, HPLC determination was adopted to determinate salvianolic acid B in the extract and capsules and to determinate ginsenosides content of American ginseng in capsules. It established reasonable, feasible quality standards. This study implements effective quality control from Chinese medicine extraction to the preparation to ensure that the hypoglycemic capsules have controllability and stability, which prepare basis experimental data of being approval by government. This has provided new, safe and effective traditional Chinese medicine preparations.