Pharmaceutical And Pharmacodynamic Researches On Sanyuzhentong Granules

Sanyuzhentong Granules(SYZTKL) are traditional Chinese medicines containing herbs: Sargentodoxae Caulis, Taraxci Herba, Typhae Pollen, Alismatis Rhizoma, Persicae Semen, Curcumae Rhizoma, Toosendan Fructus, Sparganii Rhizoma, Corydalis Rhizoma, Radix Salciae Miltiorrhizae, Cyperi Rhizoma, which have the effect of pelvic inflammatory disease, a significant effect. All-stasis and blood circulation to detoxify, dampness analgesic power post, and so on. Under the guidance of TCM theory and according to the State Food and Drug Administration, the article carries out the pharmaceutical and pharmacodynamic research using modern science and technology.1. Study of the preparationIn the study of preparation technology, according to the effectiveness of prescription indications, clinical drug characteristics and the nature of the active ingredients of drugs, we design preparation process:(1)Extract conditions were optimized. Using high performance liquid chromatography (HPLC) fingerprint technology, water amount, extraction time and the number of extraction times on the yield of extract were evaluated by orthogonal test design with multi-index of content of amygdalin and salvianolic acid B, the total area of characteristic peaks of HPLC and the yield of powdered extract. The optimum condition of the water extraction was obtained. The raw material amount was extracted with 8 volumes of water three times for 1.5 h per extraction process. (2)Alcohol precipitation process optimization copper and more uniform experimental design to determine the best alcohol precipitation process conditions for the extraction of liquid concentration 1.2:1 (g:mL); alcohol 6 times; stand for 24h; (3)The resulting supernatant by alcohol precipitation under conditions of 0.08Mpa,60℃ recovering ethanol under reduced pressure and concentrated to a relative density of 1.13～1.16,65～70℃ condensed extract, powdered by spray drying, the feedspeed of 3000 to 3500ml/h, inlet air temperature of 155～165℃, outlet air temperature of 90～95℃, solid dark brown loose powder; (4)We choose wet method the to make granula, moisture percentage, molding, melted, liquidity indicators preferred accessories; L9(34) the orthogonal Test molding process, screening out the best molding process to filter out the ratio of drug counseling (Extract powder:Lactose=1:1.5), with 95% ethanol as the wetting agent, the amount of alcohol for the raw materials and auxiliary materials 60% of total raw materials and auxiliary materials to the 2.6% of the total amount of the added amount of aspartame. In order to test the rationality of the preparation, we have research on mid-experiment for three times, and the products are detected according to all the quality control.2. Study of the quality standardWe determined the index and methods of quality control. We use TLC toidentify Sargentodoxae Caulis, Taraxci Herba, Typhae Pollen, Persicae Semen, Radix Salciae Miltiorrhizae. The results show that the spots are clear on the TLC picture and the negative control was non-interference,so we could use it as the qualition identification. HPLC is used to assay Amygdalin, Chlorogenic acid, Isorhamnetin-3-o-neohesperidin, Salvianolic acid B. The results show that the contents in every capsule of Amygdalin shouldn’t be less than 5.0 mg, Chlorogenic acid not be less than 13.0mg, Isorhamnetin-3-o-neohesperidin not be less than 9.0mg, and Salvianolic acid B not be less than 25.0mg. It says the quality of this preparation is stable. We check the moisture and melting,et al of SYZT Granules at last, too.3. Study of the stabilityIn order to examine the stability of the medicine and determine the time of validity of the medicine, we keep the wrapping material at indoor temperature and detect three batches of products according to all the indexes from the quality control.4. Study of pharmacodynamicIn order to verify the efficacy of the stasis analgesic particles observed stasis analgesic particles the rat model of blood stasis due to cold accumulation of reproductive hormones and ovarian vascular diastolic-systolic factor, explore the stasis analgesic particle therapy blood stasis due to cold accumulation gynecological diseases mechanism. The results showed stasis analgesic particles can regulate rat ovarian vascular diastolic-systolic factor changes, improve reproductive hormone levels. By writhing model and ear swelling model, to evaluate of SYZTKL analgesic anti-inflammatory effects. Results stasis analgesic particles is displayed with analgesic anti-inflammatory effects.