Optimization Of Preparation And Evaluation Of Pharmacodynamics Of The Xiaoruzeng Capsule

Objective: For the Xiaoruzeng capsules clinical usage, the technology was transformedbecause of its curative slowly for analgesic effect, Excessive dose and gastrointestinaldiscomfort after taking medicine.Methods:1.This experiment was optimized using ethanol to extract angelica, driedtangerine，green tangerine peel, angelica dahurica, radix paeoniae alba, radix glycyrrhizaeand added rhizoma corydalis. The ethanol concentration, solvent multiple, extraction time andextraction times were chosen as investigated factors, and orthogonal design was used tooptimize alcohol extraction process of xiaoruzeng capsules, selected extract rate andExtraction yield index of hesperidin, glycyrrhizin, imperatorin as assessment criteria.2. The whole wavelength scan xiaoruzeng capsule by using HPLC-DAD cancellation tothree components-hesperidin, liquorice glycosides, imperatorin from xiaoruzeng activeingredients to determine the separation,which wasselecte according to the factors of degree ofseparation and peak area.3. The hyperplasia of mammary gland rat model was established by estradiol benzoate andprogesterone and drugs were administered after creation of models, observed under lightmicroscope of pathologic changes of mammary gland in rats. Changes of breast diameter,mammilla height, serum sex hormones level and organ coefficient were measured.4. The pain-killing effect of xiaoruzeng capsule was test by hot plate model and body twistingmodel induced by acetic acid in mice.5. The maximum dose method test acute toxicity test of new xiaoruzeng capsule in mice.Result：1.New technology of the best ethanol extraction conditions was adding8times65% ethanol solution, reflux extraction2times,1.5hours every time.2. The methodological study by HPLC-DAD showed that all of the three components showedgood baseline separation and linear relationship.3. The new xiaoruzeng capsule could reduce the breast diameter and mammilla height,decrease estradiol and prolactin levels in serum, but increase the serum progesterone level.Meanwhile, lower the index of uterus and inhibit the decrease of the coefficient of thymus.4. Compared with the xiaoruzeng group, new xiaoruzeng capsule could improve the painthreshold in hot plate model method, significantly extend the latent pain period caused byacetic acid and obviously reduce the twisting reaction times caused by acetic acid.5. The mortality was zero in treatment groups. Compared with the control group, the changeof the body weight and the food intake were not significantly different in treatment group,general conditions of animals were not abnormal and the appearances of organ were normalafter the gross anatomy.Conclusions： The optimized extraction process was stable and highly efficient. TheHPLC-DAD method is found to be accurate and easy.Compared with the original milk addedelimination, the new xiaoruzeng had more remarkable curative effect to cure the mammarygland hyperplasia.what’s more,many advantages,such as low doses, strong analgesic effect,fast curative effect，and without obviously side effects.