| Objective: To establish the pharmaceutical technique and quality standard of Cangbai Qutong Capsule, and do preliminary Pharmacodynamic studies of it. Meanwhile, mechanism for analgesic and anti-inflammatory effects of this capsule will be also discussed, which will provide laboratory basis for pilot production and clinical medication.Method:(1)Study on the preparation process of Cangbai Qutong Capsule: using the method of single factor and orthogonal test design, establish the best extraction process for removing the herb medical flavor of day-lily and carry out the experimental verification;determining relevant data of mixed extract powder fluid and establish the preparation process.(2)Research on the quality standard of Cangbai Qutong Capsule: determine the content of berberine hydrochloride of Cangbai Qutong Capsule, and establish the quality standard of the preparation.(3)Study on the anti-inflammatory and analgesic effect of Cangbai Qutong Capsule: 50 clean Kunming mice were randomly divided into 5 groups, 10 rats in each following group : the Blank Controlled Group; High, Middle and Low group in regard to dosage of Cangbai Qutong Capsule(16.4g/kg, 8.24g/kg and 4.12g/kg) and Tongfengding Capsule Group(9.86g/kg). After pre-feeding for 7 days, used heat plate method, twisting method, gait rating test and ear swelling test, to observe and determine the improvement percentage of pain threshold, writhing times,gait score and auricle swelling inhibition rate of those mice.(4)Research on therapeutic effect of hyperuricemia rats model: 60 clean mice were randomly divided into six groups, 10 rats in each following group : Blank Controlled Group,Model Group, Positive Group and High, Middle and Low group in regard to dosage of Cangbai Qutong Capsule. After intraperitoneal injection of 2.5 percent oteracil potassium solution1ml/100 g for 15 days, rats would be drawn blood from their retro-orbital and then put to death.Colorimetric is used to determine the serum uric acid(SUA) levels in rat liver and kidney tissue xanthine oxidase(XOD) activity; using hematoxylin-eosin staining(HE) to detect liver and kidney tissue pathological changes.Results:(1) Study on Extraction Process of Cangbai Qutong Capsule: The order concerningimpact degree for the content of berberine hydrochloride is: the amount of water> extraction times> extraction time; for extraction time, extracting in different time exerts no significant impact on the content of berberine hydrochloride, P> 0.05, the amount of water and extraction times were significantly different, P <0.05. According to the analysis, the optimum water extraction process is A2B3C3(A for the amount of water, B is the extraction time, C is the times of extraction), that is 20 times the amount of water, the distillation time is 1.5h, and extraction for 3 times.(2) Establishing quality standard of Cangbai Qutong Capsule by determining berberine hydrochloride and controlling the preparation quality.(3) Experimental study on anti-inflammatory and analgesic of Cangbai Qutong Capsule:Compared with the Blank Controlled Group, High, Medium and Low group in regard to dosage of Cangbai Qutong Capsule could make the pain threshold in mice elevate(P<0.01), Middle Dose Group gained the most obvious effect at 60min; compared with the Blank Controlled Group, the two groups of low and medium dose significantly reduced the times of writhing,there was a significant difference(P<0.05); The three groups, the low, medium and high dose of Cangbai Qutong Capsuleat got the best effect of improving rats’ gait at the time of 15min; high dose group showed obvious effect at 30min; Cangbai Qutong Capsule groups could effectively inhibit xylene-induced ear edema in mice, and the inhibition rates were respectively 47.28%,,50.73% and 41.32%, of which the middle dose group obtained the best inhibitory effect.(4)Effect on hyperuricemia mouse model: Compared with the Blank Control Group, the content of XOD and SUA in liver and kidney tissue of the Model Group increased significantly(P <0.05), showing that the model was successful. Compared with the Model Group, SUA of Treatment Groups decreased significantly(P<0.01); while XOD in liver of groups as Medium and High regarding the dosage of Cangbai Qutong Capsule, were significantly increased(P<0.01); compared with the Model Group, the medium dose group of Cangbai Qutong Capsule can significantly reduce the pathological changes in tissue edema, swelling and inflammatory cell infiltration of rats’ livers and kidneys.Conclusion:(1) Preparation process of Cangbai Qutong Capsule getting from tests can guarantee the content of berberine hydrochloride in the standard, and lay a solid basis for thelaboratory medicine in trial production.(2) Taking determination of berberine hydrochloride as the standard quality control mechanism can ensure effectiveness and safety of this preparation, and the stability and repeatability of the quality control standard are good.(3) Cangbai Qutong Capsule can significantly increase the pain threshold of mice, reducing the times of writhing, easing and improving the gait of mice; and simultaneously control the happening and development of inflammation.(4) Cangbai Qutong Capsule can significantly reduce hyperuricemia SUA levels of mice;and significantly increased the content of XOD in liver tissue, and have certain protective effect on liver and kidney. |
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