The Pharmaceutical Study On Chuanlongshuyu Xuezhikang Capsule

Chuanlongshuyu Xuezhikang Capsule is a new drug of Chinese materia medica, which used the stems and leaves of Dioscorea nipponica Makino as medicinal materials. Non-clinical pharmacodynamics studies indicated that Chuanlongshuyu Xuezhikang Capsule can regulate the blood lipids of hyperlipemia rats. In this paper, the preclinical pharmaceutical researches of Chuanlongshuyu Xuezhikang Capsule and the stems and leaves of D. nipponica and pharmacodynamic tests were completed. And the quality standard of the stems and leaves of D. nipponica and Chuanlongshuyu Xuezhikang Capsule was formulated.The preparation of Chuanlongshuyu Xuezhikang Capsule and the medicinal material of the stems and leaves of D. nipponica were determinated according to relevent regulations presenting in the items of capsule and medicinal material respectively.The main effective components of the stems and leaves of D. nipponica are phenanthrenes and flavonoids. HPLC-PDA method was used to determine the assay in the studies of Chuanlongshuyu Xuezhikang Capsule and the stems and leaves of D. nipponica, and the content of2,2’,7,7’-tetrahydroxy-4,4’,6,6’-tetramethoxy-l,l-biphenanthrene was used as detection index.The extraction and purification conditions of the the raw materials of Chuanlongshuyu Xuezhikang Capsule was optimized by orthogonal design. The conditions were optimized according to the output of extract and the2,2’,7,7’-tetrahydroxy-4,4’,6,6’-tetramethoxy-l,l’-biphenanthrene content of the extract. The results showed that extracted three times with95%ethanol were the best extraction condition. And then the extract was purified by microporous absorbent resins. In the quality control of Chuanlongshuyu Xuezhikang Capsule, the disintegration time, uniformity of volume, moisture content, microbial limit and so on were examined. And all the indexes of the drug substances meeted the pharmacopoeia and relevent regulations. In the stability tests, the characters, identification and assaying of the stems and leaves of D.nipponica and Chuanlongshuyu Xuezhikang Capsule were tested. The result showed that the quality and stability of the product were all in conformity with the relevant provisions.Pharmacodynamic studies were performed on dyslipidemia Wistar rats which were developed by oral high fat diets. The Wistar rat were randomly divided into six groups: control group, model group, positive drug group(Xuezhikang Capsule), Chuanlongshuyu Xuezhikang Capsule high-dose group(200mg/kg), middle-dose group(100mg/kg), low-dose group(50mg/kg). The blood sample were taken at the end of the second and the forth week respectively. All the rats were fasted for16hours after the last time of treatment. Then the blood was taken and separated the serum from the blood. The sera were treated according to the instruction of reagent kits and lipids content were measured with the automatic biochemistry analysors. The results indicated that TC level in serum of Chuanlongshuyu Xuezhikang Capsule groups(200mg/kg>100mg/kg、50mg/kg) significant decrease compared with control groups(P<0.001, P<O.01�'�P<O.05), and TG levels of Chuanlongshuyu Xuezhikang Capsule middle-dose group and high-dose group were significant decrease compared with control groups(P<0.05), and the HDL-C level was increased significantly in high-dose group (P<O.05). The results indicated that Chuanlongshuyu Xuezhikang Capsule had good effect of regulating dyslipidemia.The result of our experiment showed that optimized preparation technology was reasonable, low cost, and suit for industrialization manufacture. The quality standard of the prepatetion had good controllability, and the method of the measurement was well accurate, fine repeatability, and fit to control the quality of preparations effectively. Chuanlongshuyu Xuezhikang Capsule can decrease TC and TG level as well as increase HDL-C level of the dyslipidemia Wistar rats sera.