The Quality Evaluation And Clinical Eficacy Study Of Jinyin QingRe Oral Liquid

ObjectiveTo establish JinYin QingRe Oral Liquid HPLC fingerprint method for quality control, inspect the stability and toxicity.and evaluating the clinical curative effect of JinYin QingRe Oral Liquid.Methods1.HPLC fingerprint study of Jinyin Qingre Oral LiquidSelected the appropriate HPLC conditions.and automatic matched the10batch JinYin QingRe oral liquid chromatogram map by the Traditional Chinese medicine fingerprint similarity evaluation software(2004A)’, analysised of the similarity, confirmed the common peak,and than established the fingerprint methed.2.The stability test of JinYin QingRe Oral LiquidAccording to the Chinese Pharmacopoeia (2010edition)’pharmaceutical preparations stability test guidelines’,stability test including stress testing, accelerated test and long term stability test.we tested the stabilioty by inspecting the character,pH, relative density and the content change of Gardenoside. Chlorogenic acid and Dan phenolic acid B in the test condition.3.The Toxicity study of JinYin QingRe oral liquidAccording to ‘Traditional Chinese medicine, Natural Medicine acute toxicity studies technical guidelines’and’Traditional Chinese medicine, Natural Medicine long-time toxicity studies technical guidelines’,We carried out the acute toxicity and long-time toxicity study of Jin Yin QingRe Oral Liquid. The largest volume and the largest drug concentration of Jinyin Qingre Oral Liquid lavaged in mice, inspected the acute toxicity reaction of mice.50,20,5times dosage of Jinyin Qingre Oral Liquid lavaged in rat for four weaks,then executed part of rat, inspected the blood picture,the biochemical index and the pathological, the rest of rat withdrawaled back for a week and then did the same inspection with the rat ahead4. The clinical efficacy study of Jin Yin QingRe Oral LiquidAccording to the ’New drug of TCM bed research guidelines’,collected100’GanDan SiRe’ patients,and randomly divided into control group(give the drug of DanFei LiGan Ning)40patients, treatment group(give the drug DanFei LiGanNing and JinYin QingRe Oral Liquid)60patients. Classificated and quantitated the clinical symptoms,counted the score of the control group and treatment group, Comprehensive evaluated of therapeutic effect of JinYin QingRe oral liquid.Results1. Established the HPLC fingerprint methed of JinYin QingRe Oral Liquid,the mobile phase mobile phase A:0.05%phosphoric acid solution and mobile phase B:acetonitrile by gradient elution;flow=0.8ml.min-1, λ=254nm, Column box temperature30℃.15peaks existed and included Chlorogenic acid, Geniposide, Salvianolic acid B in the HPLC fingerprint of JinYin QingRe Oral Liquid.2. The result of stress testing,accelerated test and long-time stability test showed that the appearance,pH and relative density of Jinyin Qingre Oral Liquid all did not change significantly,but the content of geniposide, chlorogenic acid and salvia acid B appeared different degree reduce, among40%;One year long-time stability test showed that medicinal composition reduced less than10%.3. Mice of acute toxicity experiment all survived, did not appear obvious signs of intoxication. The blood indicators and biochemical indicators of50times dosage group from long-term toxicity test compared with the blank group and20times groups have significant differences (P<0.05). Pathological results showed that the high dosage of Jinyin Qingre Oral Liquid had a certain damage to the rat liver, spleen and kidney,but no delayed toxicity reaction.4. According to the score of the contral group and treatment group, Evaluated the effect of the treatment as significant effect, Effective and ineffective. JinYin QingRe Oral Liquid combined DanFei LiGanNing treat acute viral hepatitis, silt bile hepatitis, cholecystitis,the significant effect rate was61.7%, effective rate was31.7%,the total effective rate was93.3%.had a significant differences with contral group, drug combination could improve treatment effect.Conclusions1. The HPLC fingerprint methed of JinYin QingRe Oral Liquid was stabilityand simple,This method can provide more in formation for the quality control of Jinyinqingre Oral Liquid.2.Jinyin Qingre Oral Liquid was stable in the room temperature storage conditions,strong light and high temperature could influence to the stability, according to result of long-time stability test,could initially set the period of validity was lyear.3.Jinyin Qingre Oral Liquid was harmful to the liver and kidney while high doses of used,so initially set20-30ml one day,and2-3days was a period of treatment.4. JinYin QingRe Oral Liquid was applicable to treat hyperbilirubinemia which cased by viral hepatitis, silt bile hepatitis, cholecystitis.