Development And The Pharmacodynamics Research Of JingFang Kanggan Effervescent Tablet

JingFang Kanggan Effervescent Tablet is a compound preparationwhich contains two kinds of TCMs, Schizonepeta tenuifolia Briq andSaposhnikovia divaricata （Turcz.） Schischk, from which we extractedthe active ingredients and made into effervescent oral tablet withmodern preparation craft. We studied on the extraction craft, preparationcraft, quality specification and the stability of this preparation, as well asits acute toxicity(LD₅₀) and pharmacodynamics. As a result, we obtainedits craft of extraction and preparation, and establish its initiatory qualityspecification.The resultes of the research on Saposhnikovia divaricata （Turcz.）Schischk （Fangfeng） indicated that the optimal extraction conditionswere: water（8:1, v/v） as the dissonant, extraction for 1.5h per time, 3times totally. The duplicate test and pilotscale experiment havedemonstrated that this craft was basically rational, for the extration rate ofchromone in the extracta sicca, which is the active ingredient ofFangfeng and used as detection index in our tests, was above 70 percent.Because the active ingredients of Schizonepeta tenuifolia Briq（Jingjie） are volatile oil and alcohol-soluble ingredients, the extration rate of former and the yield of latter were used as the indexes when westudied the extration craft of Jingjie. The volatile oil was made intoβ-CDclathrate, in order to be conserved better and educe more effects. Theβ-CD clathrate not only increased the availability and reduced thevolatility, but also concealed the bad odor of the volatile oil. Results ofTLC indicated that the chromatography behaviour of volatile oil afterclathration was similar to before, without significant deviation. Theduplicate test and pilotscale experiment have demonstrated that this craftwas basically stable and feasible. On the base of above experiments, westudied the usage amount of correctant and effervescent with thedetection indexes of pH, taste and disaggregation time of this preparation.Therefore, the basic prescription was obtained. The result of pilotscaleexperiment indicated that the preparation craft was also rational and thequality of tablets, determined by routine control, met requirement. Weapplied the technologies of TLC and HPLC to determine qualitation andquantitation of the primary active components in this preparation, andestablished its initiatory quality specification.According to the Technical Requirement for New TraditionalChinese Medicine Research, we studied the stability of this preparation.The results indicated that all its indexes occured little deviation on theconditions of the pseudomarket package, 40℃, 75ï¼…relative humidity（RH）, placed for 6 months, as well as on the conditions of the pseudomarket package, 25℃, 60ï¼…RH, also placed for 6 months.The results of pharmocological research indicated that JingFangKanggan Effervescent Tablet has rather in vivo and vitro antibacterialactivity and in vivo anti-influenza A and B virus activities. It also canreduce higher temperature of rats induced by dry yeast and the higertemperature of rabbits induced by endotoxin, which means thepreparation has rather antipyretic and anti-inflammatory activities.Results of toxicological research indicated the LD₅₀ of this preparation istoo small to determine, and its maximum tolerable dose（MTD） is 280times of human oral dose.In conclusion, the craft of this preparation is basically rational, itsquality specification is feasible and its stability fits the requirement.Meanwhile, it has anti-virus, antipyretic and anti-inflammatory activities.