Study On Quality Standard Of Jinganmin Capsule

As a compound preparation of Chinese and western medicine, Jinganmin capsulehas the antipyretic and analgesic effects. The product formulation contains Lonicerajaponica Thunb., Cicadella viridis (Linnaeus) and salicylic acid, it used for fever,muscle pain, stuffy nose, runny nose, sneezing, sore throat,headache and othersymptoms which caused by the common cold or influenza. There were not anyrelevant provisions about the three kinds of prescription composition in the originalquality standard of Jinganmin capsule, so the standards of quality level is low and it isdifficult to ensure effective monitoring of product quality. In order to control, ensureproduct quality stability and ultimately ensure the efficacy and safety of the products,according to the current state requirements of improving drug quality standard, it isnecessary to perfect and improve its quality standard based on the original standard ofJinganmin capsule.In this paper, we have studied the TLC identification method for Lonicerajaponica in Jinganmin capsule, also, we studied the HPLC determination method andits content limit for free salicylic acid in the capsule. At the same time, the TLCidentification method of Cicadella viridis (Linnaeus) in Jinganmin capsuleshas beenstudied. The detail were described as follows.1. TLC identification of Lonicera japonica Thunb. in Jinganmin capsuleIn this experiment, the TLC identification method for the Lonicera japonicaThunb. in Jinganmin capsule have been tested and chlorogenic acid, which is aneffective components in Lonicera japonica Thunb, was used as reference substance.Through the comparative study, we found that both silica gel and polyamide TLC canbe used to identify the Lonicera japonica Thunb. in Jinganmin capsule. But thepolyamide TLC spots are more clearly, the degree of separation, reproducibility,specificity and durability are better than silica gel thin-layer chromatography, so thechoice is polyamide thin layer chromatography.2. TLC identification of Cicadella viridis (Linnaeus) in Jingamin capsuleThe TLC identification method for the Cicadella viridis (Linnaeus) in Jingamin capsule have been tested, indirubin, which is an effective components inCicadella viridis (Linnaeus), was used as reference substance.Due to the difficult of observation indirubin spots in the test solution of the Jinganmincapsule, finally, we did not write it in the new quality standard.3. HPLC determination of the content of free salicylic acid in Jinganmin capsuleThis experiment established the HPLC determination method of the content offree salicylic acid in Jinganmin capsule. The chromatographic conditions andapplicability were tested. In the methodological study, the sample processing method,chromatographic conditions, specificity, linearity, repeatability, accuracy, precision,durability, stability have been researched respectively. Morover, the chromatographiccolumn in different brands, different manufacturers and different length wereinvestigated.The experimental results showed that the method had high specificity,good repeatability, high accuracy, and better durability. In addition, according to theexperimental results, at the same time referenced USA Pharmacopoeia, ChinaPharmacopoeia and related national standards, to determine the free salicylic acid inJinganmin capsule is limited to5%of the labeled amount of aspirin.The paper applied thin layer chromatography and high performance liquidchromatography method to improve the quality standard of Jinganmin capsule, theresearch result is of positive significance to the whole product quality control anddrug safety.This experimental result provides a scientific basis for the improved qualitystandard of the Jinganmin capsule, although the method for identification of FoCicadella viridis (Linnaeus) needs further study, for the follow-up exploration on thetest work and the identification method, it has certain guiding significance.