Study On New Quality Standard Of Strong Cold

Qiangliganmao tablets are indexed 《20copies into preparations of Chinese medicine》.It is the most common Over-the-Counter(OTC) dug in China,s market for the treatment of a cold. Patients can buy freely, so its quality standards should be formulated more strictly. The medicine has an effect on cooling and refreshing nourish, clearing heat and detoxification, analgesic.Its mainly be used for treating cold, fever headache, cough and sore throat. The prescription contains4-Acetamidophenol and Lonicera japonica, Forsythia suspensa (Thunb.) Vahl, Platycodon grandiflorus (Jacq.) A. DC nine traditional Chinese medicine suppressed by certain proportion.The current quality standards of Qiangliganmao tablets for [Character][Identifi-cation][Inpection][Content] is determined.Above four indicators were limited certainly: The tabets Of apparent was described; Determined by using a microscopic to identify Platycodon grandiflorus (Jacq.) A. DC powder;Estalished a method to identify the qualitative and content of4-Acetaminophen by UV; Determined in accordance with the tablet under disintegration. It can be seen that the current standards have fowlling vulnerabilities and should be increase test content:1、Under Identification items, only4-Acetaminophen qualitative identification, While4-acetaminophen is determined undercontent items,so there is no need for qualitative identification; Owing to the qiangli-ganmaotablets for the national traditional Chinese medicine protection of exclusive varieties, the main active components from traditional Chinese medicine was not identified, It can lead to a drug feeding process risk and should be fully identify representative components. By consultating factory, In the preparation, the feeding ratio of Forsythia suspense (Thunb.) Vahl and Lonicera japonica are relative to other relatively large,so we choose it as a qualitative identification index. The preparation are complicated, single qualitative identification is not fully reflecting the overall composition of the preparation, so we reasonably increase qiangliganmao tabets HPLC fingerprint under the identification items.2、Under Content items, Because of the Qiangliganmao tablets is traditional Chinese and Western Medicine and complex composition, It was not determined the main active ingredients content of traditional Chinese medicine; As the preparation contains relatively large Forsythia suspen-sa(Thunb.)Vahl and its main active ingredient is phillyrin,so we select it as a representative of Chinese medicine ingredient content whitch was measured;In recent years,4-acetaminophen used process often leaded to adverse reactions have been reported, the preparation of ministerial standards using UV points photometric method for the determination of the content of4-acetaminophen, This method is complex and cumbersome whitch was process of using, many confounding factors, there is a big deviation. In this paper, using high-performance liquid chromatography to measure4-acetaminophen and Forsythin. Establishing a more comprehensive, reasonable and workable new drug quality is imperative.Based on the above discribed, this study focused on simplifications and vouner-abilities of the current standants of Qiangliganmao tabets, It complements and enhances the current standards. through the the experiments the following were completed.Established the method of application of thin layer chromatography (TLC)for qualitative identificationLonicerajaponica TLC map:With sodium carboxymethyl cellulose as binder silica gelG as an adsorbent, butyl acetate:formic acid:water (7:2.5:2.5) as an expansion agent, and removed, dried, examined under a uv lamp (365nm).Phillyrin TLC map:Used silica gel G as an absorbent, chloroform-methanol-formic acid (9:1:0.2)as an expansion agent,10%sulfuric acid in ethanol solution (v/v) as a chromogenic regent, and heated105℃to view color.2. High performance liquid chromatography (HPLC) technique used in content determination.Forsythin content determined:By using C18column the Kromasil-E50542(250mmx4.6mm) at35℃; Mobile phase:methanol:acetonitrile:water (20:10:50), with a flow rate of1.0ml-min-1. This was injected by20μL sample and detected the componment under277nm, Forsythin has good linear range at0.196to2.156ug/ml, the regression equation Y=122163x-11351, R2=0.9997.4-Acetaminophen content determined:By using C18column the Kromasil E50542-(250mmx4.6mm) at35℃; Mobile phase:methanol-water (35:65), with a flow rate of1.0ml-min-1. This was injected by5μL sample and detected the componment under249nm,4-Acetaminophen has good linear range at2.14to25.68ug/ml, the regression equationY=955412x+48232, R2=0.9994.3、Qiang li gan mao tablets HPLC fingerprint of the preliminary inquiry.The fingerprints were analyzed by HPLC methods, By using C18column the Kromasil E50542-(250mmx4.6mm) at25℃; Mobile phase:Acetonitrile-0.4%phosphoric acid aqueous solution (12:88), with a flow rate of1.0mlmin-1. This was injected by10μL sample and detected the componment under327nm, Seven marker peaks were separated by HPLC.The similarity factor of fingerprints for2,5batches of samples of each batch of7samples of fingerprint similarity over0.9. The quantitative linear range of chlorogenic acid were0.03ug-0.33ug/ml, and the average recoveries were101.27%. The established method in study on fingerprints of Qiang li gan mao tablets is ripid,simple and reliable, It can be used specifically for quality control of Qiang li gan mao tablets.On the basis of these experiments, the original standard was amended to increase the reasonable test content, and improve the original content detection methods, so the accuracy of the results is assured. Through the new quality standards, On the one hand by a supplement to make the standard more comprehensive, more reasonable; On the other hand by the original standard to improve the content of acetaminophen methodology makes the results more accurate. Study of two, greatly improve the safety of drugs used.