Study On Quality Standard Of Mixture Of Chronic Pharyngitis

Chronic pharyngitis is a diffuse inflammation of pharynx mucosa, submucosal lymphoidtissue and, as part of the upper respiratory tract of chronic inflammation, is difficult to cure.The clinical symptoms is presented as throat discomfort, foreign body sensation, and itchingcough sputum viscosity, et al.Chronic pharyngitis mixture, forming a prescription of traditional Chinese medicinecurative effect good, the prescription composition as follows: salt bamboo bee, fructus forsythiae,oroxylum indicum, radix isatidis, roughhaired holly root, herba schizonepetae, bupleurumroot, hedyotis diffusa, platycodon grandiflorum and licorice root. In order to ensure the stablequality of each batch of product, and guarantee the safety of clinical medication, the aim ofthis project is to investigate the quality control standards of the chronic pharyngitis mixture.,Using different extraction methods to separate the functional components of the chronicpharyngitis mixture, then, they are identified and their contents are determined. Meanwhile,the routine inspection method is verified, to determine the quality control index, and todevelop the quality standards. The major results in this paper are as follows:1.The main ingredients are identified by thin layer chromatography (TLC), the separationand identification methods are optimized. Four herbs, namely forsythia, hedyotis diffusa,bupleurum root, schizonepeta are qualitative identified by the optimum chromatographiccondition. and all show the good TLC separation effect, with clear spots w. In comparisonwith reference standards, the four herbs showed the same color spots, with no interference ofnegative control, which can be used as qualitative identification of the chronic pharyngitismixture.2. The mixture routine examination items, such as pH, density, volume difference, andmicrobial limit are validated. Results show that the detection methods on pH value, density,volume difference detection are refined, which can be protocol the control index according tothe results; mixture of chronic pharyngitis have a strong inhibitory effect to the microbial,thus the conventional method and culture medium diluted method cannot be used as themethods of microbial limit examination, however, conventional membrane filtration methodcan eliminate the influence. Therefore, it should choose membrane filtration method to checkmicrobial limit in the preparation.3. Two main ingredients are determined by high performance liquid chromatography,include phillyrin in fructus forsythiae and (R,S)-goitrin in radix isatidis. The optimal condition of the former is as follows: the mobile phase is acetonitrile-0.1%phosphate (25:75, v/v), thedetection wavelength is277nm, column temperature is30℃with flow rate of1.0ml/min;loading of phillyrin within0.2~4μg has the linear correlation (r=0.9998), the average recoveryis99.2%, RSD is1.2%(n=9). The optimal condition of the latter is as follows: the mobilephase is methanol-0.01mol sodium dihydrogen phosphate (pH7.2;93:7, v/v), the detectionwavelength is245nm, column temperature is30℃with flow rate of1.0ml/min; loading of0.02~0.4μg (R,S)-goitrin is linear good (r=1.0000), the average recovery is98.5%, RSD is1.1%(n=9).Conclusions: the development of quality standards is scientific and reasonable, whichcan provide a basis for quality control of the chronic pharyngitis mixture, and provide areference for other hospital pharmaceutical preparations to formulate quality standard.