Chronic bronchitis refers to chronic non-specific inflammation of the trachea, bronchial mucosa and its surrounding tissues, clinically characterized by cough, expectoration, or chronic process accompanied by wheezing and repeated attack.Zhike Huatan Tablets is the sixth category of national TCM drug classification, the prescription contains fifteen herbs, including dried tangerine peel, Pinellia, etc. According to theory of TCM collateral disease, combined with modern medical analysis on the etiology and pathology of chronic bronchitis, the prescription is summarized from years of clinical practice. Used in the treatment of chronic bronchitis infections, Zhike Huatan Tablets combination with antibiotics can alleviate the symptoms, and when it is used separately, it has obvious effect on controlling cough, sputum, and asthma symptoms.This topic is mainly on the study of the preparation technology and the quality standard of the Zhike Huatan Tablets guided by the traditional Chinese medicine theory.The study of the preparation process:the influencing factors such as extraction times, the concentration and amount of ethanol, extraction time were investigated by Single factor experiment and Orthogonal test. And the optimum extraction conditions were ascertained as follows:adding6times amount of60%ethanol, extracting for two times, the first2hours, the second1.5hours; the licorice, medicinal water extraction process of extraction time, solvent dosage, extraction time was examined, and the extraction process with water extraction was determined as follows:water extraction for two times, each time for1.5hours, adding9times amount for the first time, the second time with7times amount of water; the tangerine peel, cinnamon extraction process of volatile oil was determined as a plus10times amount of the water, extracting for5hours. The preparation of molding process was studied such as the one-step granulating temperature, liquid density, the infusion pump frequency and other parameters. After the3batch of pilot test, the results showed that the process is stable and feasible.The quality standard study:the TLC method was established for the pinellia, ternata, cassia twig, mustard, cordate houttuynia, radix scutellariae, licorice, forsythia. The hesperidin content in dried tangerine peel was determined using HPLC. The results showed that the method was simple and has good reproducibility, therefore it can be used to control the quality of Zhike Huatan Tablet. |