Preparation Technology And Qualite Control Of Compound Licorice Soft Capsule Contents

Asthma is a common and frequently occurring disease,which has become one of the major chronic diseases seriously threatening public health and quality of life.Once asthmatic patients get sick,they need to take medicines for life.In recent years,with the progress of social industrialization,the increase of various pollutions,especially the frequent occurrence of haze,has led to an increasing incidence of asthma and an increasing trend year by year.According to the World Health Organization,as many as 300 million people worldwide suffer from asthma,so there is a huge demand for asthma drugs worldwide.However,there is a lack of effective clinical anti-asthma drugs with good prognosis.Traditional Chinese medicine has unique advantages in the treatment of asthma diseases,At present,the research of traditional Chinese Medicine and the prescriptions of Chinese herbal medicine for treating asthma have become a hot spot.Therefore,it is imperative to develop a new Chinese medicine for the treatment of asthma.Objective: To prepare a compound licorice soft capsule with good anti-asthma activity.Based on the study of the ancient Chinese Kushen and Gancao soup and the oriental Dangui,Kushen and Gancao soup in the Eastern Han Dynasty Zhang Zhongjing's "Jin Kui Yao Lue",the research group optimized the traditional Chinese medicine prescription with licorice as the sovereign drug,Sophora flavescens and Angelica sinensis as the minister drug.Pharmacological studies have shown that the prescription has both anti-inflammatory and diastolic airway smooth muscle effects.In this study,soft capsules were used as drug-loading bodies,which improved the taste,moisture absorption and volatile defects of the drug,and had the characteristics of large drug loading.The preparation technology of compound licorice soft capsule was studied in this paper.The quality of compound licorice soft capsule was comprehensively controlled by multi-index content determination combined with fingerprinting technology.The First Part Study on the preparation technology of the content of compound licorice soft capsuleMethods: The contents of compound licorice soft capsules were screened and optimized by single factor investigation and orthogonal design.Taking the sedimentation volume ratio F and the redispersibility R as indicators,the reasonable prescription and technology were optimized to prepare the content of compound licorice soft capsule.Results: The dosage ratio of powder to PEG 400 is 1:1.25,the dosage of beeswax is 2%,and the dosage of soybean phospholipid is 0.4%.Conclusion: The content prepared by this method is uniform,stable and has good fluidity.The Second Part The content determination of compound licorice soft capsuleMethods:HPLC method was established to determine the content compound licorice soft capsule.The main effective components of liquiritin,isoliquiritin,liquritigenin and glycyrrhizic acid were quantitatively analyzed.Results: The calibration curve of liquiritin,isoliquiritin,liquritigenin and glycyrrhizic acid were linear in the range of 4.98~99.6?g/m L?1.055~21.1?g/m L?0.255~5.1?g/m L ? 4.75 ~ 95?g/m L,respectively.The recovery rate of the samples was between 95.00% and 105.00%,and the RSD values were all less than 2%.The contents of four main components of liquiritin,isoliquiritin,liquritigenin and glycyrrhizic acid in 10 batches of compound licorice soft capsule samples were determined,and the content was basically stable.The average content of liquiritin was 3.2245 mg/g,the average content of isoliquiritin was 0.0854 mg/g,the average content of liquritigenin was 0.2619 mg/g,and the average content of glycyrrhizic acid was 6.17 mg/g.Conclusion: The established method has strong repeatability,good stability,simple operation and high recovery rate.A feasible detection method and basis for the formulation of quality standard of compound licorice soft capsule were explored.The Third Part Study on the fingerprints of compound licorice soft capsule contentsMethods: HPLC method was used to determine the contents of 10 batches of compound licorice soft capsules,and the similarity evaluation system of traditional Chinese medicine chromatographic fingerprint(2012.130723 version)was used for evaluation,and a common model was established.Results: The HPLC fingerprints of the contents of 10 batches of compound licorice soft capsules identified 23 common peaks,and 3 of them were identified,namely liquiritin,liquritigenin and glycyrrhizic acid.The fingerprint similarity of each batch of samples was >0.85,and the similarity was good.Conclusion: The study of the fingerprint provides a theoretical basis for better control of its intrinsic quality.In this paper,the preparation process of the content of compound licorice soft capsule was screened,and the content with good uniformity,good fluidity and good stability was prepared.The preparation method can be used as the preparation method of compound licorice soft capsule.Provide a reliable experimental basis for future large production.Through the study of its content determination,the quality standard of compound licorice soft capsule was established.The common pattern of fingerprint was established to provide a reliable scientific basis for more comprehensive evaluation and control of the quality of compound licorice soft capsule.