| Children are a special group of people.Because childhood is the special life stage with continuous growth and development.Children are vulnerable to external infection due to weak body function and resistance.And most infections are caused by viruses.Prescription of compound Qing Qin granules,derived from clinical experience prescription of veteran physician,consists of four traditional Chinese medicine(Folium Isatidis,Bupleurum,Scutellaria and Honeysuckle).The prescription can play an role in heat-clearing and damp-drying,purging fire and detoxifying toxicosis,reconciling exterior and interior and defervescence and elevating yang.In addition,the compound has characteristics including mild defervescence,stable effects and few side effects.Objective: The purposes of this study are to confirm the optimum technological conditions of compound Qing Qin granules,establish comprehensive and stable quality standards and investigate the stability of the prescription.Method: The medicinal materials were extracted with ethanol via hot reflux method according to physicochemical properties of active ingredients in each medicine.Optimum extraction process was confirmed by orthogonal test method using the extraction content of indirubin in Folium Isatidis as detection index.In addition,optimum forming process was identified by screening of excipients type,excipients dosage,wetting agent and so on using wet granulation and single factor method.Moreover,content determination method of compound Qing Qin granules was established by way of HPLC method using content of indirubin as detection index.Moisture,particle size and drying loss of the compound were examined and TLC identification of medicines in prescription were performed on the basis of methods in Chinese pharmacopoeia in order to establish a comprehensive quality standards of Qing Qin granules.Results: Finally,optimum technological conditions of compound Qing Qin granules were confirmed as follows: Four traditional Chinese medicine(FoliumIsatidis,Bupleurum,Scutellaria and Honeysuckle)were weighed and 10 times of80% ethanol were added to these medicines.The medicines were extracted via reflux for 2 times,each time 3 hour.Then the extracts were combined,filtered,concentrated and desiccated to obtain extract powder.Subsequently,excipients and wetting agents were added to these extract powder in the ratio of extract powder: starch: lactose:aspartame: 5%PVPK30 80% ethanol solution(1: 1: 0.75: 0.2%: 0.42ml)and were prepared into granule after uniform mixing.Finally,compound Qing Qin granules were obtained after desiccation under 50?,sieving,filling and packing.The determination results of moisture,particle size,drying loss and weight difference under granule item met the requirements.The results of TLC identification indicated that spots of test sample in the TLC chromatograms were the same as those of reference drugs and reference substances and the negative samples had no interference.The results of system suitability test for proposed determination method all met the requirements of pharmacopoeia.The established method was found to have strong specificity,good linearity,good precision,good stability,good repeatability and good recovery after methodology validation and can be used to the quality control of compound Qing Qin granules.The results of preliminary stability study showed that the granules were of good stability,which could meet general transportation and storage conditions.Conclusion: In this study,the optimum technological conditions and the quality standards of compound Qing Qin granules were confirmed and established respectively.The proposed methods were found to be simple,efficient,accurate and stable and can control the quality of compound Qing Qin granules effectively,which can provide reference and theoretical basis for the industrial production of the granules in future. |
PDF Full Text Request