The Pharmaceutical Research Of Qing Li Throat Granules

In recent years,people's living standards have improved much better with the rapid development of economic and technology in our country,however,it make the quality of air decline and the ecological environment is getting worse and worse day by day that in the wake of massive construction and uninterrupted operation in the factories,the expansion of houses,and the massive use of automobiles,as well as exhaust gases,waste water,unreasonable disposal of solid waste and extensive exploitation of coal.Coupled with people's eating habits and improper use of drugs,resulting in many diseases appear in our side,throat disease is a common upper respiratory disease in modern society,for example,pharyngeal pain,swelling,swallowing difficulties in patients.The daily life and body have some adverse effects,so timely treatment.Qing Li Throat Granules prescription for the clinical experience,containing six herbs,such as,Lonicera japonica,Andrographis Wall.ex Nees,Scutellaria L,Paeonia suffruticosa Andr,Magnolia denudata Desr.and Glycyrrhiza uralensis Fisch,indicate heat toxic pharyngitis with heat detoxification and cooling blood anti-inflammatory effect,its efficacy is clear and small side effects.Objective:To establish the best extraction technology and preparation technology for Qing Li Throat Granules,establish a systematic,safe and stable quality standard,and carry out a preliminary pharmacological study on the stability of the granules.Methods:According to the physical and chemical properties of the active ingredients of each herb in the preparation and the properties of all the active ingredients,the ethanol refluxing method and the water extraction method were adopted.Through orthogonal experiment and single factor investigation,taking the extraction rate of chlorogenic acid,the active ingredient of the Lonicera japonica,as the detection index,the best extraction process was optimized;according to the principle of "holding intoa group and pressing gently" wet granulation,the use of single factor study method,the preparation of excipients,dosage,order of addition and wetting agents were screened to determine the best preparation process;thin layer chromatography on the preparation of Lonicera japonica,Andrographis Wall.ex Nees,Scutellaria L,Paeonia suffruticosa Andr,and other herbs for qualitative identification;Taking chlorogenic acid content as the detection index,the content of the preparation granules was determined by high performance liquid chromatography to establish the quality standard of Qing Li Throat Granules' system,and the method was inspected.The investigation items included: investigation of the linear relationship,sexual investigation,repeatability investigation,intermediate precision study,stability study and recovery study.The stability of the preparation for preliminary study to examine the impact of high temperature,high humidity,light and other factors on the preparation.Results:The optimum extraction process of Lonicera japonica,Andrographis Wall.ex Nees,Scutellaria L,Paeonia suffruticosa Andr,Magnolia denudata Desr.and Glycyrrhiza uralensis Fisch(15: 12: 9: 6: 6: 9)was determined by orthogonal test and single factor test,The amount of solvent is 10 times,reflux extraction 3 times,each time 3h.The filtrate was concentrated under reduced pressure and dried to give extract powder.Then extract powder and excipients by the appropriate ratio of mixing evenly,with 80% ethanol wet granulation,40 ? drying,Sieving,packaging,that was the preparation.According to the testing requirements under the "2015 Chinese Pharmacopoeia" granules,the inspection on moisture content,grain size,dry weight loss and the weight difference,etc,all of which are in accordance with the requirements.TLC identification test results show that the method is relatively simple operation,special and strong,in the TLC for the test and reference drugs and reference materials in the corresponding position shows the same spots,and negative samples without interference;The established method for determination of high performance liquid phase has been proved to have high sensitivity and good separation effect.The methodological investigation results and system suitability testresults are in line with the requirements of Pharmacopoeia,so these two methods can be included in the quality standards of clearing throat particles.Stability study showed that the preparation has good stability,but the content of chlorogenic acid in the high temperature,high humidity and light conditions will produce slight changes,so the storage should be placed in a cool,dry and dark place.Conclusion:This article not only determined the optimum process conditions for Qing Li Throat Granules,but also established the Qing Li Throat Granules' system with stable quality standards.The standard is efficient,accurate,simple,and good stability,providing reference and theoretical basis for the industrialized production of the preparation in the future.