Study On Preparation Technology And Quality Standard Of Mongolian Medicine Wu Wei Sha Ji Capsules

Objective:Mongolian medicine Wu Wei Sha Ji Powder is mainly composed of Hippophae rhamnoides L,Glycyrrhiza uralensis Fisch,Auckiandialappa Decne,white raisin,Gardenia jasminoides J.Ellis and other five herbs.It has the effect of clearing heat and eliminating phlegm,relieving cough and asthma,and is used for lung heat and long cough,asthma and phlegm,chest fullness,chest pain and other symptoms.This prescription is recorded in the’Chinese Pharmacopoeia’and is widely used in clinical practice.In order to develop the safety,effective and stable new preparation,this experiment systematically studied the preparation process and quality standard of Mongolian medicine Wu Wei Sha Ji Capsule,and carried out preliminary stability research work,basically completed the pharmaceutical research part of new Chinese medicine.Methods:In this experiment,the ethanol extraction method was used to determine the total flavonoid content and the extract rate and the high-performance liquid phase determination of geniposide,liquiritin,and costunolide as indicators.The ethanol concentration,decoction times,decoction time,and solvent amount were investigated.The single factor investigation test was carried out.The L₉（3⁴）orthogonal design was used to select the best extraction process of Mongolian medicine Wu Wei Sha Ji Capsule,and the preparation process of Mongolian medicine Wu Wei Sha Ji Capsule was determined.Through the pilot study,three batches of samples were prepared.According to the proposed quality standard test,three batches of pilot samples met the relevant provisions of quality standards,indicating that the preparation process was reasonable,stable and feasible.In the study of quality standards,the prescription medicinal materials were qualitatively and quantitatively analyzed.TLC was used to identify the four medicinal materials of Hippophae rhamnoides L,Glycyrrhiza uralensis Fisch,Auckiandialappa Decne.and Gardenia jasminoides J.Ellis in Mongolian medicine Wu Wei Sha Ji capsule.The method for simultaneous determination of geniposide,liquiritin and costunolide by HPLC was established.The results showed that the method was reasonable and accurate.The general inspections were in accordance with the relevant standards under the"capsules"in the fourth volume of the 2020 edition of the Chinese Pharmacopoeia.Results:（1）The optimal extraction process of Mongolian medicine Wu Wei Sha Ji Capsule was established:Hippophae rhamnoides L,Glycyrrhiza uralensis Fisch,Auckiandialappa Decne,white raisin,Gardenia jasminoides J.Ellis and other medicinal materials were mixed with 12 times the amount of ethanol reflux extraction,extracted 2 times,1 hour each time,combined extract,concentrated into paste,dried,crushed to fine powder,loaded into capsules,and made into capsules.（2）The quality standard of Mongolian medicine Wu Wei Sha Ji capsule was established:the character of the preparation was observed,and the character was determined to be a hard capsule,and the content was a dark brown powder;aroma,sour,sweet and bitter,astringent;the thin layer identification spots of Seabuckthorn,Aucklandiae Radix,Glycyrrhizae Radix et Rhizoma and Gardeniae Fructus were separated clearly without negative interference.The contents of geniposide,liquiritin and costunolide in the samples were 14.42 mg/g,2.30 mg/g and 4.67 mg/g,and the RSD was less than 2.0%.All samples disintegrated within 30 minutes,which met the disintegration time limit requirements.The moisture content was less than 9.0%,which met the moisture requirements of capsules.The average loading capacity of the preparation was 0.32 g,and the loading range was 0.3174-0.3238 g/capsule,which met the requirement of the loading difference limit of±10%.Conclusions:1.Through the screening of experimental conditions,the prepar ation process and molding process of Mongolian Wu Wei Sha Ji Capsule were determined.2.The thin layer chromatography identification of Hippophae rhamn oides L,Glycyrrhiza uralensis Fisch,Auckiandialappa Decne and Gardenia jasm inoides J.Ellis is specific and can be used for the qualitative identification of the preparation.3.The content of geniposide,liquiritin and costunolide in Mong olian medicine Wu Wei Sha Ji capsule was determined by HPLC.This method is simple and reproducible,and provides a good experimental basis for the dev elopment and quality control of Mongolian medicine Wu Wei Sha Ji capsule.