Studys On The Preparation And Quality Standards Of Jitongxiao Capsule

Asa clinical experience in the treatment of lumbar disc herniation,Jitongxiao capsule has the effect of tonifyingQi,promoting blood circulation,relieving pain,and disinhibiting water,and has achieved remarkable effect in clinical application.In this experiment,the preparation process of the capsule,the stability of the preparation and other aspects were investigated.Meanwhile,the quality standards were established to make the preparation stable,safe and controllable.The literature review:After consulting the literature,Summarzing the main clinical treatment methods of lumbar disc herniation,and the clinical application of Jitongxiao capsule were summarized.And understand the active ingredients of the single herb in the prescription and its pharmacological effects,in order to lay the foundation for the appropriate extraction method.Preparation process research:This side by Radix Paeoniae Alba,Plantago phllium,Pueraria lobata,vinegar rhizorna corydalis,Astragalus,Ly copus lucidus,Rhizoma Alismatis,Angelica,Ligusticum wallichii,Eucommia ulmodes,Lumbricus,Rhizoma Sparganii,Zedoary,Radix Stephaniae have 14 herbs.Among them,Radix Paeoniae Alba,Plantago phllium,Pueraria lobata,vinegar rhizorna corydalis,Astragalus,Lycopus lucidus,Rhizoma Alismatis were extracted by refluxing with water,and the other seven herbs,such as Angelica and Chuanxiong,became fine powder.Using L9(34)orthogonal method and multi-index evaluation,the best extraction method was determined based on the indexes of paste yield,alcohol extract,paeoniflorin content,puerarin content and total saponins content.When the concentration process was inspected,the pressure and temperature at normal temperature and vacuum concentration were examined to select the best condition,and the appropriate relative density(80℃ thermal measurement)of the thick paste was determined and mixed with the other seven powders.grain.Through the inspection of the molding techniques,a suitable preparation process was determined.Quality Standard Study:A thin-layer chromatographic method for the identification of Zedoary,Radix Stephaniae,Radix Paeoniae Alba,Pueraria lobata,rhizorna corydalis,and Astragaluswas established.Microscopic identification of the fine powders of Angelica,Ligusticum wallichii,Eucommia ulmodes,Lumbricus,Rhizoma Sparganii,Zedoary,Radix Stephaniae was established.Using the method of HPLC for determine the contents of the fangchinoline and tetrandrine in Radix Stephaniae,and the methodological investigation was conducted.Through the determination of the contents of multiple batches of samples,the content of fangchinoline and tetrandrine in the compound was determined.Study on the stability of pharmaceutical preparations:For ensuring the safety and stability of the drug,a long-term stability test of 6 months was performed on the Jitongxiao capsule,every 3 months check once,the results showed that the preparation was relatively stable in terms of traits,contents,and inspections within a stable period of 6 months.