| Objective: To develop the famous prescription Longzi Xiaozhong prescription into cream,and to study the preparation technology,quality standard,preliminary stability and so on,so as to provide the basis for the application of preparation in medical institutions and further application of new Chinese medicine.Methods:(1).Preparation technology research: By referring to relevant literature and combining the physicochemical properties of pharmaceutical ingredients and related excipients,the dosage form was selected and the process route was designed;Using baicalin dry extract yield and transfer rate as indexes,solid-liquid ratio,extraction times and extraction time as factors,Box-Behnken response surface design was used to optimize the water extraction process.Using β,β’-dimethylacrylyl arkanin transfer rate as evaluation index,single factor test was carried out to study oil extraction process conditions.In the study of molding process,Box-Behnken response surface method was used to design and optimize the prescription,single factor method was used to screen the main process parameters,and the emulsification temperature,stirring time and stirring temperature of the molding cream were investigated.(2)Study on quality standard:identification of prescription drugs by TLC;Check cream character,grain size,load,microbial limit;The contents of draconin A and draconin B were determined by high performance liquid chromatography(HPLC).(3)Preliminary stability investigation:mainly investigate the stability of the tested sample under the influence of thermal stability test,acceleration test,long-term test and other factors.Results:(1)Preparation process: The extraction process of Longzi Xiaozhong cream was divided into two parts: water extraction and oil extraction.The optimal conditions of water extraction were as follows: the ratio of material to liquid was 1:10,the soaking time was 45 min,the water extraction time was 1h,and the extraction time was 2 times.Oilextraction was deep-fried at low temperature,the ratio of material to liquid was 1:2,and the temperature was 100℃ ～ 120℃ for 1min.(2)In the study of quality standard,the TLC spots of rhubarb,scutellaria,Borneol,Phellodendris and Coptis chinensis were clear and reproducible,negative without interference,and could be included in the draft of quality standard.The contents of draconin A and draconin B were determined by HPLC.The results showed that draconin A was in the range of 0.011mg/ m L to 0.056mg/m L,draconin B was in the range of 0.024mg/m L to 0.094mg/m L,and there was A good linear relationship between the peak area of draconin A and the injection volume.The average recovery of draconin A was 99.22%,RSDS were 2.74%.The average recovery rate of draconin B was 97.72%,RSDS were 2.58%,and the average content of the three batches of samples was 0.2588mg/g.The content determination of draconin A and draconin B was included in the draft quality standard.(3)Preliminary stability investigation: thermal stability test,accelerated test,long-term test results showed that there was no obvious change in the character of the tested products,all the checks were in line with the standard provisions;Good stability.Conclusions: The index component transfer rate of Longzi Xiaozhong cream prepared by using the design route of water extraction and oil extraction process is good,the methodology investigation is in line with the regulations,the preparation process is feasible,the quality is controllable,the quality of Longzi Xiaozhong cream can be controlled by adjusting the investigation factors and preparation process parameters,the prepared cream,all the inspection items are in line with the regulations,and the preliminary stability is good. |
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