| The existing water decocting extraction technology of traditional Chinese medicine drug granules cannot effectively extract the active components of endogenous enzymes,alcohol-soluble and fat-soluble parts,which leads to low bioavailability of traditional Chinese medicine drug granules.In order to improve the bioavailability of medicinal materials and avoid the waste of medicinal materials resources,based on the deficiency of existing traditional Chinese medicine drug granules,this study took Scutellariae radix as the research object to complete the research on the preparation technology,quality control standard and stability of the Scutellariae radix holo-component granules.Firstly,the effects of different factors on the extraction effect of active components from different parts of Scutellariae radix were investigated.Then,the optimal extraction process was determined by orthogonal experiment.Three levels of each factor were selected.The optimal extraction process for each part of Scutellariae radix was determined as follows:(1)Endogenous enzyme parts,liquid to material ratio of 8:1,extraction for 0.5 h,extraction for 2 times;(2)Water-soluble parts,liquid to material ratio of 10:1,decocted at 100℃ for 1.5 h,extracted once;(3)Alcohol-soluble parts,liquid to material ratio of 14:1,decocted at 80℃ for 1.0h,extracted once.(4)Fat-soluble parts,liquid to material ratio of 10:1,decocted at60℃ for 1.0 h,extracted once.In the aspect of granules forming preparation,the extract mixture of each part of Scutellariae radix: soluble starch: dextrin=2:2:1 was granulated,softened with water,and dried under pressure at 40℃.The preparation technology is stable and reliable,which could provide reference for the preparation technology of holo-component granules of other medicinal materials.Compared with the Scutellariae radix granules prepared by traditional water decocting process,the content of active components of Scutellariae radix holo-component granules was higher,and the active components were aglycones such as baicalein and wogonin,which were easier to be absorbed by human body.According to the granules detection standard under the General Rule 0104 of the Chinese Pharmacopoeia(2020 edition),the quality control standard of Scutellariae radix holo-component granules was studied,and all the indexes were in line with the pharmacopoeia regulations.In this part of the study,baicalein and wogonin in the finished granules were identified by TLC,and the content of them was determined by HPLC.The results showed that the chromatographic spots of baicalein and wogonin were clear and the separation effect was good.The linear relationship between baicalein and wogonin was good in the range of 0.05μg ～ 1μg,and the average content of baicalein and wogonin in the finished pellet was 10.11mg/g and 2.43 mg/g respectively.The method is stable and reliable,and can be used for the quality control of the Scutellariae radix holo-component granules.According to the stability requirements of granules in Chinese Pharmacopoeia(2020 edition),the stability of three batches of finished granules was studied for one month.The results showed that,except the enzyme activity,the stability indexes of the three batches of particles did not fluctuate significantly,and the stability was good.Therefore,the mass of Scutellariae radix holo-component granules is relatively stable,and further studies should be conducted on the stability of enzyme activity in the granules.In conclusion,the preparation process of Scutellariae radix holo-component granules determined in this paper is stable and feasible,and the quality control method can be used for the quality control of Scutellariae radix holo-component granules.Except for enzyme activity,the indexes of Scutellariae radix holocomponent granules have good stability,which provides data reference for the later research of other medicinal materials holo-component granules. |
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