| Cornus Fructus is a kind of rare traditional medicine which has the function of tonifying liver and kidney and collecting astringent and fixing and removing.It has a long history of cultivation and application in China.Corni Fructus is often used in Chinese herbal pieces of Corni Fructus,but it has many disadvantages,such as excessive dosage,complicated decocting process and inconvenient carrying.The appearance of traditional Chinese formula granules not only solves the problem of Chinese herbal pieces of Corni Fructus,but also keeps the medicine character of itself to the greatest extent on the basis of Chinese herbal pieces of Corni Fructus,and has the advantages of no-decocting,easy to take and simple to make.According to the regulation and requirements of the“Exposure Draft”,the quality control and detection of Corni Fructus-Chinese herbal pieces of Corni Fructus-Corni Fructus piece standard decoction-Corni Fructus formula granuless were carried out one by one.The combined use pattern of multi-component chemical characterization and biological potency was used to evaluate the quality of Corni Fructus Formula Granules,and the draft quality standard of Corni Fructus formula granules was drawn up.In order to ensure the quality of Corni Fructus and the safety of clinical medicine,to provide data reference for the formulation of quality standards of related departments,to standardize the market of Corni Fructus,and to effectively popularize the Corni Fructus Formula Granules in clinical practice,promoting the development and comprehensive utilization of Corni Fructus.The main findings are as follows:1.Quality evaluation of Corni Fructus:The appearance of flaky or cylinfrical,mostly dark red.The moisture content ranges from 8.47%?13.05%,the total ash content from 4.02%?6.00%,and the extent content from 50.01%?63.75%.The content range of Gallic acid is 0.02%?0.13%,the content range of Morroniside is 0.96%?2.14%,and the content range of 5-HMF is 0.29%?1.30%,the content of Loganin ranger from 0.45%?1.26%and the Protocatechuic acid ranged from 0.01%?0.15%.All comply with the provisions of the first Corni Fructus in the 2015 edition of Chinese pharmacopoeia.2.Quality evaluation of decoction pieces of Corni Fructus:Soft texture,mostly purple-black.The range of water content is 4.47%?12.65%,the range of total ash content is 3.50%?6.00%,and the range of extract content is 50.00%?58.60%.All comply with the provisions of the first Chinese herbal pieces of Corni Fructus in the 2015 edition of Chinese pharmacopoeia.The contents of Gallic acid ranger from 0.16%?0.79%,5-HMF from 0.24%?0.71%,Protocatechuic acid from 0.02%?0.11%,and Morroniside from 0.64%?1.85%.The contents of Sweroside ranged from 0.13%?0.21%,Loganin from 0.07%?0.34%,and Cornuside from 0.17%?0.31%.The total contents of Morroniside and Loganin in batches of Corni Fructus reached 1.2%.3.Quality evaluation of Corni Fructus standard decoction:The acceptable content of Gallic acid is 0.15%?0.66%,the acceptable content of 5-HMF is 0.16%?0.29%,the acceptable content of Protocatechuic acid is 0.02%?0.06%,and the acceptable content of Morroniside is 0.5 7%?3.08%,the acceptable range of Sweroside was 0.03%?0.15%,that of Loganin was 0.06%?0.30%and that of Cornuside was 0.07%?0.23%.The total contents of Morroniside and Loganin in 10 batches of Corni Fructus standard decoction accord with the Chinese pharmacopoeia,reaching 1.2%.The extractum rate ranger from 46.11%?55.33%,and the average extractum rate was 50.34%.The results showed that the range of Gallic acid was 63.33%?96.88%,the range of 5-HMF was 28.57%?96.43%,the range of Protocatechuic acid was 62.07%?93.68%,the range of Morroniside was 83.33%?178.60%,and the range of Sweroside was 38.12%?91.61%,the range of Loganin was 50.06%?6.41%,and the range of Cornuside was 36.66%?86.33%.4.Study on preparation technology of Corni Fructus formula granules:The results of the optimization of the preparation process showed that the Corni Fructus formula granules were prepared according to the "Exposure Draft",the malt and the essence were used as the auxiliary materials,and the ratio of dry extract powder and malt and the essence was 1:0.8,the suitable soft material was made and sprayed with 85%ethanol and dried at 60? to obtain the Corni Fructus formula granules.5.Quality Evaluation of Corni Fructus formula granules:Water content ranges from 1.84%?3,70%.It has good solubility and can be dissolved in 90 ? hot water within 5 minutes.In particle size inspection,the unqualified rate ranged from 6.25%?11.07%.All of them are in accordance with the Chinese pharmacopoeia.The total contents of Morroniside and Loganin in 10 batches of Corni Fructus formula granules were more than 1.2%.The results showed that the range of Gallic acid was 28.50%?77.23%,the range of 5-HMF was 26.37%?87.56%,the range of Protocatechuic acid was 75.00%?100.00%,the range of Morroniside was 50.72%?94.20%,and the range of Sweroside was 27.22%?90.00%,the range of Loganin was 18.52%?87.50,and the range of Cornuside was 78.52%?94.70%.Preliminary study on the efficacy of Corni Fructus formula granules by in vitro cell experiment results showed that Corni Fructus formula granules had significant inhibitory effect on the proliferation of HepG2 hepatocellular carcinoma cells in 96h when the concentration of Corni Fructus formula granules was 100mg/L.When the concentration of HepG2 hepatocellular carcinoma cells.To sum up,in this paper,the standardized preparation technology and the quality standard of the extract of Corni Fructus were drawn up,and a mostly comprehensive and unique quality evaluation method of Corni Fructus was obtained,which laid a foundation for the follow-up study of Corni Fructus. |
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