| Traditional Chinese Medicine (TCM) formula granule is a new formulation which reform Chinese Herbal Medicine under the leadership of the State Administration of TCM. They don’t only retain the original medicinal potency and efficacy, but also show some other advantages, including subtraction with the disease, decocting-free, precise dosage, what’s more formula granules adapt to the fast pace modern life and meet the demand of market which is popular to the patients. However, the uniform quality standards and production was not found yet, which cause some resistance to formula granules be used in clinical applications. Whether the TCM formula granules and herbals had the same material basis and show the same efficacy became a hotspot for Chinese medicine researchers. In the paper, we have investigated the material basis difference between the Dachengqitang (DC) formula granules and traditional decoction in the, Bio thermal activity and main efficacy. Hoping to provide some scientific data for TCM formula granules reasonable application in clinical.The paper includ two parts:Literature Review and Experimental Study.Literature Review:Firstly, we have reviewed the advantages and disadvantages of formula granules, and its development in recent years. Material basis, efficacy and clinical efficacy progress of the DC formula granules and herbal have been compaired. Secondly, the researches in recent years on DC in material basis and pharmacological effects have been reveiwed. Finally, we have reviewed current research and application of bio-thermal activity detection method in pharmacy. By reviewing the literature, we found that these studies have made remarkable achievements, but there many issues need to be resolved to comparatively evaluating the TCM formula granules and decoction. For all the reasons above, we investigated the difference between DC formula granules and traditional decoction using qualitative and quantitative analysis techniques, combined with bio-thermal activity detection method and conventional pharmacological tests. Hoping to provide some scientific data for the reasonable application of TCM formula granules in clinical.Experimental Study:Firstly, qualitative and quantitative comparison of three different batches of DC formula granules and decoction were carried out using HPLC and UV spectroscopy. The results show that the color of particles darker than decoction in the same batch, and the PH value of formula is slightly higher than the decoction, and the HPLC chromatogram similarity degrees of three different batches were89.7%,94.8%,91.4%respectively. The quantitative results show that the content of free anthraquinone and total anthraquinone in DC decoction were slightly higher than the recipe particles. Secondly, we compared the difference of formula granules and Decoction by bio-thermal activity test. The results show that both of them showed obvious inhibit activity, and the activity of E.coli organisms heat are no significant difference (P>0.05) between DC formula and decoction. Finally, we compared the effect of defecation and peristalsis on mice between formula granules and decoction. The results show that both of them can significantly promote bowel movement, strengthen the small bowel, and showed no statistically significant (P>0.05) between the same dose groups. Results from the study above indicates that there are no significant difference between formula granules and decoction, which giving a guidance for the use of DC formula granules and Pieces in clinical.Under the guidance of Chinese medicine theory, this paper combined pharmacy, analytical chemistry, pharmacology, bio-thermodynamics, statistical to systematically evaluating the DC formula granules and decoction in material basis, Bio thermal activity and main efficacy, which provides experimental data for clinical application of DC Granules at the first time. Moreover, in recent years, biological thermodynamics showed high stability, good reproducibility. biological thermodynamics have been widely used to screening traditional Chinese medicines, evaluating Chinese herbs, quality control and evaluation of traditional Chinese medicine, etc. This paper used bio-thermal activity detection and the experimental results were verified by pharmacological tests. Therefore, this paper provided new ideas and methods for further comparative study of TCM granules and decoction, and provided as a duigence for TCM granules quality control and evaluation. |
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