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This paper, taking the formulation of national drug standards for traditional Chinese medicine (TCM) dispensing granules as a case study, explores the improvement of the formation mechanism of national drug standards, and promotes the reform of streamline administration, delegate powers, and improve regulation and services of national standards management, so as to release the vitality of the research and development of standards of drug manufacturers. After nearly two decades of pilot production of TCM dispensing granules, a large number of researches and discussions have been conducted on the formulation of unified standards of TCM dispensing granules from manufacturing enterprises to national standard administration departments, it was found that this work was difficult on the basis of the original drug standard formation mechanism. The authors tried to improve and innovate the formation mechanism of national drug standards, to provide methods and ideas for the formulation and unification of national standards for TCM dispensing granules, and to provide references for the formulation of other national drug standards.
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To investigate the effect of Sishen Wan (SSW) on intestinal flora in diarrhea-predominant irritable bowel syndrome (IBS-D) rats and explore the efficacy of this regiment for improving IBS-D, we divided 45 SPF male SD rats randomly into control, disease, SSW, Ershen Wan (ESW) and Wuweizasan (WWZS) groups. The spleen-kidney-yang deficiency type IBS-D rat model was prepared by a composite factor and administered for 14 days. After collecting the feces of the rats, total DNA was extracted from the stool samples. Primers were designed based on the 16S r RNA V3 to V4 regions of the bacteria, and used for high-throughput sequencing with the Illumina Miseq platform. We found that SSW can effectively reduce the diarrhea index (P<0.05) and reduce the high sensitivity of intestinal tract (P<0.05) of IBS-D rats. The principal component analysis (PCA), principal co-ordinates analysis (PCoA) and non-metric multidimensional scale analysis (NMDS) based on the Beta diversity distance showed that there were significant differences in the composition of the gut microbiota among the five groups (P<0.05). The disease group has the lowest in abundance, uniformity and diversity of gut microbiota. Compared with the control group, the disease group showed a significant increase in Proteobacteria, Actinobacteria, Veillonococcus and Mycoplasma (P<0.05), but a significant reduction in Pleaverella (P<0.05). Compared with the disease group, SSW administration caused significant reduction in the Proteobacteria and Mycoplasma (P<0.05), but significant increases of Clostridium, Turicibacter and Romboutsia (P<0.05). Our study shows that SSW has the potential as a therapeutic regiment for treatment of IBS-D due to partial regulation of the intestinal flora. In addition, there is a synergy between ESW and WWZS.
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<p><b>OBJECTIVE</b>To evaluate the preventive effect of salvianolate (Sal B) on glucose metabolism disorders of dimethylnitrosamine (DMN)-induced cirrhotic rats.</p><p><b>METHODS</b>Fifty-five Wistar rats were randomly divided into a control group (n=10) and a cirrhotic group (n=45) according to a random number table. Liver cirrhosis was induced by intraperitoneal administration of DMN. The cirrhotic rats were divided into model, Sal B and metformin groups (n=15), respectively. Rats in the model group were given saline, two treatment groups were given Sal B (50 mg/kg), metformin (150 mg/kg) respectively for 28 consecutive days, while rats in the control group were injected 0.9% saline with same volume of vehicle. Body weight was measured everyday. Insulin sensitivity was determined by euglycemic hyperinsulinemic clamp. Organ index, glucose tolerance test (OGTT), and fasting plasma glucose (FPG), fasting insulin (FINS), hepatic glycogen, hydroxyproline (HYP) and liver function were detected at the end of the treatment. Area under the curve (AUC) for OGTT was calculated. Liver and pancreas histology were determined by histopathological examination with hematoxylin and eosin staining (HE), Sirius Red staining and Masson's trichrome staining, respectively. Hepatic expression of α-smooth muscle actin (α-SMA) and collagen (Col I) were evaluated by immunohistochemical staining.</p><p><b>RESULTS</b>Compared with the model group, Sal B significantly increased body and liver weight, liver-body ratio, glucose infusion rate (GIR), FPG, FINS levels and hepatic glycogen at the end of administration (P<0.05 or P<0.01). Meanwhile, Sal B significantly decreased AUC for OGTT, spleen weight, spleen-body ratio, aminotransferase and HYP level (P<0.05 or P<0.01). Sal B was also effective in alleviating necrosis of liver tissue, suppressing fibrosis progression and inhibiting the expression of α-SMA and Col I in liver. Compared with the metformin group, Sal B had advantages in ameliorating FPG, hepatic glycogen, spleen weight, organ index, liver function and cirrhosis (P<0.05). Metformin increased insulin sensitivity more potently than Sal B (P<0.05).</p><p><b>CONCLUSIONS</b>Sal B could improve glucose metabolism in cirrhotic rats by protecting hepatic glycogen reserve, increasing insulin sensitivity, and alleviating pancreatic morphology abnormalities. Sal B was clinically potential in preventing glucose metabolism anomalies accompanied with cirrhosis.</p>
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At the end of 2017, the former China Food and Drug Administration promulgated " the Guiding Principles for the Assessment of Chinese Medicine Resources" whose purpose is establishing the concept of " the production of Chinese traditional medicines, herbal pieces and etc. should be based on the premise of ensuring the production and quality of Chinese medicine resources" for a licensed holder of a drug listing or a production enterprise of Chinese Medicine by assessing this work through the resources of Chinese Medicine which finally achieves the strategic significance of promoting the sustainable utilization of Chinese medicine resources. Under the guidance of the overall idea of "the total amount is not reduced and the supply is guaranteed", this paper focuses on the following two methods of assessment: ①"family property assessment" of Chinese medicine resources based on "fixed total amount". ② "Supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee". In this paper, we discuss the difference and relationship between the national survey of Chinese medicine resources and the assessment of Chinese medicine resources. Finally, we put forward a basic strategy called" supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee" that will guide the Industrial production of traditional Chinese medicine.
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This paper comprehensively analyses the background and meaning of The Technological Guiding Principle for Assessment of Chinese Medicine Resources enacted by the former CFDA ( China Food and Drug Administration), moreover, it also points out that the Chinese medicine resources assessment with the purpose of guaranteeing the sustainable supplying capacity of Chinese medicine resources is the premise of new drug development; the Chinese medicine resources assessment which takes quality guarantee as the core is a significant action to promote the fixing of place of origin and quality-management antedisplacement for the traditional Chinese medicine industry; in this regard, the Chinese medicine resources assessment which aims at realizing the whole-process traceability is the key to building the high-quality modern traditional Chinese medicine brand. The Chinese medicine resources assessment which takes the classical prescription as the entry point is the embodiment of the protection of traditional Chinese medicine resources and international vision of regulation, which aims at clarifying the thinking for the relevant enterprises to carry out the Chinese medicine resources assessment. Base on the general thinking of ensuring that the "total amount of Chinese medicine resources is fixed and the supply is guaranteed", this paper clarifies two methods of Chinese medicine resources assessment: "family property assessment" of Chinese medicine resources based on "fixed total amount", "supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee". In this regard, the basic strategy of "supply and demand balance assessment" of Chinese medicine resources based on "guaranteed supply" is put forward and it is believed that the resources assessment will lead to the significant adjustment of traditional Chinese medicinal materials production. It becomes the only way for the development of various Chinese medicine production enterprises to realize the comprehensive improvement of Chinese medicine quality, brand construction, the establishment of preferential price mechanism.
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Osteoarthritis is a common joint disease, which seriously affects the patient's health and quality of life. It results in substantial social and economic costs. Etiology and pathogenesis of OA is still not completely clear, but people paid more attention on Cytokines, especially IL-1, which is considered as core factor in the development of OA. In recent years, many clinical trials considered IL-1 as a target treatment for OA. It provided a new treatment method. This article is to overview the mechanism of IL-1 in OA cartilage damage.
Subject(s)
Animals , Humans , Disease Progression , Interleukin-1 , Genetics , Allergy and Immunology , Osteoarthritis , Genetics , Allergy and Immunology , PathologyABSTRACT
Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.
Subject(s)
Adverse Drug Reaction Reporting Systems , Drugs, Chinese Herbal , Injections , Methods , Medicine, Chinese Traditional , MethodsABSTRACT
Therapeutic efficacy is the point of starting and ending for research and developing of new traditional Chinese drugs, and clinical trials could provide a good platform for its efficacy evaluation. The characteristics of Chinese patent medicine is clarified in this paper by comparing its difference from Chinese herbal decoction, and the characteristics and difficulties in clinical trials for developing Chinese new drugs were also probed in referrence to the present situation and progress of the concerning topics.