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ObjectiveTo analyze the antidepressant quality markers(Q-Marker) of Bupleuri Radix(BP) before and after vinegar-processing by ultra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS), multivariate statistical analysis and network pharmacology. MethodUPLC-Q-TOF-MS was used to analyze the chemical basis of raw and vinegar-processed products of BP, and principal component analysis(PCA) orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to identify the differential components in BP that changed significantly before and after vinegar-processing, which were regarded as candidate quality markers(Q-Marker). Then the disease-drug-component-target network related to antidepressant effect of BP was constructed by network pharmacology, and the antidepressant Q-Marker of raw and vinegar-processed products of BP was determined. Rats were randomly divided into blank group, model group, fluoxetine group(2.67 mg·kg-1) and total saponin group(0.72 mg·kg-1), except the blank group, rats in the other groups were subjected to chronic unpredictable mild stress(CUMS). Three weeks after the start of modeling, rats in each administration group were given the corresponding dose of drugs once a day for 4 weeks, and rats in the blank and model groups were given normal saline with dose of 10 mL·kg-1. At 1 day before modeling, 21 days and 28 days after administration, body mass weighing, sucrose preference test and open field test were performed on each group . After 28 days of administration, real-time fluorescence quantitative polymerase chain reaction(Real-time PCR) was used to detect the mRNA expression levels of phosphatidylinositol 3-kinase(PI3K), protein kinase B(Akt), mammalian target of rapamycin(mTOR), glycogen synthase kinase-3β(GSK-3β), forkhead box transcription factor O3a(FoxO3a) and β-catenin in hippocampal tissues of rats in each group, while protein expression levels of PI3K, Akt, mTOR and FoxO3a in hippocampal tissues of rats in each group were detected by Western blot. ResultThere were 19 components in BP showed significant changes before and after vinegar-processing, and 9 components such as saikosaponin A, saikosaponin B1, saikosaponin B2, saikosaponin C and saikosaponin D were identified as potential Q-Marker through S-plot differential marker screening. Combined with the disease-drug-component-target network, saikosaponin A, saikosaponin B1, saikosaponin B2 and saikosaponin D were identified as antidepressant Q-Marker of raw and vinegar-processed products of BP. According to the results of pharmacodynamic tests, after 28 d of administration, compared with the blank group, the body mass, sucrose preference index and open field total score of rats in model group, fluoxetine group and total saponin group decreased significantly(P<0.01). Compared with the model group, the body mass, sucrose preference index and open field total score in total saponin group increased significantly(P<0.01). Compared with the blank group, mRNA expression levels of PI3K, Akt, mTOR and β-catenin in hippocampus of rats in the model group decreased significantly(P<0.05), while mRNA expression levels of GSK-3β and FoxO3a increased significantly(P<0.05). Compared with the model group, mRNA expression levels of PI3K, Akt, mTOR and β-catenin in hippocampus of rats in the total saponin group were increased significantly(P<0.05), while mRNA expression levels of GSK-3β and FoxO3a decreased significantly(P<0.05). Compared with the blank group, the protein expression levels of Akt and mTOR in hippocampus of the model group decreased significantly(P<0.01), while the protein expression levels of PI3K and FoxO3a increased significantly(P<0.01). Compared with the model group, the expression level of Akt in hippocampus of the total saponin group increased significantly(P<0.01), the mTOR expression level was increased but not statistically significant, while the protein expression levels of PI3K and FoxO3a decreased significantly(P<0.01). ConclusionThe chemical constituents of BP changed greatly after vinegar-processing, and the antidepressant Q-Marker of raw and vinegar-processed products of BP was determined by chemical basis, pharmacodynamics, network pharmacology and signaling pathway, which provided a reference for further research on quality control, pharmacodynamic substance basis and processing mechanism of BP.
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By consulting ancient herbal books and modern literature, this paper systematically sorted out and researched the processing history, relevant processing norms in recent years, modern processing technology, chemical composition changes of processed products and their pharmacological mechanism of Scutellariae Radix, in order to provide a basis for the further development of Scutellariae Radix decoction pieces. According to the textual research of ancient books, there were many kinds of processing auxiliary materials of Scutellariae Radix, such as wine, vinegar, salt, honey, pig bile and so on, among which the wine processing was the most diverse and detailed, and the processed products such as raw products, stir-fried products, wine-processed products, fried charcoal products were still in use. The modern processing techniques of Scutellariae Radix mainly focus on the processing aspects of softening and slicing, wine processing and charcoal frying, and the research methods are relatively unified. At present, it is found that the changed chemical constituents of Scutellariae Radix after processing are flavonoids, polysaccharides, volatile oils and trace elements, etc. Pharmacological effects of processed products are hemostasis, antibacterial, anti-inflammatory, antioxidant, analgesic and antipyretic, treatment of lung diseases, treatment of colitis, etc. However, in the studies of Scutellariae Radix processing, there is a lack of research on the structural changes of chemical components caused by processing and a comprehensive comparative study on the pharmacological effects of various processed products. Based on this, it is suggested to carry out systematic research on the processing technology to processing mechanism, further explore the relationship between the change rule of material basis and pharmacological action before and after processing of Scutellariae Radix, and deepen the exploration of molecular mechanism and clinical application of processed products of Scutellariae Radix, in order to clarify the scientific connotation of the processing mechanism of Scutellariae Radix, and lay a foundation for the subsequent expansion of the application of Scutellariae Radix decoction pieces and the formulation of processing standards.
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Objective It analyzes the characteristics of the policy text of Sanming City on the basis of two dimen-sions,policy tools and policy objectives,to accumulate the experience of abolishing the increase in the price of tradi-tional Chinese medicine tablets in Sanming City,and puts forward some reflections.Methods Using literature re-search combined with content analysis,a two-dimensional analysis framework of policy tools and objectives was constructed to code 26 policy documents published publicly in Sanming City from January 2013-April 2023 regarding the policy of abolishing the markup on Chinese medicine tablets.Results A total of 87 articles were coded,with de-mand-type,supply-type and environment-type accounting for 16.09 per cent,34.49 per cent and 49.42 per cent respectively,with the overall distribution of policy tools favouring the use of supply-type and environment-type;and there was a certain tendency towards a certain policy objective,"ensuring the quality of Chinese medicine tablet","improving the price mechanism of Chinese medicine tablets","standardising the use of Chinese medicine tablets","strengthening the organisation and implementation,and implement the government's responsibility to invest"ac-counted for 11.49%per cent,39.08 per cent,18.39 per cent and 31.03 per cent respectively.Conclusion Innovative use of demand-based tools,such as market shaping,to promote the development of the beverage production chain in a high quality manner;taking into account the level of the regional economy,returning the price initiative to the market,optimising the market structure of the traditional Chinese medicine beverage industry,and cooperating with publicity measures to promote the implementation of the policy;and reforming the personnel and remuneration system of the pharmacy staff and regulating medical practices.
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High quality is the premise for the implementation of high quality and good price for decoction pieces, and grade is the most direct manifestation of high quality of decoction pieces. However, there is still a lack of scientific and reasonable methods for evaluating the grade of decoction pieces, and it is urgent to establish a widely recognized and unified standard for the grade of decoction pieces to ensure the quality of the decoction pieces and guarantee the safety and efficacy of clinical use. Based on this, this paper focused on analyzing the problems of the current grade evaluation methods, such as unclear distinction between quality standards and grade standards, unreasonable selection of grade evaluation indicators, and inaccurate application of mathematical statistical methods. Based on the analysis of the grade evaluation of decoction pieces, this paper proposed four criteria for establishing the grade evaluation method of decoction pieces, namely universality, comprehensiveness, reliability and convenience, in order to establish a more reasonable and unified grade standard for decoction pieces and promote the quality improvement of decoction pieces and the development of the industry.
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OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese medicine (TCM) decoction pieces in accordance with provincial standards (hereinafter referred to as “local TCM decoction pieces”). METHODS Through simulation scenarios and collecting actual cases ,the conditions of trans-provincial distribution of local TCM decoction pieces were listed ;the official websites were searched or relevant personnel of drug supervision were interviewed;the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted out. Based on the stakeholder theory ,the benefits and risks of main stakeholders were discussed to put forward relevant suggestions from the perspective of benefit /risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial standards,sold and used them in A province ;enterprises in B province produced TCM decoction pieces according to the B provincial standards ,sold and used them in A province ;enterprises in B province produced TCM decoction pieces according to the C provincial standards ,sold and used them in A province. At present ,there are no clear relevant provisions of national laws about trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of the official website of drug regulatory department to online consultation ,and only Shandong ,Shanghai,Liaoning and Jiangxi have issued replies or normative documents. Totally 41.9%,38.7% and 32.3% of the provinces respectively allow the trans-provincial distrbution of local TCM decoction pieces in the above 3 conditions;in addition ,32.3%,16.1% and 22.6% provinces have unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM decoction pieces ,but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug regulatory departments clarify the relationship between the national and local standards for TCM decoction pieces and dingrl375@163.com differentiate the varieties of collection ;clear the regulatory requirements for trans-provincial distribution of local TCM decoction pieces by issuing high-level legal d ocuments;enrich regulatory measures and means ,and gradually adjust the requirements of trans-provincial distribution of local TCM decoction pieces .
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OBJECTIVE To improve the a pplicability of the prescription pre-review system to traditional Chinese medicine (TCM),and improve the quality of prescription review and rational drug use. METHODS The inappropriate pre-review rules of TCM prescription in prescription automatic screening system of our hospital were summarizd ,review rules were revised and the review process was standardized purposefully. The data of prescription review of Chinese patent medicine and TCM decoction pieces were collected from outpatient and emergency department of our hospital in the second quarter of 2020 (before the optimization of review rules )and the fourth quarter of 2021(after the optimization of review rules ). The reasonable rate of prescription and effective rate of intervention before and after the optimization of review rules were compared,and unreasonable problems were counted. RESULTS In our hospital ,the pre-review system had poor applicability in reviewing TCM prescriptions. There were some problems ,such as inconsistent or nonstandard names of TCM decoction pieces ,unreasonable dosage range settings,mechanical review of repeated drug use ,excessively strict review of “eighteen incompatible medicaments ”and“nineteen medicaments of mutual restraint ”and lack of safety warnings for special populations. In view of the above problems ,our hospital standardized the name of TCM decoction pieces ,and optimized the review rules such as dose range of TCM decoction pieces , usage and dosage of Chinese patent medicine ,repeated medication ,drug interaction ,drug taboos for special people ,etc. After the revision of the rules ,the qualification rate of Chinese patent medicine prescriptions increased from 97.38% to 98.17%(P>0.05), and the rate of effective intervention increased from 42.86% to 79.71%(P<0.05);the qualification rate of TCM decoction pieces prescriptions increased from 47.98% to 79.29%(P<0.05),and the rate of effective intervention increased from 11.17% to 29.13%(P<0.05). The number of unreasonable problems such as excessive daily dosage of TCM ,excessive dosage range ,drug interaction and drug contraindications for special groups decreased significantly in our hospital (P<0.05). There was no statistical significance in the number of unreasonable problems of repeated medication between 2 groups (P>0.05),but there was a downward trend. T he total number of unreasonable problems had also decreased significantly (P<0.05). CONCLUSIONS The optimization measures of review rules in our hospital canimprove the applicability of the review system for TCM prescriptions,and improve the quality of prescription review and the level of rational drug use. However ,review rules of indications and the effectiveness of prescription intervention still needs to be further improved.
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As the last procedure of traditional Chinese medicine(TCM) applied in clinical practice, prescription-based processing(PBP) is an important guarantee for the quality and clinical efficacy of TCM, which can not only maximize the effect of processed product, but also exert the characteristics of syndrome differentiation and treatment in TCM. However, due to various reasons, most medical institutions have no PBP business. As a result, doctors can only use the conventional decoction pieces available on the market, which also greatly limits their flexible medication, with certain impacts on the normal development of the curative effect of TCM. Therefore, the article explained the necessity of PBP from three aspects. In addition, according to Chinese Pharmacopoeia and the characte-ristics of TCM decoction pieces, the varieties suitable for PBP were summarized and proposed, and also some suggestions about developing PBP are given. The PBP is one of the characteristic techniques in TCM, with special technical requirements and profound scientific connotation. The development of PBP will not only promote the processing of TCM and ensure the clinical efficacy, but also promote the vigorous development of TCM.
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Drugs, Chinese Herbal , Medicine, Chinese Traditional , PrescriptionsABSTRACT
Texture analyzer is a multifunctional physical property analyzer. Through a variety of test modes such as compression, puncture, shearing and stretching, hardness, adhesion, elasticity, cohesiveness and other physical property parameters are characterized. The results are objective, sensitive, and accurate, which can provide theoretical basis and reference for interpretation of basic theoretical, optimization of prescription technology and quality control research of pharmaceutical preparations. Firstly, the principles, test modes, measurement indexes and measurement data analysis methods of texture analyzer were summarized in this paper. Secondly, the application progress of texture analyzer in solid preparations, semi-solid preparations, liquid preparations, traditional Chinese medicine decoction pieces and their intermediates was described in detail, and compared with the commonly used measurement methods of physical property indicators. Finally, the application prospects of texture analyzer and its research contents to be improved were reviewed, so as to facilitate the use of texture analyzer by pharmaceutical researchers to promote the development of related fields of pharmaceutics, and to provide new ideas and methods for the research and development of pharmaceutical preparations.
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As an important treasure for the research and development of new Chinese medicines, the classical prescriptions have a long medical history in China and are the summary of the clinical experience of the medical experts in the past dynasties. To support the research and development of classical prescriptions,relevant encouraging policies were issued by the state and relevant administrative departments. It is one of the key problems in the development process of classical prescriptions to verify and determine the processing methods of prescription herbal drugs. At present, there is no consensus or standard on such problems of classical prescriptions. In this paper, we sorted out and analyzed the related content of the herb processing for classical prescriptions, summarized the characteristics of the processing methods in the Catalogue of classical prescriptions(First Batch) and the problems faced in the textual research, and put forward some suggestions on the processing and textual research, including four research strategies: sorting out the mainstream methods for herbs in various periods of classical prescriptions, clarifying histological changes in the processing methods, determining the processing methods based on the drug processing characteristics, determining the processing methods based on the processing functions and identifying the processing methods according to the clinical efficacy and indication, so as to provide ideas and references for the research of processing methods involved in classical prescriptions.
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China , Drug Prescriptions , Drugs, Chinese Herbal , Medicine, Chinese Traditional , PrescriptionsABSTRACT
The time of decocting plays an important role in ensuring the clinical efficacy of Chinese medicine decoction and the quality of traditional Chinese medicine, but from ancient times to the present, the judgment of the endpoint of Chinese medicine decoction has always been a technical problem. In this paper, the decocting time and the judgment methods in the Chinese medicine classics "Treatise on Febrile Diseases" and "Treatise on Differentiation and Treatment of Epidemic Febrile Disease" were analyzed. Certain laws of decocting time were found. It was demonstrated that the main factors affecting the decocting time were the disease, the efficacy of the prescriptions, the drug properties, and the characteristics of the medicine, etc. Combined with modern research results, the judgment method of the endpoint of traditional Chinese medicine decoction was expounded, hoping to seek a reasonable scientific basis for the boiling time of Chinese medicine decoction and the extraction process of modern Chinese medicine preparation, and provide a theoretical basis for ensuring the clinical efficacy of Chinese medicine decoction and the quality of Chinese medicine preparations.
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China's Prescription Management Measures stipulates that pharmacists shall examine and verify the appropriateness of drug use of prescription medication. Due to the complexity and diversity of TCM decoction piece, there has been no sufficient clinical report on the application of TCM prescription preview software. TCM prescription audit now stays on pharmacists' artificial trial stage. The points of intervention are reviewed in the middle and afterwards. It cannot be implemented in the same time when the prescription is prescribed by the clinician and previewed by the clinical pharmacist, which is called the preview of prescriptions. Due to the different abilities and experience of pharmacists in TCM treatment based on syndrome differentiation and the time limit of prescription preview, unqualified prescriptions are inevitably omitted during the review. Shanghai Yangpu District Hospital of TCM developed by cooperating with Shanghai Literature Pavilion "TCM Clinical Prescription Preview Audit System" was used to realize the intellectualization of the examination in advance to put forward, formed the real-time intervention. It realizes the intellectualization of "preview" prescription, combines manual "middle" and "afterwards" review and comment, and forms the whole-process monitoring of preview real-time intervention, reviewed in the middle and afterwards intervention, which greatly improves the rational rate of TCM prescriptions. The results of artificial group reviewed in 2018 and intelligent system reviewed in 2019 were applied to the method of comparative study. "TCM clinical prescription preview audit system" has obvious advantages over manual preview of TCM prescriptions. The advantage lies in that the intervention point of prescription review is advanced to the "preview" point, and the detection rate of unqualified prescriptions is significantly improved. Compared with the manual method, the intelligent method of TCM clinical prescription preview system has a great advantage in improving the rational clinical use of TCM prescriptions.
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Chinese herbal medicine decoction pieces(CHMDP), one of the main forms of traditional Chinese medicine(TCM) in clinic, have been widely used. However, the irrational use is increasingly serious due to the lack of the indicators for judging the rational use of CHMDP in medical institutions and the codes and standards for the clinical use of CHMDP. In order to regulate the rational clinical use of CHMDP, improve the clinical efficacy and ensure the drug safety for the patients, clinical pharmaceutical experts and clinical medical experts from 40 third-grade class-A hospitals nationwide were organized to give the "expert consensus on clinical application of CHMDP" in terms of prescription writing, combined use of drugs, use of special drugs, and drug use for special population. Detailed analysis and argumentation were conducted in accordance with the laws and regulations, Chinese Pharmacopoeia 2015 edition, Chinese Pharmacopoeia Code Notice for Clinical Use of Medicine, Administrative Regulations for Prescriptions, Administrative Specifications for Hospital Prescription Review(interim), and Chinese Traditional Medicine Prescription Format and Writing Specifications, as well as relevant project findings.
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Humans , Consensus , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Prescriptions , Reference StandardsABSTRACT
Objective: To analyze the quality of Angelicae Dahuricae Radix (ADR) from national drug evaluation sampling, continuously improve and revise the standard determination method, and ensure the safety of public drug use, six index components of ADR medicinal material and decoction pieces were determined by combining HPLC fingerprint chromatography and quantitative analysis of multi-components by single marker (QAMS). Methods: The determination and exploratory study were carried out according to the National Standard. The establishment of steamed Angelicae dahurica HPLC fingerprint, method for multiple assessment of six index components to conduct a methodological survey determination of multi-index component content of 20 batches of Angelicae dahurica tablets, the final determination of the quality of Angelicae dahurica. Result:s A total of 239 batches of ADR were received from 189 enterprises, in which 225 batches were qualified and 14 batches were unqualified. The qualified rate was 94%. A method that determined content of six kinds of coumarin in ADR decoction pieces using imperatorin as control was established, which could solve the problem of difficulty in obtaining control and consuming long determination time. It would better indicate the drug quality. Conclusio:n The method we had established could be used in qualitative and quantitative analysis of oxypeucedanin hydrate, byakangelicin, oxypeucedanin, berapten, imperatorin and isoimperatorin in ADR decoction pieces. Through this random inspection, it is found that there were still some quality problems in ADR decoction pieces. The quality supervision of traditional Chinese medicine should be strengthened further.
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The quality constant evaluation method was applied to the grading evaluation of Albiziae Cortex decoction pieces. The morphological and component indexes of 12 batches of the decoction pieces were measured, their quality constants were calculated and graded. The results showed that the quality constant ranged from 0.041 to 0.167. If the percentage quality constant ≥ 80%was the first-grade decoction pieces, <80%and ≥ 50%was the second-grade decoction pieces, <50%was the third-grade decoction pieces; the quality constant of the first-grade decoction pieces was ≥ 0.133 6, the second-grade decoction pieces was ≥ 0.083 5 and <0.133 6, and the third-grade decoction pieces was <0.083 5. In this paper, the authors further applied the quality constant evaluation method of skin piece in the grading evaluation of Albiziae Cortex decoction pieces, which proved that the method was reasonable and scientific, and it can provide a reference for the quality grading of this decoction pieces.
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Classical traditional Chinese medicine(TCM) excellent prescriptions is an outstanding representative in prescriptions of traditional Chinese medicine,clinical medicine effective tool,and the essence of traditional culture of Chinese medicine.The research and development of classical TCM excellent prescriptions has attracted great attention from group in the whole industry chain of TCM,a series of guiding suggestions and targeted literature laid a good foundation for research and development of classical TCM excellent prescriptions.In this paper,based on the CNKI database,literature about suggestions or enlightenments of classical TCM excellent prescriptions was sorted and refined in order to build the research outline of classical TCM excellent prescriptions,and it was concluded that literature research was the premise,medicine/decoction pieces with good quality was the foundation,standard substance was the core,high quality was the guarantee and preferential policies were the impetus,and related discussions were carried out.All these were expected to promote the research of classical TCM excellent prescriptions and development of related industries.
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Objective To investigate the effect of self-made traditional Chinese medicine(TCM) decoction on pregnancy outcome in patients with hypertensive disorder complicating pregnancy. Methods A total of 124 pregnant hypertensive patients admitted to the Department of Critical Care of Guizhou Provincial People's Hospital from October 2016 to October 2018 were enrolled. The 62 patients who were treated with western medicine conventional method;62 patients who were treated with self-made TCM decoction on the basis of western medicine conventional method. The western medicine conventional treatment group was given magnesium sulfate combined with nicardipine; the self-made TCM treatment group was supplemented with TCM decoction on the basis of conventional western medicine treatment (composition: uncaria, raw oyster 20 g, gastrodia elata, eucommia, salvia miltiorrhiza, medlar rehmannia glutinosa each 15 g, rhizoma, mulberry parasitic, astragalus, ophiopogonis each 10 g. Severe headache and dizziness plus tortoise shell, gentian grass 15 g, anemarrhenae 10 g; severe edema plus cassia twig, aristolochiae 15 g, astragali, ginger skin 10 g), be decocted in water for oral dose, morning and evening oral, one dose a day, 1 week for a course of treatment, the two groups were continued for 4 weeks after the evaluation of clinical efficacy. The changes of blood pressure and blood coagulation parameters, placental bed arterial hemodynamics, pregnancy outcome index were observed before and after treatment; antihypertensive effects and adverse reactions after treatment were recorded. Results After treatment, the systolic blood pressure (SBP), diastolic blood pressure (DBP), Fibrinogen (Fib), placental bed arterial pulsation index (PI), end-systolic blood flow velocity and end-diastolic blood flow velocity ratio (S/D) and resistance index (RI) in both groups were lower than those before treatment, the prothrombin time (PT) and activated partial thromboplastin time (APTT) were significantly longer than before treatment, and the time-averaged flow rate (TAV) increased than that before treatment; SBP, DBP, Fib, PI, S/D and RI were significantly lower in self-made TCM treatment group than those in western medicine conventional treatment group [SBP (mmHg, 1 mmHg = 0.133 kPa): 114.26±17.07 vs. 132.72±17.64, DBP (mmHg): 82.98±6.24 vs. 90.09±6.48, Fib (g/L): 3.21±0.45 vs. 3.64±0.31, PI: 0.59±0.14 vs. 0.75±0.15, S/D: 1.70±0.21 vs. 1.93±0.25, RI: 0.43±0.08 vs. 0.54±0.12, all P < 0.05], PT, APTT, TAV in self-made TCM treatment group were significantly higher than western medicine conventional treatment group [PT (s): 12.26±0.57 vs. 11.72±0.44, APTT (s): 27.11±1.34 vs. 25.69±1.48, TAV (cm/s): 15.64±2.88 vs. 12.49±2.76, all P < 0.05]. The rate of cesarean section, postpartum hemorrhage, fetal heart abnormality and neonatal asphyxia in self-made TCM treatment group were significantly lower than those in western medicine conventional treatment group [cesarean section rate: 9.84% (6/61) vs. 27.78% (15/54), postpartum hemorrhage rate: 1.64% (1/61) to 14.81% (8/54), fetal heart abnormal rate: 3.28% (2/61) vs. 16.67% (9/54), the incidence of neonatal asphyxia: 1.64% (1/61) vs. 12.96% (7/54), all P < 0.05]. The total effective rate of the self-made TCM treatment group was significantly higher than that of western medicine conventional treatment group [98.39% (61/62) vs. 87.10% (54/62), P < 0.05]. However, there was no significant difference in the incidence of adverse reactions between the self-made TCM treatment group and western medicine conventional treatment group [16.39% (10/61) vs. 16.67% (9/54), P > 0.05]. Conclusion Self-made TCM decoction can improve the maternal and infant outcomes by improving the hypercoagulable state and placental hemodynamics in hypertensive patients with hyperthyroidism, the antihypertensive effect is remarkable and the safety is good.
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Objective To determine the water absorption coefficient of single-flavor root and rhizome Chinese herbal medicine pieces at room temperature, and guide the water addition in the decoction process of decocting machine of Chinese herbal.Methods The water absorption coefficient of 222-flavor root and rhizome Chinese herbal medicine pieces were studied, the simulated prescriptions were decocted according to the recommended formula of the decocting machine manufacturer and the water absorption coefficient, and the amount of liquid were obtained by the two methods which were compared with the amount of liquid required.Results The water absorption coefficients of roots and rhizomes with different textures were quite different.The amount of liquid obtained according to the manufacturer′s recommended formula was quite different from the amount of liquid required and there was no rule to follow.The error of the amount of liquid obtained according to the water absorption coefficient and the amount of liquid required was small and regular.Conclusion The experimental determination of the water absorption coefficient of traditional Chinese medicine decoction pieces could guide the amount of water added to the decoction machine.
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Objective To analyze the characteristics and regularity of the dosage of single-flavored traditional Chinese medicine decoction pieces, and to provide reference for determining the reasonable dosage range. Methods The dose distribution of single-flavored drugs with a frequency of more than 10% of the total prescriptions from January to June2018 was investigated, and compare with the 2015 edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as "Chinese Pharmacopoeia") and other recommended doses. Results There were 32 kinds of single-flavored traditional Chinese medicine decoction pieces, which accounted for more than 10% of the total prescription. The top 5 dose distributions were 10 g, 15 g, 9 g, 30 g and 6 g, respectively, accounting for nearly 90%.These 32 pieces were not used in large-dose applications in our outpatient prescriptions, and there were some ultralow-dose applications; there were 21 pieces with more than 90% of the doses in the scope of the Chinese Pharmacopoeia. In the clinical use of traditional Chinese medicine decoction pieces, there were cases of out of the scope of the Chinese Pharmacopoeia, but were not prominent. Conclusion The reasonable dosage ranges of commonly used traditional Chinese medicines needs further study; the clinical use of traditional Chinese medicine decoction pieces should consider both safety and dose-effect relationship.
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Decoction piece is the basic unit of traditional Chinese medicine(TCM) prescriptions, and it is also the main material basis for clinical efficacy of TCM. The clinical efficacy of TCM decoction pieces is very important for the overall efficacy of TCM prescriptions. However, the current quality evaluation of TCM decoction pieces mainly focuses on the amount of intrinsic substances and compositions. The basic researches such as toxicology and pharmacology are deeply, but lacking with the evidences from clinical evaluation. Therefore, the current decoction pieces quality evaluation system is difficult to objectively reflect the clinical effect of traditional Chinese medicine, forming the only componential theory or blindly pursuing the large volume and heavy weight of medicine materials. The quality standard of Chinese decoction pieces is biased,with concerns that "TCM will die from Chinese medicine". Therefore, this paper proposes that it is urgent to clinically evaluate the TCM decoction pieces,and regard the clinical evaluation as a starting point and a foothold for the quality evaluation of TCM decoction pieces, based on the origin identification, origin evaluation, product evaluation, content evaluation, and harmful substance detection as an auxiliary support. Finally a new quality evaluation system for TCM decoction pieces with a clinical evaluation as the core is formed, which is composed of six steps, aiming to promote the quality improvement of TCM decoction pieces. Of course, because there is no mature experience in the clinical evaluation of TCM decoction pieces, the quality evaluation system has some challenges such as complex processes and high cost, but it is essential for maintaining the quality of medicinal materials and life safety. Therefore, it is of importance and urgency to construct and implement the quality evaluation system.
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Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese TraditionalABSTRACT
·AIM: To study the clinical efficacy of integrative therapy in the treatment of non-proliferative diabetic retinopathy.·METHODS: Ninety patients ( 90 eyes ) in our hospital with non - proliferative diabetic retinopathy were randomly divided into three groups. All three groups were treated with diabetes drugs to control blood sugar. The first group was treated with western medicine, the second group was treated with Chinese medicine decoction Traditional Chinese Medicine ( TCM ) treatment, and the third group was treated with the combination of those two methods. All patients were recorded and analyzed changes of clinical effects after 6 courses of treatment.·RESULTS: After 6 courses of treatment, the total efficacy rate of the third group was 86%, markedly higher than that of the first group (57%, P<0. 05) as well as the second group (60%, P<0. 05). The integrative group improved more markedly in terms of vision, macular edema absorption, and ERG b-wave amplitude restoration, the difference being statistically significant (P<0. 05) when compared to the first and the second group.· CONCLUSION: Integrative treatment of diabetic retinopathy could effectively improve the therapeutic effect in patients with non-proliferative retinopathy.