OBJECTIVE: To conduct qualitative and quantitative analyses of Tripterygium hypoglaucum in Yinning Tablets, a compound preparation of traditional Chinese herbal medicine. METHODS: Thin-layer chromatography (TLC) was used for qualitative analysis of Tripterygium hypoglaucum in Yining Tablets and the analytical protocols were optimized. High-performance liquid chromatography (HPLC) was used to quantitatively analyze the content of triptolide (the main active ingredient of Tripterygium hypoglaucum) in Yinning Tablets. RESULTS: The results of TLC analysis showed that the test sample of Yinning Tablets and the positive control samples both produced clear, well separated spots without obvious interference in the blank samples. Assessment of the influences of the thin-layer plates from different manufacturers, temperature and humidity on the test results demonstrated good durability of the test. HPLC analysis of triptolide showed a good linear relationship within the concentration range of 1-100 μg/mL (regression equation: A=22.219C-19.165, r=0.9999); the contents of triptolide in 3 batches of Yinning tablets were 0.34, 0.34, and 0.28 μg per tablet, all within the range of 0.28-0.34 μg per tablet. It was finally determined that each Yinning tablet should not contain more than 0.6 μg of triptolide. CONCLUSION TLC and HPLC are simple, accurate, durable and specific for qualitative and quantitative analyses of Tripterygium hypoglaucum in Yinning Tablets.
China ; Chromatography, High Pressure Liquid/methods* ; Plant Preparations ; Tablets ; Tripterygium/chemistry*

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.
Drugs, Chinese Herbal ; Herbal Medicine ; Medicine, Chinese Traditional ; Pharmaceutical Preparations ; Plant Extracts ; Quality Control

Professor believes that infantile cerebral palsy is located in the brain and closely related to the kidney. The clinical treatment should focus on the brain theory and root at the kidney. In pathogenesis, infantile spastic cerebral palsy refers to flaccidity of and spasticity of . The principle of treatment should be balancing and , promoting the circulation of the governor vessel and regulating the spirit/mind. In clinical treatment, the comprehensive therapy of acupuncture and herbal medicine is adopted. In acupuncture, the acupoints on the head and the face are dominant and the body acupoints are selected rigorously and precisely. The herbal formula with and is used and taken orally with warm water. In acupoint application treatment, and are the main herbal medicines for the external application at Shenque (CV 8) and Baihui (GV 20). All of the above therapies are used in combination to co-achieve the effect of regaining consciousness, opening orifices and benefiting the intelligence. The clinical therapeutic effect of this comprehensive therapy is significant.
Acupuncture Points ; Acupuncture Therapy ; Cerebral Palsy ; therapy ; Herbal Medicine ; Humans ; Plant Preparations ; therapeutic use

With the development of society, more and more foreign natural medicines have entered China, but they are faced with the problem that they are not given with the traditional Chinese medicine(TCM) properties when they are used with other TCM. When we carried out the research on introducing foreign natural plant resources to TCM, gradually, a new research model and field with original characteristics of TCM--the study of new foreign introducing TCM had been formed. In the process of it, we explored and summarized research rules to form the research paradigm, which will be conducive to the standardization and scientization of new foreign introducing TCM research. For the research of foreign introducing TCM, we analyzed the research background, reviewed the application history, sorted out the research status, elaborated the concept and summarized the research achievements. On this basis, we put forward the concept and system of the modern research paradigm of new foreign introducing TCM, studied and clarified the core elements, properties and research principles of this paradigm, and summarized the research contents and methods of new foreign introducing TCM. We interpreted the foundation of paradigm construction from multiple perspectives. The paradigm was the practical application of theoretical innovation of TCM. Under the guidance of it, more and more varieties of new foreign introducing TCM will be studied, the study will be more standardized, the conclusions will be more scientific and reliable, which will inspire and guide more researchers to focus on the research of new foreign introducing TCM, and the paradigm itself will be constantly improved. The construction and application of the paradigm will certainly accelerate the innovative research of foreign introducing TCM and play a historic role in promoting the enrichment of traditional Chinese medicine varieties.
China ; Drugs, Chinese Herbal ; Internationality ; Medicine, Chinese Traditional ; Plant Preparations/standards* ; Research Design

This study aims to explore the evaluation model for the proficiency testing of heavy metal and harmful element residues in pharmaceuticals,and to provide reference for the proficiency testing program and proficiency testing result in the field of residue analysis. The proficiency test result of cadmium determination in honeysuckle as an example. The algorithm A,NIQR,and Horwitz function are used to calculate the assigned value and the standard deviation. Z was obtained at the same time. If | Z | ≤2,the result is satisfactory. If 2< | Z | <3,the result is questionable. If | Z | ≥3,the result is unsatisfactory. In addition,the median value is the assigned value,and deviation(D%) is used. If D% is not more than 16%,the result is satisfactory; if D% is more than 16%,the result is unsatisfactory. After analysis,in the results of questionable or dissatisfied laboratories calculated by algorithm A and NIQR,the deviation error of some data is within the scope of the standard. In the results of the satisfactory laboratory evaluated by the Horwitz function,some data deviation errors far exceed the standard range. The evaluation result of the D% meets the requirements. According to heavy metal and harmful element trace analysis methods,this study is the first to apply D% to the evaluation of the detection ability of heavy metals and harmful elements in pharmaceuticals. This method makes the evaluation result more reasonable,and has important reference significance for the evaluation of other proficiency test results.
Cadmium ; analysis ; Laboratories ; Laboratory Proficiency Testing ; Lonicera ; chemistry ; Pharmaceutical Preparations ; standards ; Plant Preparations ; standards ; Trace Elements ; analysis

Chrysosplenium nudicaule,Tibetan name " Yajima",is recorded as an effective medicine for the treatment of liver and gallbladder diseases by Tibetan Pharmacopoeia published in the past dynasties,but its traditional efficacy has not yet been investigated by means of modern pharmacological research methods. In this paper,the protective effect of extract of C. nudicaule(ECN) on liver injury in mice was observed by using the mice model of intrahepatic cholestasis(IC) induced by α-naphthyl isothiocyanate(ANIT) and the possible mechanism by which ECN work as the therapeutic agent was discussed. The results showed that the serum levels of AST,ALT,ALP,DBIL,TBIL and TBA of the model mice were notably reduced in dose-dependent manner(P<0. 01,P<0. 05). The activity of SOD and GSH-Px in the liver homogenate of mice was increased,while the content of MDA was decreased(P<0. 01,P<0. 05).Pathological examination of liver in mice showed that ECN could improve the pathological changes of liver tissue in mice. The mRNA expression level of genes related to bile acid metabolism were detected by RT-PCR and the results suggested that ECN could significantly increase the expression of genes such as BSEP,FXR and MRP2(P<0. 01,P<0. 05),meanwhile significantly reduce the expression of CYP7 A1(P<0. 01,P<0. 05). These results confirmed the protective effect of ECN on intrahepatic cholestasis-induced liver injury in mice,and indicated that the mechanism may be related to activating FXR and its target genes,reducing bile acid synthesis and increasing bile acid excretion. This study provides a modern pharmacological basis for the clinical application of Yajima in Tibetan medicine.
Animals ; Cholestasis, Intrahepatic ; chemically induced ; drug therapy ; Liver ; Medicine, Tibetan Traditional ; Mice ; Plant Preparations ; pharmacology ; Saxifragaceae ; chemistry

The herbal formula, DF-02, consisting of Ephedra intermedia and Rheum palmatum are used for the treatment of the metabolic diseases such as obesity and liver fibrosis in Korean local clinics. We aimed to develop the simultaneous analytical conditions for four standards, (+)-pseudoephedrine (PSEP) and (−)-ephedrine (EP) for E. intermedia, and aloe-emodin (AE) and chrysophanol (CP) for R. palmatum using HPLC-UV techniques. The validated conditions yielded the high precision (relative standard deviation (RSD) < 3.65%) and the recoveries (94 – 106%) using the calibration curves with high linearity (R² > 0.9994). As a result, four standards of DF-02 were simultaneously determined under the developed method, which will be utilized for the quality control or evaluation of DF-02 and many herbal preparations containing E. intermedia and R. palmatum.
Calibration ; Chromatography, High Pressure Liquid ; Ephedra ; Liver Cirrhosis ; Metabolic Diseases ; Methods ; Obesity ; Plant Preparations ; Quality Control ; Rheum

BACKGROUND: Herbs have been used worldwide as complementary and alternative medicines. In Korea, herbs for medical purpose are strictly controlled by the Korea Food and Drug Administration (KFDA). But it does not provide standards for metal antigens. OBJECTIVE: This study conducted to identify the metal contents of Korean herbs and herbal products and to give information on counselling metal allergic patient. METHODS: The concentration of three metal allergens with high antigenicity, cobalt (Co), chromium (Cr), nickel (Ni) was quantitatively determined using inductively coupled plasma with a mass spectrometer after nitric acid (HNO₃) digestion. The herbal objects are as follows: 1) ten kinds of herb plants, 2) ten herbal products sold in Korean drugstores, and 3) ten herbal extracts prescribed by Korean herbal doctors. RESULTS: In 30 samples, Ni and Cr were detected in all items. Co was not detected in two drugstore products. CONCLUSION: Although the levels of metal detected in this study were very low relative to international guidelines and KFDA regulations, the herbal preparations contained similar or higher metal levels than known metal-rich foods. It can cause problems when it added to the daily diet and cause deterioration of skin lesions of metal sensitized person.
Allergens ; Chromium ; Cobalt ; Complementary Therapies ; Dermatitis ; Diet ; Digestion ; Herbal Medicine ; Humans ; Korea ; Metals ; Nickel ; Nitric Acid ; Plant Preparations ; Plasma ; Skin ; Social Control, Formal ; United States Food and Drug Administration

Background: Herbal supplementation has been used by diabetic patients, unfortunately it has regulatory, safety, and efficacy concerns. Objective: This review was conducted to determine the best evidence in terms of the identified active substance, mechanism of action, pre-clinical and clinical studies of commonly used local herbal preparations. Methods: This is a qualitative review of both local and international published medical literature to identify and summarize information on the use of herbal supplementation in diabetes. Results: After the initial review, the authors identified thirteen herbal preparations that have been investigated for its anti-diabetic properties. Six have extensive studies including randomized controlled trials but cinnamon and fenugreek seed are not readily available locally. Their detailed review eventually focused on four locally available herbal preparations i.e. bitter melon, turmeric, aloe vera and banaba. They decrease glucose absorption and gluconeogenesis, improve glucose utilization and insulin production. Unlike conventional anti-diabetics, herbal preparations also have favorable effect on lipid metabolism and anti-oxidant effect. Bitter melon seems to be the best herbal preparation. But human studies of bitter melon showed it is inferior to conventional anti-diabetic drugs in terms of its anti-diabetic effect but better in terms of its effect on lipid metabolism and anti-oxidant properties. Turmeric, aloe vera and banaba have also been shown to have anti-diabetic effects. Conclusion In summary, herbal preparation may have multiple beneficial effect for patients with diabetes. Use of combined preparations can produce complementation of the effects and may be a promising approach to the use of herbal supplementation as treatment standard among patients with diabetes.
Dietary Supplements ; Plant Preparations

Background: In the past musculoskeletal complaints were treated with topical preparations from medicinal plants until the advent of NSAIDs. However, because of the side effects of NSAIDs, interest has increased on going back to the use of topical traditional herbal medicines in patients with musculoskeletal pain. Objective: This review was conducted to identify the active substance, its mechanism of action, pre-clinical and clinical studies and propose a topical herbal formulation balancing its analgesic and anti-inflammatory effect with skin care effect among patients with various somatic pain conditions. Methods: This is a qualitative review of both local and international published medical literature to identify and summarize information on the use of topical herbal preparation for the treatment of musculo-skeletal pain. Results: After the initial review, the authors identified six herbal preparations that have been investigated for its analgesic and anti-inflammatory properties in clinical trials. They eventually arrived at a consensus to consider the final combination of ginger, capsaicin, peppermint and virgin coconut oil. Gingerol, a naturally occurring plant phenol, is one of the major components of ginger known to have diverse pharmacologic effects including anti-oxidant, anti-apoptotic, and anti-inflammatory activities in vitro and in vivo. Capsaicin is a highly selective agonist for the transient receptor potential vanilloid 1 receptor expressed in nociceptive sensory nerves. The mechanisms underlying capsaicin-induced analgesia likely involve reversible ablation of nociceptor terminals. Local application of peppermint oil generates a long-lasting cooling effect on the skin and result to muscle relaxation. Ginger, capsicum and peppermint have been shown in clinical trials to relieve musculoskeletal pain and inflammation. Virgin coconut oil on the other hand has no analgesic effect but has been shown in some studies to be favorable for skin conditions and facilitate skin penetration of some substances. Conclusion Using combined preparation may have the advantage of complementation of its effect i.e. analgesic and anti-inflammatory effect of ginger, warm sensation of capsicum and the cold sensation of peppermint.
Musculoskeletal Pain ; Anti-Inflammatory Agents, Non-Steroidal ; Plant Preparations