Traditional Medicine Products Research Articles

Analysis of Chemical Materials of Sodium Diclofenac Drugs In Legal Private Food Which is Different in Makassar

Sore herbal medicine is one of the traditional medicine products that many people interested in due to it can eliminate the muscle pain and arthritis, accelerate blood circulation, strengthen body endurance and eliminate pain through out the body. One of the medicinal chemicals which is commonly added in thesore herbal medicine is diclofenac sodium. This study aimed to analyze the chemical content of diclofenac sodium drug in the sore herbal medicine dosage fom. There were 7 herbal medicine this research is 7 kinds of brand circulating in Makassar city with the criteria most demand by the society. Qualitative analysis of the diclofenac sodium drug was conducted by thin layer chromatography (TLC), used silica gel stationary phase and the mobile phase of ethyl acetate : gacial acetic acid : toluene (60:40:1). The result showed that A, C and G positive sample contain dicklofena sodium with Rf value equal to diclofenac sodium standard, Rf = 0,69. The quantitative analysis by UV-Vis spectrophotometry at the wavelength 280 nm with variation of concentration 4, 6, 8, 10, 12, 14 and 16 ppm was obtained diclofenac sodium content for sample A with 154 mg/g, for C 28,302 mg/g and sample G 6,908 mg.g.
 
 Keyword: Diclofenac Sodium, Rheumatic Paint, Spectrophotometry UV-Vis

AN OVERVIEW OF THE JUDICIARY AGAINST THE MARKETING AUTHORIZATION WHICH WAS REPEALED OF TRADITIONAL MEDICINAL PRODUCTS BRAND PI KANG SHUANG IN SAMARINDA BASED ON LAW NO. 36 OF 2009 ON HEALTH

In traditional medical products brands Pi Kang Shuang, experiencing problems with marketing authorization that are not listed on the traditional medical products Pi Kang Shuang brands, there are two problems in this thesis any reason What are the factors still circulating products not my traditional medical Pi Kang Shuang brands do not have a marketing authorization in Samarinda and how control center taken for the Food and Drug Administration's efforts (BBPOM) on the circulation and trafficking in conventional drugs that have not been recorded in the city of Samarinda. The purpose of this study was to determine the cause of traditional medicines that were not registered in the city of Samarinda trading and identify enforcement conducted by the Food and Drug Administration Center (BBPOM) in Samarinda for violating trading traditional medicines that are not registered and do not have BPOM number in the city of Samarinda. Writing method that I use is an experimental research done by direct observation of spaciousness for data collection, processing and analysis of law data on enforcement brand traditional medicinal Pi Kang Shuang products who do not have marketing authorization, which is where the study's authors are still trading products exist traditional medical Pi Kang Shuang brands. The concept of the book is provided to improve the supervision of the Centre for Food and Drug Control, provide guidance on traditional medicine which has a legitimacy that would come at a time when there is no longer in traditional medicine has not traded for marketing authorization

Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production.

Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules. Despite their classification as medicinal products is already well recognized, there is still a lack of information and indications to validate methods and to adapt the noncompendial and compendial methods to these peculiar biological products with intrinsic characteristics that differentiate them from classic synthetic or biologic drugs. In the present paper, we present the results of the validation studies performed in the context of MSC development as ATMPs for clinical experimental use. Specifically, we describe the validation policies followed for sterility testing, endotoxins, adventitious viruses, cell count, and immunophenotyping. Our work demonstrates that it is possible to fully validate analytical methods also for ATMPs and that a risk-based approach can fill the gap between the prescription of the available guidelines shaped on traditional medicinal products and the peculiar characteristics of these novel and extremely promising new drugs.

Chemical Form and Bioaccessibility of Mercury in Traditional Tibetan Medicines

Extremely high mercury (Hg) concentrations have been identified in traditional Tibetan medicine (TTM) products, but the chemical form and bioaccessibility of Hg remain unknown. We conducted experiments to explore whether the Hg contained in TTM is toxic. We determined that HgS is not the exclusive form of Hg in TTM; other compounds could be present in substantial quantities, ranging from 2 to 52% of the total Hg in commonly used TTMs. A substantial amount of Hg could be released from TTM after ingestion. In total, an average of 12 μg of Hg (mostly inorganic)/g (range of 0.41–25 μg of Hg/g) in TTMs was released into the liquid phase in simulated human gastrointestinal environments. However, different from the results from ingestion by fish, the release of Hg from TTM in the intestinal environment is larger than that in the gastric environment by a factor of 2. In the case of joint ingestion with protein-rich products, releases of methyl Hg and inorganic Hg from TTM in gastrointestinal environments could be...

Discussion on assessment method of Chinese medicine resources

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.

DNA barcoding for the efficient and accurate identification of medicinal polygonati rhizoma in China.

Polygonati rhizoma (PR), a traditional medicinal and edible product with various bioactive components (Polygonatum polysaccharides, saponins, phenols, and flavonoids), is widely consumed in China. However, other species with morphological characteristics similar to those of the actual components are being used to replace or adulterate PR, causing issues with quality control and product safety. The morphological similarity of PR and its substitutes makes classic morphological identification challenging. To address this issue, DNA barcoding-based identification using ITS2 and psbA-trnH sequences was applied in this study to evaluate the efficiency and accuracy of this approach in identifying PR samples collected from 39 different regions in China. The identification of PR by this method was confirmed by other methods (phylogeny-based and character-based methods), and all the samples were clearly and accurately distinguished. This study highlights the efficient and accurate nature of DNA barcoding in PR identification. Applying this technique will provide a means to differentiate PR from other altered formulations, thus improving product quality and safety for consumers of PR and its products.

DEVELOPMENT OF QUALITATIVE PHARMACOGNOSTIC AND HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC FINGERPRINTING OF MORPHOLOGICAL SIMILAR SPECIES OF GENUS FICUS

Objective: Ficus deltoidea (FD) and Ficus benjamina (FB), popularly known as “jack tree/mas cotek” and “pimpri/java fig,” respectively, in India and are used in folk medicine to treat the wound, ulcers, diabetes, microbial infections, and inflammatory disorders. Such therapeutic claims have also been justified in the literature by their rich chemical diversity. Both the plant species are morphologically similar and used unauthentically as the traditional medicinal product. Although these plants are sold in the local market by a traditional medicinal healer, we did not find any authenticated data on its quality.Methods: In the present study, quality standards of both the plant drugs have been developed and compared by performing morphological, microscopical, physicochemical, phytochemical, and high-performance thin-layer chromatographic (HPTLC) analysis. using CAMAG Linomat 5 instrument (Kindly delete the bold matter).Results: It was revealed that both the plant species have similar pharmacognostic features with some differences in type of stomata, presence of marked midrib, arrangement of the cell, cell structures, and meristele. HPTLC data revealed that the primary component in FD leaves (FDL) and FB leaves (FBL) extracts was found at Rf 0.67 and 0.37 with the respective peak area of 35.61% and 34.71%. The peaks at Rf 0.17 and 0.27 can be appeared as the chemical marker to highlight the quality of FDL, whereas peaks at Rf 0.87 and 0.95 can be considered to identify and chemically standardize the FBL.Conclusion: This study highlighted essential characters which contribute to the standardization, identification, and authentication of plant drugs.

Efficacy of Saussurea costus (Qost) Oil as an Iranian Traditional Medicine Product on Female Urinary Incontinence; Double Blinded Randomized Clinical Trial

Background and objectives: Urinary incontinence is a public complaint that causes discomfort, embarrassment and costs. Also, there are some limitations and insufficiencies of drug therapy and surgical complications. This study has compared the effect ofSaussurea costus (qost) oil as an Iranian traditional medicine product and other contemporary medicine treatment methods on female urinary incontinence. Methods: A parallel double blinded placebo-controlled study was conducted. Thirty to 70 years old women with urinary incontinence were allocated in placebo and intervention groups, 41 patients in each group.Intervention and placebo groups received qost oil and placebo, respectively by local application twice daily below the navel without massage. The results were evaluated with valid questionnaires (ICIQ-SF and I-QOL). For evaluation, Chi-square test, independent-sample t-test and repeated measure analysis of variance were used. Significant p value was Results: A significant decrease in mean scores of the questionnaires during the study was noted in the qost group compared to the placebo group (p<0.001). Before the intervention, thirty one patients in the placebo group and 33 patients in the qost group had mixed urinary incontinence (p=0.794). Urge symptom s(nocturia, urine frequency and urgency to urination) were completely discontinued in 25 patients in the qost group (78.1%) and 7 patients in the placebo group (22.6%) (p<0.001). Conclusion: The results suggested the oil to be effective in treatment of urinary inconsistence.

Influence of harvest stage on the pharmacological effect of Angelica dahurica

BackgroundBaizhi (Angelica dahurica) has been widely used as a traditional Chinese herbal medicine, functional food and cosmetic product ingredient, mostly because of the high furanocoumarin compounds in roots. The cropping system of Baizhi with its unique summer dormancy feature, is easily affected by the transition of its growth stages. The aim of this study was to analyze the quantity (size, form and dry weight [DW]) and quality (antioxidant and furanocoumarin content) of taproot and lateral root from three growth stages of Baizhi; vegetative (V-stage), summer dormancy (S-stage) and bolting stage (B-stage).ResultsRoot length and diameter were lower at V-stage than the other two stages, and S-stage had higher lateral root to total root ratio. However, the highest root DW was observed at S-stage. Antioxidant activity was revealed by 2,2-diphenyl-l-picrylhydrazyl and Fe2+ chelating assay, and the content of six furanocoumarin compounds, including xanthotoxin, bergapten, oxypeucedanin, imperatorin, phellopterin and isoimperatorin, was analyzed by liquid chromatography. Although the antioxidant activity was less at S-stage than the other stages, furanocoumarin contents showed little variation.ConclusionConsidering the high DW and stable furanocoumarin composition, S-stage is the best harvest stage than the other stages because of its richer total pharmacological content.

Rapid Simultaneous Determination of Andrographolides in Andrographis paniculata by Near-Infrared Spectroscopy

ABSTRACTThe potential of near-infrared spectroscopy (NIRS) for the quality control of traditional Chinese medicine has been evaluated. Seven quantitative parameters, andrographolide, deoxyandrographolide, dehydroandrographolide, neoandrographolide, moisture, ash content, and alcohol-soluble extract of Andrographis paniculata, were evaluated by NIRS. The reference values of andrographolides were determined by high-performance liquid chromatography, and the others were obtained using the standard methods of the 2015 Chinese Pharmacopoeia. The predicted values were determined by a quantitative model using NIRS based on partial least square regression. Different spectral preprocessing methods, spectral ranges, and optimum number of factors were selected to optimize the models. All models were estimated by the combination of various parameters, including the correlation coefficient of calibration for andrographolide, deoxyandrographolide, dehydroandrographolide, neoandrographolide, moisture, ash content, alcohol-soluble extract (values of 0.980, 0.984, 0.989, 0.983, 0.987, 0.988, 0.979, respectively), root mean square error of calibration (values of 0.156, 0.038, 0.050, 0.029, 0.604, 0.431, 0.135, respectively), root mean square error of prediction (values of 0.169, 0.041, 0.050, 0.033, 0.280, 0.493, 0.140, respectively), root mean square error of cross-validation (values of 0.626, 0.114, 0.158, 0.046, 1.145, 0.774, 0.508, respectively), and ratio of standard deviation to standard error of prediction (values of 4.583, 4.690, 4.796, 4.899, 4.899, 4.690, 5.099, respectively). The results show that the calibration models by NIRS are reliable and can be applied for the quantification for seven parameters from A. paniculata for quality control in traditional Chinese medicine production and processing.

Geographical discrimination of Glechomae Herba based on fifteen phenolic constituents determined by LC-MS/MS method combined with chemometric methods.

Glechomae Herba (GH) is rich in bioactive phenolic constituents and is widely used for treatment of cholelithiasis, urolithiasis and dropsy. The simultaneous determination of phenolic constituents in GH from different geographical origins is significant for authentication and quality control purposes. In this study, we developed a strategy integrating targeted analysis and chemometric methods for quality evaluation and discrimination of GH from different geographical origins. Firstly, an accurate and reliable liquid chromatography-tandem mass spectrometry method was developed for simultaneous quantification of 15 phenolic constituents in GH from different geographical origins. The established method was well validated in terms of desirable specificity, linearity, precision and accuracy. Secondly, the quantitative data were subjected to principal component analysis and orthogonal partial least squares discriminant analysis. Thirdly, a heatmap visualization was employed for clarifying the distribution of 15 phenolic compounds in GH from different geographical origins. These results indicated that GH samples from Shandong province obviously differ from those from other provinces in the content of bioactive phenolic constituents. Collectively, the proposed platform might be a suitable tool for quality evaluation and discrimination of GH from different geographical origins, providing promising perspectives in tracking the formulation processes of traditional Chinese medicine products.

Fat and protein content in Turkish hazelnut (Corylus colurna L.) in Kastamonu province

Turkish hazelnut (Corylus colurna L.), the mother land and natural spreading area of which is Anatolia, is one of the important hazelnut species in Turkey. Moreover, thanks to its adaptation capability to extreme climate and poor soils conditions, it is a forest tree species playing a key role in climate change scenarios. Turkish hazelnut, a Euro-Siberian flora element in Turkey, is a taxon present in the ''Low Risk'' category according to the IUCN Red List. Turkish hazelnut which spreads disorderly-partially and in an isolated way in small stands, groups, clusters as individuals, has the most intense spreading in the Northwestern Anatolian forests in Anatolia. The fruits of the Turkish hazelnuts are being utilized as a valuable traditional medicinal herbal product in different regions of the world. This paper aims to identify and to compare the fat and protein composition of Turkish hazelnut kernels among and within four populations (Ağlı-Tunuslar, Ağlı-Müsellimler, Araç-Güzlük and Tosya-Küçüksekiler) in Kastamonu region. According to the results of the study; the mean values of fat and protein content were found to be 62.78% and 16.32% respectively. In terms of protein values, significant differences were identified among the populations. However, there were no significant differences among the populations regarding the fat values. The highest median value of the protein was found in Ağlı-Tunuslar with a rate of 18.43%. There is no variation within populations as to fat and protein values. The study suggests that similar studies be continued in detail based on different ecological conditions and genotypes.

Effects of drying methods on contents of bioactive compounds and antioxidant activities of Angelica dahurica.

Baizhi (Angelica dahurica) has been widely used as a traditional Chinese herbal medicine, functional food and cosmetic product ingredient, mostly because of the high furanocoumarin compounds in roots. Because the fresh root is perishable, drying techniques are needed to maintain a higher-quality product. Freeze-drying is the best method but energy-consuming and costly. The aim of this study was to analyze the quality (antioxidant and furanocoumarin content) of Baizhi roots after freeze-drying (the control) and in-the-shade, 40 and 70°C drying. Antioxidant activity was revealed by 2,2-diphenyl-1-picrylhydrazyl and Fe2+ chelating assay, and the content of six furanocoumarin compounds, including xanthotoxin, bergapten, oxypeucedanin, imperatorin, phellopterin and isoimperatorin, was analyzed by liquid chromatography. Antioxidant activity was greater in roots with in-the-shade, 40 and 70°C drying than freeze-drying. The furanocoumarin content pattern was similar with 70°C drying and freeze-drying. A. dahurica roots dried at 70°C may be an alternative method for maintaining high quality.

The Effect of Flixweed-Honey Vaginal Product on Cervicitis: a Clinical Trial

Background and objectives: Cervicitis is a common and recurrent gynecologic disease which is usually resistant to treatments. This study was conducted to investigate the effect of Iranian traditional medicine (ITM) product, flixweed- honey, on cervicitis. Methods: A quasi-experimental study was conducted as a clinical trial before and after the intervention at the School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. The married women referring to the clinic aged 17-55 years with a diagnosis of cervicitis who were not pregnant and breastfeeding, without any history of cervical polyps and pelvic surgery, and non-concurrent use of herbal or other chemical medicines were included in the study. During this research, 97 patients were treated through the vaginal use of flixweed- honey for two weeks. One week after the treatment, clinical symptoms were examined. Results: Among 97 patients who were evaluated in this study, 72 returned for follow-up. All subjective and objective parameters including vaginal irritation, itching, discharge, bleeding and pain after coitus, tenderness, and cervical wound size and friability improved significantly in comparison to the time before taking the medication. There was no treatment; five patients (0.69%) who took the medication had vulvovaginal itching that was resolved after 3-4 days. Conclusions: Vaginal product of flixweed– honey could be used in the treatment of clinical symptoms of cervicitis regardless of the reason causing cervicitis, without causing severe or serious side effects.

Potensi Tumbuhan Kelakai (Stenochlaena palustris (Burm.F.) Bedd.) asal Kalimantan Tengah sebagai Afrodisiaka

The necessity of traditional medicine is efficacious as aphrodisiac increasing every year. The Dayak community believes that Kelakai roots have efficacy as an aphrodisiac drug, but no studies were conducted relating to the efficacy of the Kelakai roots. Traditional medicinal products are efficacious as aphrodisiac have a hormone-like effect, usually contain active ingredients that have estrogenic properties among other things, progesterone, androgenic, adaptogenic, and ketogenic. Materials that are androgenic or adaptogenic nature helps maintain and restore stamina. This research was aimed to determine the content of the active compound on the Kelakai roots that efficacious as an aphrodisiac and to determine the profile of Thin Layer Chromatography (TLC) of active compound contained in Kelakai roots. This study used the identification method of chemical compounds such as starches and aleurone, tannins, catechols, flavonoids, alkaloids, saponins, and steroids for simplicia powder and ethanol extract of Kelakai roots. The extraction of Kelakai roots done by soxhletation and TLC used to identify a specific chemical compound. The result showed that Kelakai Roots contain active compounds potentially aphrodisiac namely alkaloids and saponin. While the TLC profile obtained is the presence of stains on the appearance of a non-polar eluent (Chloroform: Ethyl Acetate) with a ratio of 7: 3, 8: 2, 9: 4 with each Rf value is 0.70 cm (7: 3), 0.94 cm (8: 2) and 0.94 cm (9: 4). This research reported for the first time the potential of Kelakai roots as an aphrodisiac. Thus, further work will focus on the study of the pharmacological effects of Kelakai roots.

The effect of consumers’ perception to the satisfaction of use of traditional medicines in Medan

Consumption of chemical medicines fluctuated in 2009-2014, whereas the consumption of solid traditional medicine increased in 2009-2014. The purpose of this study is to analyse the influence of consumers’s perception on the consumption of traditional medicinal plants. The data was analysed by using a binomial logit regression analysis. It is found that the consumers’s perceptions affect customer satisfaction simultaneously are the health benefits variable, quality of traditional medicine variable, price of traditional medicine and available product; the health benefits variable and quality of traditional medicine variable partially have significant effects to customers’s satisfaction simultaneously satisfaction partially; the health benefit variable and quality of traditional medicine is found to have a marginal effect of 7% and 4%, respectively.

α-Mangostin, A Natural Xanthone, Induces Apoptosis and ROS Accumulation in Human Rheumatoid Fibroblast-Like Synoviocyte MH7A Cells.

Rheumatoid arthritis (RA) is a complicated and heterogeneous chronic disease with the characteristic of progressive joint destruction, deformity and disability. It is associated with not only genetic but also environmental factors. Many studies suggest that RA-derived fibroblast-like synoviocyte (RA-FLS) is involved in the pathogenic process of RA. The apoptosis and proliferation of RA-FLS is of great importance in the development and progression in RA. Nowadays, more and more traditional Chinese medicine (TCM) or natural products are studied in the treatment of RA. To investigate the effects of several natural products and the apoptosisinduced effect of α-mangostin and its underlying mechanisms in RA-FLS MH7A cells. The effects of natural products on MH7A cells were detected by MTT assay. Annexin V-FITC/PI double labeling and DAPI staining were adopted to observe the apoptosis induced by α-mangostin. The apoptosis related proteins were measured with western blotting analysis. ROS accumulation was determined by DHE staining. Xantones, including Garcinone C, α-mangostin and γ-mangostin, significantly inhibited the MH7A cell viability. And α-mangostin induces apoptosis in MH7A cells. Further study showed that α-mangostin increased the ratio of Bax/Bcl-2 and increased the ROS generation in MH7A cells. α-Mangostin induces the apoptosis of MH7A cells through increasing ROS accumulation and the ratio of Bax/Bcl-2, suggesting that α-mangostin should be benefit to the therapy of RA.

Hormesis and dose-responses in herbal traditional Chinese medicine (TCM) alone are insufficient solving real clinical TCM challenges and associated herbal quality issues

Traditional Chinese medicine (TCM) products, as herbal treatment options for minor illnesses or functional ailments, have a long history in China and other Asian countries (1-6), and are used as complementary medicine even for more serious diseases in other countries including Germany (7).

The Effect of the Traditional Medicine Product (Milk-Cuscuta) on Skin Hyperpigmentation in Patients with Melasma

The Effect of the Traditional Medicine Product (Milk-Cuscuta) on Skin Hyperpigmentation in Patients with Melasma

Fuzheng Huayu capsule as an adjuvant treatment for HBV-related cirrhosis: A systematic review and meta-analysis.

Fuzheng Huayu (FZHY) capsule, a formulated traditional Chinese medicine product with 6 Chinese herbs, is widely used for HBV-related cirrhosis as an adjuvant treatment. However, the efficacy of FZHY capsule for HBV-induced cirrhosis did not be comprehensively proved by systematic analysis. Our current analysis was aimed to assess the efficacy and safety of FZHY capsule by an evidence-based method. Databases, including China National Knowledge Infrastructure, Wangfang, VIP medicine information system, Pubmed, Embase, and Cochrane Library, were searched, and the randomized controlled trials of FZHY capsule were used for the treatment of HBV-associated liver cirrhosis. Meta-analysis was performed by Review Manager 5.3. The efficacy rate, alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), albumin (ALB), Procollagen III protein (PIIIP), hyaluronic acid (HA), laminin (LN), Collagen C Type IV (IV-C), Child-Pugh score, portal vein diameter, spleen thickness, HBeAg negative conversion rate, and HBV-DNA negative conversion rate were systematically assessed. The Cochrane Risk of Bias tool was used to evaluate the methodological quality of eligible studies. Nineteen studies with 1,769 patients were included in the meta-analysis. Compared to conventional treatment, FZHY capsule was effective by increasing the efficacy. FZHY capsule was more efficient in improving ALT, AST, TBIL, PIIIP, HA, LN, IV-C, Child-Pugh grading score, portal vein diameter, spleen thickness, and HBV-DNA negative conversion rate with no serious adverse reactions. Nevertheless, a variety of well-designed randomized controlled trials are needed to confirm these findings since small samples were applied in the previous studies.