Comprehensive HPTLC Fingerprinting for Quality Control of an Herbal Drug – The Case of Angelica gigas Root

Planta Medica ◽  
2018 ◽  
Vol 84 (06/07) ◽  
pp. 465-474 ◽  
Author(s):  
Débora Frommenwiler ◽  
Jonghwan Kim ◽  
Chang-Soo Yook ◽  
Thi Tran ◽  
Salvador Cañigueral ◽  
...  
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Herbal Drugs ◽  
Proof Of Concept ◽  
Herbal Drug ◽  
Angelica Gigas ◽  
Decursinol Angelate ◽  
Suitable Reference ◽  
Hptlc Method

AbstractThe quality of herbal drugs is usually controlled using several tests recommended in a monograph. HPTLC is the method of choice for identification in many pharmacopoeias. If combined with a suitable reference material for comparison, HPTLC can provide information beyond identification and thus may simplify quality control. This paper describes, as a proof of concept, how HPTLC can be applied to define specifications for an herbal reference material and to control the quality of an herbal drug according to these specifications. Based on multiple batches of cultivated Angelica gigas root, a specific HPTLC method for identification was optimized. This method can distinguish 27 related species. It also can detect the presence of mixtures of A. gigas with two other Angelica species traded as “Dang gui” and is suitable as well for quantitative assessment of samples in a test for minimum content of the sum of decursin and decursinol angelate. The new concept of “comprehensive HPTLC fingerprinting” is proposed: HPTLC fingerprints (images), which are used for identification, are converted into peak profiles and the intensities of selected zones are quantitatively compared to those of the corresponding zones of the reference material. Following a collaborative trial involving three laboratories in three countries, the method was applied to check the quality of further candidates for establishing an appropriate reference material. In conclusion, this case demonstrates that a single HPTLC analysis can provide information about identity, purity, and minimum content of markers of an herbal drug.

DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

scholarly journals The Use of SEM and Light Microscopy for the Characterization of Hypericum foliosum Aerial Part as a Medicinal Plant

2008 ◽  
Vol 14 (S3) ◽  
pp. 107-108
Author(s):  
R. Serrano ◽  
P. Ferreira ◽  
E.T. Gomes ◽  
O. Silva
Keyword(s):  
Quality Control ◽  
Medicinal Plant ◽  
Light Microscopy ◽  
Plant Material ◽  
Aerial Part ◽  
Chemical Characterization ◽  
Correct Identification ◽  
Herbal Drugs ◽  
Herbal Drug

The first step in quality control of herbal drugs is ensuring the correct identification of the plant intended for use. The required analytical procedures (macroscopic characterization of the entire or fragmentized material, microscopic characterization after pulverization of the plant material and chemical characterization), are usually described on quality monographs reported in authoritarian texts such as the European 6th Pharmacopoeia. Further information related to the name of the each herbal drug, the herbal drug definition, purity tests and assay are also provided.

Quality Standards for Herbal Drugs and Herbal Drug Preparations – Appropriate or Improvements Necessary?

Planta Medica ◽  
2017 ◽  
Vol 84 (06/07) ◽  
pp. 350-360 ◽  
Author(s):  
Reinhard Länger ◽  
Erich Stöger ◽  
Wolfgang Kubelka ◽  
Keith Helliwell
Keyword(s):  
Critical Evaluation ◽  
Quality Standards ◽  
Herbal Drugs ◽  
Herbal Drug ◽  
Scientific Discussion ◽  
Single Marker ◽  
Plant Constituents ◽  
Traditional Manufacturing

AbstractStandards for quality control as defined in the European Pharmacopoeia contribute significantly to a consistent and high quality of herbal drugs, herbal drug preparations, and herbal medicinal products. The minimum content of single plant constituents is considered of high relevance. Therefore, nearly all monographs on herbal drugs or herbal drug preparations contain an obligatory assay.However, a critical evaluation of the data published for such assayed constituents reveals that in most cases these constituents have to be considered as purely analytical markers without correlation to quality or efficacy. Examples where the assay does not meet its objective support the need to adapt current quality standards. Moreover, the trend to increase the content of certain constituents may lead to significant modifications to traditional manufacturing processes.In order to initiate a scientific discussion, the role of the assay in the context of quality requirements, quality documentation in the manufacturing process, safety, and efficacy is discussed and possible alternatives to the single marker assay are examined.

scholarly journals Review on Standardization Parameters of Churna

2017 ◽  
Vol 5 (5) ◽  
Author(s):  
Dipika R. Turankar ◽  
Sneha Kubde
Keyword(s):  
Quality Control ◽  
Plant Material ◽  
Analytical Techniques ◽  
Quality Assurance Program ◽  
Herbal Drugs ◽  
Control Test ◽  
Chemical Profile ◽  
Ayurvedic Drugs ◽  
Quality Control Test

Ayurved has a long and strong heritage use of  Polyherbal drugs and formulations to treat various diseases. Standardization of Ayurvedic formulations is an important step for the establishment of a consistent biological activity, a consistent chemical profile or simply a quality assurance program for production and manufacturing of herbal drugs. It is a burning topic in Ayurvedic drug industry nowadays. Tremendous work is going on for standardization of Ayurvedic drugs to prove its reproducibility, compatibility and safety on modern parameters.                    Concept of churna is well established in Ayurvedic pharmaceutics for therapeutic purposes as well as for production of other formulations. There is sound description of its various method of preparation along with shelf life period in Ayurveda. Implication of latest analytical techniques is the demand of time to standardize different churna. Plant material may vary in physiochemical content and therefore in its therapeutic effect; according to different places of collection, with different times in a year for collection, with collection at the same time and places but in different years and with a particular medicinal plant. Adding to this variability is the fact that in herbal medicine several plants may be used together in the same preparation. It is very important that a system of standardization is established for every medicine in the market because the scope for variation in different batches of medicine is enormous. This means that there should be a quality control test for the entire preparation to ensure quality of the product.

scholarly journals High-Performance Thin Layer Chromatography for Quality Control of Multicomponent Herbal Drugs: Example of Cangzhu Xianglian San

2010 ◽  
Vol 93 (5) ◽  
pp. 1390-1398 ◽  
Author(s):  
Zhi Li ◽  
Irmgard Merfort ◽  
Eike Reich
Keyword(s):  
Quality Control ◽  
Chemical Composition ◽  
Thin Layer ◽  
Principal Components ◽  
Mobile Phase ◽  
High Performance ◽  
Herbal Drugs ◽  
Herbal Drug ◽  
Qualitative And Quantitative ◽  
Layer Chromatography

Abstract Due to their complexity, multicomponent herbal drugs pose enormous analytical challenges for quality control (QC). Although they may have traditionally been used for hundreds of years, the information about their chemical composition is often still limited. Selecting suitable markers to monitor the identity and potency of the mixture is, therefore, difficult. There is also the possibility of natural variability for each plant. This paper illustrates a pragmatic and practical approach to QC of a multicomponent herbal drug by HPTLC. Cangzhu Xianglian San (CXS), composed of the herbal drugs Coptis rhizome, Aucklandia root, and Atractylodes rhizome (30 + 20 + 60, w/w/w), is used as an example. A characteristic fingerprint can be generated for CXS with tolueneethyl acetatemethanolisopropanolwater (60 + 30 + 20 + 15 + 3, v/v/v/v/v) mobile phase on HPTLC silica gel 60 conditioned with ammonia. While the corresponding monograph of the Chinese Veterinary Pharmacopoeia focuses only on the detection of berberine, one of the principal components of Coptis rhizome, the proposed method of identification determines the presence of all three components in the drug after derivatization with anisaldehyde reagent. The same method can also be used to quantitatively determine the content of berberine by scanning densitometry. This paper provides details about the validation of the qualitative and quantitative determinations.

scholarly journals Problems in Evaluating Herbal Medicinal Products

2008 ◽  
Vol 3 (12) ◽  
pp. 1934578X0800301
Author(s):  
Jozef Corthout
Keyword(s):  
Quality Control ◽  
Analytical Method ◽  
Analytical Methods ◽  
Milk Thistle ◽  
Herbal Drugs ◽  
Herbal Drug ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
St John's Wort ◽  
Herbal Medicinal

Compared to chemical drugs, the quality control of herbal medicinal products poses many problems due to the complexity of herbal drugs, herbal drug preparations and the products themselves, and due to the use of different analytical methods (selective and non-selective) giving different results. To illustrate this, three groups of herbal medicinal products were assayed by different analytical methods: products containing St. John's wort (colorimetry and HPLC), milk thistle (spectrophotometry and HPLC) and ginkgo (HPLC). These studies show that complete and correct labeling is necessary for the evaluation of herbal medicinal products and that for the majority of plants the knowledge of the applied analytical method is essential for a proper verification of conformity.

scholarly journals Herbal Drugs Forensic

2021 ◽  
Author(s):  
Shalvi Agrawal ◽  
Astha Pandey
Keyword(s):  
Side Effects ◽  
Forensic Science ◽  
Herbal Product ◽  
Plant Part ◽  
Herbal Drugs ◽  
Herbal Drug ◽  
Crude Drugs ◽  
Quality Of Products ◽  
Common Plant

Due to pandemic Covid-19, suddenly the vast population is drawn towards herbal drug treatment in India. In India, Ayurveda is practised to a greater extent as it does not have any side effects or other major effects. They are also added in many nutraceutical products like Chyawanprash, honey, etc. There are a lot of medicinal floras sold in the market in the form of small twigs, pieces of roots, stems or leaves of which decoction is made and consumed. The consumers are unaware of the authenticity of these crude drugs that lead to the deterioration in their health owing to the consumption of inferior quality of products or their substitute or the illicit bioadulterants which look like any other common plant part. The herbal drugs could also be in the form of tablet, powder, etc. which might be adulterated with look-alike plant products. Thus, a new branch of Forensic Science, i.e. Herbal Drugs Forensic which deals with identification of fake herbal product by various techniques which might be chemical or biological in nature has come up. In fact, the analytical methods for the testing of various bioconstituents need to be standardized and validated. Thus to prevent herbal drug fraud, it has become necessary to develop the methods for their detection through an emerging field of Forensic Science, i.e. Herbal Drugs Forensic.

Development and Application of Quality Control System for Highway Subgrade Construction

2019 ◽  
Vol 2 (5) ◽  
Author(s):  
Tong Wang
Keyword(s):  
Quality Control ◽  
Real Time ◽  
Detection Method ◽  
System Development ◽  
Effective Control ◽  
Construction Process ◽  
Development Mode ◽  
The Road ◽  
Whole Process

The compaction quality of the subgrade is directly related to the service life of the road. Effective control of the subgrade construction process is the key to ensuring the compaction quality of the subgrade. Therefore, real-time, comprehensive, rapid and accurate prediction of construction compaction quality through informatization detection method is an important guarantee for speeding up construction progress and ensuring subgrade compaction quality. Based on the function of the system, this paper puts forward the principle of system development and the development mode used in system development, and displays the development system in real-time to achieve the whole process control of subgrade construction quality.

Construction Control As A Strategy For Improving The Quality Of Buildings And Structures

2020 ◽  
Keyword(s):  
Quality Control ◽  
Life Cycle ◽  
Construction Control ◽  
Construction Sites ◽  
Actual Problem ◽  
Construction Market ◽  
Construction Products ◽  
Underlying Causes ◽  
Required Quality

In construction production, the safety of constructing buildings and structures is achieved by ensuring the required quality as a result of systematic construction control based on the implementation of a complex of technical, economic and organizational measures at all stages of the object's life cycle. The article deals with the actual problem of improving the quality of construction products-buildings and structures in conjunction with the activities of construction control bodies. The article presents the advanced foreign and domestic experience of ensuring the quality control at the construction sites, providing for the prevention of the underlying causes of defects and increasing the interest of the contractors directly. On the basis of the analysis of the current situation with quality control at the construction market, ways to improve its efficiency by developing a unified system of technological implementation of relevant requirements for the quality of construction products, determining the rational number and business load of construction control engineers, as well as the active activities of self-regulatory organizations in this area are offered.

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