TH48992A - Processes for quality control and standardization of medicinal plant products. - Google Patents

Abstract

DC60 (09/12/54) Procedures for defining standard specifications for medicinal plant substances. Processes include (i) prepare test solutions or extracts for testing of the body. Like substances from plants used as Medicines that are known to have properties or properties, but (Ii) the solution or extraction section is subjected to two analyzes. Methods or more that include (a) combined NMR procedures, spectroscopy, and computer-based recognition techniques, and (b) one or more biological pattern detection techniques (iii) yield results. Based on the analytical methods used in steps (ii) and (iv), the standard specifications for such plant substances are defined by Based on the results obtained in (iii) steps, a suitable example of a medicinal plant substance may be obtained. Continue to be tested for standardization.It can be earned The acceptance or rejection depends on whether it provides an internal or external analysis of part or all of the details given in step (iv). Standards and Quality Control It can be specially used with a mixture of plant substances used to make drugs. A method for defining a standard specification for medicinal plant substances. The process consists of (i) preparing a test solution or extraction component for testing. Like plant substances used to make drugs that Known to have a treasure or a treasure, but (Ii) Give the solution or extraction to two analyzes. Methods or more include (a) the contribution of NMR spectroscopy and computer-based recognition techniques and (b) one or more biological pattern techniques (iii) obtained from the analytical methods that Used in stages (ii); And (iv) define the standard specification for such plant substances by Based on the results obtained in the (iii) steps, a member of the constituents of the medicinal plant may be Get further testing for entrance to the standard criteria, it can be obtained An acknowledgment or rejection, depending on whether it provides an internal or external analysis, part or all of the details given in the procedure (iv). Provide standard and quality control It can be specially used with a mixture of plant substances used to make drugs.

Claims (6)

1. Procedures for defining standard specifications for medicinal plant substances. The process consists of (i) preparing a test solution or extraction component for testing. Like plant substances used to make drugs that Known to have a treasure or a treasure, but (Ii) Give the solution or extraction to two analyzes. Methods or more include (a) the contribution of NMR spectroscopy and computer-based recognition techniques and (b) one or more biological pattern techniques (iii) obtained from the analytical methods that Used in stages (ii); And (iv) define the standard specification for such plant substances by The results were obtained in (iii) steps. 2. Methods for obtaining samples of plant substances used to make drugs. Where the example is according to the individual The standards are set. Before for that substance The procedure consists of (i \ ') preparation of a test solution or a test extract of a medicinal plant substance (ii \'). The solution or extract is analyzed by A combination of NMR spectroscopy and pattern recognition techniques Based on a computer (iii \ ') obtained an analysis of the procedure (II \') and (iv \ ') selected member samples. If the results obtained from the procedure (III \ ') meet the standard details. For such substances provided in step (IV \ ') of the process set out in claim 1 3. Procedure according to claim 2, where procedure (iv \') is replaced by ( iv \ 'a) Solution or extract prepared in step (I \') to bioconfiguration technique. One or more images (iv \ 'b) yield results from or from each of the techniques used in the procedure (iv \' a) and (iv \ 'c) select member samples if the results obtained in the step (III \ ') Set out in Claim 2 and (IV \' b) above corresponds to The standard details for such substances are set out in step (IV) of the process set out in claim 1 4. Process of any of the above claims, whereby the NMR specification. Troscopy and pattern recognition techniques that Computer-based, consisting of (a) administering the test solution or extraction component to performing an NMR spectroscopy and recording one or more NMR specs and (b) providing data obtained from or for each NMR specification. Trump against Multivariate analysis to get the point One or more points on the score plot (score plot) 5. Method of claim for any one of the claims. Previously, where multivariate-eight analysis was a key component analysis (PCA). 6. The process of following one of the claims of the claim. Before, where the biological model technique The picture was selected by Analysis of binding inhibition with receptor units or enzymes 7. Process according to claim 6, whereby protease analysis Omic contains (i) given target cells selected according to clinical indications, where The plant substances used to make the drug work. And curing target cells With the tested sample of the said substance, and (ii) the incubated cells to electrophoresis on a 2-D gel and see the change in the show. The nature of the protein in the resulting cell From contact with the solution or the extracts. 8. Process according to one of the claims. The previous page also contains purification, test solution or Test extraction of pre-membership samples, the combination of NMR, spectroscopy, and computer-based recognition. 9. Process according to one of the pre-claim claims. Functional substances from plants used to make medicine, consisting of or derivatives from the whole plant part of the plant. Extraction or Plant Part 1 0. Methods to provide standard details for medicinal plant substances. Processes include (i \ '\' \ ') preparation of test solutions or test extracts of plant substances. Used to make such drugs that are Known to have possessions or have Each property required for the standard substance (ii \ '\' \ ') is given a test solution or test extractor to the NMR spectroscopy and record one or more NMR spectra (iii \'). '\' \ ') Takes information obtained from the said NMR spectrum or from Each one was analyzed for multi-ware. To make one point or Rather than on the scorecard and (iv \ '\' \ ') defines the extent of acceptance around the point established in (iii \' \ '\') steps in the figure or in the garden image. One of the standard details For substances from the aforementioned plants 1 1. Process according to claim 10, where mal analysis The TiVariate of step (iii \ '\' \ ') is done by unsupervise 1. 2. Processes for obtaining a sample of plant substances used to make medicine. Where the sample is according to the individual Detailed, previously set standards For that substance The process consists of (i \ '\') preparation of the test solution or the test extraction part. As to the test of such plant substances (ii \ '\'), give the test solution or extraction test to the NMR spectroscopy and record one or more NMR spectroscopy (iii \ '\'). ') The data obtained from the said NMR spectrum or from each of them were analyzed for multiplexing. To obtain a scoreboard with one or more points (IV \ '\'), select a member sample that satisfies that standard description only when the point is created. On scoreplots in step (iii \ '\') are within the acceptable limits as set forth in the standard description in the procedure (iv \ '\' \ ') of the procedure set out in clause. Holds the right number 10 1 3. Process according to any of the preceding claims where the plant substance is derivative from or consists of: Two or more mixtures of different plants 1 4. Process according to claim 13 where the mixture is a drug from a system of used drugs. It comes as a form by using a mixture of various plants or extracts of different plants. 5. Process according to claim 14 where the system of traditional medicine is Chinese medicine or Ayevidic medicine, which is used in the traditional way 1. 6. Procedure based on one of the previous claims, where an example of a message from Medicinal plants with each of the properties or properties required for a standardized substance are examples of plant substances. That have been certified or passed an examination of known origin