Take you into the study of Chinese medicine medicine (technology) - separation purification and testing
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Last Update: 2020-10-31
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Source: Internet
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Author: User
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with the continuous development of Chinese medicine science and technology, many new technologies and methods have appeared in recent years, such as Chinese medicine separation purification technology and testing, bionic extraction method, high-speed centrifugal separation technology. The application of these new technologies and methods makes the separation of Traditional Chinese medicine not only conform to the traditional theory of Traditional Chinese medicine, but also achieve the goal of efficient separation and purification.
I,
Standard Substances
Research
1, Fingerprint Map Research
2, Feature Composition Preparation Separation
3, Structural Identification
4, Standard Material Stability Research
Second, Production Process Research
Small Test, Process Verification, Pilot
Designing the Best Process Conditions through Different Influence Factors and Levels;
III, Quality Standards Research
1, Quality Standards Research Procedures
Access to data - Design - Research methods - inspection, identification, determination of samples - draft development - trial and error - modified and perfected.
2, quality standard design and improvement
quality standard design from the production, circulation, use, storage, physiological utility and clinical application of all aspects of the understanding of the factors affecting the quality of drugs, targeted design and testing projects.
safety: medicinal doping, heavy metal detection, pesticide and toxin residues, toxic composition limits, etc.;
effectiveness: fingerprint map, feature composition measurement,
chromatography
identification, micro-identification, etc.
4. Stability Research
Stability Research:
1, Stability Box:
annual verification to ensure that temperature, humidity, lighting and other conditions meet stability test requirements;
2, Stability Management:
provides stability research program design, project management, stability sample storage and testing, data trend analysis, drug shelf life assessment.
Separation Purification and Testing:
I, Impurity Research
This diagram is a map of the purity of an API, which requires: a study of a major impurity peak of tR-20.49 min, first by preparing a single body of impurities (purity requirements >98.5%), and then structural analysis.II, target
compounds
custom separation
first of all, the raw material analysis preliminary determination of the type of fingerprint peak, and then through the results of the determination to develop the relevant purification program, and then the formulation of the program to obtain the desired target, and finally through MS,
NMR
,
IR
, UV to determine the structure of the relevant compounds.III, raw material purification process research
through process development and optimization to meet customer needs (product purity, single miscellaneous, etc.), the optimized process can meet the production costs and quality requirements of enterprises.
example: the customer provides raw materials for process improvement to obtain the target product, requiring purity >99.5 percent, single <0.1 percent., product testing and method development
according to the experimental purposes of the design of project programs, and according to the project research guidelines and standards of detection SOP system standardized product testing and method development.case
: Measuring the content of a nucleotide in a
extract
establishing a method for determining the content of UV and HPLC of the nucleotide components in the extract, comparing the changes in the content before and after hydrolysis, evaluating the content of the target components by UV and liquid at the same time, and conducting hydrolysis time survey, UV color conditions inspection, liquid phase analysis method inspection, methodological verification and multi-batch sample testing.Chengdu Biotech can provide a complete set of services for Chinese medicine research (Chinese medicine separation and purification technology), for you to reduce the cost of research and development of new drugs, improve research and development efficiency.
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