Technical requirements for research on preparation technology of new Chinese medicine

Technical requirements for research on preparation technology of new Chinese medicine

[Editor's note] The preparation process is an important part of the research on new drugs of traditional Chinese medicine. The research on the preparation process of traditional Chinese medicine should be guided by the theory of traditional Chinese medicine. The prescriptions of the drugs in the other agent should be analyzed, and the modern science and technology should be used to select the series of samples, process route design, process technology conditions screening and pilot test, and collate the research materials. And summarizing, making the preparation process scientific, reasonable, advanced and feasible, so that the new drug developed can be safe, effective, controllable and stable. The preparation process research should adopt new technologies, new processes and new auxiliary materials as much as possible to improve the research level of traditional Chinese medicine preparations.

1 dosage form selection is an essential form of drug use. The choice of the dosage form should be based on clinical needs, the nature of the drug, the subject and dosage of the drug, and determined by literature studies and preliminary tests. In order to give full play to the characteristics of various dosage forms, new dosage forms should be selected as much as possible to achieve the effects of high efficacy, small dose and small side effects, and convenient production, storage, transportation, carrying and use.

2 Extraction process research

Since the development of new Chinese medicines is generally based on Chinese herbal medicines, in order to achieve high efficacy and low dosage requirements, except for a few cases, the medicinal materials can be directly used, and the general medicinal materials need to be extracted. For the various factors affecting the extraction effect, the extraction process can be studied from three aspects.

2.1 Identification and pretreatment of medicinal materials

The identification and pretreatment of Chinese medicinal materials is the basis for ensuring the quality of the preparation. The original medicinal materials must be identified before the feeding, and those who meet the relevant regulations and prescription requirements can use it. In addition, according to the prescription requirements of the drug, the material, characteristics and different extraction methods, the drug should be processed, cut, gunned, crushed and so on. Any medicinal material that needs special processing shall state the purpose of the preparation and provide the basis for the method.

2.2 Extraction process design

Traditional Chinese medicine has complex ingredients and different effects. Therefore, before the process design, according to the function and indications of the prescription, the active ingredients and pharmacological effects of each traditional Chinese medicine should be analyzed through literature review; combined with clinical requirements and new drug categories, the active ingredients or effective parts and their physical and chemical properties should be understood. According to the extraction principle and pre-test, select the appropriate extraction method, design a reasonable process route, and provide design basis.

2.3 Research on technical conditions of extraction process

After the extraction process route is determined, according to the characteristics and extraction methods of the medicinal materials, the factors that may affect the extraction effect are fully considered, scientific and reasonable experimental design is adopted, and comprehensive evaluation indicators and methods are adopted, which are accurate, simple, representative and quantifiable. , screening reasonable extraction process technical conditions. When there are mature technical conditions that can be used for reference, the basis for the formulation of reasonable technological conditions can also be provided through relevant literature. A reasonable extraction process should reach the advanced level of similar research (providing corresponding literature).

3 separation and purification, concentration and drying process research

3.1 Separation and purification process research

The separation and purification process includes two aspects: one is to separate the chemical solution from the dregs and its visible particles, and the method of filtration, centrifugation and sedimentation can be used. Generally, the corresponding separation methods and conditions should be selected according to the nature of the liquid to obtain a clear liquid. The second is to remove the ineffective and harmful components, try to retain the active ingredients or effective parts, and use various purification, purification and refining methods to provide qualified raw materials or semi-finished products for different types of new drugs and dosage forms. The choice of method should vary according to the type of new drug, the dosage form, the route of administration, the amount of prescription, and the degree of physicochemical properties associated with quality. Targeted experiments should be designed to examine the rationality of each step of the purification and purification method and the retention rate of the measured components to provide a purified product content index and basis for formulation. For the newly established method, the feasibility of the method, the reliability and safety study, and the corresponding research materials should be provided.

3.2 Concentration and drying process research

Concentration and drying should be based on the nature of the material and factors affecting the concentration and drying effect, preferably methods and conditions to achieve a certain relative density or water content. The rationality and feasibility of the process should be evaluated by the yield of concentrated dry matter and the content of index components.

4 formulation formability study

The formulation formability study should be carried out under the premise of stable technical conditions of the extraction process and the quality of the semi-finished products, including two aspects: formulation formulation design and formulation molding process research.

4.1 Formulation design

The prescription design of the preparation is a process of screening appropriate excipients and determining the prescription of the preparation according to the nature of the semi-finished product, the characteristics of the dosage form, the clinical requirements, the route of administration, and the like. In principle, the physicochemical properties of the raw materials and their influencing factors related to the formability and stability of the preparation should be studied first, and then the corresponding evaluation indicators and methods should be established according to the characteristics of the various auxiliary materials in different dosage forms. Screen the types and amounts of excipients. The dosage of the preparation should be based on 1000 preparation units (tablets, granules, grams, milliliters, etc.), and the name and amount of the auxiliary materials should be written to clarify the basis for determining the dosage and dosage of the preparation. Zui should eventually provide research materials including the purpose of selecting excipients, test methods, results (data) and conclusions.

4.2 Preparation of the molding process

The preparation molding process is to process the semi-finished products and auxiliary materials, and the process of forming the dosage form and forming the final product of Zui should generally adopt the advanced molding process route according to the material characteristics. Handle the relationship with the prescription design of the preparation, screen the reasonable material processing methods and methods of each process, apply the corresponding advanced molding equipment, and select the appropriate finished packaging materials. Provide detailed data on the technical conditions of each process of the molding process.

5 pilot study

The pilot study is the verification and improvement of the rationality of the laboratory process, and is the necessary link to ensure that the preparation [method] achieves operability. Samples of quality standards, stability pharmacology and toxicology, and clinical research should be prepared by a mature process of pilot research. The scale of the pilot test should be more than 10 times of the prescription amount of the preparation. The adaptability of the process, equipment and its performance should be investigated during the pilot test. The key technical parameters of the preparation process should be strengthened, and the preparation process suitable for production should be revised and improved. At least three batches of pilot production data shall be provided, including the amount of material to be fed, the quantity of semi-finished products and quality indicators, the amount of auxiliary materials, the amount of finished products and the yield, etc., for general quality inspection, microbial limit inspection and content determination results.

6 Sorting and requirements of research materials

The preparation process research data should generally include: preparation side, preparation method, process flow, process rationality study, pilot test data and reference materials. Process rationality studies should include formulation selection, extraction, separation and purification, concentration and drying, and molding processes. Research data compilation must be based on original experimental results and data. The data is required to be accurate, the chart is clear, and the conclusions are reasonable. The preparation process flow chart should list the process conditions and main technical parameters in a straightforward and concise manner.

Source of information: HC Network

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