What are the applications of macromolecular compounds in the production of pharmaceutical formulatio

Macromolecular compounds have penetrated into every step of pharmaceutical production. Macromolecular compounds have been widely used as excipients in various formulations. In addition, macromolecular compounds can be used directly as drugs or as carrier materials for small molecule drugs to improve the efficacy of drugs, and macromolecular compounds also have important applications in the preparation of new drug delivery systems, such as sustained-release preparations.

Macromolecular compound materials can also be used as packaging materials for pharmaceutical formulations.

GCP: Good Practice for Drug Clinical Trials.

Solubilizer: refers to surfactants with solubilizing ability. Solubilization is the process by which some poorly soluble drugs increase their solubility in a solvent and form a solution under the action of surfactants.

Co-solvent: refers to the formation of soluble intermolecular complexes, resalts or associations between insoluble drugs and the third substance added to the solvent to increase the solubility of the drug in the solvent. (Most of the co-solvents are low-molecular-weight compounds).

Latent solvent: refers to a mixture of solvents that can improve the solubility of poorly soluble drugs. Latent solubility refers to the use of two or more mixed solvents, when each solvent in the mixed solvent reaches a certain ratio, the solubility of the drug appears to a maximum.

Liquor: A concentrated ethanol solution that directs the onset of drugs.

Tincture: refers to a clear liquid preparation made by leaching or dissolving a drug with a specified concentration of ethanol, and can also be diluted with a flow extract.

Glycerin: refers to a solution made by dissolving the drug in glycerol for external use.

Suspension: refers to the heterogeneous liquid preparation formed by dispersing insoluble solid drugs in a particulate state in a dispersion medium.

Emulsion: refers to a heterogeneous dispersion system formed by two immiscible liquids, one of which is dispersed in the form of small droplets in the other liquid.

Polymer materials are used in almost any dosage form.

Liquid preparations: suspensions, extenders, emulsifiers, solubilizers, wetting agents, semi-) solid preparations: various excipients for tablets, ointment bases, suppository bases, used in almost all dosage forms.

Problems that should be paid attention to in drug research due to the complexity of biochemical drugs, the quality of products obtained by different raw materials and production processes will be different, including the content and proportion of the main ingredients, and the types and content of other ingredients, etc., and these differences are often not reflected in the quality standards. Therefore, when conducting biochemical drug research, we should first consider the problem based on "non-imitation".

1. Pay attention to the control of raw materials and processes, combine with quality standards, and control the quality of products more comprehensively.

2. After the product is launched, do not easily replace raw materials, change the production process, change the dosage form (especially the water injection, powder injection, and large infusion exchange), extend the validity period, etc. If the above changes are required, corresponding research should be carried out on the impact of the changes on the quality, safety and effectiveness of the product (this impact refers to the real quality of the product, not just the quality control indicators in the quality standards), including pharmacy, pharmacology and toxicology and clinical research.

3. Because the quality of biochemical drugs is guaranteed by the whole process control, the stock solution (or semi-finished product) should not be sold freely, otherwise it will not only increase the possibility of re-infection in the circulation link, but also be detrimental to the quality control of the finished product throughout the process.

4. The inactivation process and verification of animal-derived viruses is a subject that needs to be jointly studied and developed by developers, reviewers, and experts in relevant fields.

Because people's understanding of animal-derived viruses and the relationship between animal-derived viruses and human infectious diseases is gradually deepening, the inactivation and process verification of viruses will continue to become more scientific and reasonable with the improvement of people's understanding.

The above briefly introduces the general preparation methods, process and quality research of biochemical drugs, as well as the problems that should be paid attention to in the research process, so that developers can further understand the characteristics and quality control points of biochemical drugs, pay attention to source control and process control when conducting biochemical drug research, and establish the concept of full control of biochemical drugs, especially after the product is marketed, if some changes are made in the supplementary application, it is necessary to carry out corresponding pharmacy for the impact of the changes on the quality, safety and effectiveness of the product, pharmacology, toxicology and clinical research.

a. The use of chemistry can comprehensively apply natural resources and protect the environment in which we live;

b. New energy and new materials can be developed to improve human living conditions;

c. The use of chemistry can synthesize drugs to help the body resist various bacteria and diseases;

d. Chemistry is one of the important basic sciences, which has developed rapidly in the interpenetration with physics, biology, self-bending geography, astronomy and other disciplines, and has also promoted the development of other disciplines and technologies

Therefore, choose D

Extraction Pharmaceutical: Extraction of active ingredients from natural medicines, followed by structural modification. Flavonoids are common.

Chemical pharmaceuticals: Drugs are synthesized by chemical methods, but most of the raw materials or original models are derived from natural medicines. For example, some anti-cancer drugs and synthetic design of the first cover of drugs are boring.

Biotechnology pharmaceuticals: Biological means such as microbial fermentation, or cell engineering, genetic engineering, etc., are commonly used to make various hormone drugs (penicillin, oxytetracycline, etc.), monoclonal antibodies, etc.

Biopharmaceuticals are the most widely used drugs today and can be produced in large quantities with unlimited potential.

This book contains more than 150 best-selling small molecule drugs in the foreign pharmaceutical market. For each drug molecule, this book comprehensively and systematically introduces information about its chemical structure and chemical total synthesis route. The chemical structures of the starting materials, intermediates, and reaction products involved in the reaction are given in detail.

For each step of the chemical synthesis reaction, detailed chemical reagents, reaction conditions, and literature sources are given. The synthesis route introduced in this book can reflect the highest level of drug synthesis from one side. The content of the book is concise, easy to understand, with strong practicality and high academic value.