Pharmaceutical Sciences of Traditional Chinese Medicine

Author: Chief Editor: Zheng Pinqing
Publisher:
Publish Date: 2002-01-01
Features:
Content Summary
Pharmaceutical Preparation is an interdisciplinary applied science with a broad scope, rich content, and strong practicality. The book is divided into 20 chapters, focusing on the fundamental knowledge, basic theories, production processes, and quality control of traditional Chinese medicine preparations. Each chapter begins with a summary of the chapter's content, followed by review questions at the end of each chapter. The book also includes experimental guidance at the end. It is suitable for teaching in pharmaceutical preparation and traditional Chinese medicine programs, as well as for reference in vocational secondary schools, correspondence courses, and intermediate to advanced technical training. It can also be used as a reference for pharmaceutical workers in drug factories and pharmacies.
Excerpt:
The production status of preparations reflects a country's industrial production level and is closely related to the quality of the preparations. This is closely linked to the application of basic pharmaceutical knowledge. Pharmaceutical Preparation is the most direct and widely applied discipline for pharmaceutical workers in traditional Chinese medicine. The theories, knowledge, and techniques it elaborates are fundamental to their professional activities. Since dosage forms are the final form of drugs before they are administered to the body, they are crucial to the full realization of the drug's effects. Therefore, pharmaceutical workers must ensure that all preparations meet relevant regulations and requirements. The quality of preparations not only affects the strength of the therapeutic effect but also influences production costs and may even endanger patients' lives. Thus, all pharmaceutical workers should adopt a serious and meticulous attitude, employ rigorous and detailed methods, study this course and related subjects diligently, master modern scientific and technological knowledge, and gain a solid understanding of the theoretical knowledge and practical skills of pharmaceutical preparation. They must strictly adhere to operational procedures, continuously improve production standards, and develop and create more high-quality traditional Chinese medicine preparations to meet the growing needs of modern healthcare.
II. Common Terminology and Technical Terms in Pharmaceutical Preparation
For the purpose of learning, it is essential to understand the meanings of some common and specialized terms. Due to the confusion in naming conventions, a correct understanding and mastery of their substantive meanings are crucial for mastering this course.
(1) Drugs and Medicines
Drugs refer to substances used for prevention, treatment, or diagnosis of diseases, collectively known as "drugs" or simply "medicines." Modern medical practice employs a vast number of drugs. Medicines are substances used for the prevention, treatment, diagnosis, and regulation of human physiological functions, with specified indications, dosages, and methods of use. They include traditional Chinese medicinal materials, prepared Chinese medicinal materials, traditional Chinese medicine preparations, chemical raw materials and their preparations, antibiotics, biochemical products, radioactive drugs, blood products, and diagnostic drugs. In essence, there is no difference between drugs and medicines—they are both substances used to prevent and treat diseases. However, medicines often refer to the types of drugs, some of which require further processing before clinical use. Therefore, in practice, medicines are included within the scope of drugs, but the concept of drugs is broader. However, people often use the terms "drugs" and "medicines" interchangeably.
(2) Pharmacy and Dosage Forms
Pharmacy refers to drugs that have been processed and prepared for clinical use. Any finished product prepared according to traditional Chinese medicine theory using medicinal materials (including prepared materials) for the prevention and treatment of diseases is collectively referred to as traditional Chinese medicine pharmacy. Dosage forms are the appropriate forms of pharmacy. Generally, they refer to the categories of pharmacy. For example, decoctions are one type of dosage form, pills are another, and common dosage forms of traditional Chinese medicine pharmacy include powders, wines, tablets, ointments, and injections.
(3) Traditional Chinese Medicine Pharmacy, Pharmacy Preparation, and Traditional Chinese Medicine Preparations
Traditional Chinese medicine pharmacy refers to the preparation of medicinal materials into pharmaceutical preparations with specific specifications, as specified in pharmacopoeias or approved by pharmaceutical regulatory authorities. The production of traditional Chinese medicine pharmacy is usually carried out in traditional Chinese medicine factories. Some medical institutions with "pharmacy preparation licenses" can also produce some traditional Chinese medicine pharmacy for their own use, but not for external sale. Pharmacy preparation refers to the preparation of pharmacy based on a doctor's temporary prescription, specifically for a particular patient, and includes dosage instructions. The preparation process is usually carried out in the pharmacy preparation room of a traditional Chinese medicine pharmacy. Traditional Chinese medicine preparations are pharmaceutical preparations produced in large quantities based on effective, widely used, and stable traditional Chinese medicine prescriptions, folk remedies, or secret formulas, which are commonly used by the public. Their characteristics generally include a unique name, appropriate packaging, clear indications, functions, dosage instructions, and can be purchased directly by patients without a doctor's prescription. Their production must be approved by higher pharmaceutical regulatory authorities. Examples include Liu Shen Wan (Six), Yin Qiao Jie Du Wan (), Huo Xiang Zheng Qi Shui (), and Qi Li San (), all of which are traditional Chinese medicine preparations, or simply "Chinese patent medicines." The preparation and preparation of pharmacy were once referred to as "adjusting a hundred medicines," meaning the technical operation of preparing traditional Chinese medicine pharmacy. In modern times, the discipline that studies the production process and theory of pharmacy is called pharmacy, while the discipline that studies the preparation and administration of pharmacy is called preparation. Since the principles and technical operations of preparation and preparation are very similar and closely related, the discipline that combines both is called pharmacy. With the development of pharmacy, most preparations are now produced in factories, so the content of preparation is involved little in pharmacy in China today. At the same time, traditional Chinese medicine preparation has become an independent discipline. Therefore, this course focuses on the production technology and theory of traditional Chinese medicine pharmacy in factories, hence the name "Traditional Chinese Medicine Pharmacy."
In summary, "preparation," "preparation," and "preparation" all belong to the category of "pharmacy," which are finished products made from raw drugs. "Preparation" can also be the raw material for "preparation" and "preparation." Both "preparation" and "preparation" are reserve preparations made according to existing prescriptions. "Preparation" and "preparation" are directly administered to patients, with clear medical purposes and dosage instructions, and are the final products of drugs that patients can use directly. For example, deer horn is an animal medicinal material. After processing it into a paste, it becomes a preparation called "deer horn glue." The pharmacy preparation room of a traditional Chinese medicine pharmacy prepares deer horn glue according to a doctor's prescription into 2g × 6 packets, distributes it to patients for oral use three times a day, once 1 packet, which becomes a preparation. If a traditional Chinese medicine factory prepares deer horn glue with other medicinal materials such as Astragalus, oyster shell, turtle shell, ginseng, safflower, white peony root, angelica sinensis, prepared rhubarb, rehmannia glutinosa, and black-bone chicken according to a certain proportion into pills and names it "Black-Bone Chicken and White Peony Pill" for direct sale, it becomes a preparation.
(4) Drug Dosage
Drug dosage refers to the quantity of medicine used, commonly known as dosage. In a narrow sense, it refers to the amount of medicine taken by a patient. The amount of medicine used in clinical practice not only changes in quantity but also produces qualitative changes in its effect. For example, red sage root has a nourishing effect when used in small doses but a blood-stimulating effect when used in large doses. For instance, the rabbit uterine test of Ligusticum chuanxiong shows that it exhibits an excitatory effect at low doses but an inhibitory effect at high doses. Therefore, the dosage should be accurate and appropriate. Pharmaceutical workers must strictly follow the prescription specifications for preparation and must not arbitrarily increase or decrease the total amount of drugs or the dosage of individual herbs in the prescription. The effect of a drug depends on the dosage, but this relationship is very complex and cannot be said to be proportional. Generally, when the dosage is too small, the expected therapeutic effect cannot be achieved. Once the dosage reaches a certain level, it begins to take effect and produces a therapeutic effect. Within a certain range, the larger the dosage, the stronger the effect and the higher the efficacy. However, if the dosage exceeds a certain limit or is too large, it may undergo a qualitative change, even leading to poisoning or other adverse side effects. This relationship is shown in Figure 1-1. Below are several common terms related to dosage:
1. Usual dosage refers to the commonly used therapeutic dosage that produces a therapeutic effect. The Pharmacopoeia of China has clear stipulations on this. The single dose and daily dose in the usual dosage refer to the relatively appropriate dosage in general treatment, that is, the lowest and highest dosage that adults should take once and daily. When used in practice, the dosage should be adjusted within this range based on factors such as the patient's physical condition, pathological condition, age, weight, gender, and the nature of the drug, as well as the route of administration.
2. Maximum dosage refers to the largest therapeutic dosage that produces a therapeutic effect without risk. It is slightly higher than the highest dosage in the usual dosage and is very close to the minimum toxic dosage, making it difficult to master. Therefore, it is rarely used in practice, except when emergency treatment of critically ill patients is considered. The single dose and daily dose in the maximum dosage refer to the highest dosage for adults once and daily. Under normal circumstances, they should not be exceeded. If there is a special situation requiring them to be exceeded, a "!!" mark should be added to the prescription. Otherwise, pharmaceutical workers should refuse to dispense.
3. Median lethal dose is abbreviated as LD50, which refers to the dosage at which 50% of experimental animals die after a certain period of administration and observation, calculated statistically.