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一、生物药剂学的内容及含义生物药剂学(Biopharmacy或Biopharmaceutics)是研究药物及其剂型在体内的吸收、分布、代谢与排泄过程的学科,以阐明药物的剂型因素、用药对象的生理因素与药物的体内效应(包括疗效及毒副作用)三者之间的关系,为正确评价药剂质量、合理用药提供理论的依据。过去一直认为药物的疗效与副作用纯粹是由药物化学结构本身所决定的,至于将药物制成某种剂型如酊剂、片剂、糖浆剂等只是便于临床具体应用而已。实际则不然。如国外某药厂生产抗凝药双香豆素片疗效一直肯定,后发现某些轻症病人常只需服用半片即可,便把片子做大,以便分开服用,但是临床很快发现此药无效。对照试验发现含量与崩解度都合格,但在人工肠液中做“溶出速率”测定比原片剂要慢,于是该厂改进了处方与生产工艺,提供第三种片剂。不久病人又反映药效太强。这说明即使同一药物,由于制剂处方与生产条件的改变,往往改变了药效,像这样的例子是不少见的。 二、药物吸收机理及影响药物吸收的因素 口服药物吸收入血,首先要通过胃肠道。其胃肠屏障(生物膜)具有很高的选择性,它能允许或阻止若干物质通过。氨基酸、糖类、脂肪酸以及所有生命所需物质在健康人中均易通过此屏障。口服药物大多数是以“被动转运”方
First, the content and meaning of biological pharmacy Biopharmacy or Biopharmaceutics is to study the absorption of drugs and their formulations in the body absorption, distribution and metabolism of the process of excretion to clarify the drug formulation factors, the physical factors of drug use and In vivo effects of drugs (including efficacy and side effects), the relationship between the three, in order to correctly evaluate the quality of drugs, rational use of drugs to provide theoretical basis. In the past, the efficacy and side effects of drugs were always determined purely by the chemical structure of the drug itself. As for the formulation of drugs such as tinctures, tablets and syrups, it is only convenient for clinical application. The actual is not. Such as the production of anticoagulant drugs abroad certain biochemicals coumarin tablets have been affirmed, and found that some patients with mild often only need to take half of the film, they put the film bigger in order to be taken separately, but the clinical soon found that the drug invalid. The control trial found that both the content and disintegration were acceptable, but the “dissolution rate” was measured in the artificial intestinal juice slower than the original tablet, so the factory improved the prescription and the production process to provide the third tablet. Shortly after the patient also reflects the efficacy too strong. This shows that even the same drug, due to prescription formulations and production conditions change, often change the efficacy, such as this example is not uncommon. Second, the mechanism of drug absorption and factors affecting drug absorption Oral drug absorption into the blood, the first to pass the gastrointestinal tract. Its gastrointestinal barrier (biofilm) has a high selectivity, it can allow or prevent the passage of a number of substances. Amino acids, sugars, fatty acids and all the substances needed by life are easy to pass this barrier in healthy people. Oral medication most of the “passive transfer” side