USP-88-生物实验

1、88 BIOLOGICAL REACTIVITY TESTS, IN VIVO The following tests are designed to determine the biological response of animals to elastomerics, plastics, and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. It is essential to make available the specific surface area for extraction. When the surface area of the specimen cannot be determined, use 0.1 g of elastomer or 0.2 g of plastic or other material for e

2、very mL of extraction fluid. Also, it is essential to exercise care in the preparation of the materials to be injected or instilled to prevent contamination with microorganisms and other foreign matter. Three tests are described. The Systemic Injection Test and the Intracutaneous Test are used for elastomeric materials, especially to elastomeric closures for which the appropriate Biological Reactivity Tests, In Vitro 87 have indicated significant biological reactivity. These two tests are used f

3、or plastics and other polymers, in addition to a third test, the Implantation Test, to test the suitability of these materials intended for use in fabricating containers and accessories thereto, for use in parenteral preparations, and for use in medical devices, implants, and other systems.These three tests are applied to materials or medical devices, if there is a need for classification of plastics and other polymers based on in vivo biological reactivity testing.For the purpose of this chapte

4、r, these definitions apply: the Sample is the specimen under test or an extract prepared from such a specimen. A Blank consists of the same quantity of the same extracting medium that is used for the extraction of the specimen under test, treated in the same manner as the extracting medium containing the specimen under test. A Negative Control1 is a specimen that gives no reaction under the conditions of the test.CLASSIFICATION OF PLASTICS Six Plastic Classes are defined (see Table 1). This clas

5、sification is based on responses to a series of in vivo tests for which extracts, materials, and routes of administration are specified. These tests are directly related to the intended end-use of the plastic articles. The choice of extractants is representative of the vehicles in preparations with which the plastics are likely to be in contact. The Table 1 classification facilitates communication among suppliers, users, and manufacturers of plastics by summarizing the tests to be performed for

6、containers for injections and medical devices if a need for classification exists.Table 1. Classification of Plastics Plastic ClassesaTests to be ConductedIIIIIIIVVVITest MaterialAnimalDoseProcedurebxxxxxxExtract of Sample in Sodium Chloride InjectionMouse50 mL/kgA (IV)xxxxxxRabbit or Guinea Pig0.2 mL/animal at each of 10 or 6 sitesB (IC) xxxxxExtract of Sample in 1 in 20 Solution of Alcohol in Sodium Chloride InjectionMouse50 mL/kgA (IP)xxxxxRabbit or Guinea Pig0.2 mL/animal at each of 10 or 6

7、sitesB (IC) xxxExtract of Sample in Polyethylene Glycol 400Mouse10 g/kgA (IP)xxRabbit or Guinea Pig0.2 mL/animal at each of 10 or 6 sitesB (IC) xxxxExtract of Sample in Vegetable OilMouse50 mL/kgA (IP)xxxRabbit or Guinea Pig0.2 mL/animal at each of 10 or 6 sitesB (IC)xxImplant strips of SampleRabbit4 strips/animalC xxImplant SampleRat2 Samples/animal Ca Tests required for each class are indicated by “x” in appropriate columns. b Legend: A (IP)Systemic Injection Test (intraperitoneal); B (IC)Intr

8、acutaneous Test (intracutaneous); CImplantation Test (intramuscular or subcutaneous implantation). With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of three standard temperatures: 50, 70, and 121. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction (e.g., IV-121, which represents a class IV plastic extracted at 121

9、, or I-50, which represents a class I plastic extracted at 50).Plastics may be classified as USP Plastic Classes IVI only on the basis of the response criteria prescribed in Table 1.This classification does not apply to plastics that are intended for use as containers for oral or topical products, or that may be used as an integral part of a drug formulation. Table 1 does not apply to natural elastomers, which are to be tested in Sodium Chloride Injection and vegetable oils only.The Systemic Injection Test and the Intracutaneous Test are designed to determine the systemic and local, respectively, biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts p

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