ASTM F750-1987(2007)e1 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse《用给老鼠有系统注射评定药物材料浸渍物》.pdf

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1、Designation: F 750 87 (Reapproved 2007)e1Standard Practice forEvaluating Material Extracts by Systemic Injection in theMouse1This standard is issued under the fixed designation F 750; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,

2、 the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTEFormatting and grammar were corrected editorially throughout in April 2007.1. Scope1.1 This practice covers a

3、nonspecific, acute toxicity testused for detecting leachables from materials used in medicaldevices.1.2 The liquids injected into the mouse are those obtainedby Practice F 619 where the extraction vehicles are saline,vegetable oil, or other liquids simulating human body fluids.1.3 Two procedures are

4、 outlined: Method A for intravenousinjection and Method B for intraperitoneal injection.1.4 This practice is one of several developed for theassessment of the biocompatibility of materials. Practice F 748may provide guidance for the selection of appropriate methodsfor testing materials for a specifi

5、c application.2. Referenced Documents2.1 ASTM Standards:2F 619 Practice for Extraction of Medical PlasticsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices3. Summary of Practice3.1 The extract liquid is prepared in accordance with Prac-tice F 619. The extraction

6、 vehicles are saline and vegetable oil,or other extraction vehicles, as described in Practice F 619. Theextract liquid is injected into mice, and the animals areobserved at regular intervals for 72 h for reactions, survival,etc.4. Significance and Use4.1 This practice is intended to help assess the

7、biocompat-ibility of materials used in medical devices. It is an acutetoxicological test designed to detect the presence of injuriousleachable substances.4.2 This practice may not be appropriate for all types ofimplant applications. The user is cautioned to consider theappropriateness of the method

8、in view of the materials beingtested, their potential applications, and the recommendationscontained in Practice F 748.4.3 The only limitation applicable is the extract preparation.Refer to Sections 4.3 and 4.4 of Practice F 619 for a descriptionof this limitation.5. Apparatus5.1 MiceThe mice shall

9、be albino-type, healthy and notpreviously used, and shall weigh between 17 and 23 g. Animalcare shall be in accordance with the “Guide for Care and Useof Laboratory Animals.”3Age, sex, and weight shall berecorded and reported. All the mice for each extraction vehicleshall be from the same source. Fo

10、r each extraction vehicle, aminimum of ten mice are used in the test. If the results of thisfirst test group are inconclusive, then 20 more mice will beneeded to complete the test of one extraction vehicle for oneplastic.5.1.1 During the test the mice shall be fed normally withcommercially available

11、 feed and tap water.5.2 CagesThere shall be one cage for the five miceexposed to one extract liquid. Each mouse in a cage shall beuniquely identified, and this identification shall be recorded.Male and female mice shall be housed separately, and theircages are positioned in a manner which prevents t

12、he accidentaltransfer of feces or bedding from cage to cage.5.3 SyringeSterile syringes, not greater than 3 mL involume, with a precision of 60.10 mL shall be used.5.3.1 Method ASterile needles of 25 to 2712 gage shall beused.5.3.2 Method BSterile needles of 21 to 26 gage shall beused.6. Sampling6.1

13、 Sample in accordance with Practice F 619.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Feb. 1, 2007. Published February 2007.

14、 Originallyapproved in 1982. Last previous edition approved in 2002 as F 750 87 (2002)e1.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summ

15、ary page onthe ASTM website.3U.S. Department of Health, Education, and Welfare, Guide for Care and Use ofLaboratory Animals, Publication No. NIH 78-23, Bethesda, MD, 1978.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7. Sample and

16、Test Specimen7.1 GeneralThe sample is the plastic or other materialexposed to the extraction procedure. As a result of theextraction in Practice F 619, for each extraction vehicle thereare available: (1) a sample extract liquid, and (2) a blankextract liquid. These extract liquids are to be injected

17、 into thetest animals within 24 h of the end of the extraction procedure.Record the storage conditions if the liquid extract is not usedimmediately after preparation.7.1.1 There are usually two extract liquids (a blank and asample) prepared from an extraction vehicle. Samples based onother extractio

18、n vehicles may be available, as described inPractice F 619, or as required by the standard for the medicaldevice.7.2 Method A, Intravenous:7.2.1 The extract liquid is usually prepared from a salineextraction vehicle. The dose of the extract liquid is 50 mL/kgof body weight for each mouse, injected a

19、t a steady rate of notmore than 0.1 mL/s. If a hypotonic or hypertonic extract liquidis used, then the injection rate is adjusted appropriately.7.2.2 Aqueous extract liquids shall be nominally isosmoticbefore injection. For example, sodium chloride may be addedto distilled water extracts.7.3 Method

20、B, IntraperitonealThe extract liquid is pre-pared from a vegetable oil extraction vehicle. The dose of theextract liquid is 50 mL/kg of body weight for each mouse.8. Procedure8.1 Method A, Intravenous:8.1.1 Use saline, and similar extraction vehicles designatedfor intravenous injection.8.1.2 Agitate

21、 each extract liquid vigorously prior to with-drawal of each injection dose to ensure even distribution of theextracted matter. If particulates are clearly present, then theextract liquids shall be injected by the intraperitoneal method.Optional: measure and record pH.8.1.3 For each extraction vehic

22、le, use ten mice, five for thesample extract liquid and five for the blank extract liquid.Weigh all mice, and record their weights. Use a system ofmarking to identify each individual mouse within each groupof five.8.1.4 Inject the predetermined amount (see 7.2.1)ofthesample extract liquid into the t

23、ail vein of each of the five mice.Inject the blank extract liquid in the same way into five othermice. The use of warm water or a heat lamp may help dilate thetail veins for ease of injection.8.1.5 Observe all animals immediately after injection, again4 h after injection, and then at 24, 48, and 72

24、h, respectively,after injection for symptoms of slight, moderate, or markedtoxicity or death (Table 1). Record the observations. Measureand record the body weights of all animals at 24, 48, and 72 hpostinjection.8.2 Method B, Intraperitoneal:8.2.1 Method B is to be used with vegetable oil and simila

25、rextraction vehicles designated for intraperitoneal injection.8.2.2 Agitate each extract liquid vigorously prior to with-drawal of each injection dose, to ensure even distribution ofextracted matter. If the extract liquid contains particulates,record and report observations.8.2.3 For each extraction

26、 vehicle use ten mice, five for thesample extract liquid and five for the blank extract liquid.Weigh all mice, and record their weight. Use a system ofmarking to identify each individual mouse within each groupof five.8.2.4 Inject the predetermined amount (see 7.3)ofthesample extract liquid intraper

27、itoneally into each of the fivemice. Inject the blank extract liquid in the same way into fiveother mice.8.2.5 Observe all animals immediately after injection, again4 h after injection, and then not earlier than 24, 48, and 72 h,respectively, after injection for symptoms of slight, moderate,or marke

28、d toxicity or death (Table 1). Record the observations.Measure and record the body weights of all animals at 24, 48,and 72 h postinjection.TABLE 1 Response to Systemic Injection AssayResponse DescriptionNormal, no symptoms Mouse exhibits no adverse physicalsymptoms after injection.Slight Mouse exhib

29、its slight but noticeablesymptoms of hypokinesia, dyspnea, orabdominal irritation after injection.Moderate Mouse exhibits definite evidence ofabdominal irritation, dyspnea,hypokinesia, ptosis, or diarrhea afterinjection. (Weight usually drops tobetween 15 and 17 g.)Marked Mouse exhibits prostration,

30、 cyanosis,tremors, or severe symptoms ofabdominal irritation, diarrhea, ptosis, ordyspnea after injection. (Extreme weightloss; weight usually less than 15 g.)Dead, expired Mouse dies after injection.F 750 87 (2007)e129. Interpretation of Results9.1 If during the 72-h observation period none of thea

31、nimals treated with the sample extract liquid shows a substan-tially greater biological reaction than the animals treated withthe blank extract liquid, the sample meets the requirements ofthe test.9.2 ReactionIf two or more animals show either markedsymptoms of toxicity or die, then the sample does

32、not meet therequirements of the test.9.3 RetestIf any animals injected with the sample showslight signs of toxicity, and not more than one animal showsmarked symptoms of toxicity or dies, repeat the test usinggroups of ten mice each. A substantial decrease in body weightfor all animals in the group,

33、 even without other symptoms oftoxicity, requires a retest using groups of ten mice each. In thisrepeated test, the requirements of the test are met if none of theanimals injected with the sample shows a substantially greaterreaction than that observed in the animals injected with theblank.9.4 A ret

34、est (see 9.3) requires that the extraction procedurebe done a second time, since the extraction fluids must be usedwithin 24 h of the end of the extraction.10. Report10.1 Describe the sample that was extracted, including,generic name, trade name, manufacturers code, lot number,catalog number, date o

35、f manufacture, formulation, fabricationprocedures or processes, and so forth, as appropriate. Similarly,describe the extraction vehicle and the conditions of theextraction (temperature and time).10.2 Report the number of mice used, each mouses weight,sex and age, and whether the mouse was exposed to

36、 the sampleor blank extract.10.3 Report whether a retest was necessary and if so, thereasons for the retest.10.4 For each mouse used, including those used in a retest,report the clinical signs and the extract response: whether thereaction was none, slight, moderate, marked, or death. Thisapplies to

37、all mice, whether injected with the sample extractliquid or with the blank extract liquid.11. Precision11.1 PrecisionIntralaboratory and interlaboratory repro-ducibility has not been systematically determined. Reproduc-ibility may be inferred from previous round robin studies.4,512. Keywords12.1 acu

38、te toxicity tests; biocompatibility; intravenous in-jection; intraperitoneal injections; mouse/mice; test animalsASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advi

39、sed that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either

40、reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If

41、 you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individ

42、ual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).4Brewer, John H., “Toxicity Standards for Plastics,” Bulletin Parent

43、eral DrugAssn. Vol 19, 1965, pp. 2228.5Materials Science Toxicology Laboratories, University of Tennessee Center forthe Health Sciences, Memphis, Tenn., “Determination of Levels of Chemical Purityfor Biomaterials Used as Surgical Implants,” Round Robin Evaluation of PrimaryAcute Toxicity Screening Protocols, Quarterly Report No. 1516, Part II, ContractNo. FDA 223-73-5231, 1978.F 750 87 (2007)e13