| Objective Observed the security and tissue compatibility of self-regulating new lactic acid/glycerol ploymeric material by animal experiments, to supply the database and reference data of further applying in clinic。Method 1) PreParation of new lactic acid/glycerol ploymeric material,from research institute of chemical engineering and technology, Hunan university. 2) Hemolytie test:10ml of extracts of the solution of the lactic acid/glycerol ploymeric materials, sterilized distilled water and saline were aequired. Then 0.2ml anti-coagulated diluted fresh blood of rabbit was added in each group. Atfer 60 min in water bath at 37℃, they were centrifugated for 5 minutes(1000 r/min). The super suspension was aequired and was measured at 545nm by use a spectrophotomete. 3) Acute test of total body toxieiyt:20 healhty mouse a were divided into two groups randomly.Mouse of the test group were injeeted the extracts of the ploymeric materials through vein(50ml/kg), the concentration was 100g/L.And the control group mouse were injected with saline(50ml/kg). Atfer instant,24hours, 48hours,72hours,the general behavior, the change of body weight,toxieity manifestation and death number was observed. 4) Inrtadermal stimulation tests:To evaluate the potential and degree of subcuticular stimulation reaction,the primary irritation index(PII)was worked out by observing at the rate point of animals back after the subcutaneous injection of the solution of the lactic acid/glycerol ploymeric material.5) Implant and Chronic toxicity test:Twenty-Four SD rats were randomized into 2 groups (n=12),Lactic acid/glycerol ploymeric material were implanted subcutaneously in the corresponding rat dorsum respectively;Sham group was designed as the control group without any material implantation, to abserve the situation of local surgery。Blood was drawn at different points, the functional indexes of liver and kidney were measured, and the histopathology of liver and kidney were abserved after 12 weeks.To evaluate the toxic reaction on the whole body。Animals were sacrificed by air embolization, Observe the implants and surrounding tissue taken to give microscopic section at different points。Results 1) Hemolytie test:The hemolysis ratio of the saline group was 0 percent and the stilled water group was 100 percent. The hemolysis ratio of lactic acid/glycerol ploymeric material was 1.47 percent.2) Acute test of total body toxieiyt:All animals were alive in the labor period, and no toxieosis symptom or ill effect was found within the 72 hours.There was no diffrence between the lactic acid/glycerol ploymeric material groups and saline group.3) Inrtadermal stimulation tests:the solution was injected into the back of animal,the PII was measured from 0 to 0.4,and the stimulation reaction was very slight according to the criteria,There are no potential of skin sensitization to the materials under the experimental conditions.4) Implant and Chronic toxicity test:all the biochemical examinations and the histopathology of liver and kidney are normal, There was no significant difference among the two group (p>0.05), Not tissue damage was found in organs of the local, Pathologic tissue section showed that the peripheral packed tissue of materials and the inflammation change accorded with the general regularity of inflammatory outcome。Conclusion The new lactic acid/glycerol ploymeric material has good security and biocompatibility. Further study of the material to provide a reliable basis for the biological, and has a good developmental prospect。...
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