Thought and method of reproductive toxicity research in traditional Chinese medicine / 药学学报

Reproductive toxicity research takes an important place in traditional Chinese medicine pre-clinical safety evaluation. Modern reproductive toxicity experiment includes drug-related miscarriage, fetal death, teratism, and adverse effects on fertility, genital system, embryonic development and fetus, which is different from contraindicated in pregnancy in traditional Chinese medicine theory. Now the three-phases reproductive toxicity study is the method mainly applied in traditional Chinese medicine reproductive toxicity evaluation. Besides that, alternative methods of whole embryos culture and embryonic stem cell test are also used in traditional Chinese medicine embryo toxicity evaluation. This article reviews research progress and pre-clinical evaluation on reproductive toxicity of traditional Chinese medicine.

Methodology for preclinical assay of pseudoallergy of injectable drugs (I)--mouse model for assay of pseudoallergy induced by injections / 中国中药杂志

<p><b>OBJECTIVE</b>To develop animal models and methodologies for assay of pseudoallergy induced by injectable drugs.</p><p><b>METHOD</b>Mouse anaphylactoid reaction model was developed by intravenous injection of test substance solutions containing Evans blue (EB). Scores of ear blue staining and quantitation of ear EB exudation were the parameters for the pseudoallergy reaction.</p><p><b>RESULT</b>Mouse anaphylactoid reaction was characterized as vascular hyperpermeability which was detectable in ears by quantitation of blue staining score and EB exudation. Compound 48/80 and histamine caused severe ear bluing and EB exudation by inducing obvious vascular hyperpermeability which indicated that they can induce mouse pseudoallergy. Intravenous injection of either normal saline or 5% glucose injection showed no ear bluing. The mouse pseudoallergy model was validated by intravenous injections of western drugs and Chinese medicine.</p><p><b>CONCLUSION</b>Mice could be developed into pseudoallergy model for preclinical safety evaluation of injectable drugs. The pseudoallergy reaction in this model is of high clinic consistency, sensitivity, reproducibility, and maneuverability. The model is suitable for the evaluation for pseudoallergy induced by injectable products prepared from Chinese materia medica This model can also be used for safety assay and quality control in manufacturing process, spot checking of marketed products, screening of allergen as well as studying of pseudoallergy mechanism.</p>

Methodology for preclinical assay of pseudoallergy of injectable drugs (II) rat model for assay of cutaneous pseudoallergy induced by injections / 中国中药杂志

<p><b>OBJECTIVE</b>To develop animal models and methodologies for assay of pseudoallergy induced by injectable drugs.</p><p><b>METHOD</b>Rats cutaneous anaphylactoid reaction model was developed by intravenous injection of 0. 6% Evans blue(EB) followed by intracutaneous injection of test substance solutions 50 microL. Diameters of subcutaneous blue spots and EB exudation were assayed.</p><p><b>RESULT</b>Rat anaphylactoid reaction was characterized as vascular hyperpermeability which was measured by diameters of blue spots inside the skin and the EB exudation of the blue spots. Compound 48/80 caused severe bluing and EB exudation in the skin by inducing obvious vascular hyperpermeability which indicated that it can induce rat skin pseudoallergy. Normal saline or 5% glucose injection showed no obvious reactions. The rat pseudoallergy model was validated by intracutaneous injections of western drug injections and Chinese medicine.</p><p><b>CONCLUSION</b>Rats could be developed into skin pseudoallergy model for preclinical safety evaluation of injectable drugs. The pseudoallergy reaction in this model is of high clinic consistency, sensitivity, reproducibility, and maneuverability. The model is suitable for the evaluation for pseudoallergy induced by injectable products prepared from Chinese materia medica This model can also be used for safety assay and quality control in manufacturing process, spot checking of marketed products, screening of allergen as well as studying of pseudoallergy mechanism.</p>

Comparative study on pseudoanaphylactoid reactions induced by pulse-activating injection before and after improving technology / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate a possibility to improve the security of pulse-activating injection by comparing the difference of pseudoanaphylactoid reactions (PR) induced by pulse-activating injection before and after improving technology.</p><p><b>METHOD</b>The analysis of vascular permeability of the mice's ears: ICR mouse were divided into different test groups, and intravenously injected with solutions of different concentration of pulse-activating injection before and after improving technology, positive control Compound 48/80 and 5% glucose injection. All test substances were mixed with 0. 4% Evans blue. The reaction and vascular permeability of the ears were observed and measured 30 min after injection. The vascular permeability of the rat's skin: the rats were intravenous injected with 0. 6% Evans blue normal saline solution first, 10 minutes later, the same test substances were intradermal injected into the back of rats, there are 16 injected spots in the back of rat. The rats were sacrificed and the diameter of locus ceruleus and the content of Evans blue leaked out were measured 20 min after injection.</p><p><b>RESULT</b>Pulse-activating injection before improving technology with dose of 16.7 mL x kg(-1) ( in 1.67 times the clinical dose ) caused obvious vascular hyperpermeability in ICR mice. In the group of pulse-activating injection before improving technology with dose of 10 mL x kg(-1) (in clinic equivalent dose), no obvious vascular hyperpermeability in the ears were observed. The degrees of vascular hyperpermeability in the group of pulse-activating injection after improving technology with dose of 16.7 mL x kg(-1) were more lessen than the same dose of injection before improving technology. Pulse-activating injection before improving technology caused obvious exudation, oedema locus ceruleus in the injection site of rat's back, and it showed a certain dose-effect relation. Pulse-activating injection after improving technology caused locus ceruleus in the injection site too, but the diameters of the locus ceruleus were shorter than the diameters in the group of pulse-activating injection before improving technology, and the contents of leaked out Evans blue were fewer. All of these showed that PR of skin induced by pulse-activating injection after improving technology is alleviated.</p><p><b>CONCLUSION</b>Pulse-activating injection before improving technology cause obvious vascular hyperpermeability, but the same dose of pulse-activating injection after improving technology can't cause obvious vascular hyperpermeability. The result indicated that the pulse-activating injection before improving technology can cause PR, improving technology can lessen the degree of PR induced by the injection.</p>

Relationship between specific immunocyte and pseudoanaphylactoid reactions induced by Shuanghuanglian injection / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate the relationship between specific immunocyte and pseudoanaphylactoid reactions (PR) induced by Shuanghuanglian injection (SHLI).</p><p><b>METHOD</b>ICR mice, SCID mice and BALB/C athymic mouse were divided into different test groups, the mice were intravenously injected with solutions of different concentration of SHLI, positive control Compound 48/80 and normal sodium. All test substances were mixed with 0. 4% Evans blue. The reaction and vascular permeability of the ears were observed and measured 30 min after SHLI injected.</p><p><b>RESULT</b>SHLI of 300, 600 mg x kg(-1) caused obvious vascular hyperpermeability in ICR mice, but the same dose of SHLI didn't cause vascular hyperpermeability in SCID mice and BALB/C athymic mouse.</p><p><b>CONCLUSION</b>SHLI in equivalent and 2 times the clinical dose can cause PR in ICR mice, but the same dose of SHLI can't cause PR in SCID mice and BALB/C athymic mouse, so specific immunocyte maybe take part in the SHLI-induced PR.</p>

Establishment of the curriculum system for fostering practical medical talents / 中华医学教育探索杂志

For the employment orientation of graduates in clinical medical major from three-year medical eduction,a curriculum system,which will be used to foster practical medical talented person for urban and rural communities,has been proposed in this paper.We will take measures,which not only further defines training target and requirement for the practical medical person from the short school system and guides students to alterate their ideological concept but also reconstructures new curriculum system and reforms teaching methods,to ensure the implementation of the training objectives