芩丹扶正胶囊的制备及其抗微波辐射损伤效应

Preparation of Qindanfuzheng capsule and its effect against microwave radiation damage

目的:对芩丹扶正胶囊的制备工艺进行质量控制,分析该方对微波辐射损伤的影响。方法:实验于2006-03-01/30在吉林医药学院中药抗微波辐射损伤实验室完成。①将黄芩375g,麦冬375g,丹皮300g,黄芪300g等10味中药材按水煎醇沉法各自单独提取,提取液浓缩至稠膏状,减压干燥、粉碎过筛(80目)。合并上述诸药,制软材,制颗粒,装入0号胶囊即得芩丹扶正胶囊。②选择健康Wistar大鼠60只,雌雄各半,按随机数字表法分为5组,即正常对照组、微波辐射后4,6d组、微波辐射+药物治疗4,6d组,每组12只。除正常对照组外,各组大鼠均经高强度微波照射1次,时间5min。微波辐射+药物治疗4,6d组大鼠于照射后8h开始灌胃给予芩丹扶正胶囊,1次/d,2mL/次(0.134g/kg),连续用药4d和6d后处死。微波辐射后4,6d组大鼠分别于微波辐射4d和6d后处死。正常对照组与微波辐射+药物治疗6d组大鼠同时处死。将各组大鼠麻醉处死取血,分离血清,测定各组大鼠热休克蛋白70(用积分扫描面积表示)、尿素氮含量及丙氨酸氨基转移酶、天冬氨酸氨基转移酶活性。结果:60只大鼠全部进入结果分析,无脱失。①胶囊制备质量控制结果:芩丹扶正胶囊成品粉末经硅胶G薄层色谱分析,供试品色谱中与黄芩苷、麦冬对照品色谱在相同位置,显相同颜色的斑点;所制胶囊符合《中国药典》2005年版(一部)附录IL胶囊剂项下有关的各项规定。②各组大鼠血液指标比较:与正常对照组相比,辐射后4d组大鼠血清热休克蛋白70含量显著降低(P<0.05),血清丙氨酸氨基转移酶、天冬氨酸氨基转移酶活性及尿素氮含量均显著升高(P<0.05)。微波辐射+药物治疗4d组大鼠血清丙氨酸氨基转移酶活性显著低于辐射后4d组(P<0.05);微波辐射+药物治疗6d组大鼠血清热休克蛋白70含量显著高于辐射后6d组(P<0.05),尿素氮含量显著低于辐射后6d组(P<0.05)。结论:芩丹扶正胶囊的制备工艺合理,方法可靠,制剂质量可控。该方对高强度微波辐射损伤具有较好的保护作用。

AIM： To carry out quality control in Qindanfuzheng capsule of preparation method and analyze the effect of this method on microwave radiation leading to damage. METHODS： The experiment is accomplished at Traditional Medicine Anti-Microwave Radiation Laboratory of Jilin Medical College from March 1^st to 30^th 2006.①Ten kinds of traditional medicine, including 375 g baikal skullcap root, 375 g dwarf lilyturf tuber, 300 g cinnabar, 300 g membranous milkvetch root and so on were extracted by water and deposited by alcohol; The extract was condensed to dense ointment, then dried by decompression; smashed and griddled （eighty holes）. United above-mentioned medicine, to produce soft material and grains, put into number 0 capsule, it was Qindanfuzheng capsule. ②A total of 60 Wistar rats （half male and half female） were randomly divided into 5 groups, norreal control group, 4 days and 6 days groups after microwave radiation, and 4 days and 6 days groups of microwave radiation connection with traditional medicine with 12 in each group, Except normal control group, others were irradiated by high intensity once for 5 minutes. Medicine treat group was given medicine by gastric perfusion once a day and 2 mL every time （0A34 g/kg） at 8 hours after irradiation, was respectively continuously give medicine, 4 days and 6 days later, rats were executed at one time. The rats in the 4 days and 6 days groups after microwave radiation were killed after 4 and 6 days after microwave radiation. The rats in the normal control group and 6days group of microwave radiation connection with traditional medicine were killed at the same time. Blood was extracted from rats of each group after anesthetizing and killing. Serum was separated. Contents of heat chock protein 70 （expressed with integral scanning area） and blood uria nitrogen as well as activities of alanine aminotransferase and aspartate aminotransferase were measured in each group. RESULTS： A total of 60 rats were involved in the result analysis, no drop-out.①Result of quality control in preparation of the capsule： The samples were compared with control material of baikal skullcap root glycosides and dwarf lilyturf tuber, the position of the G chromatography and the stain color were same; capsules accorded to rules of capsule in appendix IL of （Chinese Pharmacopoeia）. ②Blood index of rats in each group： The serum heat shock protein 70 decreased significantly in rats of the 4 days group after microwave radiation as compared with the normal control group （P 〈 0.05）, while activities of serum alanine aminotransferase and aspartate aminotransferase and content of blood uria nitrogen increased markedly （P 〈 0.05 ）. Activity of alanine aminotransferase was lower remarkably in the 4 days group of microwave radiation connection with traditional medicine than in the 4 days group after microwave radiation （P 〈 0.05）. Content of serum heat shock protein 70 was higher obviously in the 6 days group of microwave radiation connection with traditional medicine than in the 6 days group after microwave radiation （P 〈 0.05）, while the content of blood ufia nitrogen was lower significantly than that in the 6 days group after microwave radiation （P 〈 0.05 ）. CONCLUSION： The preparation technique of Qindanfuzheng capsule is reasonable, the method is reliable, and technique quality can be controlled. It has better protection to high intensity of microwave radiation injury.