CN105381313A - 一种维生素d组合物及其用途 - Google Patents
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Abstract
本发明属于药物制备与应用技术领域，涉及一种维生素D组合物及其用途，维生素D组合物中各成份的重量百分比为：维生素D10-50％，芹菜根粉10-20％，秋葵汁5～15％，燕麦粉1-5％，紫甘薯粉10-60％，鱼粉1-5％，食盐0.5％，各原料的总量为100％；采用现有的喷雾干燥法将各原料混合后制成每粒重0.3-1.0g的粉末状胶囊，每克维生素D组合物中含维生素D不少于200μg，用于改善糖尿病遗传物质稳定性，成年人每日服用1～3粒胶囊，餐后半小时后服用；其原料易得，制备工艺成熟，制备方法易控，疗效明显，无副作用，安全可靠，加工成本低，食用环境友好。
Description
技术领域：
本发明属于药物制备与应用技术领域，涉及一种用于改善糖尿病患者遗传物质稳定性的维生素D组合物，通过控制维生素D的用量，改善糖尿病患者遗传物质的稳定性，降低DNA氧化损伤。
背景技术：
糖尿病是一组由于胰岛素分泌缺陷和/或胰岛素作用障碍所致的以高血糖为特征的慢性代谢性疾病，是全球范围内流行的严重危害公众健康的疾病，持续高血糖与长期代谢紊乱等可导致全身组织器官，特别是眼、肾、心血管及神经系统的损害及其功能障碍和衰竭，严重者可引起失水，电解质紊乱和酸碱平衡失调等急性并发症酮症酸中毒和高渗昏迷，而且越来越多的研究表明糖尿病患者体内糖脂代谢紊乱，自由基产生增多，导致氧化应激压力增大，当体内抗氧化系统不能及时清除过多的氧化物质时，就会导致DNA氧化损伤，而DNA氧化损伤会形成导致微核产生的无着丝粒染色体片段，这意味着高糖环境下微核率也随之升高。
维生素D(VD)是一种重要的调节钙磷平衡和脂质代谢的激素，VD除了这些常见的功能以外，还有一些其他的功能，如调控糖脂代谢和胰岛素抵抗、免疫调节以及降低氧化应激压，研究证明VD状态与糖脂代谢和胰岛素抵抗密切相关，甚至与遗传基因的多态性有关，VD可以通过增强先天和适应性的免疫反应的活性以及细胞因子的释放来增强免疫系统的功能。据最新文献报道，芹菜根、秋葵和紫甘薯等天然植物成份对维生素D具有辅助提升功效，特别对于糖尿病患者具有减轻病情的功效。近年来，VD对糖尿病患者糖脂代谢及抑制染色体和DNA损伤方面的功能得到了越来越多的关注。然而，关于VD对糖尿病患者遗传物质稳定性的影响尚未见报道。
发明内容：
本发明的目的在于克服现有技术存在的缺点，寻求设计提供一种用于改善糖尿病患者遗传物质稳定性的维生素D组合物，能够调节糖尿病患者的糖脂代谢，减少糖尿病患者的氧化应激压力，降低DNA氧化损伤和微核率，维持遗传物质的稳定性。
为了实现上述目的，本发明所述维生素D组合物中各成份的重量百分比为：维生素D10-50％，芹菜根粉10-20％，秋葵汁5～15％，燕麦粉1-5％，紫甘薯粉10-60％，鱼粉1-5％，食盐0.5％，各原料的总量为100％；采用现有的喷雾干燥法将各原料混合后制成每粒重0.3-1.0g的粉末状胶囊，每克维生素D组合物中含维生素D不少于200μg，用于改善糖尿病遗传物质稳定性，成年人每日服用1～3粒胶囊，餐后半小时后服用。
本发明涉及的维生素D、燕麦粉、鱼粉和食盐均采用市售产品；芹菜根粉的制备工艺为：先将新鲜芹菜根洗净后榨汁并过滤得到滤汁，再将滤汁进行蒸发干燥，先在0～20℃温度下抽真空后使温度上升至20℃～37℃，经24～18小时抽真空蒸发干燥后得到干燥固体，然后研磨成100-150目的粉末。
本发明所述的秋葵汁制备工艺为：将新鲜秋葵清洗干净，放入80-100℃开水中浸煮10-15分钟，捞出后立即放入3-10℃冷水中浸3-5分钟再捞出，然后采用现有技术按秋葵与纯净水1：1的重量比进行压榨和过滤得秋葵汁。
本发明所述紫甘薯粉为鲜紫甘薯切成3-5mm片状，控温20-45℃自然晾干后，磨制成100-150目的粉末。
本发明与现有技术相比，其原料易得，制备工艺成熟，制备方法易控，疗效明显，无副作用，安全可靠，加工成本低，食用环境友好。
附图说明：
图1为本发明实施例3各组大鼠的诱导DNA损伤图。
图2为本发明实施例3糖尿病大鼠的微核形态图。
具体实施方式：
下面通过实施例并结合附图对本发明作进一步说明。
实施例1：
本实施例所述维生素D组合物中各成份的重量百分比为：维生素D10-50％，芹菜根粉10-20％，秋葵汁5～15％，燕麦粉1-5％，紫甘薯粉10-60％，鱼粉1-5％，食盐0.5％，各原料的总量为100％；采用现有的喷雾干燥法将各原料混合后制成每粒重0.3-1.0g的粉末状胶囊，每克维生素D组合物中含维生素D不少于200μg，用于改善糖尿病遗传物质稳定性，成年人每日服用1～3粒胶囊，餐后半小时后服用。
本实施例涉及的维生素D、燕麦粉、鱼粉和食盐均采用市售产品；芹菜根粉的制备工艺为：先将新鲜芹菜根洗净后榨汁并过滤得到滤汁，再将滤汁进行蒸发干燥，先在0～20℃温度下抽真空后使温度上升至20℃～37℃，经24～18小时抽真空蒸发干燥后得到干燥固体，然后研磨成100-150目的粉末。
本实施例所述的秋葵汁制备工艺为：将新鲜秋葵清洗干净，放入80-100℃开水中浸煮10-15分钟，捞出后立即放入3-10℃冷水中浸3-5分钟再捞出，然后采用现有技术按秋葵与纯净水1：1的重量比进行压榨和过滤得秋葵汁。
本实施例所述紫甘薯粉为鲜紫甘薯切成3-5mm片状，控温20-45℃自然晾干后，磨制成100-150目的粉末。
实施例2：制造糖尿病大鼠模型
本实施例选取SPF级SD雄性大鼠100只，体重在180g～220g之间，正常喂养一周后随机分组对照组和造模组两组，其中对照组(12只)喂养不含维生素D的基础饲料，造模组(88只)喂养含68.5％基础饲料、20％蔗糖、10％猪油和1％胆固醇的高糖高脂饲料，喂养4周后，对造模组大鼠空腹腹腔注射链脲佐菌素(STZ)35mg/kg，对照组注射相同量的柠檬酸钠缓冲液；注射后24h和72h测大鼠空腹血糖，两次血糖均＞11.1mmol/L的为造模成功；本实施例中88只大鼠共造模成功80只，造模成功率为91％，实验过程中，所有大鼠自由饮水，饮食与之前的保持一致。
实施例2：
本实施例将实施例2中造模成功的大鼠按血糖随机分为5组，每组16只，将实施例1所述的维生素D组合物溶于大豆油，每天按各组剂量灌胃，连续灌胃6周后进行标本的采集与检测及统计处理，剂量分别为：
N(正常对照组,灌胃生理剂量的维生素D组合物)：36IU/kg体重；
DM(糖尿病模型组,灌胃生理剂量的维生素D组合物)：36IU/kg体重；
5N(糖尿病组,灌胃5倍维生素D组合物)：180IU/kg体重；
25N(糖尿病组,灌胃25倍维生素D组合物)：900IU/kg体重；
125N(糖尿病组,灌胃125倍维生素D组合物)：4500IU/kg体重；
200N(糖尿病组,灌胃200倍维生素D组合物)：7200IU/kg体重；
(1)标本的采集与检测：灌胃第6周末，检测大鼠空腹血糖，处死大鼠后取大鼠动脉血、股骨及各脏器，分离大鼠血清，检测血生化指标，用现有的彗星电泳法检测大鼠外周血液淋巴细胞DNA损伤，并对大鼠骨髓进行微核试验检测大鼠骨髓细胞微核率；
(2)统计处理：采用SPSS17.0统计软件对采集到的数据进行单因素方差分析，数据呈正态分布，用均数±标准差表示，数据两两比较用LSD方法进行，以p＜0.05为具有统计学意义；6组大鼠统计分析的结果见表1和表2，由表1可知，自发DNA氧化损伤在5N(57±17.327)组和25N组(76.75±25.559)比模型组(113.5±55.514)显著降低(p＜0.05)，且5N组(57±17.327)与N组(45.4±14.524)相比没有统计学差异，证明5N组能显著降低糖尿病大鼠的自发DNA氧化损伤，并使其接近正常水平，而125N和200N未观察到类似的作用；当用10μmol/lH2O2.诱导DNA损伤时，VD各干预组(5N:166.88±59.977；25N:174.50±86.761；125N:192.67±34.737；200N:212.14±90.744)和DM组(206.63±65.968)之间相比没有显著的统计学差异，然而5N,25N组与N组相比没有显著的差异，证明5倍和25倍的VD干预能使DNA诱发损伤接近正常水平，适量的VD补充可明显降低大鼠骨髓细胞微核率，5N、25N、125N组大鼠微核率较DM组大鼠骨髓微核率明显降低，差异有统计学意义(p＜0.05)，而200N组未观察到类似的作用，详见表2。由此可知，适量的VD补充可以通过降低自发DNA氧化损伤和降低微核率来改善DM大鼠的遗传稳定性。
表1：不同剂量维生素D对各组大鼠DNA损伤的影响
a:与N相比，p＜0.05；b:与5N相比；c:与5N相比，p＜0.05。
表2：维生素D对各组大鼠微核率的影响
a:与N相比，p＜0.05；b:与DM相比p＜0.05；c:与5N相比，p＜0.05；d:与25N相比，p＜0.05；e:与125N相比，p＜0.05。
实施例4：
本实施例将实施例1制备的VD组合物用于部分糖尿病患者，成年人糖尿病患者80人，每人每天分三次服用VD组合物共计0.9-3克，连续服用2-3个月，对比服用前后的结果表明，23人病情明显好转，45人有转好指标，无病例加重，说明本发明产品具有改善糖尿病病情的功效。
Claims (6)
1.一种维生素D组合物，其特征在于各成份的重量百分比为：维生素D10-50％，芹菜根粉10-20％，秋葵汁5～15％，燕麦粉1-5％，紫甘薯粉10-60％，鱼粉1-5％，食盐0.5％，各原料的总量为100％；采用现有的喷雾干燥法将各原料混合后制成每粒重0.3-1.0g的粉末状胶囊，每克维生素D组合物中含维生素D不少于200μg。
2.根据权利要求1维生素D组合物，其特征在于所述维生素D、燕麦粉、鱼粉和食盐均采用市售产品。
3.根据权利要求1维生素D组合物，其特征在于所述芹菜根粉的制备工艺为：先将新鲜芹菜根洗净后榨汁并过滤得到滤汁，再将滤汁进行蒸发干燥，先在0～20℃温度下抽真空后使温度上升至20℃～37℃，经24～18小时抽真空蒸发干燥后得到干燥固体，然后研磨成100-150目的粉末。
4.根据权利要求1维生素D组合物，其特征在于所述秋葵汁的制备工艺为：将新鲜秋葵清洗干净，放入80-100℃开水中浸煮10-15分钟，捞出后立即放入3-10℃冷水中浸3-5分钟再捞出，然后采用现有技术按秋葵与纯净水1：1的重量比进行压榨和过滤得秋葵汁。
5.根据权利要求1维生素D组合物，其特征在于所述紫甘薯粉为鲜紫甘薯切成3-5mm片状，控温20-45℃自然晾干后，磨制成100-150目的粉末。
6.一种如权利要求5所述维生素D组合物的用途，其特征在于用于改善糖尿病遗传物质稳定性，成年人每日服用1～3粒胶囊，餐后半小时后服用。
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