CN105395650B - 舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用 - Google Patents
舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用 Download PDFInfo
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Abstract
本发明提供了舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用。所述的舒肝宁制剂由茵陈提取物、栀子提取物、黄芩苷、板蓝根提取物、灵芝提取物及辅料制备而成。本发明所述舒肝宁制剂能促进大鼠的骨形成，增加骨密度，能有效治疗骨质疏松及其并发症。可用于治疗糖尿病中枢神经病变或糖尿病周围神经病变。
Description
发明领域
本发明涉及舒肝宁制剂的新用途，特别涉及舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用。
背景技术
骨质疏松症、退行性骨关节病为中医痹症范畴，是一种不分地域环境影响的常见多发性疾病，特别是老年人常见多发病症，可引起腰背痛、全身关节疼痛、疲乏无力，严重危胁着人体健康。骨质疏松症(osteoporosis)是一种系统性骨病，其特征是骨量下降和骨的微细结构破坏，表现为骨的脆性增加，因而骨折的危险性大为增加，即使是轻微的创伤或无外伤的情况下也容易发生骨折。骨质疏松症是一种多因素所致的慢性疾病。在骨折发生之前，通常无特殊临床表现。该病女性多于男性，常见于绝经后妇女和老年人。随着我国老年人口的增加，骨质疏松症发病率处于上升趋势，在我国乃至全球都是一个值得关注的健康问题。
舒肝宁制剂由茵陈提取物、栀子提取物、黄芩苷、板蓝根提取物、灵芝提取物及辅料制备而成。具有清热解毒，利湿退黄，益气扶正，保肝护肝。用于湿热黄疸，症见面目俱黄，胸肋胀满，恶心呕吐，小便黄赤，乏力，纳差，便溏；急、慢性病毒性肝炎见前述症状者。得片剂细粉，填装胶囊，即得胶囊剂，回收乙醇并浓缩至适量发明人在经过大量实验研究发现，舒肝宁制剂还具有一定的治疗骨质疏松及其并发症药物的作用。
发明内容
本发明的目的在于，提供舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用。
本发明通过以下技术方案实现的：舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用。
前述的应用中，所述的并发症包括糖皮质激素性骨质疏松、骨性关节炎或骨质增生。
前述的应用中，所述的舒肝宁制剂由茵陈提取物、栀子提取物、黄芩苷、板蓝根提取物、灵芝提取物及辅料制备而成。
前述的应用中，所述的舒肝宁制剂这样制备：取茵陈提取物、栀子提取物、黄芩苷、板蓝根提取物及灵芝提取物，加入一种或多种药学上可以接受的辅料，再按照药学领域的常规方法，制备成医药领域中可接受的剂型。
前述的应用中，所述剂型包括注射制剂或外用制剂。
前述的应用中，所述注射制剂的制备方法为：取黄芩苷加注射用水适量混悬，加10％氢氧化钠溶液使溶解；取茵陈提取物、栀子提取物、板蓝根提取物和灵芝提取物四味，分别加注射用水溶解，混匀，加0.2％活性炭，搅匀，煮沸15分钟，滤过，用10％氢氧化钠溶液调节pH值至7.5～8.0，加注射用水至规定量，滤过，灌封，灭菌，即得。
为了使本领域普通技术人员更好的理解本发明，以下通过实验及实施例来进一步阐述本发明的用途：
实验例.药理实验研究
1材料与方法
1.1实验动物和分组
30只健康wistar雌性大鼠，1l周龄，体重约150g。按体重匹配随机分为正常对照组、模型组和治疗组，每组10只。
1.2主要试剂
本发明制剂，按实施例1进行制作；抗酒石酸酸性磷酸酶(TRAP)和骨碱性磷酸酶(BALP)的ELISA检测试剂盒购自RD Biosciences公司；免疫组化一抗兔抗鼠抗OPG抗体购自Abcam公司，二抗羊抗兔抗体购自Invotrigen公司。
1.3实验方法
Wistar大鼠饲养一周后，模型组和治疗组分别给予5mg/kg地塞米松肌注，每周一次，连续注射12周建立骨质疏松大鼠的动物模型，对照组肌注相同剂量的生理盐水，治疗组注射完毕留取尾静脉血。水合氯醛腹腔麻醉后，DEXA骨密度仪检测大鼠股骨骨密度，各组均取2只处死，HE染色观察股骨结构的病理改变。经股骨骨密度检测和病理学观察，证实骨质疏松大鼠模型构建成功后，治疗组大鼠尾静脉注射本发明制剂，以0.05ug/kg剂量注射，1次/周，连续15周，而模型组和对照组注射与本发明制剂剂量相等的生理盐水，每周1次，连续注射15次。注射完毕后，DEXA骨密度仪检测各组大鼠股骨骨密度；各组大鼠同样留取尾静脉血，ELISA法检测治疗组大鼠治疗前后以及对照组和模型组治疗后大鼠血清TRAP和BALP水平的变化；各组大鼠处死后取双侧股骨，免疫组化法检测各组大鼠股骨OPG水平的变化；股骨脱钙、石蜡包埋、矢状位切片，HE染色观察其病理形态学改变。
1.4统计学处理
采用SPSS 13.0统计软件，两两比较采用独立样本T检验，多个样本均数间的比较采用单因素方差分析，以P<0.05有统计学意义。
2结果
2.1骨质疏松大鼠模型的建立
治疗前各组大鼠股骨骨密度：地塞米松处理后，模型组和治疗组大鼠股骨骨密度明显低于正常对照组(P<O.05)，而模型组和治疗组无明显差别(P>0.05)，见表1。
表1 治疗前各组大鼠股骨骨密度比较
与正常组比较：*P<0.01；与模型组比较：+P>0.05，#P<0.01。
2.2对糖皮质激素性骨质疏松大鼠的治疗作用
2.2.1治疗前后，治疗组大鼠骨代谢指标的变化：与治疗前相比，治疗组大鼠经治疗后，血清骨碱性磷酸酶水平明显升高(P<0.01)，而酒石酸酸性磷酸酶水平有所下降，但无明显统计学差异(P>0.05)，见表2。
表2 治疗组大鼠治疗前后骨代谢指标变化
注：与治疗前相比，*P<0.Ol，+P>0.05。
2.2.2治疗后各组大鼠骨代谢指标的变化：治疗组治疗15周后，对照组和治疗组大鼠血清骨碱性磷酸酶水平明显高于模型组(P<0.05)；对照组抗酒石酸酸性磷酸酶水平明显低于模型组(P<0.05)，而治疗组抗酒石酸酸性磷酸酶水平与模型组无明显差异(P>0.05)；对照组和治疗组两种代谢指标均无明显差异(P>0.05)，见表3。
表3 各组大鼠骨代谢指标的变化
与正常组比较：*P<0.05，+P>0.05；与模型组比较：#P<0.05。
2.2.3治疗前后治疗组大鼠股骨骨密度的变化：治疗前和治疗后，治疗组大鼠股骨骨密度无明显差异(P>O.05)，见表4。
表4 治疗组大鼠治疗前后股骨骨密度
与治疗前比较：*P>0.05。
2.2.4治疗后各组大鼠股骨骨密度的变化：治疗后，治疗组大鼠股骨骨密度显著高于模型组(#P<0.05)，且模型组股骨骨密度水平明显低于对照组(*P<0.01)，治疗组与对照组接近，且无明显差异(+P>0.05)见表5。
表5 治疗后各大鼠股骨骨密度
与正常组比较：*P<0.01，+P>0.05；与模型组比较：#P<0.05。
结论：本发明药物制剂能能够促进大鼠的骨形成，增加骨密度，能有效治疗骨质疏松及其并发症。
与现有技术相比，本发明所述舒肝宁制剂能促进大鼠的骨形成，增加骨密度，能有效治疗骨质疏松及其并发症。可用于治疗糖尿病中枢神经病变或糖尿病周围神经病变。
具体实施方式
实施例1。
配方：茵陈提取物4g、栀子提取物3g、黄芩苷22g板蓝根提取物5g及灵芝提取物3.5g。
工艺：取黄芩苷加注射用水适量混悬，加10％氢氧化钠溶液使溶解；取茵陈提取物、栀子提取物、板蓝根提取物和灵芝提取物四味，分别加注射用水溶解，混匀，加0.2％活性炭，搅匀，煮沸15分钟，滤过，用10％氢氧化钠溶液调节pH值至7.5～8.0，加注射用水至规定量，滤过，灌封，灭菌，即得。
用法用量：静脉滴注，一次10～20ml，用10％葡萄糖注射液250～500ml稀释后静脉滴注，一日1次；症状缓解后可改用肌内注射，一日2～4ml，一日1次，或遵医嘱。
注意事项：1、孕妇及过敏体质者慎用；
2、注射前严密观察药液性状，有浑浊、沉淀、絮状物时严禁使用。
规格：每支装2ml、10ml或20ml
贮藏：密封，避光。
有效期：1.5年。
功能与主治：治疗骨质疏松及其并发症。
Claims (2)
1.舒肝宁制剂在制备治疗骨质疏松及其并发症药物中的应用；
所述舒肝宁制剂的制备方法为：配方：茵陈提取物4g、栀子提取物3g、黄芩苷22g板蓝根提取物5g及灵芝提取物3.5g；工艺：取黄芩苷加注射用水适量混悬，加10％氢氧化钠溶液使溶解；取茵陈提取物、栀子提取物、板蓝根提取物和灵芝提取物四味，分别加注射用水溶解，混匀，加0.2％活性炭，搅匀，煮沸15分钟，滤过，用10％氢氧化钠溶液调节pH值至7.5～8.0，加注射用水至规定量，滤过，灌封，灭菌，即得。
2.如权利要求1所述的应用，其特征在于：所述的并发症包括糖皮质激素性骨质疏松、骨性关节炎或骨质增生。
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