CN110664902A - 一种用于促进骨愈合骨代谢的仲黄中药制剂及制备方法 - Google Patents
一种用于促进骨愈合骨代谢的仲黄中药制剂及制备方法 Download PDFInfo
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Abstract
本发明涉及一种用于促进骨愈合骨代谢的仲黄中药制剂,原料组成成分按重量份计包括:杜仲13~14份、熟地黄13~14份、骨碎补13~14份、淫羊藿8~10份、菟丝子8~10份、丹参8~10份、山茱萸8~10份、当归8~10份、白芍8~10份、枸杞子8~10份、桃仁8~10份、红花5~7份、黄芪13~14份、牛膝9~11份。本发明的中药组分取得了很好的临床疗效。大量临床观察表明,本方具有用于补肾活血,益肝健脾,生骨强筋。用于骨质疏松症、骨折、骨性关节炎、颈腰肌劳损及软组织损伤。骨质疏松症属肾虚血疲证,症见周身疼痛、腰膝酸痛、痪软无力,甚则弯腰驼背、筋肉挛缩、舌淡暗或有疲斑、脉沉涩或沉弦等症均具有很好的治疗效果。
Description
技术领域
本发明属于中药制备技术领域,尤其涉及一种用于促进骨愈合骨代谢的仲黄中药制剂及制备方法。
背景技术
骨质疏松症(osteoporosis,OP)的特点是低骨密度(BMD),骨的微体结构破坏,骨强度降低,骨骼的脆弱性增加和骨折的风险增大。近年来,它已成为-个主要的健康危害,折磨着全球超过2亿人,OP临床上主要表现为腰背疼和病理性骨折,是一种以骨量降低和骨组织微结构破坏为特征,骨的脆性增加和易于骨折为特点的一种代谢性骨病。OP分为原发性和继发性两类。原发性骨质疏松症(primaryosteoporosis,POP)分为Ⅰ型和Ⅱ型,Ⅰ型即绝经后骨质疏松症,Ⅱ型即老年性骨质疏松症,研究表明,原发性OP的发生多种因素共同作用的结果,在遗传因素与后天生物学因素、力学因素及生理状态和自然生活环境因素等因素共同作用下诱发的一种全身性、生活方式性疾病。继发性OP常由内分泌代谢疾病(如Ⅰ型糖尿病、性腺功能减退症、甲状旁腺功能亢进、甲状腺功能亢进及库欣综合征等)或全身性疾病引起。绝经后骨质疏松症(postmenopausalosteoporosis,PMOP)又称Ⅰ型骨质疏松,因绝经后卵巢合成***减少所致,为骨量减少和骨组织微结构破坏,以致骨骼脆性增高从而易发生骨折的一种全身性疾病。防治骨质疏松症的药物包括骨吸收抑制剂、骨形成促进剂和骨矿化药物等。目前西药治疗能减慢和控制骨量丢失,但其副作用多、价格昂贵,而中医药治疗骨质疏松症价格便宜,毒副作用少,便于患者长期服用,越来越多的学者关注中医药治疗骨质疏松症的效果。
中医药治疗骨质疏松症的特点是整体观念和辨证论治及自然重建,能增加激素分泌水平,促进骨形成,抑制骨吸收,增加骨有机质和骨密度,体现了中医药治疗骨质疏松症自然重建和整体观念的作用优势。中医认为本病与衰老的关系极为密切,而肾气虚损是导致衰老的主要原因,通过对相关文献的总结分析,对骨质疏松症病因病机认为:肾精亏虚为本,瘀血阻络为标,病机特点可概括为肾虚、血瘀的全身性疾病。肾主骨生髓,肾精不足,不能生髓滋养骨质,而致筋弱骨痿,精气虚衰可致气血运行不畅导致血瘀,血瘀又加重了本病的进展,出现“不通则痛”,痛则不敢和不愿活动,不喜日照,阻滞人体正常气血的运行。
发明内容
本发明的目的是提供一种用于促进骨愈合骨代谢的仲黄中药制剂及制备方法。
本发明的技术方案如下:.一种用于促进骨愈合骨代谢的仲黄中药制剂,原料组成成分按重量份计包括:杜仲13~14份、熟地黄13~14份、骨碎补13~14份、淫羊藿8~10份、菟丝子8~10份、丹参8~10份、山茱萸8~10份、当归8~10份、白芍8~10份、枸杞子8~10份、桃仁8~10份、红花5~7份、黄芪13~14份、牛膝9~11份。
优选的,原料组成成分按重量份计包括:杜仲12份、熟地黄12份、骨碎补12份、淫羊藿9份、菟丝子9份、丹参9份、山茱萸9份、当归9份、白芍9份、枸杞子9份、桃仁9份、红花6份、黄芪12份、牛膝10份。
一种用于促进骨愈合骨代谢的仲黄中药制剂的制备方法,具体的配制工艺步骤如下:
(1)水煎药物的提取:按处方比例称取需用量的杜仲、熟地黄、淫羊藿、骨碎补、黄芪、菟丝子、构祀子、当归、白芍、山茱英、丹参、桃仁、红花、牛膝14味中药材,加入8倍量的水,浸泡1小时,加热煎煮1.5小时,滤过,药渣再加水6倍量,同上水煎1.5小时,滤过,合并两次滤液;滤液浓缩至稠膏,各用。
(2)浸膏中辅料的加入及干燥:将上述备用水煎稠膏,按每1个处方加入糊精500份拌匀,干燥,粉碎,过100目筛,按药粉总量1.5%加入甜菊素,用递增法充分混匀,用适宜浓度的乙醇制成颗粒,50-60℃干燥,整粒,备用。
(3)颗粒的分装与质检:将以上半成品颗粒,按每袋9份分装袋中,质检,即得。
优选的,步骤(1)中,滤液浓缩至相对密度1.25-1.30(60℃)的稠膏。
优选的,步骤(2)中,加入糊精拌匀后60-65℃干燥,粉碎,过100目筛。
(一)、杜仲:杜仲中含有多种化学成分,主要有木脂素类、环烯醚萜类、苯丙素类、多糖类和杜仲胶等。其中木脂素类和环烯醚萜类所占的比例较大,其次是黄酮类及其他化合物。
1、木脂素类:按其结构特点可分为单环氧木脂素、双环氧木脂素、环木脂素和新木脂素等类型。
2、苯丙素类:有11种咖啡酸、松柏酸、愈创木丙三醇、松柏苷、丁香苷、间羟基苯丙酸、绿原酸、绿原酸甲酯、香草酸、寇布拉苷等。
3、环烯醚萜类:杜仲醇、杜仲醇苷、京尼平、脱氧杜仲醇、京尼平苷、京尼平苷酸、桃叶珊瑚苷、哈帕苷丁酸酯、筋骨草苷、雷扑妥苷、杜仲醇苷、车叶草苷、车叶草酸、去乙酰车叶草酸、10-乙酰鸡屎藤苷表杜仲醇等。桃叶珊瑚苷是环烯醚苷类化合物的一种,也是杜仲中有效活性成分之一。
4、黄酮类:黄酮类化合物也是杜仲的主要有效成分之一。主要有槲皮素、山奈酚、紫云英苷、异槲皮苷、芦丁。
5、杜仲多糖是杜仲的又一活性成分。组成明确的有:酸性聚糖杜仲糖A(EucommanA)和杜仲B(Eucomman B)。杜仲糖A是由L-***糖、D-半乳糖、D-葡萄糖、L-鼠李糖,D-半乳糖醛酸按摩尔比8:6:4:5:8组成;杜仲糖B的结构主要为ɑ-1,2-L-鼠李糖,1,4-D-半乳糖。这两种多糖对网状内皮***均有活化作用,可增强机体非特异性免疫功能。
(二)熟地黄:
1、环烯醚萜及其苷类:地黄的化学成分以苷类为主,其中又以环烯醚萜苷类为主。从鲜地黄及干地黄中,己分离鉴定出20多种苷类:梓醇,二氢梓醇,乙酰梓醇,益母草苷,桃叶珊瑚苷,单蜜力特苷,蜜力特苷,Rehma份lutinA、B、C、D,Acteoside,地黄苷A、B、C、D,Cerebrosid及含氯的份lutinoside,RehmaionosideA、B、C,Rehmapicroside,PurpureasideC,海胆苷,CistanosideA、F,JionosideA、B,Jio份lutosideA,B,去羟桅子苷,筋骨草苷,8-表番木鳖酸,乙酰梓醇苷等。
2、氨基酸:主要含丙氨酸、撷氨酸、精氨酸、天冬氨酸、异亮氨酸、亮氨酸、丝氨酸、脯氨酸、谷氨酸、甘氨酸、苯丙氨酸、苏氨酸、胱氨酸及赖氨酸等。
3、微量元素:地黄中的无机离子及微量元素,K、M份、Ca、P、Na、Fe、Cu、Al、Si、B、Sr、Zn、Ba、Cr、Ti、Ni、Co,从熟地黄中分离鉴定了acteoside及5-羟甲基糠醛。
(三)淫羊藿:淫羊藿属植物的化学成分目前报道有74种,主要为黄酮类,其次为多糖、木脂素类、酚苷类、紫罗酮类、倍半萜类、苯乙醇苷类、生物碱类。另外还发现了胡罗卜苷、对羟基苯甲酸、2,4-二羟基苯甲酸、异甘草素、甘草素、黄芪苷、山柰素、2-羟基-3,4,6,7-四甲氧基-9,10-二氢菲、木樨草素、大黄素、3-羟基2-甲基-吡喃酮,以及挥发油、蜡醇三十一烷、棕搁酸、硬脂酸、亚麻酸、银杏醇、葡萄糖和果糖等。
(四)骨碎补:
1、黄酮类:从骨碎补中分离得到的黄酮类化合物主要为黄酮、二氢黄酮和黄烷醇,此外,还有少量的查耳酮和橙酮。
(1)黄酮及其苷:该类化合物主要为以山柰酚(I)和木犀草素(II)为苷元的黄酮苷类化合物。
(2)二氢黄酮及其苷:骨碎补中的二氢黄酮类成分主要为北美圣草素、袖皮素和苦参黄素及其苷类,袖皮苷是骨碎补中的重要活性成分。
(3)黄烷醇及其苷:骨碎补中分离得到的该类化合物主要为以儿茶精、阿夫儿茶精、表儿茶精和表阿夫儿茶精为苷元的黄烷醇苷类化合物。
(4)其他类型黄酮及其苷:除以上几种类型的黄酮外,骨碎补中还含有查耳酮和橙酮。
2、三萜类:三萜类化合物主要为环阿屯烷型四环三萜和何伯烷型五环三萜,还含有少量的其他类型的五环三萜。
3,酚酸类:为骨碎补中另一种主要的化合物类型。骨碎补所含的酚酸类成分主要为苯甲酸和苯丙酸类,其中苯丙酸类化合物主要以肉桂酸、阿魏酸、咖啡酸为苷元。
(五)黄芪:
1、黄芪多糖:黄芪多糖主要有葡聚糖和杂多糖,其中葡聚糖又有水溶性葡聚糖和水不溶性葡聚糖,黄芪中所含的杂多糖多为水溶性酸性杂多糖,主要由葡萄糖、鼠李糖、***糖和半乳糖组成,糖醛酸含量少,由半乳糖醛酸和葡萄糖醛酸组成,而有些杂多糖仅由葡萄糖和***糖组成。
2、皂苷类成分:皂苷类为黄芪中重要的有效成分。主要有黄芪皂苷I,Ⅱ,Ⅲ,IV,V,VI,Ⅶ,异黄芪皂苷I,Ⅱ,Ⅲ及大豆皂苷I等。除大豆皂苷I、黄芪皂苷VII外,其余均以9,19-环羊毛脂烷型的四环三萜皂苷类为苷元,总称为黄芪皂苷或黄芪总皂苷。
3、黄酮类成分:黄酮类成分多达30余种,主要有槲皮素、山柰黄素、异鼠李素、鼠李异柠檬素、羟基异黄酮、异黄烷、芦丁、芒柄花素、毛蕊异黄酮等
4,氨基酸:黄芪中含有氨基酸共25种,如天冬酰胺、天门冬氨酸、苏氨酸、丝氨酸、谷氨酸、脯氨酸、甘氨酸、丙氨酸、胱氨酸、蛋氨酸、异亮氨酸、亮氨酸等
5、其他:黄芪中还含有微量元素、叶酸、亚麻酸、亚油酸、甜菜碱、胆碱、咖啡酸、香豆素、尼克酸、核黄素、维生素P、淀粉E等。
(六)菟丝子:菟丝子的主要药效成分为黄酮类化合物,此外还含有木脂素类化合物、甾体类化合物等,菟丝子的化学成分主要包括黄酮类、多糖类、生物碱类、萜类、甾体类、挥发油以及木质素等化合物。其中,总黄酮的含量约为30%。黄酮类为菟丝子的主要有效成分,主要的黄酮类化合物有山奈酚、槲皮素、金丝桃苷、紫云英苷等。此外,菟丝子中还含有大量的糖苷,16种氨基酸以及钙、镁、铁、锰、铜、锌等微量元素。
(七)当归:当归的成分分为挥发油部分与水溶性部分。
1、挥发油部分:当归中挥发油包括“酸性、酚性、中性”三个部分,其含量可达0.2%-0.4%。
2、水溶性部分:当归中含“阿魏酸、丁二酸、烟酸、尿嘧啶、腺嘌呤、豆甾醇、D-葡萄糖苷、香荚兰酸、钩吻荧光素”。此外当归中含当归多糖与多种氨基酸。
(八)白芍:白芍的化学成分主要为单萜及其苷类、三萜类、黄酮及其苷类、鞣质化合物类、多糖类、挥发油等。
(九)丹参:丹参的化学成分主要分为脂溶性成分和水溶性成分两大类:
1、脂溶性成分:丹参的脂溶性成分大多为共扼醌、酮类化合物,主要包括以下物质:丹参酮I,丹参酮IIA,丹参酮IIB,丹参酮V,丹参酮VI,隐丹参酮,羟基丹参酮,丹参酸甲酯,次甲基丹参醌,紫丹参甲素、乙素、戊素,丹参新酮,1,2-二氢丹参醌,丹参醇I,丹参醇II,丹参醇Ⅲ,二氢丹参酮I,异丹参酮II,异隐丹参酮等。其中含量较高的为丹参酮IIA和隐丹参酮。
2、水溶性成分:丹参的水溶性成分主要为酚酸类物质,其中包括:丹酚酸甲又称丹参素,D(+)3-13,4二羟基苯乳酸,丹参酸乙,丹参酸丙,琥珀酸,丹参酚酸A,丹参酚酸B,丹参酚酸C,熊果酸原儿茶醛,咖啡酸,丹参酸钾,丹参酚酸钾,迷迭香酸,迷迭香酸甲酯,鼠尾草酚,丹参内酯,丹参二醇A,丹参二醇B,丹参二醇C,丹参新酮IV。水溶性的丹参酚酸类具有抗氧化、抗凝血、抗血栓形成、调血脂及细胞保护作用。
(十)红花:从红花中得到的化学成分包括黄酮、生物碱、聚炔、亚精胺、木脂素、倍半萜、有机酸、留醇、烷基二醇和多糖等。
(十一)牛膝:
1、齐墩果酸型三萜皂苷类化合物:牛膝中齐墩果酸型三萜皂苷大多具有1~4个糖残基联接在齐墩果酸的C-3或C-28位,形成单糖链或双糖链,糖链由1~2个单糖残基组成,主要为葡萄糖、鼠李糖和葡萄糖醛酸。三萜皂苷是牛膝中的主要活性成分。
2、甾酮类化合物:牛膝中所含甾酮多为昆虫***活性甾酮,目前己分离到的甾酮有:牛膝甾酮、蜕皮甾酮、族节花甾酮A、podecdysone C,族节花甾酮D、漏芦甾酮B,水龙骨甾酮B,26-pentahydroxy-cholestan7,12-dien6-one,achyranthesterone A、牛膝甾酮A、紫茎牛膝甾酮(又名红苋甾酮)。
3、多糖类化合物:多糖被认为是牛膝的第三类活性成分。其中具有免疫活性的肽多糖ABAB,其中肽的含量占24.7%,主要由甘氨酸、谷氨酸、门冬氨酸和丝氨酸组成。牛膝中水溶性寡聚糖AbS,由葡萄糖和甘露糖组成。
4、其他类化学成分:牛膝中还含有有机酸:如杜鹃花酸、琉拍酸、软脂酸;生物碱:如小檗碱、巴马亭、黄连碱、表小檗碱、甜菜碱。黄酮:如芦丁、槲皮素-3-O-葡萄糖苷、山柰酚-3-O-葡萄糖苷。环二肽:如环(酪氨酸-亮氨酸)和环(亮氨酸-异亮氨酸)。甾醇:如菠甾醇、菠甾醇葡萄糖苷、谷甾醇、胡萝卜苷、豆甾醇以及挥发油、氨基酸、5-羟甲基糠醛等成分。
三、根据处方药物主要有效成分的理化性质,确定了科学合理的制备工艺。
(一)制备工艺确定的依据:在查阅处方各药物文献,了解各药物主要有效成分及理化性质的基础上,根据处方14味药物所含有效成分和主要成分的理化性质和医疗机构制剂对制备工艺的技术要求,将处方14味药物采用混合水煎法提取各药物有效浸膏。因处方中的杜仲、熟地黄、淫羊藿、骨碎补、黄芪、菟丝子、枸杞子、当归、白芍、山茱英、丹参、桃仁、红花、牛膝等均主要含水溶性有效组分或属有效成分尚不明确的药物,根据中药水煎入药的传统工艺及“混煎增溶”的原理,为减少颗粒剂的服用量,故将处方中14味药物,采用水煎法提取处方各药物的有效浸膏。
(二)制剂的制备工艺:按处方比例称取需用量的以上14味药物,加入水8倍量,浸泡1小时,加热煎煮1.5小时,滤过,药渣再加水6倍量,同上水煎1.5小时,滤过,合并两次滤液;滤液浓缩至相对密度1.25-1.30(60℃)的稠膏,加入糊精500份,拌匀,置60-65℃干燥,粉碎,过100目筛,按药粉总量1.5%加入甜菊素,用递增法充分混匀,用适宜浓度乙醇制粒,50-60℃干燥,制成1000份颗粒,按每袋9份分装,即得。
其具体的配制工艺步骤如下。
(1)水煎药物的提取:按处方比例称取需用量的杜仲、熟地黄、淫羊藿、骨碎补、黄芪、菟丝子、构祀子、当归、白芍、山茱英、丹参、桃仁、红花、牛膝14味中药材,加入8倍量的水,浸泡1小时,加热煎煮1.5小时,滤过,药渣再加水6倍量,同上水煎1.5小时,滤过,合并两次滤液;滤液浓缩至相对密度1.25-1.30(60℃)的稠膏,各用。
(2)浸膏中辅料的加入及干燥:将上述备用水煎稠膏,按每1个处方加入糊精500份拌匀,于60-65℃干燥,粉碎,过100目筛,按药粉总量1.5%加入甜菊素,用递增法充分混匀,用适宜浓度的乙醇制成颗粒,50-60℃干燥,整粒,备用。
(3)颗粒的分装与质检:将以上半成品颗粒,按每袋9份分装袋中,质检,即得。
本发明的有益效果为:
1)本发明的中药组分是从长期临床实践中总结出来的有效经验方,并取得了很好的临床疗效。大量临床观察表明,本方具有用于补肾活血,益肝健脾,生骨强筋。用于骨质疏松症、骨折、骨性关节炎、颈腰肌劳损及软组织损伤。骨质疏松症属肾虚血疲证,症见周身疼痛、腰膝酸痛、痪软无力,甚则弯腰驼背、筋肉挛缩、舌淡暗或有疲斑、脉沉涩或沉弦等症均具有很好的治疗效果。
2)本品的制备工艺是在查阅处方14味药物相关研究文献的基础上,根据处方各味药物所含有效成分和主要成分的理化性质和原方剂传统用药为汤剂的习惯,将处方14味药物采用水煎煮提取的简便传统提取工艺。本工艺充分提取了处方各药物的有效成分,从而保证了药物的质量和临床疗效。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1为制剂的配制工艺流程图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进-步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
下面结合具体实施例对本发明的应用原理作进-步描述。
应该指出,以下详细说明都是例示性的,旨在对本申请提供进-步的说明。除非另有指明,本文使用的所有技术和科学术语具有与本申请所属技术领域的普通技术人员通常理解的相同含义。
正如背景技术部分所介绍的,目前西药治疗能减慢和控制骨量丢失,但其副作用多、价格昂贵,而中医药治疗骨质疏松症价格便宜,毒副作用少,便于患者长期服用,越来越多的学者关注中医药治疗骨质疏松症的效果。
本实施例提供一种用于促进骨愈合骨代谢的仲黄中药制剂,原料组成成分按重量份计包括:杜仲13~14份、熟地黄13~14份、骨碎补13~14份、淫羊藿8~10份、菟丝子8~10份、丹参8~10份、山茱萸8~10份、当归8~10份、白芍8~10份、枸杞子8~10份、桃仁8~10份、红花5~7份、黄芪13~14份、牛膝9~11份。
原料组成成分按重量份计包括:杜仲12份、熟地黄12份、骨碎补12份、淫羊藿9份、菟丝子9份、丹参9份、山茱萸9份、当归9份、白芍9份、枸杞子9份、桃仁9份、红花6份、黄芪12份、牛膝10份。
一种用于促进骨愈合骨代谢的仲黄中药制剂的制备方法,具体的配制工艺步骤如下:
(1)水煎药物的提取:按处方比例称取需用量的杜仲、熟地黄、淫羊藿、骨碎补、黄芪、菟丝子、构祀子、当归、白芍、山茱英、丹参、桃仁、红花、牛膝14味中药材,加入8倍量的水,浸泡1小时,加热煎煮1.5小时,滤过,药渣再加水6倍量,同上水煎1.5小时,滤过,合并两次滤液;滤液浓缩至稠膏,各用。
(2)浸膏中辅料的加入及干燥:将上述备用水煎稠膏,按每1个处方加入糊精500份拌匀,干燥,粉碎,过100目筛,按药粉总量1.5%加入甜菊素,用递增法充分混匀,用适宜浓度的乙醇制成颗粒,50-60℃干燥,整粒,备用。
(3)颗粒的分装与质检:将以上半成品颗粒,按每袋9份分装袋中,质检,即得。
步骤(1)中,滤液浓缩至相对密度1.25-1.30(60℃)的稠膏。
步骤(2)中,加入糊精拌匀后60-65℃干燥,粉碎,过100目筛。
为了使得本领域技术人员能够更加清楚地了解本申请的技术方案,以下将结合具体的实施例详细说明本申请的技术方案。
本发明实施例中所用的试验材料均为本领域常规的试验材料,均可通过商业渠道购买得到。
1.1诊断标准
1.1.1西医诊断标准
根据中国老年学学会骨质疏松委员会骨质疏松诊断标准学科组制定的《中国人原发性骨质疏松症诊断标准(第二稿)1999年》:
①全身疼痛,多以腰背部疼痛为明显,如自发性全身骨疼痛、活动痛、触压痛等症状。骨痛;身高变矮、驼背;骨折;呼吸***障碍。
②脊柱常有后凸畸形。
③骨密度检测出现阳性征象:用双能x线骨密度仪(DEXA)测量腰椎第2-4椎体骨密度的平均值或股骨颈的骨密度值。
骨密度标准:参考世界卫生组织(WHO)的标准,结合我国国情,以汉族妇女DEXA测量峰值骨量(均值为M)为依据,目前尚无统-标准情况下,不同民族、地区和性别可参考。
>M-1SD:正常;
≤M-1SD~2SD:骨量减少;
<M-2SD:骨质疏松症;
<M-2SD:伴有-处或多处骨折,为严重骨质疏松症;
<M-3SD以上:无骨折,也可以诊断为严重的骨质疏松症。
1.1.2中医证候诊断标准
参照2002年《中药新药治疗骨质疏松症的临床研究指导原则》制定[2]
肾虚血瘀证候的诊断标准:
肾虚血瘀:
主症:腰膝酸痛,痿软无力,甚则弯腰驼背
次症:筋肉挛缩,骨折,多有外伤史或久病史,舌淡暗或有瘀斑,脉沉涩或沉弦或沉细。
1.2病例选择
1.2.1纳入标准
①符合西医诊断标准;
②符合中医证候诊断标准;
③年龄45-80岁,男女均可,女性应是无生育能力的绝经期后妇女(至少绝经-年以上);
④签署进入研究知情同意书。
1.2.2排除标准
①继发性骨质疏松症:有明确严重的原发疾病,包括内分泌性(如甲状腺功能亢进症、糖尿病等)、肾性、营养性、血液性、药物、失用性、先天性所致的骨质疏松症患者;
②长期服用其它有关治疗药物,不能立即停用者,长期服用影响骨代谢的药物;
③晚期畸形、残废、丧失劳动力者;
④过敏体质及对多种药物过敏者;
⑤合并心、脑、肝、肾和造血***等严重疾病、精神病患者,恶性肿瘤患者;
⑥由于各种原因未按规定用药、无法判定疗效或资料不全者;
⑦参加其它临床研究的患者。
1.2.3脱落和剔除标准
①经筛选合格、并知情同意进入随机化研究的患者,因故未完成本方案所规定的观察周期;
②使用2周后出现严重的不良反应者;
③自行退出或未完成整个疗程而影响疗效或安全性判断的病例,均应视为脱落;
④服药2周以上无效停用或改用它药,按无效处理,不得剔除。
2.观察方法
选择我院2008年5月到2013年5月OP患者240例,采用随机对照的原则,使用SPSS19.0软件产生随机序列,随机分为治疗组120例,对照组120例,共有223例完成观察周期,治疗组110例,对照组113例,脱落17例,其中治疗组10例,对照组7例。治疗组年龄从44-80岁,平均64.51±16.83岁,男性50例,女性60例;对照组年龄从52-80岁,平均63.78±17.20岁,男性51例,女性62例。经统计学分析(t检验或检验),两组在年龄、性别、民族、病情分级、中医证候积分等方面无显著差异,均P>0.05,说明两组-般资料具有可比性(见表1)。
表1两组患者临床资料比较
2.1治疗方法
设西药对照组和中药治疗组二组,每组120例,共选择240例,随机分入各组,随机序列由随机数字表生成。
2.1.1治疗组
杜仲12份、熟地黄12份、骨碎补12份、淫羊藿9份、菟丝子9份、丹参9份、山茱萸9份、当归9份、白芍9份、枸杞子9份、桃仁9份、红花6份、黄芪12份、牛膝10份,上十四味水煎,一日一剂,分2次早晚温服。
2.1.2对照组
予口服钙尔奇D片600m份,每日2次,早晚两次温水服用。(惠氏制药有限公司批准文号:国药准字H10950030)。
二组连续服药3个月,比较治疗前及治疗后的临床症状、肾阳虚症状积分、腰椎2-4和股骨颈骨矿含量和骨密度、骨碱性磷酸酶(BAP)、氨基端中段骨钙素(N-B份P)。
2.2临床症状评估标准
共设置治疗前、治疗后3个月两个观察时间点。疼痛评分:自发性疼痛指休息时自发性疼痛,触压痛指中等力度检查患处疼痛,活动痛指骨骼受累处活动时疼痛。疼痛指标均采用视觉模拟评分法(VAS)评分法,在横线上标以0到10数字,0为无痛,10为剧痛,让患者把疼痛级别圈在相应数字对应的位置上。
2.2.1中医肾阳虚症状积分
包括腰膝酸软、畏寒肢冷、夜尿频多、气短懒言和神疲倦怠。按其症状程度计分,症状持续而严重者计3分,症状时轻时重或经常反复发作者计2分,症状轻微或偶然出现者计1分,无症状者计0分。
2.2.2骨密度和骨矿含量测定
采用美国份ELunarProdi份y·AdvancePA+300164型双能X线骨密度仪(DEXA)测定全部受试者腰椎前后位(L2-4)和双侧股骨颈fNeck)BMD值。每日测量前用标准体模校正后进行,精确度误差1%,准确度>98%。
2.2.3骨代谢指标测定
检测指标包括比较治疗前及治疗后的临床症状、肾阳虚症状积分、腰椎前后位(L2—4)和双侧股骨颈fNeck)BMD值、骨碱性磷酸酶(BAP)、氨基端中段骨钙素(N-B份P)。
2.3统计处理
2.4知情同意书
向受试者提供临床试验的详细情况,包括试验目的、试验性质、可能的收益和风险、可供选择的其它方法以及符合赫尔辛基宣言规定的受试者的权利和义务等,使受试者了解后表示同意,并签署知情同意书。
3.疗效评定标准
3.1临床疗效判定
骨质疏松症疗效判定标准参考1992年第-届国际骨代谢学术会议资料及《骨质疏松》-书制定
显效:腰脊酸疼等症状基本消失,疼痛症状积分下降≥2/3,骨密度值较前上升;
有效:腰脊酸疼等症状明显好转,疼痛症状积分下降≥2/3,骨密度值检查无下降;
无效:腰脊酸疼等症状无好转,疼痛症状积分下降≤1/3,骨密度值较前下降。
3.2中医证候疗效判定标准
采用尼莫地平法计算:[(治疗前积分—治疗后积分)÷治疗前积分]×100%。
临床痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥90%;
显效:中医临床症状、体征明显改善,证候积分较少≥70%,<90%;
有效:中医临床症状、体征好转,证候积分较少≥30%,<70%;
无效:中医临床症状、体征无明显改善,甚至加重,证候积分减少不足30%。
4.临床结果
4.1二组治疗后临床疗效比较(见表2)
表2二组治疗后临床疗效表
注:与对照组比较,P<0.01
4.2治疗前后肾阳虚症状积分比较
治疗组治疗后各项积分和总积分明显降低,与治疗前和对照组治疗后比较,差异均有显著性意义(P<0.05)(见表3)
注:与治疗前比较﹡P<0.05,与对照组比较△P<0.05。
4.3治疗前后骨密度、骨矿含量变化比较
治疗后患者骨密度、骨矿含量指标均明显改善,与治疗前和对照组治疗后比较,
差异均有显著性意义(P<0.05)(见表4)
注:与治疗前比较﹡P<0.05,与对照组比较△P<0.05。
4.4治疗前后骨代谢指标比较
治疗后患者氨基端中段骨钙素(N-B份P)、骨碱性磷酸酶(BAP)等骨代谢指标均明显改善,与治疗前和对照组治疗后比较,差异均有显著性意义(P<0.05)(见表5)
表5两组患者治疗前后骨钙素比较(n份/ml)
注:与治疗前比较﹡P<0.05,与对照组比较△P<0.05。
表5可见,两组治疗前后自身比较,经统计学处理有差异(P<0.05)。治疗后组间比较经统计学处理有差异(P<0.05),结果提示治疗组能有效提高骨质疏松患者的骨钙素水平。
表6两组病例治疗前后骨碱性磷酸酶对比(U/L)
注:与治疗前数据比较﹡P<0.05,与对照组比较△P<0.05。
表6可见,治疗组能降低骨碱性磷酸酶,治疗组治疗前后自身对比,经统计学检验有差异(P<0.05),对照组治疗前后自身对比,经统计学检验无差异(P<0.05)。治疗后组间比较,经统计学检验有差异(P<0.05)。
5讨论
5.1骨质疏松症的危害性
骨质疏松症(osteoporosis,OP)指以低骨量及骨组织微结构退行性病变为特征的一种全身性骨骼疾病,属于原发性骨质疏松症(osteoporosis,OP),临床主要表现为疼痛、身材变矮及骨折。骨质疏松症女性的发病率高于男性,且主要集中在绝经后妇女中[3],绝经是骨质疏松发生的重要的独立危险因子,绝经后女性骨质疏松性骨折发生率比绝经前高2倍,具有很高的致死率、致残率并严重影响生存质量,有研究表明骨质疏松性骸骨骨折后,3,6,12,24,36,60,96,120月后的死亡率分别为10%,14%,18%,27%,32%,45%,55%,68%。
5.2骨质疏松症的治疗现状
防治骨质疏松症的药物包括骨吸收抑制剂、骨形成促进剂和骨矿化药物以及中医中药等。目前,越来越多的学者关注中医药治疗骨质疏松症的效果。
5.3中医药防治骨质疏松症的优势
5.3.1目前西药治疗能减慢和控制骨量丢失,但其副作用多、价格昂贵。而中医药治疗骨质疏松症价格便宜,毒副作用少,便于患者长期服用。近年来中医学者在临床和实验方面作了大量研究,认为中医药治疗骨质疏松症的机理是通过对机体全身性的调节作用,使患者下丘脑-垂体-多个靶腺轴,以及植物的神经***和免疫功能的紊乱恢复。简而言之,中医药防治骨质疏松症是一种对机体整体的调整过程,作用于多个环节,从而达到纠正机体激素失衡和负钙平衡作用的功效。治疗效果上显示中医药具有抑制骨吸收和促进骨形成的双重作用。所以,中医药在治疗本病中逐渐显示出其巨大优势。
5.3.2相关临床研究表明[5,6]温补肾阳补血活血法能够提高骨密度,改善骨质疏松患者临床症状。
5.4仲黄颗粒制剂对骨质疏松症的临床症状的治疗作用
中医认为疼痛的产生机理主要分为两个方面:
5.4.1虚症,不荣则痛,例如气血不足。
5.4.2实证,不通则痛,如肝郁气滞、疲血阻络等。骨质疏松症患者虚实夹杂,本虚标实。肝肾亏虚,气血不足,营卫不荣,外邪入侵,因虚致疲,经络不通,不通则痛,故骨质疏松患者以腰背疼痛为主要临床症状。
仲黄颗粒制剂既补肝、脾、肾之不足,又养血活血生骨。仲黄颗粒制剂治疗组临床症状明显改善,总有效率(包括显效、有效)为98.1%,对照组总有效率91.1%,二组比较,差异有显著性(P<0.01)。
5.5仲黄颗粒制剂对肾阳虚症状的影响
辨证论治是中医诊断和治疗疾病的基本原则。本研究选择肾阳虚证患者作为研究对象,温补肾阳补血活血作为治法,符合中医辩证施治观。目前大多数学者认为骨质疏松症与肾虚紧密相关。许志奇等[7]在对肾虚患者的骨矿含量进行了研究,结果表明肾虚证患者的骨矿含量苷遍低于正常人,男女性肾虚组与正常人组相比较,骨矿含量有显著性差异,男女性各年龄组肾虚证的发病率与年龄呈正相关。郭素华等[8]就其它脏器亏损对骨质疏松是否有影响进行了研究,结果提示:肾虚证较肺虚证及脾虚证,骨密度下降更明显。国内外众多学者采用去势法复制的骨质疏松症动物模型,在研究中看到了动物下丘脑—垂体—性腺轴功能紊乱、低下,与中医肾虚证相似。并观察到模型动物的性激素水平下降,骨矿含量显著下降,骨矿化沉积受限,骨吸收与骨形成的偶连出现缺陷等。因此把阳虚症状作为-个重要的临床表现是合理的。二组经服药3个月后,治疗后治疗组各项积分和总积分明显降低,与治疗前和对照组治疗后比较,差异均有显著性意义(P<0.05)。结果表明,杜仲补肾健骨汤能有效改善骨质疏松症的肾阳虚症状。
5.6仲黄颗粒制剂对骨密度和骨矿含量的影响
骨密度和骨矿含量是骨质量的-个重要标志,是骨质疏松的诊断,骨折危险性的预测和治疗后效果评定的重要依据。多项研究表明补肾生骨颗粒中药对于减少骨吸收,增加骨重建是有效的。李青南等[9]研究了淫羊藿提取液对醋酸***所致大鼠骨质疏松的骨形态学的影响。结果淫羊藿提取液预防组的骨吸收率比激素组减少70%,骨量接近正常组水平,提示淫羊藿提取液能抑制骨吸收,促进骨形成,防治激素所致的骨质疏松。李亚平[10]发现杜仲叶具有类激素作用,能增进大鼠骨髓生成和增加其骨质的强度。李朝阳[11]等研究发现,黄芪提取液具有防止去卵巢大鼠骨丢失的作用,且与己烯雌酚的作用相近。谭晓卫[12]等进行了丹参对骨膜游离移植血管束植入影响的实验研究,结果显示:丹参能促进成骨细胞的活动而抑制破骨细胞的活动,当骨膜移植于恰当的部位时,丹参促进新生骨的改建。二组对比,治疗组治疗后骨密度和骨矿含量明显改善((P<0.05),表明仲黄颗粒制剂具有提高BMC和BMD的作用,其作用机理有待进-步研究查明。
5.7仲黄颗粒制剂对氨基端中段骨钙素(N-B份P)、骨碱性磷酸酶(BAP)的影响
骨质疏松症的发病特点是骨的转换增高,骨质流失加快,松质骨变化更显著,易发椎骨及长骨端部的骨折事件。仲黄颗粒制剂治疗后能有效提高骨质疏松患者的骨钙素水平、降低骨碱性磷酸酶(BAP),改善骨代谢。
5.8仲黄颗粒制剂组方的理论依据
祖国医学对治疗骨质疏松症积累了丰富的经验,根据辨证论治等应用某些方药具有较好疗效,上文已有详细论述。本研究使用的仲黄颗粒制剂是基于中医基础理论和临床实践,以及历代医家对骨质疏松症及相关方药的研究成果进行拟方的。
3.结语
本研究首先从原发性骨质疏松症的中医认识、中医辨证分型和治则研究、现代医学对骨质疏松症的研究、中西医结合对骨质疏松症的研究等方面的研究现状进行了小结。然后自拟方补肾生骨颗粒,采用单盲随机研究法,对我院门诊自2008年5月——2013年5符合纳入标准的240例患者进行研究。研究中,观察二组治疗前后的临床症状、肾阳虚症状积分,测定骨矿含量、骨密度等骨代谢指标。采用SPSS19.0软件进行统计学处理。所有数据以表示,治疗前后比较用t检验。
通过该临床研究得出以下结论:
(1)仲黄颗粒制剂能较有效改善疼痛和活动功能等临床症状。
(2)仲黄颗粒制剂能较有效改善腰膝酸软、畏寒肢冷、夜尿频多、气短懒言、神疲倦怠等临床症状。
(3)仲黄颗粒制剂能较明显提高骨密度和骨矿含量。
总之,仲黄颗粒制剂防治骨质疏松症临床疗效满意,值得临床推广使用,但其作用机制有待进-步研究。
当然,上述说明也并不仅限于上述举例,本发明未经描述的技术特征可以通过或采用现有技术实现,在此不再赘述;以上实施例仅用于说明本发明的技术方案并非是对本发明的限制,参照优选的实施方式对本发明进行了详细说明,本领域的普通技术人员应当理解,本技术领域的普通技术人员在本发明的实质范围内所做出的变化、改型、添加或替换都不脱离本发明的宗旨,也应属于本发明的权利要求保护范围。
Claims (5)
1.一种用于促进骨愈合骨代谢的仲黄中药制剂,其特征在于:原料组成成分按重量份计包括:杜仲13~14份、熟地黄13~14份、骨碎补13~14份、淫羊藿8~10份、菟丝子8~10份、丹参8~10份、山茱萸8~10份、当归8~10份、白芍8~10份、枸杞子8~10份、桃仁8~10份、红花5~7份、黄芪13~14份、牛膝9~11份。
2.根据权利要求1所述的用于促进骨愈合骨代谢的仲黄中药制剂,其特征在于:原料组成成分按重量份计包括:杜仲12份、熟地黄12份、骨碎补12份、淫羊藿9份、菟丝子9份、丹参9份、山茱萸9份、当归9份、白芍9份、枸杞子9份、桃仁9份、红花6份、黄芪12份、牛膝10份。
3.一种根据权利要求1所述的用于促进骨愈合骨代谢的仲黄中药制剂的制备方法,其特征在于:具体的配制工艺步骤如下:
(1)水煎药物的提取:按处方比例称取需用量的杜仲、熟地黄、淫羊藿、骨碎补、黄芪、菟丝子、构祀子、当归、白芍、山茱英、丹参、桃仁、红花、牛膝14味中药材,加入8倍量的水,浸泡1小时,加热煎煮1.5小时,滤过,药渣再加水6倍量,同上水煎1.5小时,滤过,合并两次滤液;滤液浓缩至稠膏,各用。
(2)浸膏中辅料的加入及干燥:将上述备用水煎稠膏,按每1个处方加入糊精500份拌匀,干燥,粉碎,过100目筛,按药粉总量1.5%加入甜菊素,用递增法充分混匀,用适宜浓度的乙醇制成颗粒,50-60℃干燥,整粒,备用。
(3)颗粒的分装与质检:将以上半成品颗粒,按每袋9份分装袋中,质检,即得。
4.根据权利要求1所述的一种用于促进骨愈合骨代谢的仲黄中药制剂的制备方法,其特征在于:步骤(1)中,滤液浓缩至相对密度1.25-1.30(60℃)的稠膏。
5.根据权利要求1所述的一种用于促进骨愈合骨代谢的仲黄中药制剂的制备方法,其特征在于:步骤(2)中,加入糊精拌匀后60-65℃干燥,粉碎,过100目筛。
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US11331339B2 (en) * | 2019-09-30 | 2022-05-17 | Chenland Nutritionals, Inc. | Compound composition with function of promoting bone and joint health and application thereof |
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