CN105343426A - 一种治疗股骨头缺血性坏死的药物及其制作方法 - Google Patents
一种治疗股骨头缺血性坏死的药物及其制作方法 Download PDFInfo
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Abstract
本发明提供了一种治疗股骨头缺血性坏死的药物，该药物是由下列重量配比的药剂制成：龟甲：10-30份、熟地黄：7-20份、山药：3-10份、肉苁蓉：3-10份、枸杞子：7-20份、山茱萸：7-20份、川芎：3-10份、杜仲：3-10份、桑寄生：3-10份、伸筋草：3-10份、甘草：3-10份、白术：7-20份、淫手藿：7-20份、五加皮：3-10份、丹参：7-20份、当归：7-20份、泽泻：3-10份、延胡索：3-10份、红花：3-10份、牛膝：3-10份、牡丹皮：3-10份。本发明对于治疗股骨头缺血性坏死具有极佳的疗效，可以明显改善股骨头坏死引起的疼痛，以及关节活动障碍和行走距离等症状和体征。
Description
技术领域
本发明涉及中药制剂技术领域，特别涉及一种治疗股骨头缺血性坏死的药物及其制作方法。
背景技术
目前，股骨头缺血性坏死多数是以局部创伤、滥用激素药、过量饮酒等引起的，其共同的核心问题是各种原因引起的股骨头的血液循环障碍，而导致骨细胞缺血、变性、坏死。临床以髋关节疼痛，活动受限，严重的时候导致跛行，属于中医学“痹症”里“骨痹”范畴。股骨头缺血性坏死的发病机理：骨外血管损伤与骨内高压学说普遍为骨科界学者所接受。骨外血管损伤，侧枝循环建立障碍或建立不全是发生缺血性坏死的潜在因素。股内高压可使股骨头血流减少，变成骨组织缺血缺氧，代谢紊乱和骨髓组织水肿，渗出增加以致进一步使骨内压增高形成恶性循环。
发明内容
本发明的目的是提供一种治疗股骨头缺血性坏死的药物及其制作方法，本发明的药物可以明显改善股骨头坏死引起的疼痛，以及关节活动障碍和行走距离等症状和体征。
为实现上述目的，本发明采用以下技术方案实现：
一种治疗股骨头缺血性坏死的药物，该药物是由下列重量配比的药剂制成：龟甲：10-30份、熟地黄：7-20份、山药：3-10份、肉苁蓉：3-10份、枸杞子：7-20份、山茱萸：7-20份、川芎：3-10份、杜仲：3-10份、桑寄生：3-10份、伸筋草：3-10份、甘草：3-10份、白术：7-20份、淫手藿：7-20份、五加皮：3-10份、丹参：7-20份、当归：7-20份、泽泻：3-10份、延胡索：3-10份、红花：3-10份、牛膝：3-10份、牡丹皮：3-10份。
所述龟甲炮制而成。
所述泽泻炒制而成。
一种治疗股骨头缺血性坏死的药物的制作方法，按照重量份数配比取上述中药饮片，将经筛选洗净的中药饮片去除杂质，采用干燥箱烘干，80℃≤烘干温度<100℃，烘干后用粉碎机粉成小于100目的细粉，装入药粉桶中，用Co60照射灭菌消毒后，加炼蜜合坨制丸。
所述药物与炼蜜的配比为：1:1。
中医认为机体体质虚弱，抗病能力低下，肝肾精血不足，致使骨质疏松，是股骨头缺血坏死的潜在原因。病变涉及肝、脾、肾。肾为先天之本，主骨生髓，肾健则髓生，髓满则骨坚。反之，则髓枯骨萎，失去应有的再生能力。肝主筋藏血与肾同源，二者荣衰与共，若肝脏受累、藏血失司，不能正常调节血量，血液营运不周，营养难济，是造成股骨头坏死的重要因素。脾主运血，脾失健运、无化气源，则筋骨肌肉皆无气以生。病变发生后，骨与软骨挫裂伤，气血不通畅，经脉瘀阻，血行障碍，肢体失去营养，再生和修复能力减退，因而产生本病。本发明方中运用龟甲、熟地黄滋补真阴，淫羊藿、肉苁蓉温补肾阳，枸杞子、山茱萸助其滋阴益肾养肝，配以泽泻以泄肾浊，使补而不腻。久病乏力，则筋骨赢弱，气血亏虚，故用杜仲、桑寄生、伸筋草、五加皮强腰膝，健筋骨、白术、山药、甘草补气健脾，丹参、当归以养血，以上诸药使得气血阴阳共补。又用川芎、延胡索行气止痛，红花、牛膝、牡丹皮活血散瘀，使得血行气畅，补而不滞。
与现有的技术相比，本发明的有益效果是：
一种治疗股骨头缺血性坏死的药物及其制作方法，本发明的药物为纯中药制剂，具有活血祛瘀、疏经通络、消肿止痛、强筋壮骨的功效；扶正祛邪，一方面滋补肝肾，养血滋阴，益气温阳，另一方面活血化瘀，疏经通络，行气，则疼痛自消。故本发明对于治疗股骨头缺血性坏死具有极佳的疗效，可以明显改善股骨头坏死引起的疼痛，以及关节活动障碍和行走距离等症状和体征。
具体实施方式
一种治疗股骨头缺血性坏死的药物，该药物是由下列重量配比的药剂制成：龟甲：10-30份、熟地黄：7-20份、山药：3-10份、肉苁蓉：3-10份、枸杞子：7-20份、山茱萸：7-20份、川芎：3-10份、杜仲：3-10份、桑寄生：3-10份、伸筋草：3-10份、甘草：3-10份、白术：7-20份、淫手藿：7-20份、五加皮：3-10份、丹参：7-20份、当归：7-20份、泽泻：3-10份、延胡索：3-10份、红花：3-10份、牛膝：3-10份、牡丹皮：3-10份。
所述龟甲炮制而成。
所述泽泻炒制而成。
一种治疗股骨头缺血性坏死的药物的制作方法，按照重量份数配比取上述中药饮片，将经筛选洗净的中药饮片去除杂质，采用干燥箱烘干，80℃≤烘干温度<100℃，烘干后用粉碎机粉成小于100目的细粉，装入药粉桶中，用Co60照射灭菌消毒后，加炼蜜合坨制丸。
所述药物与炼蜜的配比为：1:1。
实施例1：
一种治疗股骨头缺血性坏死的药物是由下列重量配比的药剂制成：龟甲(制)：10份、熟地黄：7份、山药：3份、肉苁蓉：3份、枸杞子：7份、山茱萸：7份、川芎：3份、杜仲：3份、桑寄生：3份、伸筋草：3份、甘草：3份、白术：7份、淫手藿：7份、五加皮：3份、丹参：7份、当归：7份、泽泻：3份、延胡索：3份、红花：3份、牛膝：3份、牡丹皮：3份。
制法：将上述中药饮片经筛选洗净，去除杂质，采用干燥箱烘干，烘干温度<100℃，烘干后用粉碎机粉成细粉(过100目筛)，装入药粉桶中，用Co60照射灭菌消毒后，加炼蜜(1：1)合坨制丸。
实施例2：
一种治疗股骨头缺血性坏死的药物是由下列重量配比的药剂制成：龟甲(制)：20份熟地黄：14份、山药：6份、肉苁蓉：6份、枸杞子：14份、山茱萸：14份、川芎：6份、杜仲：6份、桑寄生：6份、伸筋草：6份、甘草：6份、白术：14份、淫手藿：14份、五加皮：6份、丹参：14份、当归：14份、泽泻(炒)：6份、延胡索：6份、红花：6份、牛膝：6份、牡丹皮：6份。
制法：其制法同实施例1的制法。
实施例3：
一种治疗股骨头缺血性坏死的药物是由下列重量配比的药剂制成：龟甲(制)：30份熟地黄：20份、山药：10份、肉苁蓉：10份、枸杞子：20份、山茱萸：20份、川芎：10份、杜仲：10份、桑寄生：10份、伸筋草：10份、甘草：10份、白术：20份、淫手藿：20份、五加皮：10份、丹参：20份、当归：20份、泽泻(炒)：10份、延胡索：10份、红花：10份、牛膝：10份、牡丹皮：10份。
制法：其制法同实施例1的制法。
临床报告
临床资料：
1、一般资料
122例股骨头缺血性坏死患者，男76例，女46例，年龄29-63岁，平均47岁。试验组64例，对照组58例。
2、诊断依据
2.1采用1993年全国股骨头缺血性坏死专题讨论会上修改的髋关节功能评定标准，根据疼痛、生活能力、关节活动度及行走距离综合评价，每项分为6级，Ⅱ级最差，Ⅵ级最好。
疗效总评定：优80分，良60分，可40分，差＜40分。
2.2X线评定标准
优：股骨头呈球形，密度恢复正常，囊性变消失，植骨区小梁生长良好。良：股骨头呈球形，密度基本恢复正常，植骨区有骨小梁生长。可：股骨头呈球形，密度较正常骨质偏低，植骨区周围仍存在少量囊性及硬化骨质。差：股骨头呈椭圆形，坏死区骨质硬化，骨小梁消失。
3、治疗方法
试验组：患者本发明一种治疗股骨头缺血性坏死的药物，每次6.0g，每日2次。
对照组：患者口服健骨生丸，一次4.5g-9g，一日3次，由北京匡达制药厂生产。
4、疗效评定结果(见表1、表2)
表1治疗前后功能比较
经Ridit检验，2组之间功能评定治疗前差异无显著性(P＜0.05)；治疗后2组之间差异有显著性(P＜0.01)
表2治疗后X线情况比较
| 组别 | 例数 | 优 | 良 | 可 | 差 |
| 试验组 | 64 | 46(72％) | 10(16％) | 6(9％) | 2(3％) |
| 对照组 | 58 | 4(7％) | 14(24％) | 16(28％) | 24(41％) |
经Ridit检验，2组之间差异有显著性(P＜0.01)。
总结：治疗前后功能比较，试验组共64例，治疗后40分以上的为97％；对照组58例，治疗后40分以上的为79％，试验组明显优于对照组。治疗前后X线情况比较，试验组64例，治疗后“可”以上的为62例，比率为97％，对照组58例，治疗后“可”以上的为34例，比率为59％，试验组明显优于对照组。
Claims (5)
1.一种治疗股骨头缺血性坏死的药物，其特征在于，该药物是由下列重量配比的药剂制成：龟甲：10-30份、熟地黄：7-20份、山药：3-10份、肉苁蓉：3-10份、枸杞子：7-20份、山茱萸：7-20份、川芎：3-10份、杜仲：3-10份、桑寄生：3-10份、伸筋草：3-10份、甘草：3-10份、白术：7-20份、淫手藿：7-20份、五加皮：3-10份、丹参：7-20份、当归：7-20份、泽泻：3-10份、延胡索：3-10份、红花：3-10份、牛膝：3-10份、牡丹皮：3-10份。
2.根据权利要求1所述的一种治疗股骨头缺血性坏死的药物，其特征在于，所述龟甲炮制而成。
3.根据权利要求1所述的一种治疗股骨头缺血性坏死的药物，其特征在于，所述泽泻炒制而成。
4.一种如权利要求1所述的治疗股骨头缺血性坏死的药物的制作方法，其特征在于，按照重量份数配比取上述中药饮片，将经筛选洗净的中药饮片去除杂质，采用干燥箱烘干，80℃≤烘干温度<100℃，烘干后用粉碎机粉成小于100目的细粉，装入药粉桶中，用Co60照射灭菌消毒后，加炼蜜合坨制丸。
5.根据权利要求4所述的一种治疗股骨头缺血性坏死药物的制作方法，其特征在于，所述药物与炼蜜的配比为：1:1。
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