CN104547178A - 一种治疗甲亢的中药组合物 - Google Patents
一种治疗甲亢的中药组合物 Download PDFInfo
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Abstract
本发明涉及一种治疗甲亢的中药组合物,该中药组合物由如下重量配比的原料组成:地稔根22~26份、苘麻子22~26份、肿节风18~22份、苦木18~22份、东风橘根16~20份、金沸草10~14份、松萝16~20份、香橼10~14份、紫贝齿13~17份、罗布麻叶10~14份、暴马丁香10~14份、剑花4~8份、鼠曲草4~8份、九里香叶7~11份、蓍草7~11份、苦石莲10~14份、鬼箭羽6~10份、枸骨叶18~22份;并按照一定的工艺方法进行提取后,与药剂学上可接受的辅料而制成的口服制剂。发明中药组合物具有清泄肝热,化痰疏肝,活血化瘀,滋阴平肝的功效。
Description
技术领域
本发明涉及一种治疗甲亢的中药组合物,属于中药领域。
背景技术
甲状腺功能亢进症(简称甲亢)系指多种病因导致甲状腺功能增强,甲状腺激素分泌过多所致的临床综合征,临床表现为:甲状腺肿大分泌过多症候群(包括高代谢症候群及精神神经,心血管消化骨骼肌肉系统症状)可见经前黏液性水肿指端粗厚等,本病女性多见,男女比例约为1:4~6,发病率高达2%~3%,成为高发性内分泌疾病之一。
中医学把甲亢归为瘿病,认为发病与七情内伤和体质因素有关。《诸病源候论》中提出瘿病与忧思气结等有关,而临症指南医案曰:躁急、善怒、气火结瘿,中医一般认为甲亢的病机为本虚标实,发病初期以肝肾阴亏阴虚火旺为主;中期多虚实夹杂,阴亏与火痰瘀并存,而以实为主;后期则因火痰瘀邪积久不散更加耗伤气阴,又变成气阴两虚之候,虚为主并可兼夹实邪。总之,气阴两虚为病机之本,火、郁、痰、凝、血瘀为病机之标。甲亢以“肝”的病证为主,而在肝的病证中,又以肝肾阴虚兼有肝阳上亢型为主;另外,亦可参见心、脾受损之证。常采用的治法以滋补肝肾、平肝潜阳为主。然甲亢既有阴虚肝亢的共性,又有不同阶段可表现出以肾、心、脾等脏气失调为临床表现;故又辅以养心益肾、舒肝健脾之法;由于甲亢多伴有眼病及冲状腺肿大,而造成患者精神负担,根据中医对甲亢眼病及甲状腺肿的辨证,在治法上辅以化痰行气、活血化瘀之法,收到较好效果。
西医临床常用治疗方法为抗甲状腺药物和手术辐射治疗,而抗甲状腺药物如他巴唑、丙基硫氧嘧啶等的作用机制是通过抑制甲状腺上皮细胞内过氧化物酶,使无机碘不能转变为有机碘,一碘酪氨酸和二碘酪氨酸不能相偶联。但对甲状腺内已合成的激素无抑制释放作用,长时间服用西药,也会产生耐药性导致疾病容易复发。但若采用手术辐射治疗,会对人体有巨大的副作用,病人依从性不好。目前,尚缺乏针对甲亢的有效治疗的药物。而传统的中医药在治疗甲亢方面具有毒副作用小,疗效可靠独有的优势。
发明内容
本发明的目的是克服现有技术不足,提供一种疗效显著,且毒副作用小的治疗甲亢中药组合物。
本发明的中药组合物选择地稔根、苘麻子、肿节风、苦木进行配伍,使得处方具有清泄肝热的功效。其中选用地稔根:清热凉血;苘麻子:可清热利湿,解毒,退翳;肿节风:清热凉血,活血消斑;苦木:清热,祛湿,解毒。方中配以东风橘根、金沸草、香橼、松萝、紫贝齿、罗布麻叶、暴马丁香、剑花、鼠曲草、凤尾七药材,其中选用东风橘根:顺气化痰;金沸草:祛风散寒,化痰止咳;松萝:清热解毒,止咳化痰;香橼:舒肝理气,宽中化痰;紫贝齿:平肝明目;罗布麻叶:平抑肝阳,清热利尿;暴马丁香:清肺祛痰;剑花,清热润肺,化痰止咳;鼠曲草:祛痰,止咳平喘;凤尾七:疏肝解郁。诸药相配,使得处方具有化痰疏肝的功效。方中再配以九里香叶、蓍草、苦石莲、鬼箭羽药材,九里香叶:活血散瘀;蓍草:活血化瘀;苦石莲:散瘀,止痛,清热;鬼箭羽:活血化瘀,通经活络;四药相配,使得处方具有活血化瘀的功效。最后方中配伍枸骨叶,枸骨叶:清热养阴、平肝、益肾。方中诸药合用,进行配伍,使得全方的产生协同增效作用。全方具有清泄肝热,化痰疏肝,活血化瘀,滋阴平肝之功效,对甲亢患者可达标本兼治之效。
本发明的中药组合物的用量和制备工艺方法也是经过大量摸索总结得出来的,各组分用量在下述重量份范围都具有较好的疗效:
本发明的中药组合物是由下述工艺制备而成:
A.处方组成及重量配比:地稔根22~26份、苘麻子22~26份、肿节风18~22份、苦木18~22份、东风橘根16~20份、金沸草10~14份、松萝16~20份、香橼10~14份、紫贝齿13~17份、罗布麻叶10~14份、暴马丁香10~14份、剑花4~8份、鼠曲草4~8份、九里香叶7~11份、蓍草7~11份、苦石莲10~14份、鬼箭羽6~10份、枸骨叶18~22份;
B.制备方法:将上述18味中药材,按下述步骤操作:
(1)取肿节风、东风橘根、紫贝齿药材,混合粉碎成100目的药粉,备用;
(2)取香橼、苦木、九里香叶、鬼箭羽,加入药材重量比为9倍量60%乙醇,回流提取2次,每次1h,滤过,合并滤液并回收乙醇至无醇味后,药液浓缩干燥后,并粉碎成干膏粉,过筛,药渣备用;
(3)将(2)中的药渣再与地稔根、苘麻子、金沸草、松萝、罗布麻叶、暴马丁香、剑花、鼠曲草、蓍草、苦石莲、枸骨叶药材合并,加水煎煮2次,第一次加药材重量比为9倍量水,煎煮2h,第二次加药材重量比为8倍量水,煎煮1h,滤过,合并得滤液,滤液减压浓缩成相对密度1.30~1.35稠膏,加入步骤(1)中的药粉,搅拌均匀后,经减压干燥成干膏粉,过筛,备用;
(4)将(2)和(3)中的干膏粉,充分混匀后,即得中药活性成分,再加入药剂学上常用的辅料制成各种不同口服制剂,即得。
作为本发明的优选,它是由如下重量份的原料药组成:地稔根24份、苘麻子24份、肿节风20份、苦木20份、东风橘根18份、金沸草12份、松萝18份、香橼12份、紫贝齿15份、罗布麻叶12份、暴马丁香12份、剑花6份、鼠曲草6份、九里香叶9份、蓍草9份、苦石莲12份、鬼箭羽8份、枸骨叶20份。
本发明的中药组合物的活性成分可以加入制备不同剂型所需的各种常规的辅料,如崩解剂、润滑剂、填充剂、粘合剂等以常规的中药制剂方法制备成任何一种常用的口服剂型,如颗粒剂、片剂、硬胶囊剂等。
本发明是在传统中医理论和临床经验指导下,精选出各原料药及其配比,利用中医君臣佐使配伍,使其中药相互间产生协同作用,提高了本发明的中药组合物临床疗效。并能适应复杂病情的治疗要求,使得全方具有清泄肝热、化痰疏肝、活血化瘀,滋阴平肝的功效。且本发明中药组合物的制备方法,简便、科学有效将中药复方中的有效物质提取完全,并有效保证本发明中药组合物的质量稳定性。本发明的中药组合物有效抑制患者甲状腺的分泌,减少甲亢患者的症状等。经临床验证,本发明的中药组合物的临床治愈的总有效率高达96.4%以上,并有愈后不复发,具有副作用小的优点。
具体实施方式
以下是本发明的具体实施例,对本发明的技术方案做进一步作描述,但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1 本发明中药组合物片剂的制备
(1)取肿节风20g、东风橘根18g、紫贝齿15g药材,混合粉碎成100目的药粉,备用;
(2)取香橼12g、苦木20g、九里香叶9g、鬼箭羽8g,加入药材重量比为9倍量60%乙醇,回流提取2次,每次1h,滤过,合并滤液并回收乙醇至无醇味后,药液浓缩干燥后,并粉碎成干膏粉,过筛,药渣备用;
(3)将(2)中的药渣再与地稔根24g、苘麻子24g、金沸草12g、松萝18g、罗布麻叶12g、暴马丁香12g、剑花6g、鼠曲草6g、蓍草9g、苦石莲12g、枸骨叶20g药材合并,加水煎煮2次,第一次加药材重量比为9倍量水,煎煮2h,第二次加药材重量比为8倍量水,煎煮1h,滤过,合并得滤液,滤液减压浓缩成相对密度1.30~1.35稠膏,加入步骤(1)中的药粉,搅拌均匀后,经减压干燥成干膏粉,过筛,备用;
(4)将(2)、(3)中备用的干膏粉,充分混匀后,与适量淀粉、糊精混匀,制粒,压制成1000个片剂。
实施例2 本发明中药组合物的颗粒剂制备
(1)取肿节风18g、东风橘根20g、紫贝齿13g药材,混合粉碎成100目的药粉,备用;
(2)取香橼10g、苦木18g、九里香叶7g、鬼箭羽10g,加入药材重量比为9倍量60%乙醇,回流提取2次,每次1h,滤过,合并滤液并回收乙醇至无醇味后,药液浓缩干燥后,并粉碎成干膏粉,过筛,药渣备用;
(3)将(2)中的药渣再与地稔根22g、苘麻子26g、金沸草10g、松萝20g、罗布麻叶10g、暴马丁香14g、剑花8g、鼠曲草4g、蓍草11g、苦石莲10g、枸骨叶18g药材合并,加水煎煮2次,第一次加药材重量比为9倍量水,煎煮2h,第二次加药材重量比为8倍量水,煎煮1h,滤过,合并得滤液,滤液减压浓缩成相对密度1.30~1.35稠膏,加入步骤(1)中的药粉,搅拌均匀后,经减压干燥成干膏粉,过筛,备用;
(4)将(2)、(3)中备用的干膏粉,充分混匀后,与适量的糊精、蔗糖,混匀,制粒,干燥,制成1000g颗粒剂。
实施例3 本发明中药组合物胶囊剂的制备
(1)取肿节风22g、东风橘根16g、紫贝齿17g药材,混合粉碎成100目的药粉,备用;
(2)取香橼14g、苦木22g、九里香叶11g、鬼箭羽6g,加入药材重量比为9倍量60%乙醇,回流提取2次,每次1h,滤过,合并滤液并回收乙醇至无醇味后,药液浓缩干燥后,并粉碎成干膏粉,过筛,药渣备用;
(3)将(2)中的药渣再与地稔根26g、苘麻子22g、金沸草14g、松萝16g、罗布麻叶14g、暴马丁香10g、剑花4g、鼠曲草8g、蓍草7g、苦石莲14g、枸骨叶22g药材合并,加水煎煮2次,第一次加药材重量比为9倍量水,煎煮2h,第二次加药材重量比为8倍量水,煎煮1h,滤过,合并得滤液,滤液减压浓缩成相对密度1.30~1.35稠膏,加入步骤(1)中的药粉,搅拌均匀后,经减压干燥成干膏粉,过筛,备用;
(4)将(2)、(3)中备用的干膏粉,充分混匀后,加入适宜的辅料,制粒,装胶囊,制成1000粒硬胶囊剂。
为了进一步验证本发明成品制剂的疗效,我们将上述具体实施例1中制备的成品片剂药物进行了相应的临床试验,现将结果报告如下。
本发明中药组合物的对甲亢的临床观察
1.一般资料
1.1病例选择:收治117例均符合甲亢诊断标准。采用平行对照、随机的设计方法,随机分为治疗组和对照组,治疗组56例,男,13例,女43例;年龄25~50岁,平均38.6岁;病程6个月~3年,平均病程1.83±0.39年。对照组61例,男15例,女46例;年龄23~55岁,平均39.3岁;病程7个月~3.5年,平均病程1.92±0.53年。两组治疗前均未服西药或停用西药半月以上,两组在性别、年龄、病程方面差异无显著性(P>0.05),具可比性。
1.2 诊断与疗效标准所选患者均符合甲亢西医诊断标准、中医辨证分型标准和症状轻、中、重级标准,并参照卫生部制定颁布的《中药新药治疗甲状腺功能亢进症的临床研究指导原则》中的标准执行。
2.治疗方法
治疗组口服本发明实施例1组的片剂药物进行治疗,每日3次,每次口服3个剂量单位,对照组口服甲亢灵片进行治疗,每日3次,每次口服3片,两组均一个月为一个疗程,连续服用2个疗程后,观察患者治疗效果。
3.疗效标准
参照卫生部颁布的《中药新药治疗甲状腺功能亢进症的临床研究指导原则》中制定的标准。临床控制:症状消失,体重增加,脉率正常,甲状腺区震颤及血管杂音消失,甲状腺肿缩小,各项实验室检查项目恢复正常;显效:主要症状消失,体重增加,脉率基本正常,甲状腺区震颤及血管杂音消失,甲状腺肿减轻,血清T3、T4、FT3、FT4水平基本正常;有效:症状好转,脉率减慢,甲状腺肿缩小,血管杂音减轻,血清T3、T4、FT3、FT4水平基本正常;无效:症状、体征、实验室检查,均无明显改善。
4.治疗结果与分析:
表1 两组治疗后临床疗效比较
组别 | n | 临床控制 | 显效 | 有效 | 无效 | 总有效率 |
治疗组 | 56 | 31 | 12 | 11 | 2 | 96.4% |
对照组 | 61 | 20 | 17 | 9 | 15 | 75.4% |
与对照组比较,P<0.05。
由表1的试验结果可知,本发明治疗组的总有效率分别为96.4%,而服用对照组(甲亢灵片)的患者总有效率为75.4%。在用药治疗过程中,服用本发明中药组合物的患者无明显的不良反应,而且对照组患者有2例出现头晕状况,未采取相应措施处理,停药后患者的不良反应消失,随访中两组患者均未有复发。
以上结果表明,本发明的中药组合物在治疗甲亢疾病方面临床疗效显著,并优于对照组,具有统计学意义(P<0.05),这也提示,本发明中药组合物具有安全、疗效可靠、毒副作用小的特点。
表2 两组治疗前后心率,体重及甲亢指数积分的变化比较
与治疗前比较P<0.05;与对照组比较,P<0.05。
从表2可以看出,两组患者治疗前后比较,均出现心率减慢、体重增加,甲亢指数积分明显下降的症状,经统计学处理分析比较,有显著性差异(P<0.05);治疗组与对照组之间心率、体重变化差异虽无显著性,但都有较好改变的趋势;治疗组甲亢指数积分下降则较对照组明显,两组之间差异有显著性(P<0.05);说明经药物治疗后,治疗组患者的高代谢症候群、甲状腺肿大和体重减少等临床症状有明显改善,这提示,本发明的中药组合物可以有效改善甲亢患者的临床症状,有比较显著的效果。
表3 两组治疗前后血清T3、T4、FT3、FT4的变化比较
与治疗前比较,P<0.05;与对照组比较,P<0.05。
由表3实验结果可以看出,治疗组和对照组经药物治疗后,患者体内血清的T3、T4、FT3、FT4均有显著下降,并有统计学差异,且有显著性(P<0.05),治疗组下降幅度均明显优于对照组,这些数据说明,本发明的中药组合物能明显降低患者体内甲状腺激素的含量,对甲亢疾病的有良好的治疗效果。
综上所述,本发明的中药组合物在治疗甲亢疾病方面,有着明显的临床治疗效果,且不良反应发生少,可以在临床上广泛推广和使用,具有广阔的应用前景。
Claims (3)
1.一种治疗甲亢的中药组合物,其特征在于,它是由下述工艺制备而成:
A.处方组成及重量配比:地稔根22~26份、苘麻子22~26份、肿节风18~22份、苦木18~22份、东风橘根16~20份、金沸草10~14份、松萝16~20份、香橼10~14份、紫贝齿13~17份、罗布麻叶10~14份、暴马丁香10~14份、剑花4~8份、鼠曲草4~8份、九里香叶7~11份、蓍草7~11份、苦石莲10~14份、鬼箭羽6~10份、枸骨叶18~22份;
B.制备方法:将上述18味中药材,按下述步骤操作:
⑴取肿节风、东风橘根、紫贝齿药材,混合粉碎成100目的药粉,备用;
⑵取香橼、苦木、九里香叶、鬼箭羽,加入药材重量比为9倍量60%乙醇,回流提取2次,每次1h,滤过,合并滤液并回收乙醇至无醇味后,药液浓缩干燥后,并粉碎成干膏粉,过筛,药渣备用;
⑶将(2)中的药渣再与地稔根、苘麻子、金沸草、松萝、罗布麻叶、暴马丁香、剑花、鼠曲草、蓍草、苦石莲、枸骨叶药材合并,加水煎煮2次,第一次加药材重量比为9倍量水,煎煮2h,第二次加药材重量比为8倍量水,煎煮1h,滤过,合并得滤液,滤液减压浓缩成相对密度1.30~1.35稠膏,加入步骤(1)中的药粉,搅拌均匀后,经减压干燥成干膏粉,过筛,备用;
⑷将(2)和(3)中的干膏粉,充分混匀后,即得中药活性成分,再加入药剂学上常用的辅料制成各种不同口服制剂,即得。
2. 如权利要求1所述的治疗甲亢的中药组合物,其特征在于,所述的中药组合物的处方组成及重量配比为:地稔根 24份、苘麻子24份、肿节风20份、苦木20份、东风橘根18份、金沸草12份、松萝18份、香橼12份、紫贝齿15份、罗布麻叶12份、暴马丁香12份、剑花6份、鼠曲草6份、九里香叶9份、蓍草9份、苦石莲12份、鬼箭羽8份、枸骨叶20份。
3.如权利要求1或2所述的治疗甲亢的中药组合物,其特征在于,该中药组合物是片剂、颗粒剂、硬胶囊剂。
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张俊庭: "《中华名医高新诊疗通鉴》", 31 May 2000, 中医古籍出版社 * |
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