CN103768480B - 一种治疗面肌痉挛的中药及其制备方法 - Google Patents
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Abstract
本发明属于医药技术领域，具体涉及一种治疗面肌痉挛的中药及其制备方法。本发明的治疗面肌痉挛的中药，由以下重量份的中药原料药制成：箭杆风25-35份、鹿药10-20份、见血飞20-30份、师祖麻4-8份、防风10-20份、九龙盘4-8份、千只眼4-8份、蜈蚣2-4份、僵蚕6-12份、威灵仙4-8份、黄芪25-35份、白术25-35份、当归10-20份、甘草6-12份。本发明的中药具有祛风通络、舒筋活络，养阴润燥，凉血止痛的功效，临床用于面肌痉挛。该中药具有见效快，疗效好，无不良反应的优点，避免了手术和局部注射给患者带来的痛苦。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗面肌痉挛的中药及其制备方法。
背景技术
面肌痉挛指面肌不自主阵发性抽搐样收缩,一般情况下多为单侧面部,偶见双侧,常起始于眼睑下部不自主微小抽动,逐渐向颜面扩展,于紧张劳累时加重,随着病程的延长上述症状会逐渐加重,由开始时每日数次抽搐发展到每日十几次,抽搐幅度可由局部小抽搐发展致剧烈抽搐。
面肌痉挛治疗方法较多,过去常采用抗癫痫药物,辅以针灸治疗,由于药物长期应用出现耐受性,且疗效与毒副作用均存在剂量依赖性,所以受药物剂量的限制,长期疗效不理想。部分病例作茎乳孔面神经阻滞疗法,或者行经皮穿刺射频温控热凝治疗,由于其面瘫发生率达100%,故未能普及。近年来进行的显微神经血管减压术,因创伤大、技术要求高、风险性大,而不利于在中、小医院推广。局部注射乙醇、肉毒素，疼痛明显，患者治疗起来比较痛苦，脸上多出注射留下的微小针眼影响美观。
发明内容
本发明所要解决的技术问题是避免上述现有技术所存在的不足之处，提供一种治疗面肌痉挛的中药及其制备方法。该中药具有见效快，疗效好，无不良反应的优点，避免了手术和局部注射给患者带来的痛苦。
本发明是通过如下技术方案实现的：
一种治疗面肌痉挛的中药，由以下重量份的中药原料药制成：
箭杆风25-35份、鹿药10-20份、见血飞20-30份、师祖麻4-8份、防风10-20份、九龙盘4-8份、千只眼4-8份、蜈蚣2-4份、僵蚕6-12份、威灵仙4-8份、黄芪25-35份、白术25-35份、当归10-20份、甘草6-12份。
优选的，上述的治疗面肌痉挛的中药，由以下重量份的中药原料药制成：
箭杆风27-33份、鹿药13-17份、见血飞23-27份、师祖麻5-7份、防风13-17份、九龙盘5-7份、千只眼5-7份、蜈蚣2.5-3.5份、僵蚕7-11份、威灵仙5-7份、黄芪27-33份、白术27-33份、当归13-17份、甘草7-11份。
更优选的，上述的治疗面肌痉挛的中药，由以下重量份的中药原料药制成：
箭杆风30份、鹿药15份、见血飞25份、师祖麻6份、防风15份、九龙盘6份、千只眼6份、蜈蚣3份、僵蚕9份、威灵仙6份、黄芪30份、白术30份、当归15份、甘草9份。
上述的治疗面肌痉挛的中药，该中药为口服制剂，优选的，该中药的剂型形式为颗粒剂。
上述的治疗面肌痉挛的中药颗粒剂的制备方法，包含如下步骤：
（a）将箭杆风、鹿药、见血飞、师祖麻、防风、九龙盘、千只眼、当归用药材体积3～5倍量的75%乙醇浸泡10～14小时后回流提取2次，每次1小时，过滤，合并滤液，滤液在0.05～0.07MPa下减压回收乙醇至药液无醇味儿，60℃减压浓缩至相对密度为1.20～1.25的清膏；
（b）将蜈蚣、僵蚕、威灵仙、黄芪、白术、甘草6味药材加上述药材6～8倍重量的水煎煮2次，每次煎煮0.5～1.5小时，合并两次的煎出液，于60℃下减压浓缩至原煎出液体积的一半，倾出放凉，冷藏12小时，滤过，滤液60℃减压浓缩至相对密度为1.25～1.28的清膏；
（c）合并两部分清膏，混匀，减压干燥，粉碎，过100目筛，制备成浸膏粉，加入药学上可接受的辅料制成颗粒剂，即得。
产品进行质量检验，检验合格后包装消毒。每袋重10g，每克含原生药1.5～2.5g，每日服三次，每次1袋。
所述的药学上可接受的辅料选自：蔗糖、淀粉、硬脂酸镁、甘露醇、山梨醇、山梨酸或钾盐、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素A、维生素C、维主素E、维生素D、氮酮、EDTA二钠、EDTA钙钠，一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、丙二醇、乙醇、吐温60～80、司班～80、蜂蜡、羊毛脂、液体石蜡、十六醇、没食子酸酯类、琼、三乙醇胺、碱性氨基酸、尿素、尿囊素、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β～环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙等。
本发明的中药具有祛风通络、舒筋活络，养阴润燥，凉血止痛的功效，临床用于面肌痉挛。
本发明的治疗面肌痉挛的中药中，
箭杆风别名山姜、九姜连、华良姜，是姜科山姜属植物华山姜Alpinia chinensis Rosc.根状茎。辛，温。具有祛风除湿，理气活血，解毒，止痛的功效，可止咳平喘，散寒止痛，除风湿，解疮毒。用于风寒咳喘，胃气痛，风湿关节疼痛，跌损瘀血停滞，***，无名肿毒。
鹿药为百合科鹿药属植物鹿药Smilacina japonica A.Gray的根茎及根。甘苦，温。甘具有补气益肾，祛风除湿，活血调经的功效。临床主要用于治疗痨伤，阳痿，偏、正头痛，风湿疼痛，跌打损伤，乳痈，***。
见血飞为双子叶植物药芸香科植物刺异叶花椒Zanthoxylum dimorphophyllumHemsl.Var.spinifolium Rehd.Et Wils.的根或根皮。别名散血飞、黄椒、刺三加、红三百棒。辛，温，入肝、肺经。具有祛风散寒，活血舒筋，镇痛的功效。临床主要用于风寒咳嗽，风湿麻木，跌打损伤，外伤出血，大便秘结。
师祖麻为瑞香科瑞香属植物黄瑞香Daphne giraldii Nitsche2.Daphne tanguticaMaxim.3.Daphne retusa Hemsl的根皮及茎皮，别名为黄瑞香、大救驾、金腰带、黄狗皮。辛苦，温，有小毒。可祛风除湿，止痛散瘀。临床主要用于风湿痹痛，四肢麻木，头痛，胃痛，跌打损伤。
防风为伞形科植物防风的DivaricateSaposhnikoviaRoot的根，别名铜芸、回云、回草、百枝、百种，具有祛风除湿，止痛散瘀的功效。临床主要用于风湿痹痛，四肢麻木，头痛，胃痛，跌打损伤。
九龙盘为百合科九龙盘AspidistraluridaKer-Gawl.以根状茎入药。微苦，平。具有温中，散寒，祛风，活血的功效。治脘腹冷痛，风湿筋骨疼痛。
千只眼别名臭漆、透光草，来源于芸香科九里香属植物千只眼Murraya tetramera Huang，以叶和根入药。辛、微苦，微温。具有祛风解表，行气止痛，活血散瘀的功效。用于感冒发热，支气管炎，哮喘，风湿麻木，筋骨疼痛，跌打瘀血肿痛，皮肤瘙痒，湿疹，毒蛇咬伤，疟疾，胃痛，水肿等。
其余蜈蚣、僵蚕、威灵仙、黄芪、白术、当归、甘草7味药为中国药典2010版一部记载的药材。
祖国医学认为，面肌痉挛发病多因人体正气不足，脉络空虚，腠理不固，风邪挟痰入中面部阳明少阳之经，致使颜面肌腠经络痹阻，气血运行不利，肌肉筋脉失于濡养，故致面肌拘急弛纵。本发明中药中黄芪、白术补中益气，防风、僵蚕疏散面部风邪，箭杆风、鹿药、见血飞、师祖麻、九龙盘、千只眼、威灵仙、蜈蚣祛风湿，通经络，消痰涎；根据“血行风自灭”的理论，选用当归补血活血，甘草调和诸药。诸药合用，共奏补中益气，祛风除湿，活血化痰，通络止痛的功效。
本发明的优点在于：
（1）本发明提供了一种新的治疗面肌痉挛的中药，满足了临床需要。
（2）本发明将治疗面肌痉挛的中药制备成颗粒剂，既保持了汤剂吸收快、显效迅速的特点，又克服了汤剂服用前临时煎煮，久置易霉败变质的缺点，并可掩盖中药的苦味。本发明中药颗粒剂中药材全部经过精制提取，体积缩小，运输、携带、服用方便。
（3）临床试验结果表明，本发明治疗组30例患者痊愈16例，好转12例，无效2例，治愈率为53.3%，总有效率为93.3%；对照组30例患者痊愈7例，好转17例，无效6例，治愈率为23.2%，总有效率为80%；2组治愈率有极显著差异(P＜0.01)，总有效率比较有显著性差异(P＜0.05)。对照组共有6例患者出现不同程度头晕、恶心、呕吐、皮疹、腹胀、视物模糊等症状，治疗组均未出现上述不良反应。2组不良反应发生率比较有显著性差异(P＜0.05)。
具体实施方式
下面结合具体实施例对本发明作更进一步的说明，以便本领域的技术人员更了解本发明，但并不因此限制本发明。
实施例1
处方
箭杆风300g、鹿药150g、见血飞250g、师祖麻60g、防风150g、九龙盘60g、千只眼60g、蜈蚣30g、僵蚕90g、威灵仙60g、黄芪300g、白术300g、当归150g、甘草90g。
制备方法：
（a）将箭杆风、鹿药、见血飞、师祖麻、防风、九龙盘、千只眼、当归用药材体积4倍量的75%乙醇浸泡12小时后回流提取2次，每次1小时，过滤，合并滤液，滤液在0.05～0.07MPa下减压回收乙醇至药液无醇味儿，60℃减压浓缩至相对密度为1.20～1.25的清膏；
（b）将蜈蚣、僵蚕、威灵仙、黄芪、白术、甘草6味药材加上述药材7倍重量的水煎煮2次，每次煎煮小时，合并两次的煎出液，于60℃下减压浓缩至原煎出液体积的一半，倾出放凉，冷藏12小时，滤过，滤液60℃减压浓缩至相对密度为1.25～1.28的清膏；
（c）合并两部分清膏，混匀，减压干燥，粉碎，过100目筛，制备成浸膏粉，，加入蔗糖，混匀，以75%乙醇作润湿剂制粒，干燥，整粒，制成颗粒剂1000g，即得。
共制备颗粒剂100袋，每袋重10g。
用法用量：每次1袋，每日3次。
实施例2
处方
箭杆风270g、鹿药170g、见血飞230g、师祖麻70g、防风130g、九龙盘70g、千只眼50g、蜈蚣3.50g、僵蚕70g、威灵仙70g、黄芪270g、白术330g、当归130g、甘草110g。
制备方法
制备方法：
（a）将箭杆风、鹿药、见血飞、师祖麻、防风、九龙盘、千只眼、当归用药材体积5倍量的75%乙醇浸泡10小时后回流提取2次，每次1小时，过滤，合并滤液，滤液在0.05～0.07MPa下减压回收乙醇至药液无醇味儿，60℃减压浓缩至相对密度为1.20～1.25的清膏；
（b）将蜈蚣、僵蚕、威灵仙、黄芪、白术、甘草6味药材加上述药材6倍重量的水煎煮2次，每次煎煮0.5小时，合并两次的煎出液，于60℃下减压浓缩至原煎出液体积的一半，倾出放凉，冷藏12小时，滤过，滤液60℃减压浓缩至相对密度为1.25～1.28的清膏；
（c）合并两部分清膏，混匀，减压干燥，粉碎，过100目筛，制备成浸膏粉，，加入蔗糖，混匀，以75%乙醇作润湿剂制粒，干燥，整粒，制成颗粒剂1000g，即得。
共制备颗粒剂100袋，每袋重10g。
用法用量：每次1袋，每日3次。
实施例3
处方
箭杆风330g、鹿药130g、见血飞270g、师祖麻50g、防风170g、九龙盘50g、千只眼70g、蜈蚣2.50g、僵蚕110g、威灵仙50g、黄芪330g、白术270g、当归170g、甘草70g。
制备方法：
（a）将箭杆风、鹿药、见血飞、师祖麻、防风、九龙盘、千只眼、当归用药材体积35倍量的75%乙醇浸泡14小时后回流提取2次，每次1小时，过滤，合并滤液，滤液在0.05～0.07MPa下减压回收乙醇至药液无醇味儿，60℃减压浓缩至相对密度为1.20～1.25的清膏；
（b）将蜈蚣、僵蚕、威灵仙、黄芪、白术、甘草6味药材加上述药材8倍重量的水煎煮2次，每次煎煮1.5小时，合并两次的煎出液，于60℃下减压浓缩至原煎出液体积的一半，倾出放凉，冷藏12小时，滤过，滤液60℃减压浓缩至相对密度为1.25～1.28的清膏；
（c）合并两部分清膏，混匀，减压干燥，粉碎，过100目筛，制备成浸膏粉，，加入蔗糖，混匀，以75%乙醇作润湿剂制粒，干燥，整粒，制成颗粒剂1000g，即得。
共制备颗粒剂100袋，每袋重10g。
用法用量：每次1袋，每日3次。
实施例4
处方
箭杆风250g、鹿药200g、见血飞200g、师祖麻80g、防风100g、九龙盘80g、千只眼40g、蜈蚣40g、僵蚕60g、威灵仙80g、黄芪250g、白术350g、当归100g、甘草120g。
制备方法同实施例1。
实施例5
处方
箭杆风350g、鹿药100g、见血飞300g、师祖麻40g、防风200g、九龙盘40g、千只眼80g、蜈蚣20g、僵蚕120g、威灵仙40g、黄芪350g、白术250g、当归200g、甘草60g。
制备方法同实施例1。
对本发明的实施例l的制剂进行了临床药效学试验，结果如下：
一般资料
60例面肌痉挛患者均来自本院门诊或住院病人，符合单纯性“面肌痉挛”诊断。排除口颜面紧张综合征，药物引起面部表情肌的张力改变，排除桥小脑角肿瘤继发性面肌痉挛及其他颅内疾患。采用随机数字表法将患者随机分为2组:治疗组30例，男14例，女15例；年龄(36.6±6.8)岁，病程(7.2±4.1)个月；对照组30例，男12例，女18例；年龄(35.9±6.3)岁，病程(6.9±4.4个月。2组一般资料比较均无显著性差异(P＞0.05)，具有可比性。
治疗方法
对照组口服卡马西平(北京曙光制药有限责任公司生产)200mg/d，3次/d。
治疗组口服本发明实施例1制备的治疗面肌痉挛的中药，每次1袋，每日3次，饭后服用。10天为1疗程，1个疗程后观察疗效。
观察方法
每周观察发作次数、持续时间、发作程度的临床症状的改善情况，观察临床不良反应，12周为1个疗程。
疗效评定标准
痉挛强度分级标准:0级，无痉挛；1级，外部刺激引起轻度痉挛；2级，轻度痉挛，可见面部肌肉颤动，无功能障碍；3级，中度痉挛，面肌痉挛明显，有轻微功能障碍；4级，重度痉挛，有严重功能障碍，影响工作和生活。治愈:症状消失，痉挛分级为0级，3月内无复发；好转:症状明显减轻，痉挛频率、幅度均明显减小，痉挛分级下降大于1级
统计学处理
采用SPSS10.5统计软件，计数资料用卡方检验；计量资料用均数±标准差(x±s)表示，采用t检验。
结果结果详见表1。
表1治疗组和对照组疗效比较
| 组别 | 治愈 | 有效 | 无效 | 治愈率（%） | 总有效率（%） |
| 治疗组(30) | 16 | 12 | 2 | 53.3** | 93.3* |
| 对照组(30) | 7 | 17 | 6 | 23.3 | 80 |
注：**与对照组比较，P<O.01；*与对照组比较，P<O.05。
治疗组30例患者痊愈16例，好转12例，无效2例，治愈率为53.3%，总有效率为93.3%；对照组30例患者痊愈7例，好转17例，无效6例，治愈率为23.2%，总有效率为80%；2组治愈率有极显著差异(P＜0.01)，总有效率比较有显著性差异(P＜0.05)。
对照组共有6例患者出现不同程度头晕、恶心、呕吐、皮疹、腹胀、视物模糊等症状，治疗组均未出现上述不良反应。2组不良反应发生率比较有显著性差异(P＜0.05)。
Claims (4)
1.一种治疗面肌痉挛的中药，由以下重量份的中药原料药制成：
箭杆风25-35份、鹿药10-20份、见血飞20-30份、师祖麻4-8份、防风10-20份、九龙盘4-8份、千只眼4-8份、蜈蚣2-4份、僵蚕6-12份、威灵仙4-8份、黄芪25-35份、白术25-35份、当归10-20份、甘草6-12份。
2.根据权利要求1所述的治疗面肌痉挛的中药，其特征在于，由以下重量份的中药原料药制成：
箭杆风27-33份、鹿药13-17份、见血飞23-27份、师祖麻5-7份、防风13-17份、九龙盘5-7份、千只眼5-7份、蜈蚣2.5-3.5份、僵蚕7-11份、威灵仙5-7份、黄芪27-33份、白术27-33份、当归13-17份、甘草7-11份。
3.根据权利要求2所述的治疗面肌痉挛的中药，其特征在于，由以下重量份的中药原料药制成：
箭杆风30份、鹿药15份、见血飞25份、师祖麻6份、防风15份、九龙盘6份、千只眼6份、蜈蚣3份、僵蚕9份、威灵仙6份、黄芪30份、白术30份、当归15份、甘草9份。
4.根据权利要求1或2或3所述的治疗面肌痉挛的中药，其特征在于，该中药的剂型形式为颗粒剂。
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