CN108379382A - 一种中药制剂及其制备方法和应用 - Google Patents
一种中药制剂及其制备方法和应用 Download PDFInfo
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- CN108379382A CN108379382A CN201810284977.9A CN201810284977A CN108379382A CN 108379382 A CN108379382 A CN 108379382A CN 201810284977 A CN201810284977 A CN 201810284977A CN 108379382 A CN108379382 A CN 108379382A
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Abstract
本发明涉及中药制剂技术领域,尤其是涉及一种中药制剂及其制备方法和应用。所述中药制剂主要由按重量份数计的如下原料制备得到:熟地1.5‑2份、威灵仙1‑1.5份、申姜1‑1.5份、白芍0.5‑1.5份、仙灵脾0.5‑1.5份、宽筋藤0.5‑1.5份、荆芥0.5‑1.5份、补骨脂0.5‑1.5份、独活0.5‑1份、羌活0.5‑1份、桂枝0.5‑1份、甘草0.5‑1份、川椒2‑3份、艾叶40‑60份和新鲜禽蛋200‑300份。本发明所述的中药制剂采用上述原料,并进行了合理的配伍,可有效用于预防和/或治疗骨关节病、痛风和软组织损伤。
Description
技术领域
本发明涉及中药制剂技术领域,尤其是涉及一种用于预防和/或治疗骨关节病、痛风和软组织损伤的中药制剂及其制备方法和应用。
背景技术
骨关节病包括颈椎病、腰椎病、滑囊炎、滑膜炎、肩周炎、退行性关节炎、风湿性关节炎、类风湿性关节炎、骨质增生和骨头坏死等。骨关节病是难缠的疾病,患骨关节病后,关节肿痛僵直,有积液、增生或骨刺,活动艰难,影响病人的生活能力和劳动能力。
现代医学研究发现,患骨关节病的根本原因不一定是骨骼发生了病变,病根主要在于软骨等关节保护系统对骨关节保护能力的丧失。各类骨关节疾病的发生往往始于滑膜病变、软骨受损或是变性;服用某些抗炎类、激素类药物所造成的软骨损伤也是许多骨关节疾病的主要成因之一。由于关节滑膜、软骨的损伤以及关节滑液的缺失,导致关节骨骼缺少必要的保护,以至于人体一活动,关节处的骨骼因缺乏必要的软骨保护直接发生剧烈硬性摩擦,而引起患者关节疼痛、肿胀、变形、骨刺增生等多种症状。更为重要的是,人体关节器官如果免疫失调,关节必然因缺乏必要的免疫保护而造成外界炎性因子的侵入,最终导致各类骨关节疾病的发生。
痛风是由单钠尿酸盐沉积所致的晶体相关性关节病,与嘌呤代谢紊乱和/或尿酸排泄减少所致的高尿酸血症直接相关,特指急性特征性关节炎和慢性痛风石疾病,主要包括急性发作性关节炎、痛风石形成、痛风石性慢性关节炎、尿酸盐肾病和尿酸性尿路结石,重者可出现关节残疾和肾功能不全。痛风常伴腹型肥胖、高脂血症、高血压、二型糖尿病及心血管疾病等表现。
软组织损伤是指软组织或骨骼肌肉受到直接或间接暴力,或长期慢性劳损引起的一大类创伤综合症。组织受创后出现微循环障碍、无菌性炎症,致使局部肿胀疼痛。临床以患处肿胀、疼痛为主要表现。急性期,局部渗血、水肿,疼痛剧烈;晚期可能出现肌肉、肌腱的粘连、缺血性挛缩,关节周围炎,甚至引起关节僵直。
当前,随着生活节奏的加快和工作压力的加大,前述的骨关节病、痛风和软组织损伤已经成为人们的常见病、多发病,这些疾病反复发作、难以根治,因此,研究开发预防和/或治疗骨关节病、痛风和软组织损伤的药物就成为一项十分紧迫的任务。
有鉴于此,特提出本发明。
发明内容
本发明的第一目的在于提供一种中药制剂,所述中药制剂对原料药进行合理的配伍,能够通过贴敷的方式预防和/或治疗骨关节病、痛风和软组织损伤等疾病,安全,使用简便,药源广泛,副作用低。
本发明的第二目的在于提供一种所述中药制剂的制备方法,所述制备方法能完整保留药物的有效成份,并且工艺简单,能够针对不同需要制备得到不同剂型的产品,操作条件简单,适于大规模生产。
本发明的第三目的在于提供一种所述中药制剂的应用,所述中药制剂用于预防和/或治疗骨关节病、痛风和软组织损伤,能够为患者解除患病痛苦,解决长期困扰患者和医护人员的难题。
为了实现本发明的上述目的,特采用以下技术方案:
一种中药制剂,主要由按重量份数计的如下原料制备得到:
熟地1.5-2份、威灵仙1-1.5份、申姜1-1.5份、白芍0.5-1.5份、仙灵脾0.5-1.5份、宽筋藤0.5-1.5份、荆芥0.5-1.5份、补骨脂0.5-1.5份、独活0.5-1份、羌活0.5-1份、桂枝0.5-1份、甘草0.5-1份、川椒2-3份、艾叶40-60份和新鲜禽蛋200-300份。
本发明所述的中药制剂采用上述原料,并进行了合理的配伍,可有效用于预防和/或治疗骨关节病、痛风和软组织损伤。
本发明提供的中药制剂,通过熟地、威灵仙、申姜等至少十四味药材的合理配伍,并配合新鲜禽蛋中富含的蛋白质、磷脂、多种维生素、钙、钾、铁、磷等营养物质作为外用药物的有效成分,充分发挥了各原料药的协同配合作用,并且促进药物的吸收效率。这几味原料药中的活性成分相辅相成,具有积极的协同作用,利用各原料药之间的合理搭配和配伍,使所述中药制剂达到预防和/或治疗骨关节病、痛风和软组织损伤等功效,吸收快、疗效好,且愈后不易复发,并且采用纯中药药材作为原料药,药源广泛,产品副作用低。
在本发明中,熟地滋阴补血,益精填髓。一般添加量为1.5-2份,优选的为1.7-1.9份,更优的为1.8-1.9份,最优的为1.85份。
威灵仙,祛风除湿,通络止痛。一般添加量为1-1.5份,优选的为1.1-1.4份,更优的为1.2-1.3份,最优的为1.26份。
申姜,补肾,活血,止血。一般添加量为1-1.5份,优选的为1.1-1.4份,更优的为1.2-1.3份,最优的为1.26份。
白芍,平肝止痛,养血调经,敛阴止汗。一般添加量为0.5-1.5份,优选的为0.7-1.3份,更优的为0.9-1.1份,最优的为1.05份。
仙灵脾,补肾阳,强筋骨,祛风湿。一般添加量为0.5-1.5份,优选的为0.7-1.3份,更优的为0.9-1.1份,最优的为1.05份。
宽筋藤,舒筋活络,祛风止痛。一般添加量为0.5-1.5份,优选的为0.7-1.3份,更优的为0.9-1.1份,最优的为1.05份。
荆芥,祛风,解表,透疹,止血。一般添加量为0.5-1.5份,优选的为0.7-1.3份,更优的为0.9-1.1份,最优的为1.05份。
补骨脂,温肾助阳,止泻纳气。一般添加量为0.5-1.5份,优选的为0.7-1.3份,更优的为0.9-1.1份,最优的为1.05份。
独活,祛风除湿,痛痹止痛。一般添加量为0.5-1份,优选的为0.7-0.95份,更优的为0.8-0.9份,最优的为0.84份。
羌活,解表散寒,祛风胜湿,止痛。一般添加量为0.5-1份,优选的为0.7-0.95份,更优的为0.8-0.9份,最优的为0.84份。
桂枝,发汗解肌,温经通阳。一般添加量为0.5-1份,优选的为0.7-0.95份,更优的为0.8-0.9份,最优的为0.84份。
甘草,清热解毒,去痰止咳。一般添加量为0.5-1份,优选的为0.7-0.95份,更优的为0.8-0.9份,最优的为0.84份。
川椒,温中止痛,杀虫止痒。一般添加量为2-3份,优选的为2.2-2.8份,更优的为2.4-2.6份,最优的为2.5份。
艾叶,温经止血,祛湿驱寒,平喘镇咳祛痰。一般添加量为40-60份,优选的为43-57份,更优的为46-54份,最优的为50份。
本发明的中药制剂中各原料药的用量均是发明人通过大量的创造实验摸索得到的较优值,只有在这种特定的配比下才能使得得到的中药制剂中各原料药的活性成分互相匹配,具备较优的预防和/或治疗骨关节病、痛风和软组织损伤等疾病的功效。
优选的,主要由按重量份数计的如下原料制备得到:
熟地1.7-1.9份、威灵仙1.1-1.4份、申姜1.1-1.4份、白芍0.7-1.3份、仙灵脾0.7-1.3份、宽筋藤0.7-1.3份、荆芥0.7-1.3份、补骨脂0.7-1.3份、独活0.7-0.95份、羌活0.7-0.95份、桂枝0.7-0.95份、甘草0.7-0.95份、川椒2.2-2.8份、艾叶43-57份和新鲜禽蛋220-280份。
优选的,主要由按重量份数计的如下原料制备得到:
熟地1.8-1.9份、威灵仙1.2-1.3份、申姜1.2-1.3份、白芍0.9-1.1份、仙灵脾0.9-1.1份、宽筋藤0.9-1.1份、荆芥0.9-1.1份、补骨脂0.9-1.1份、独活0.8-0.9份、羌活0.8-0.9份、桂枝0.8-0.9份、甘草0.8-0.9份、川椒2.4-2.6份、艾叶46-54份和新鲜禽蛋240-260份。
优选的,主要由按重量份数计的如下原料制备得到:
熟地1.85份、威灵仙1.26份、申姜1.26份、白芍1.05份、仙灵脾1.05份、宽筋藤1.05份、荆芥1.05份、补骨脂1.05份、独活0.84份、羌活0.84份、桂枝0.84份、甘草0.84份、川椒2.5份、艾叶50份和新鲜禽蛋250份。
优选的,所述新鲜禽蛋包括生鸭蛋和生鹅蛋中的一种或几种。
鸭蛋,性凉味甘,滋阴清热、生津益胃,富含蛋白质、磷脂、多种维生素、钙、钾、铁、磷等营养物质。鹅蛋,性温味甘,补中益气、防寒、益智健脑,富含人体所必需的卵磷脂、卵白蛋白、卵黄磷蛋白、各种氨基酸、矿物质和维生素。一般用量为200-300份,优选的为220-280份,更优的为240-260份,最优的为250份。
优选的,所述中药制剂为透皮给药制剂。更优选的,所述透皮给药制剂包括溶液剂、膏剂、糊剂、气雾剂、喷雾剂、搽剂、贴剂和敷剂。进一步优选的,所述中药制剂为敷剂。所述敷剂的基材可选棉布。
本发明的中药制剂以中草药原料制备,通过中药外治法,施于人体外的皮肤、孔窍、腧穴及病变局部等部位,相较于内服法,能避免药物内服法的肝脏首过效应,具有途径直接、用药安全、使用简便、稳定可靠、副作用低等优点。
本发明还提供了一种所述中药制剂的制备方法,包括如下步骤:
按比例称取各原料,混合加水煎煮,得到药液。
优选的,按重量计,所述加水的量为新鲜禽蛋的4-8倍,优选为5-7倍,更优选为6倍。
加入上述量的水对原料进行煎煮,能够保证提取得到原料中的活性成分,并且能够避免加入量过多造成的药液浓度低,药效不足。
优选的,所述煎煮包括:加水煮沸后,继续微沸煎煮10-30min,优选继续微沸煎煮10-15min。
本发明还提供了一种所述中药制剂在制备用于预防和/或治疗骨关节病、痛风和软组织损伤的药物中的应用。
优选的,将药液淋于基材上用作外用药物。
优选的,将煎煮得到的熟禽蛋破壳,淋上药液,用作外用药物。
优选的,将煎煮得到的熟禽蛋破壳,淋上药液,并用淋有药液的基材包覆熟禽蛋,用作外用药物。
优选的,将药液淋于基材上用作外用药物敷于患处,再将淋有药液的熟禽蛋敷于患处。
先采用棉布等基材敷于患处,有助于促进皮肤表皮的孔隙扩张,再采用蛋敷时,能够进一步促进活性成分渗入皮肤中,发挥作用,增强疗效。
优选的,所述外用药物的敷用温度为41-46℃,敷用时间为0.5-1.5h,优选敷用1h。
优选的,所述骨关节病包括颈椎病、腰椎病、滑囊炎、滑膜炎、肩周炎、退行性关节炎、风湿性关节炎、类风湿性关节炎、骨质增生和骨头坏死中的一种或多种。
优选的,所述软组织损伤包括肌肉损伤、韧带损伤、筋膜损伤和肌腱损伤中的一种或多种。
与现有技术相比,本发明的有益效果为:
(1)本发明提供了一种用于预防和/或治疗骨关节病、痛风、软组织损伤的中药制剂,所述中药制剂利用各原料药之间的合理搭配和配伍,吸收快、疗效好,且愈后不易复发,并且采用纯中药药材作为原料药,药源广泛,产品副作用低;
(2)本发明提供的制备中药制剂的方法,能完整保留药物的有效成份,并且工艺简单,能够针对不同需要制备得到不同剂型的产品,操作条件简单,适于大规模生产。
具体实施方式
下面将结合具体实施方式对本发明的技术方案进行清楚、完整地描述,但是本领域技术人员将会理解,下列所描述的实施例是本发明一部分实施例,而不是全部的实施例,仅用于说明本发明,而不应视为限制本发明的范围。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
本发明提供了一种中药制剂,主要由按重量份数计的如下原料制备得到:
熟地1.5-2份、威灵仙1-1.5份、申姜1-1.5份、白芍0.5-1.5份、仙灵脾0.5-1.5份、宽筋藤0.5-1.5份、荆芥0.5-1.5份、补骨脂0.5-1.5份、独活0.5-1份、羌活0.5-1份、桂枝0.5-1份、甘草0.5-1份、川椒2-3份、艾叶40-60份和新鲜禽蛋200-300份。
本发明提供的中药制剂,通过熟地、威灵仙、申姜等至少十四味药材的合理配伍,并配合新鲜禽蛋作为外用药物的有效成分,这几味原料中的活性成分相辅相成,具有积极的协同作用,利用各原料之间的合理搭配和配伍,使所述中药制剂达到预防和/或治疗骨关节病、痛风和软组织损伤等功效,吸收快、疗效好,且愈后不易复发,并且采用纯中药药材作为原料药,药源广泛,产品副作用低。
在本发明一优选实施方式中,主要由按重量份数计的如下原料制备得到:
熟地1.7-1.9份、威灵仙1.1-1.4份、申姜1.1-1.4份、白芍0.7-1.3份、仙灵脾0.7-1.3份、宽筋藤0.7-1.3份、荆芥0.7-1.3份、补骨脂0.7-1.3份、独活0.7-0.95份、羌活0.7-0.95份、桂枝0.7-0.95份、甘草0.7-0.95份、川椒2.2-2.8份、艾叶43-57份和新鲜禽蛋220-280份。
在本发明一优选实施方式中,主要由按重量份数计的如下原料制备得到:
熟地1.8-1.9份、威灵仙1.2-1.3份、申姜1.2-1.3份、白芍0.9-1.1份、仙灵脾0.9-1.1份、宽筋藤0.9-1.1份、荆芥0.9-1.1份、补骨脂0.9-1.1份、独活0.8-0.9份、羌活0.8-0.9份、桂枝0.8-0.9份、甘草0.8-0.9份、川椒2.4-2.6份、艾叶46-54份和新鲜禽蛋240-260份。
在本发明一优选实施方式中,主要由按重量份数计的如下原料制备得到:
熟地1.85份、威灵仙1.26份、申姜1.26份、白芍1.05份、仙灵脾1.05份、宽筋藤1.05份、荆芥1.05份、补骨脂1.05份、独活0.84份、羌活0.84份、桂枝0.84份、甘草0.84份、川椒2.5份、艾叶50份和新鲜禽蛋250份。
在本发明一优选实施方式中,所述新鲜禽蛋包括生鸭蛋和生鹅蛋中的一种或几种。
在本发明一优选实施方式中,所述中药制剂为透皮给药制剂。更优选的,所述透皮给药制剂包括溶液剂、膏剂、糊剂、气雾剂、喷雾剂、搽剂、贴剂和敷剂。进一步优选的,所述中药制剂为敷剂。所述敷剂的基材可选棉布。
本发明还提供了一种所述中药制剂的制备方法,包括如下步骤:
按比例称取各原料,混合加水煎煮,得到药液。
在本发明一优选实施方式中,按重量计,所述加水的量为新鲜禽蛋的4-8倍,优选为5-7倍,更优选为6倍。
在本发明一优选实施方式中,所述煎煮包括:加水煮沸后,继续微沸煎煮10-30min,优选继续微沸煎煮10-15min。
本发明还提供了一种所述中药制剂在制备用于预防和/或治疗骨关节病、痛风和软组织损伤的药物中的应用。
在本发明一优选实施方式中,将药液淋于基材上用作外用药物。
在本发明一优选实施方式中,将煎煮得到的熟禽蛋破壳,淋上药液,用作外用药物。
破壳是指将禽蛋分成几份,无需剥除蛋壳,只需使蛋白和蛋黄外露,在其上淋药液,敷于皮肤,使得药物活性成分及禽蛋中的活性成分和营养成分渗入皮肤;并且保留蛋壳,使得蛋壳中的营养成分可被皮肤吸收,增加疗效。
在本发明一优选实施方式中,将煎煮得到的熟禽蛋破壳,淋上药液,并用淋有药液的基材包覆熟禽蛋,用作外用药物。
在本发明一优选实施方式中,将药液淋于基材上用作外用药物敷于患处,再将淋有药液的熟禽蛋敷于患处。
在本发明一优选实施方式中,所述外用药物的敷用温度为41-46℃,敷用时间为0.5-1.5h,优选敷用1h。
在本发明一优选实施方式中,所述骨关节病包括颈椎病、腰椎病、滑囊炎、滑膜炎、肩周炎、退行性关节炎、风湿性关节炎、类风湿性关节炎、骨质增生和骨头坏死中的一种或多种。所述软组织损伤包括肌肉损伤、韧带损伤、筋膜损伤和肌腱损伤中的一种或多种。
实施例1
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.5份、威灵仙1份、申姜1份、白芍0.5份、仙灵脾0.5份、宽筋藤0.5份、荆芥0.5份、补骨脂0.5份、独活0.5份、羌活0.5份、桂枝0.5份、甘草0.5份、川椒2份、艾叶40份和生鸭蛋200份,混合后,加入800份的水进行煎煮,待水煮沸后,继续微沸煎煮10min,得到药液。
实施例2
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地2份、威灵仙1.5份、申姜1.5份、白芍1.5份、仙灵脾1.5份、宽筋藤1.5份、荆芥1.5份、补骨脂1.5份、独活1份、羌活1份、桂枝1份、甘草1份、川椒3份、艾叶60份、生鸭蛋150份和生鹅蛋150份,混合后,加入2400份的水进行煎煮,待水煮沸后,继续微沸煎煮30min,得到药液。
实施例3
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.7份、威灵仙1.1份、申姜1.1份、白芍0.7份、仙灵脾0.7份、宽筋藤0.7份、荆芥0.7份、补骨脂0.7份、独活0.7份、羌活0.7份、桂枝0.7份、甘草0.7份、川椒2.2份、艾叶43份、生鸭蛋110份和生鹅蛋110份,混合后,加入1100份的水进行煎煮,待水煮沸后,继续微沸煎煮15min,得到药液。
实施例4
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.9份、威灵仙1.4份、申姜1.4份、白芍1.3份、仙灵脾1.3份、宽筋藤1.3份、荆芥1.3份、补骨脂1.3份、独活0.95份、羌活0.95份、桂枝0.95份、甘草0.95份、川椒2.8份、艾叶57份和生鹅蛋280份,混合后,加入1960份的水进行煎煮,待水煮沸后,继续微沸煎煮30min,得到药液。
实施例5
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.8份、威灵仙1.2份、申姜1.2份、白芍0.9份、仙灵脾0.9份、宽筋藤0.9份、荆芥0.9份、补骨脂0.9份、独活0.8份、羌活0.8份、桂枝0.8份、甘草0.8份、川椒2.4份、艾叶46份和生鸭蛋240份,混合后,加入1440份的水进行煎煮,待水煮沸后,继续微沸煎煮12min,得到药液。
实施例6
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.9份、威灵仙1.3份、申姜1.3份、白芍1.1份、仙灵脾1.1份、宽筋藤1.1份、荆芥1.1份、补骨脂1.1份、独活0.9份、羌活0.9份、桂枝0.9份、甘草0.9份、川椒2.6份、艾叶54份、生鸭蛋130份和生鹅蛋130份,混合后,加入1560份的水进行煎煮,待水煮沸后,继续微沸煎煮12min,得到药液。
实施例7
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.85份、威灵仙1.26份、申姜1.26份、白芍1.05份、仙灵脾1.05份、宽筋藤1.05份、荆芥1.05份、补骨脂1.05份、独活0.84份、羌活0.84份、桂枝0.84份、甘草0.84份、川椒2.5份、艾叶50份、生鸭蛋120份和生鹅蛋130份,混合后,加入1500份的水进行煎煮,待水煮沸后,继续微沸煎煮12min,得到药液。
实施例8
本实施例所述的中药制剂的制备方法,包括如下步骤:
按比例称取熟地1.85份、威灵仙1.26份、申姜1.26份、白芍1.05份、仙灵脾1.05份、宽筋藤1.05份、荆芥1.05份、补骨脂1.05份、独活0.84份、羌活0.84份、桂枝0.84份、甘草0.84份、川椒2.5份、艾叶50份和生鸡蛋250份,混合后,加入1500份的水进行煎煮,待水煮沸后,继续微沸煎煮12min,得到药液。
实施例9
将实施例7中得到的药液淋于医用棉布上,用作外用药物。待棉布冷却至41-46℃时,将棉布敷于患处,用绳带固定,覆盖一层塑料薄膜,使棉布与皮肤接触10-15min。
实施例10
将实施例7中煎煮得到的熟禽蛋破壳,保留蛋壳,分为两半,淋上药液,置于淋有药液的棉布上,用作外用药物。待禽蛋冷却至41-46℃时,将包覆禽蛋的棉布敷于患处,用绳带固定,覆盖一层塑料薄膜,使棉布与皮肤接触1h。
实施例11
将实施例9和10中的敷用方法合并,先采用棉布敷于患处10-15min后,再使用禽蛋敷于患处45-50min。
实施例12
将实施例7中制备得到的药液直接通过气雾或喷雾施用于患处。
比较例1
比较例1参考实施例7的制备方法,区别在于,按照下述重量份数称取各原料:熟地3份、威灵仙1.7份、申姜1.6份、白芍1.7份、仙灵脾1.5份、宽筋藤0.5份、荆芥2份、补骨脂2份、独活1.5份、羌活1.5份、桂枝1.5份、甘草0.3份、川椒3.5份、艾叶50份和新鲜禽蛋250份。比较例2
比较例2参考实施例7的制备方法,区别在于,按照下述重量份数称取各原料:熟地1份、威灵仙0.5份、申姜1份、白芍1份、仙灵脾0.5份、宽筋藤2份、荆芥1份、补骨脂1份、独活2份、羌活2份、桂枝0.5份、甘草1份、川椒1.5份、艾叶20份和新鲜禽蛋250份。
实验例1
60名被确诊为患有滑囊炎的患者,年龄段分布为20岁到50岁,症状主要体现在疼痛、局限性压痛和活动受限;其中,20名男性和20名女性,随机分成6组(试验组1、试验组2、试验组3、对照组1、对照组2、对照组3),每组10人。
实验方法与时间:试验组1按照实施例10所述的敷用方法敷用实施例7的中药制剂,试验组2按照实施例10所述的敷用方法敷用实施例8的中药制剂,试验组3按照实施例11的敷用方法敷用实施例7的中药制剂,对照组1按照实施例10所述的敷用方法敷用比较例1的中药制剂,对照组2按照实施例10所述的敷用方法敷用比较例2的中药制剂,对照组3按照实施例11的敷用方法敷用比较例1的中药制剂。
具体方法为:每天将外用药物敷用于患处,持续40天。
实验完成后对实验对象进行问卷调查,其中很好为“疼痛基本消失,活动恢复正常”,好为“疼痛极大缓解,活动正常”,一般为“疼痛减轻”;差为“症状并无改善”。
具体的实验结果如下表1所示:
表1实验结果
组别 | 很好(人) | 好(人) | 一般(人) | 差(人) |
试验组1 | 8 | 2 | 0 | 0 |
试验组2 | 6 | 3 | 1 | 0 |
试验组3 | 9 | 1 | 0 | 0 |
对照组1 | 2 | 4 | 1 | 3 |
对照组2 | 3 | 3 | 2 | 2 |
对照组3 | 3 | 3 | 2 | 2 |
从表1中可知,需要按照本发明所述的配方配伍所述中药制剂才能得到良好的疗效。并且,通过上述实验,本发明所述的中药制剂在12d左右即可达到疼痛基本消失,活动恢复正常的效果,诸症消失,进一步说明了本发明所述的中药制剂疗效快,治疗效果显著。
具体临床例:
临床例1:王某,男,38岁,汽车司机。近5年来,经常颈部酸痛、僵硬,活动受限,在长途驾驶后症状加重。曾采用按摩、拔罐等方法治疗,症状有所缓解,因工作繁忙无法坚持连续治疗,导致病情逐步加剧,严重时伴有头晕、恶心、呕吐症状。经检查:颈部肌肉紧绷且有压痛,可触及条索状和核块状反应物,旋颈诱发试验阳性。诊断为:椎动脉型颈椎病。采用实施例7所述的药液,通过实施例10制备外用药物,用于王某的治疗。用药3天,自觉症状减轻,颈部活动较之前灵活;用药7天,症状明显改善;用药15天,诸症消失。
临床例2:李某,女,16岁,中学生。半年前因跳舞时不慎扭伤腰部而出现腰部疼痛,并逐渐出现右臀部及右下肢后外侧疼痛及麻木。一月前病情加重,症见腰部胀痛,尤以右臀部及右下肢后外侧牵扯疼痛为甚,并见右小腿及右足麻木,腰部活动受限,坐立行走均困难。采用针灸、推拿及内服药物等保守治疗后病情未见明显好转。腰椎MRI检查诊断为:腰3-4椎间盘突出、椎管狭窄;腰5-骶1椎间盘突出。采用实施例7所述的药液,通过实施例10制备外用药物,用于李某的治疗。用药7天,腰痛伴右臀部及右下肢后外侧牵扯疼痛、麻木较前减轻,但仍不能久行久立;用药15天,腰痛伴右臀部及右下肢后外侧牵扯疼痛基本消失,久行后右小腿酸胀较明显,偶有麻木症状;用药30天,诸症基本消失,行走活动基本正常。
临床例3:周某,男,49岁,建筑工人。近2年来,膝关节肿胀疼痛,屈伸不利,稍活动后疼痛减轻;活动过多时疼痛加重,内有积液。经检查:在关节附近可触及一包块,有触痛,浮髌试验阳性。诊断为:髌骨前滑囊炎。采用实施例7所述的药液,通过实施例10制备外用药物,用于周某的治疗。用药7天,疼痛减轻,包块触痛减弱;用药15天,疼痛减弱,屈伸自如,包块缩小;用药21天,包块消失,诸症消除。
临床例4:张某,女,58岁,退休干部。左侧肩臂痛,反复发作两年余;活动受限,局部皮肤发凉,天冷时加重;曾多方诊治未见好转。诊断为:肩周炎。采用实施例7所述的药液,通过实施例10制备外用药物,用于张某的治疗。用药3天,肩臂疼痛减轻;用药7天,疼痛微弱,皮肤温度正常;用药14天,诸症消失。
临床例5:孙某,男,21岁,大学生。近2年来,面黄肌瘦,喜温畏寒,舌苔淡白,脉象微弱,双膝肿痛,形如鹤膝,步履蹒跚,行走困难。整天打针吃药,但收效甚微。诊断为:风湿性关节炎。采用实施例7所述的药液,通过实施例10制备外用药物,用于孙某的治疗。用药3天,双膝肿痛减弱;用药10天,双膝屈伸如常,肿痛极大缓解;用药28天,诸症消失。
临床例6:王某,女,76岁,退休教师。双手指关节肿胀疼痛6年余;服用西药治疗后,病情不断反复,关节疼痛进行性加重,手关节轻度变形,晨起手关节发僵。经检查:双手关节正位X线片显示类风湿性关节炎改变;查类风湿因子阳性。诊断为:类风湿性关节炎。采用实施例7所述的药液,通过实施例10制备外用药物,用于王某的治疗。用药7天,关节肿胀疼痛减轻;用药14天,疼痛减弱,晨起手关节发僵症状改善;用药36天,诸症消除。
临床例7:吴某,男,61岁,物业管理员。近1年来感足根针刺样疼痛,且进行性加重,不能行走。经检查:X线片显示足根骨质增生。诊断:足跟骨质增生。采用实施例7所述的药液,通过实施例10制备外用药物,用于吴某的治疗。用药4天,针刺样疼痛减弱;用药11天,疼痛极大缓解;用药22天,诸症消失。
临床例8:李某,男,52岁,出租车司机。2年前因雪地跌伤致左股骨颈骨折,行手术治疗后1年,出现左髋部及左腹股沟疼痛,左大腿至膝部胀痛,腰膝酸软无力,跛行,久立疼痛加重。MRI检查:左股骨头缺血性坏死(坏死早期)。诊断为:股骨头坏死。采用实施例7所述的药液,通过实施例10制备外用药物,用于李某的治疗。用药7天,左髋部及左腹股沟疼痛减轻;用药14天,左大腿至膝部胀痛极大缓解;用药35天,疼痛消失,腰膝活动正常,行立如常,诸症消失。
临床例9:赵某,女,37岁,干部。近3月来,右足踝及足跖趾关节处明显肿胀,微红不热,舌质暗红,苔白稍厚,脉弦滑。经检查:血脂偏高,血尿酸554umol/L。诊断为:痛风。采用实施例7所述的药液,通过实施例10制备外用药物,用于赵某的治疗。用药7天,足踝及足跖趾关节肿胀减轻;用药14天,肿胀微弱;用药21天,诸症消失。
临床例10:郑某,女,75岁,退休干部。一月前走路左足踝关节扭伤,次日踝关节疼痛,跛行,休息时痛减,足背略有浮肿;理疗、按摩、服药治疗未能控制走路疼痛。经检查:X线片显示诸关节骨质未见异常。诊断为:踝关节韧带扭伤。采用实施例7所述的药液,通过实施例10制备外用药物,用于王某的治疗。用药3天,踝关节疼痛减弱;用药7天,疼痛极大缓解,足背浮肿消失;用药12天,诸症消失。
以上临床例证实,本发明提供的中药制剂对于骨关节病、痛风和软组织损伤等具有优异的效果。一般情况下,在使用本发明的中药制剂后,7天内即会有一定效果,10-40天内症状基本消失,与现有的其他药品相比,具有功效全面、疗效快、使用简便,且安全副作用低等优点。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (10)
1.一种中药制剂,其特征在于,主要由按重量份数计的如下原料制备得到:
熟地1.5-2份、威灵仙1-1.5份、申姜1-1.5份、白芍0.5-1.5份、仙灵脾0.5-1.5份、宽筋藤0.5-1.5份、荆芥0.5-1.5份、补骨脂0.5-1.5份、独活0.5-1份、羌活0.5-1份、桂枝0.5-1份、甘草0.5-1份、川椒2-3份、艾叶40-60份和新鲜禽蛋200-300份。
2.根据权利要求1所述的中药制剂,其特征在于,主要由按重量份数计的如下原料制备得到:
熟地1.7-1.9份、威灵仙1.1-1.4份、申姜1.1-1.4份、白芍0.7-1.3份、仙灵脾0.7-1.3份、宽筋藤0.7-1.3份、荆芥0.7-1.3份、补骨脂0.7-1.3份、独活0.7-0.95份、羌活0.7-0.95份、桂枝0.7-0.95份、甘草0.7-0.95份、川椒2.2-2.8份、艾叶43-57份和新鲜禽蛋220-280份。
3.根据权利要求2所述的中药制剂,其特征在于,主要由按重量份数计的如下原料制备得到:
熟地1.8-1.9份、威灵仙1.2-1.3份、申姜1.2-1.3份、白芍0.9-1.1份、仙灵脾0.9-1.1份、宽筋藤0.9-1.1份、荆芥0.9-1.1份、补骨脂0.9-1.1份、独活0.8-0.9份、羌活0.8-0.9份、桂枝0.8-0.9份、甘草0.8-0.9份、川椒2.4-2.6份、艾叶46-54份和新鲜禽蛋240-260份。
4.根据权利要求3所述的中药制剂,其特征在于,主要由按重量份数计的如下原料制备得到:
熟地1.85份、威灵仙1.26份、申姜1.26份、白芍1.05份、仙灵脾1.05份、宽筋藤1.05份、荆芥1.05份、补骨脂1.05份、独活0.84份、羌活0.84份、桂枝0.84份、甘草0.84份、川椒2.5份、艾叶50份和新鲜禽蛋250份。
5.根据权利要求1-4任一项所述的中药制剂,其特征在于,所述新鲜禽蛋包括生鸭蛋和生鹅蛋中的一种或几种。
6.根据权利要求1所述的中药制剂,其特征在于,所述中药制剂为透皮给药制剂;
优选的,所述透皮给药制剂包括溶液剂、膏剂、糊剂、气雾剂、喷雾剂、搽剂、贴剂和敷剂;
更优选的,所述中药制剂为敷剂。
7.权利要求1-6任一项所述的中药制剂的制备方法,其特征在于,包括如下步骤:
按比例称取各原料,混合加水煎煮,得到药液。
8.根据权利要求7所述的中药制剂的制备方法,其特征在于,按重量计,所述加水的量为新鲜禽蛋的4-8倍;
优选的,所述加水的量为新鲜禽蛋的5-7倍;
更优选的,所述加水的量为新鲜禽蛋的6倍。
9.权利要求1-6任一项所述的中药制剂在制备用于预防和/或治疗骨关节病、痛风和软组织损伤的药物中的应用,其特征在于,将药液淋于基材上用作外用药物;
优选的,将煎煮得到的熟禽蛋破壳,淋上药液,用作外用药物;
更优选的,将煎煮得到的熟禽蛋破壳,淋上药液,并用淋有药液的基材包覆熟禽蛋,用作外用药物。
10.根据权利要求9所述的中药制剂在制备用于预防和/或治疗骨关节病、痛风和软组织损伤的药物中的应用,其特征在于:所述外用药物的敷用温度为41-46℃;
优选的,敷用时间为0.5-1.5h。
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