WO2019128510A1 - 片仔癀及其制剂在治疗带状疱疹中的用途 - Google Patents

片仔癀及其制剂在治疗带状疱疹中的用途 Download PDF

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WO2019128510A1
WO2019128510A1 PCT/CN2018/115528 CN2018115528W WO2019128510A1 WO 2019128510 A1 WO2019128510 A1 WO 2019128510A1 CN 2018115528 W CN2018115528 W CN 2018115528W WO 2019128510 A1 WO2019128510 A1 WO 2019128510A1
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treatment
herpes zoster
preparation
tze huang
pien tze
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刘建顺
洪绯
于娟
袁慧君
庄毅超
李旭鑫
林丽敏
杨小平
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漳州片仔癀药业股份有限公司
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    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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  • the invention belongs to the field of traditional Chinese medicine, and particularly relates to a new use of Pien Tze Huang and its preparation in the treatment of herpes zoster.
  • Herpes zoster is an acute infectious skin disease caused by varicella-zoster virus, characterized by clustered herpes and neuralgia distributed along the unilateral peripheral nerve. In patients with acute herpes zoster, the neuropathic pain is severe and unbearable, which seriously affects the daily work and life of the patient.
  • Pien Tze Huang is a national first-class Chinese medicine protection variety. It is made from precious Chinese herbal medicines such as natural musk, natural bezoar, snake gall, and Sanqi. It has the effects of clearing away heat and detoxifying, cooling blood and removing blood stasis, reducing swelling and relieving pain. It is commonly used in the treatment of acute and chronic viral hepatitis. , malignant tumors, acne, unknown swollen poison, bruises and various inflammations.
  • the present invention proposes a new use of Pien Tze Huang and its preparation in the preparation of a medicament for the treatment of herpes zoster.
  • the present invention provides the use of Pien Tze Huang and its preparation for the preparation of a medicament for the treatment of herpes zoster.
  • the use described above is for the use in the manufacture of a medicament for the treatment of hydrolyzed herpes zoster.
  • the use described above is for the use in the manufacture of a medicament for the treatment of acute phase herpes zoster.
  • the treatment of herpes zoster refers to shortening the blistering time.
  • the treatment of herpes zoster refers to shortening the scarring time.
  • the treatment of herpes zoster refers to reducing the incidence of post-herpetic neuralgia.
  • the prunus meal is added to a conventional excipient, and a clinically acceptable preparation is prepared according to a conventional process.
  • the pharmaceutically acceptable excipients are: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices, and the like.
  • Filling agents include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.
  • disintegrating agents include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.
  • lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.
  • suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.
  • binders include: starch syrup, polyvinylpyrroli
  • the preparation is selected from the group consisting of a tablet, a tablet, a capsule, a granule, a powder, a pill, an elixir, a wine, a ointment or a mixture.
  • the preparation for each administration of the Pien Tze Huang preparation contains 0.3-0.9 g of Pien Tze Huang.
  • the present invention also provides a pharmaceutical composition for treating herpes zoster comprising the following active ingredients: (i) Pien Tze Huang, (ii) an antiviral drug.
  • the pharmaceutical composition for treating herpes zoster wherein the antiviral drug is at least one selected from the group consisting of valacyclovir, acyclovir and mecobalamin.
  • Pien Tze Huang combined with the antiviral drugs valacyclovir, acyclovir and mecobalamin are effective in the treatment of acute zoster-type herpes zoster in the liver, which not only promotes the improvement of clinical symptoms, but also rapidly promotes herpes. Scarring, preventing the production of new herpes, relieving pain, and shortening the treatment time, in addition to reducing the incidence of post-treatment neuralgia and the incidence of adverse reactions after treatment, clinical application has obvious advantages.
  • Pien Tze Huang was produced by Zhangzhou Pien Trick Pharmaceutical Co., Ltd.
  • Pien Tze Huang is prepared into a clinically acceptable lozenge according to a conventional process by adding conventional excipients.
  • Pien Tze Huang is prepared into a clinically acceptable tablet according to a conventional process by adding conventional excipients.
  • Pien Tze Huang is prepared into a clinically acceptable capsule according to a conventional process by adding conventional excipients.
  • Pien Tze Huang is prepared into a clinically acceptable granule according to a conventional process by adding conventional excipients.
  • the lesion area does not exceed 2% of the body surface area
  • the lesions are all trunks (including limbs);
  • the onset time of herpes zoster lesions is within 72 hours;
  • herpes zoster Excluding special areas of herpes zoster, such as head and face, anterior and posterior vaginal and perianal herpes;
  • liver and kidney function is low (such as ALT, AST exceeds the upper limit of 1.5 times the normal value, Cr exceeds the upper limit of normal value), or other patients with low immune function diseases;
  • the subject is participating, or has participated in other drug clinical trials within 3 months prior to enrollment;
  • valacyclovir tablets (GlaxoSmithKline (China) Investment Co., Ltd., 0.3g each time, 2 times / day, oral) + acyclovir cream (GlaxoSmithKline (China) Investment Co., Ltd. Wipe the skin affected area, disinfect it, apply it to the affected area, 4 times / day) + mecobalamin tablets (Hangzhou Kangenbei Pharmaceutical Co., Ltd., 0.5mg each time, 3 times / day).
  • Treatment group Oral preparation of the tablets (0.3g / granules) prepared in Example 3 (produced by Zhangzhou Pien Tiao Pharmaceutical Co., Ltd., 2 capsules per time, 3 times / day) + basic treatment;
  • Control group oral Pien Tze Huang Capsule Simulator (0.3 g / granule) (ie: placebo) (2 capsules each time, 3 times / day) + basic treatment;
  • ibuprofen sustained release capsules (0.3g / capsule), take as needed, 1 capsule each time.
  • the above two groups of treatments are 7 days. After the end of the treatment, the results are observed and the curative effect is evaluated.
  • the medication use time can be extended according to the patient's recovery.
  • Safety indicators including important signs, blood routine, urine routine + urine sediment microscopy, stool routine + OB, liver function, renal function, adverse events, etc.;
  • the total effective rate of clinical treatment (healing + markedly effective + effective) / total number of cases ⁇ 100%.
  • Pien Tze Huang combined with the antiviral drugs valacyclovir, acyclovir and mecobalamin are effective in the treatment of acute zoster-type herpes zoster in the liver, which not only promotes the improvement of clinical symptoms, but also rapidly promotes herpes. Scarring, preventing the production of new herpes, relieving pain, and shortening the treatment time, in addition to reducing the incidence of post-treatment neuralgia and the incidence of adverse reactions after treatment, clinical application has obvious advantages.

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Abstract

公开了片仔癀及其制剂在治疗带状疱疹中的用途，以及一种治疗带状疱疹的药物组合物，其特征在于，包括以下活性成分：（i）片仔癀，（ii）抗病毒药物。

Description

片仔癀及其制剂在治疗带状疱疹中的用途 技术领域
本发明属于中药领域，具体涉及片仔癀及其制剂在治疗带状疱疹中的新用途。
背景技术
带状疱疹是由水痘-带状疱疹病毒引起的急性感染性皮肤病，以沿单侧周围神经分布的簇集性疱疹和神经痛为特征。带状疱疹急性期患者神经痛剧烈难忍，严重影响患者的日常工作和生活。
目前，西医对带状疱疹的治疗以抗病毒、缓解神经痛为原则，由于西药仅仅能够在一定程度上缓解患者的症状，而且由于西药存在不良反应较明显、易出现耐药性等缺陷，从而导致其临床应用存在一定的局限性。中医认为：带状疱疹发病与肝经郁热、气滞血瘀、湿热内蕴有关，导致经络阻遏、正气不足、毒邪浸淫肌肤，治疗应以清热利湿、解毒理气为主。目前，尽管已有采用双黄连、龙胆泻肝汤配合西药治疗带状疱疹的相关报道，但目前仍缺乏疗效确切、起效迅速的药物。
片仔癀是国家一级中药保护品种，采用天然麝香、天然牛黄、蛇胆、三七等名贵中药精制而成，具有清热解毒、凉血化瘀、消肿止痛的功效，临床常用于治疗急慢性病毒性肝炎、恶性肿瘤、痈疽疔疮无名肿毒、跌打损伤及各种炎症等。
目前，尚未见片仔癀及其制剂用于制备治疗带状疱疹的相关报道。
发明内容
为此，本发明提出片仔癀及其制剂在制备治疗带状疱疹的药物中的新用途。
为解决上述技术问题，本发明是通过以下技术方案来实现的：
第一方面，本发明提供片仔癀及其制剂在制备治疗带状疱疹的药物中的用途。
优选地，上述用途，所述用途为在制备治疗肝经郁热型带状疱疹的药物中的用途。
优选地，上述用途，所述用途为在制备治疗急性期带状疱疹的药物中的用途。
进一步优选地，上述用途，所述治疗带状疱疹是指：缩短止疱时间。
进一步优选地，上述用途，所述治疗带状疱疹是指：缩短结痂时间。
进一步优选地，上述用途，所述治疗带状疱疹是指：降低后遗神经痛发生率。
进一步优选地，上述用途，片仔癀加入常规辅料，按照常规工艺，制成临床上可接受的制剂。
所述药学上可接受的辅料为：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素纳等；润滑剂包括： 硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000、PEG4000、虫蜡等。
进一步优选地，上述用途，所述制剂选自锭剂、片剂、胶囊剂、颗粒剂、散剂、丸剂、酊剂、酒剂、煎膏剂或合剂。
进一步优选地，上述用途，片仔癀制剂的每次给药制剂中含片仔癀0.3-0.9g。
第二方面，本发明还提供一种治疗带状疱疹的药物组合物，包括以下活性成分：(i)片仔癀，(ii)抗病毒药物。
优选地，上述治疗带状疱疹的药物组合物，所述抗病毒药物选自伐昔洛韦、阿昔洛韦和甲钴胺中的至少一种。
本发明的上述技术方案相比现有技术具有以下优点：
临床研究发现，片仔癀联合抗病毒药物伐昔洛韦、阿昔洛韦和甲钴胺对肝经郁热型急性期带状疱疹的疗效确切，不仅能够促进患者临床症状的改善，可快速促进疱疹的结痂、阻止新疱疹的产生、缓解疼痛，而且能够缩短治疗时间，此外还能降低治疗后出现的后遗神经痛发病率和不良反应发生率，临床应用具有明显的优势。
具体实施方式
本发明以下实施例和实验例中，片仔癀由漳州片仔癀药业股份有限公司生产。
实施例1
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的锭剂。
实施例2
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的片剂。
实施例3
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的胶囊剂。
实施例4
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的颗粒剂。
实验例1片仔癀对肝经郁热型带状疱疹的治疗效果的研究
1、实验目的
研究片仔癀对肝经郁热型带状疱疹的治疗效果。
2、实验方法
2.1一般资料
2016年1月至12月收治的带状疱疹急性期患者144例，其中男性69例，女性75例，年龄34-69岁，平均50.2岁。所有患者均符合带状疱疹西医诊断标准和肝经郁热证中医诊断标准。所有患者随机分为两组，分别为治疗组和对照组，其中，治疗组72例，男性33例，女性39例；对照组72例，男35例，女性37例。两组患者在年龄、性别、病程、VAS疼痛评分等基线资料均无显著差异(P＞0.05)。
2.2纳入标准
(1)年龄18-75岁；
(2)符合西医诊断标准；
(3)符合肝经郁热证中医辨证患者；
(4)带状疱疹疼痛强度≥5分；
(5)按烧伤面积“手掌法”计算，皮损面积不超过2％体表面积；
(6)皮损部位均为躯干部(包括四肢)；
(7)带状疱疹皮损发病时间在72小时以内；
(8)入组前1周内未服用或外用过相关治疗药物；
(9)认知功能完整，签署知情同意书。
2.3排除标准
(1)排除特殊部位带状疱疹，如头面部、前后二阴及肛周疱疹患者等；
(2)皮损出现脓疱、糜烂、溃疡、坏死等，合并严重感染者；
(3)入组前一周内使用过对带状疱疹有治疗作用的药物，或使用糖皮质激素和免疫抑制剂者；
(4)过敏体质者，或对本药已知成分过敏者；
(5)患有癌症、艾滋病等其他严重疾病，肝、肾功能低下(如ALT、AST超过正常值上限1.5倍，Cr超过正常值上限)，或其他免疫功能低下疾病患者；
(6)妊娠、准备妊娠或哺乳期妇女；
(7)受试者正在参加，或在入组前3个月内参加过其他药物临床试验的；
(8)研究者认为不适宜参加本临床试验者。
2.4治疗方法
基础治疗：伐昔洛韦片(葛兰素史克(中国)投资有限公司，每次0.3g，2次/天，口服)+阿昔洛韦乳膏(葛兰素史克(中国)投资有限公司，皮肤患处擦净、消毒后，涂抹在患处，4次/天)+甲钴胺片(杭州康恩贝制药有限公司，每次0.5mg，3次/天)。
治疗组：口服实施例3制备的片仔癀胶囊剂(0.3g/粒)(漳州片仔癀药业股份有限公司生产，每次2粒，3次/天)+基础治疗；
对照组：口服片仔癀胶囊模拟剂(0.3g/粒)(即：安慰剂)(每次2粒，3次/天)+基础治疗；
其他治疗：布洛芬缓释胶囊(0.3g/粒)，按需服用，每次1粒。
以上两组疗程为7天，疗程结束后观察结果、评定疗效，可根据患者的恢复情况酌情延长药物使用时间。
2.5观察指标
(1)治疗期间观察患者止疱、结痂、止痛、痊愈时间；止疱：无新水疱出现，原有水疱开始干涸；结痂：水疱干涸结痂；止痛：疼痛消失；
(2)临床治疗总有效率；
(3)安全性指标：包括重要体征，血常规、尿常规+尿沉渣镜检、大便常规+OB，肝功能、肾功能、不良事件等；
(4)随访1个月观察患者有无遗留神经痛。
2.6疗效判断标准
痊愈：症状及体征完全消失，皮疹基本消失、疼痛消退；
显效：症状及体征明显改善，皮损消失＞70.0％，疼痛明显缓解；
有效：症状及体征有所改善，皮损消失＞50.0％，疼痛有所减轻；
无效：症状及体征无明显改善，皮损消失＜50.0％，疼痛明显。
临床治疗总有效率＝(痊愈+显效+有效)/总例数×100％。
2.7统计分析
实验结束时，同时对各项观察指标进行评价和分析，将P＜0.05作为所检验的差别有统计学意义的标准。
3、实验结果
3.1两组患者症状改善时间、后遗神经痛发生率比较
两组患者症状改善时间、后遗神经痛发生率的实验结果如表1所示。
表1 两组患者症状改善时间、后遗神经痛发生率比较
组别 n 止疱时间 结痂时间 止痛时间 后遗神经痛发生率(％)
对照组 72 5.6±1.1 8.8±1.0 6.5±1.3 27.8
治疗组 72 2.9±0.7 ** 5.7±1.3 * 6.0±0.9 2.8 **
注：与对照组相比， *P＜0.05， **P＜0.01
由表1可知，与对照组比较，治疗组的止疱时间、结痂时间显著缩短，后遗神经痛发生率显著下降，差异均有统计学意义(P＜0.05，P＜0.01)；两组的止痛时间相当，这表明片仔癀也具有良好的止痛效果。
3.2两组患者疗效比较
两组患者疗效的实验结果如表2所示。
表2 两组患者治疗效果比较
组别 n 痊愈 显效 有效 无效 总有效率(％)
治疗组 72 13 28 24 7 90.3
对照组 72 2 17 38 15 79.2
由表2可知，治疗7天后，治疗组的总有效率为90.3％，对照组的总有效率为79.2％，且治疗组的痊愈例数和显效例数均明显高于对照组的痊愈例数和显效例数。
3.3不良反应
一般不良反应有头痛、恶心、皮肤灼热、胃部不适、食欲减退、白细胞下降、失眠、蛋白尿等。对照组中发现9例患者出现不良反应，治疗组中发现2例患者出现不良反应，表明治疗组的不良反应发生率明显低于对照组的不良反应发生率。
4、实验结论
临床研究发现，片仔癀联合抗病毒药物伐昔洛韦、阿昔洛韦和甲钴胺对肝经郁热型急性期带状疱疹的疗效确切，不仅能够促进患者临床症状的改善，可快速促进疱疹的结痂、阻止新疱疹的产生、缓解疼痛，而且能够缩短治疗时间，此外还能降低治疗后出现的后遗神经痛发病率和不良反应发生率，临床应用具有明显的优势。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。

Claims (11)

  1. 片仔癀及其制剂在治疗带状疱疹中的用途。
  2. 根据权利要求1所述的用途，其特征在于，所述用途为在治疗肝经郁热型带状疱疹中的用途。
  3. 根据权利要求1所述的用途，其特征在于，所述用途为在治疗急性期带状疱疹中的用途。
  4. 根据权利要求1-3任一项所述的用途，其特征在于，所述治疗带状疱疹是指：缩短止疱时间。
  5. 根据权利要求1-3任一项所述的用途，其特征在于，所述治疗带状疱疹是指：缩短结痂时间。
  6. 根据权利要求1-3任一项所述的用途，其特征在于，所述治疗带状疱疹是指：降低后遗神经痛发生率。
  7. 根据权利要求1-6任一项所述的用途，其特征在于，片仔癀加入常规辅料，按照常规工艺，制成临床上可接受的制剂。
  8. 根据权利要求7所述的用途，其特征在于，所述制剂选自锭剂、片剂、胶囊剂、颗粒剂、散剂、丸剂、酊剂、酒剂、煎膏剂或合剂。
  9. 根据权利要求1-8任一项所述的用途，其特征在于，片仔癀制剂的每次给药制剂中含片仔癀0.3-0.9g。
  10. 一种治疗带状疱疹的药物组合物，其特征在于，包括以下活性成分：(i)片仔癀，(ii)抗病毒药物。
  11. 根据权利要求10的一种治疗带状疱疹的药物组合物，其特征在于所述抗病毒药物选自伐昔洛韦、阿昔洛韦和甲钴胺中的至少一种。
PCT/CN2018/115528 2017-12-28 2018-11-15 片仔癀及其制剂在治疗带状疱疹中的用途 WO2019128510A1 (zh)

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