CN1360899A - 牛黄皮炎药及其制备方法 - Google Patents
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Abstract
牛黄皮炎药及其制备方法,以重量计,其中牛黄0.1～1.5份、青蒿40～60份、松叶45～60份、乌梅45～60份、薄荷45～70份、冰片4～5.5份、冰醋酸90～120份。取青蒿、松叶、乌梅、薄荷粉碎成粗粉,以80～85%的乙醇为溶媒进行渗漉,收集渗漉液约700～900ml,加入冰酸酸;取冰片、牛黄分别研成细粉,加入到上述溶液中,充分搅拌、溶解、过滤,添加75%的乙醇至1000ml。本发明有较高治愈率、见效快、复发率低、无毒副作用。
Description
本发明涉及一种治疗皮肤病，特别是治疗神经性皮炎的外用药制剂及其制备方法。
目前治疗神经性皮炎的中西药物不多，且疗效不如人意，西医采用的治疗药物，虽有一些近期疗效，但复发率甚高，远期疗效差；如国外西医治疗此病内服采用抗组织胺类药物，如赛庚定、扑尔敏、息斯敏这类，外用皮质类固醇激素类药物，如尿素软膏、肤轻松软膏、地塞米松软膏等，开始使用疗效明显，但很快复发，甚至出现反跳恶化现象。久用出现皮肤萎缩皱纹甚至全身浮肿、高血压、糖尿病、痤疮等副作用。国内中医则采用内服清热解毒、祛风止痒、凉血润燥等中药，但口服药多难直达病所，见效迟缓。而外用药物多为信石、斑蝥、轻粉、雄黄、蟾酥、马钱子、闹羊花、茅膏菜、五毒酒之类组成，毒副作用较大，疗效多不理想。
本发明的目的旨在提供一种有较高治愈率、见效快、复发率低、无毒副作用的比较理想的治愈神经性皮炎的外用药剂牛黄皮炎药。
本发明的另一目的是提供该外用药剂牛黄皮炎药的制备方法。
本发明的目的是通过下述方式实现的，本发明的药物由下列组分制成：牛黄、青蒿、松叶、乌梅、薄荷、冰片、冰醋酸。以重量计，其中牛黄0.1～1.5份、青蒿40～60份、松叶45～60份、乌梅45～60份、薄荷45～70份、冰片4～5.5份、冰醋酸90～120份。
制备本发明的药物的优选重量(份)配比范围是：牛黄0.5～1.2份、青蒿50～55份、松叶50～55份、乌梅50～55份、薄荷50～60份、冰片4.2～5.2份、冰醋酸100～110份。
本发明的配制方法为：按上述配比(重量以克计)，取青蒿、松叶、乌梅、薄荷粉碎成粗粉，以80～85％的乙醇为溶媒，按3ml/min速度进行渗漉，收集渗漉液约700～900ml，加入冰酸酸摇匀；另取冰片、牛黄分别研成细粉，加入到上述溶液中，充分搅拌、溶解、过滤，添加75％的乙醇至1000ml。
附图为本发明的工艺流程图。
本发明的牛黄具有清热败毒、凉血祛风、善治一切疮疡肿毒的特点，为本发明的主药。乌梅主要成份为柠檬酸(19％)和苹果酸(15％)还含有琥珀酸、碳水化合物、谷甾醇、蜡样物质及齐墩果酸样物质。药理研究证实乌梅具有抗真菌及抗过敏作用。松叶有祛风止痒，善治顽癣疥癞的作用。青蒿、薄荷则有善入肝胆、清肝热、散郁火的作用，而冰片清凉走窜，润肤止痒为百药之先，乌梅与白醋均有酸收敛疮止痒功效，冰醋酸还有作为溶煤，调合诸药。因本发明的药剂具有清热毒、化肝火、润肌肤，止瘙痒、敛顽癣的功效。本发明通过临床应用具有治愈率高，见效快、复发率低的特点。
为表明本发明药剂对神经性皮炎的治疗效果，本发明经60例临床观察，并选两组使用皮炎宁酊及醋酸肤轻松软膏各30例，作为B、C两组对比观察。A组60例为使用本发明的药剂。以上120例患者治疗前后均作肝功能及血、尿常规检测，各项正常者纳入治疗对象。治疗结束后观察药物是否产生影响。3组性别、年龄、病程及辩证分型情况(见表1)
表1：3组的性别、年龄、病程及辩证分型比较(X+S年)
注：经方差分析，3组性别、年龄、病程及辩证分型无明显差异。
| 组别(n) | 性别(n) | 年龄 | 病程 | 辩证分型 | |
| 肝郁化血虚风 | |||||
| 火(n) | 燥(n) | ||||
| A 60 | 男 32 | 36.4+16.4 | 5.6+6.8 | 12 | 20 |
| 女 28 | 13 | 15 | |||
| B 30 | 男 15 | 38.1-17.2 | 6.7+10.1 | 8 | 7 |
| 女 15 | 10 | 5 | |||
| C 30 | 男 18 | 41.3+17.9 | 6.7+7.8 | 8 | 10 |
| 女 12 | 7 | 5 | |||
疗效观察
疗效标准参照《中医诊疗标准》制定。治愈：皮损及症状全部消退或残留色素沉着或色素消失；好转：皮损较前变薄，落屑减少。自觉瘙痒减轻或皮损消退30％以上；无效：皮损依然如故或消退不足30％。自觉症状无明显改善。
治前皮损计分法(1)皮损面积计分法：面积100cm2以上计1分，31～99cm2以上计2分；30cm2以下计3分；无皮损计4分。(2)皮痂厚薄计分方法：肥厚计1分，较厚计2分，较薄计3分，无痂皮计4分。(3)瘙痒程度计分方法：重度计1分，中度计2分，轻度计3分，无瘙痒计4分。
治后皮损计分法(1)皮损面积计分法：皮损面积无缩小或扩大计1分，皮损面积缩小31％以上计3分。无皮损计4分。(2)皮痂厚薄计分方法：皮痂厚薄无变化或增厚计1分，皮痂较前减薄30％以下计2分，皮痂较前减薄31％以上计3分，无痂皮计4分。(3)瘙痒程度计分方法：瘙痒未减轻或加重计1分，瘙痒减轻50％以下计2分，瘙痒减轻50％以上计3分，无瘙痒计4分。
在治疗第7、14、20天3个时间进行观察。复发情况则分别为3个月、6个月和1年3个月时间点进行追踪观察。
治疗结果(见表2、3、4)
表2：3组皮疹治疗前后总积分差值比较(d+Sd分)
| 组别 | n | 治疗7天 | 治疗14天 | 治疗20天 |
| A | 60 | 2.33+0.75 | 4.30+1.12 | 6.25+1.70 |
| B | 30 | 1.00+0.95 | 1.67+1.58 | 2.60+2.27 |
| C | 30 | 1.30+0.65 | 2.63+1.00 | 4.10+2.00 |
注：治疗7天F值为35.23，治疗14天F值为50.86，治疗30天F值为38.38；3个月时间段组间比较均P＜0.01。
表3：3组治疗结果比较(例)
| 组别 | 治愈 | 好转 | 未愈 | 合计 | 有效率(％) |
| A | 40 | 18 | 2 | 60 | 96.7 |
| B | 10 | 10 | 10 | 30 | 66.7 |
| C | 15 | 10 | 5 | 30 | 83.3 |
注：经Ridit分析，X2＝11.03，P＜0.005，表明3组有效率间差异非常显著，以A组疗效最佳。
表4：3组复发情况(例)
| 组别 | 3月内复发 | 6月内复发 | 1年内复发 | 未复发 | 合计 | 复发率(％) |
| A | 1 | 1 | 2 | 54 | 58 | 66.9 |
| B | 2 | 2 | 2 | 14 | 20 | 30.0 |
| C | 10 | 1 | 1 | 13 | 25 | 48.0 |
注：经Ridit分析，X2＝10，P＜＝0.005，表明3组复发率间差异非常显著，其中以A复发率为最低，C组在3个月内复发率最高。
治疗中三组均未出现明显不良反应。治疗后，肝功能及血、尿常规检查均无异常。
实施例1：
按下述配比称取原料(克)牛黄1.0、青蒿40、松叶55、乌梅45、薄荷50、冰片4、冰醋酸95，一定量75％乙醇。取青蒿、松叶、乌梅、薄荷粉碎成粗粉，以81％的乙醇为溶媒，按3ml/min速度进行渗漉，收集渗漉液约800ml，加入冰酸酸摇匀；另取冰片、牛黄分别研成细粉，加入到上述溶液中，充分搅拌、溶解、过滤，添加75％的乙醇至1000ml。
实施例2：
按下述配比称取原料(克)牛黄1.5、青蒿55、松叶50、乌梅50、薄荷60、冰片5.5、冰醋酸100，一定量75％乙醇。取青蒿、松叶、乌梅、薄荷粉碎成粗粉，以83％的乙醇为溶媒，按3ml/min速度进行渗漉，收集渗漉液约800ml，加入冰酸酸摇匀；另取冰片、牛黄分别研成细粉，加入到上述溶液中，充分搅拌、溶解、过滤，添加75％的乙醇至1000ml。
Claims (4)
1、牛黄皮炎药，其原料的药物由下列组分制成：牛黄、青蒿、松叶、乌梅、薄荷、冰片、冰醋酸，以重量计，其中牛黄0.1～1.5份、青蒿40～60份、松叶45～60份、乌梅45～60份、薄荷45～70份、冰片4～5.5份、冰醋酸90～120份。
2、根据权利要求1所述牛黄皮炎药，制备本发明药物的优选重量(份)配比范围是：牛黄0.5～1.2份、青蒿50～55份、松叶50～55份、乌梅50～55份、薄荷50～60份、冰片4.2～5.2份、冰醋酸100～110份。
3、牛黄皮炎药的制备方法，其特征在于(重量以克计)，取青蒿、松叶、乌梅、薄荷粉碎成粗粉，以80～85％的乙醇为溶媒，按3ml/min速度进行渗漉，收集渗漉液约700～900ml，加入冰酸酸摇匀；另取冰片、牛黄分别研成细粉，加入到上述溶液中，充分搅拌、溶解、过滤，添加75％的乙醇至1000ml。
4、根据权利要求1所述牛黄皮炎药的制备方法，其特征在于可取83％的乙醇为溶媒进行渗漉。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7357950B2 (en) | 2003-03-21 | 2008-04-15 | Elizabeth Anne Mazzio | Topical treatment for dyshidrosis (pompholyx) and dry skin disorders |
| US7666451B2 (en) | 2003-03-21 | 2010-02-23 | Elizabeth Anne Mazzio | Method of treating dyshidrosis(pompholyx) and related dry skin disorders |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7357950B2 (en) | 2003-03-21 | 2008-04-15 | Elizabeth Anne Mazzio | Topical treatment for dyshidrosis (pompholyx) and dry skin disorders |
| US7666451B2 (en) | 2003-03-21 | 2010-02-23 | Elizabeth Anne Mazzio | Method of treating dyshidrosis(pompholyx) and related dry skin disorders |
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