CN107320652A - 一种治疗脚气的药物喷剂 - Google Patents
一种治疗脚气的药物喷剂 Download PDFInfo
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Abstract
本发明主要涉及创新药物研发技术领域，公开了一种治疗脚气的药物喷剂，由以下原料制成：狗牙根、马蹄金、鸡骨草、田基黄、茵陈蒿、冰草、尖头叶藜、华北大黄、草麻黄、榆钱、茶条槭、蛭石、海泡石、利多卡因、氯丙嗪；原料丰富，避免产生抗药性，快速杀灭病菌，坚持用药，避免复发，减轻患者痛苦，不含酒精，对肌肤无伤害；多种植物中药成分能够抗菌抑菌，快速杀灭患处病菌，喷后4~5分钟可显著止痒，避免病菌产生抗药性，蛭石和海泡石经多次煮沸后能够吸附植物中药的色泽，避免污染鞋袜，同时丰富喷剂中的矿质元素，促进伤口愈合，加快蜕皮，使皮肤光滑细腻；利多卡因和氯丙嗪能够减少脚部汗液分泌，减少病菌滋生，缓解溃烂产生的痛痒感。
Description
技术领域
本发明主要涉及创新药物研发技术领域，尤其涉及一种治疗脚气的药物喷剂。
背景技术
脚气，俗称“香港脚”，是由一类称为“皮肤癣菌”的真菌引起的浅部真菌感染性皮肤病，脚气是皮肤科常见病，发病率居浅部真菌病首位，瘙痒难忍，散发脚臭，让人苦不堪言；目前市售的治疗脚气病的药物很多，但是多为药膏和药粉，药膏使用时需要涂抹，需要器具，且涂抹不均匀，药粉使用时需要先用热水浸泡，需要较长的时间，过程复杂，而且药膏和药粉使用时疗效较慢，多次使用后才能止痒，因为使用不便，很多患者不能坚持用药，导致脚气经常复发，因此，需要一种使用方便、疗效快的治疗脚气的药物喷剂。
发明内容
为了弥补已有技术的缺陷，本发明的目的是提供一种治疗脚气的药物喷剂。
一种治疗脚气的药物喷剂，由以下重量份的原料制成：狗牙根37~39、马蹄金37~39、鸡骨草31~33、田基黄31~33、茵陈蒿31~33、冰草27~29、尖头叶藜27~29、华北大黄27~29、草麻黄20~22、榆钱20~22、茶条槭20~22、蛭石13~15、海泡石13~15、利多卡因2.1~2.3、氯丙嗪0.6~0.8。
所述的利多卡因，为质量浓度为4~6%的毛果芸香碱溶液。
所述的氯丙嗪，为口服氯丙嗪。
一种治疗脚气的药物喷剂的制备方法，包括以下步骤：
（1）将狗牙根、马蹄金、鸡骨草、田基黄和茵陈蒿洗净，粉碎，加入狗牙根重量30~40倍量的水，混合均匀，-46~-44℃冷冻12~14小时，得冷冻料；
（2）将冰草、尖头叶藜、华北大黄、草麻黄、榆钱和茶条槭洗净，粉碎，炒至焦香，加入冰草重量50~60倍量的水，加热煮沸至体积为原来的1/2，破坏中药中的有毒成分，避免对皮肤的伤害，得煎煮料；
（3）将冷冻料和煎煮料混合均匀，加入复合酶，使复合酶的体积分数为0.03~0.05%，混合均匀，于39~41℃搅拌酶解90~100分钟，破坏中药的组织结构，促进有效成分浸出，提高原料利用率，节约成本，得酶解料；
（4）向酶解料中加入所有原料重量140~150倍量的水，混合均匀，加热煮沸至体积为原来的1/3，加入蛭石和海泡石，经多次煮沸后能够吸附植物中药的色泽，避免污染鞋袜，同时丰富喷剂中的矿质元素，促进伤口愈合，加快蜕皮，使皮肤光滑细腻，保温浸泡3~4小时，加入所有原料重量160~180倍量的水，煎煮至体积为原来的1/10，过滤，得一次滤渣和一次滤液；
（5）向一次滤渣中加入一次滤渣重量80~90倍量的体积分数为3~5%的醋酸溶液，提取中药中的碱性成分，提高药效，加快灭菌，缓解痒痛，加热煮沸至体积为原来的1/2，过滤，得二次滤渣和二次滤液；
（6）合并一次滤液和二次滤液，加热浓缩至体积为原来的1/3，向浓缩液中加入体积分数为90~92%的酒精溶液，混合均匀，使酒精的最终体积分数为56~58%，静置32~36小时，过滤，除沉淀，去除其中的糖蛋白杂质，抑制杂菌生长，提高药效，延长药物货架期，得提纯液；
（7）将提纯液进行真空旋转蒸发至无酒精，加水，至体积为所有原料重量的90~100倍，加入利多卡因和氯丙嗪，能够减少脚部汗液分泌，减少病菌滋生，缓解溃烂产生的痛痒感，混合均匀，灭菌，过0.22μm的微孔滤膜，得治疗脚气的药物喷剂；
（8）包装，检验，得成品。
所述步骤（3）的复合酶，由以下重量份的原料制成：纤维素酶34~36、半纤维素酶29~31、果胶酶23~25、淀粉酶12~14、脂肪酶7~9。
所述步骤（7）的真空旋转蒸发，温度为44~46℃、转速为57~59转/分钟。
所述步骤（7）的灭菌，温度为121℃、时间为10~15分钟。
所述治疗脚气的药物喷剂的使用方法，对患处直接进行喷雾，每天2~3次，15天为一个疗程，也可喷洒于鞋袜，喷洒量为不影响鞋袜穿用即可。
本发明的优点是：本发明提供的一种治疗脚气的药物喷剂，原料丰富，避免产生抗药性，快速杀灭病菌，坚持用药，避免复发，价格低廉，减轻患者痛苦，不含酒精，对肌肤无伤害，有效率达到99%；多种植物中药成分能够抗菌抑菌，快速杀灭患处病菌，喷后4~5分钟可显著止痒，避免病菌产生抗药性，蛭石和海泡石经多次煮沸后能够吸附植物中药的色泽，避免污染鞋袜，同时丰富喷剂中的矿质元素，促进伤口愈合，加快蜕皮，使皮肤光滑细腻；利多卡因和氯丙嗪能够减少脚部汗液分泌，减少病菌滋生，缓解溃烂产生的痛痒感；将狗牙根、马蹄金、鸡骨草、田基黄和茵陈蒿进行冷冻，破坏中药的组织结构，便于中药成分浸出；将冰草、尖头叶藜、华北大黄、草麻黄、榆钱和茶条槭进行煎煮，破坏中药中的有毒成分，避免对皮肤的伤害；将冷冻料和煎煮料混合均匀后进行酶解，破坏中药的组织结构，促进有效成分浸出，提高原料利用率，节约成本；酶解后先加水反复煎煮，再加入醋酸溶液进行煎煮，提取中药中的碱性成分，提高药效，加快灭菌，缓解痒痛；合并提取液后加入酒精溶液，静置除沉淀，去除其中的糖蛋白杂质，抑制杂菌生长，提高药效，延长药物货架期；使用方便，直接喷于患处或鞋袜均可，使用量少，见效快，坚持使用25~30天即可避免复发。
具体实施方式
下面用具体实施例说明本发明。
实施例1
一种治疗脚气的药物喷剂，由以下重量份的原料制成：狗牙根37~39、马蹄金37~39、鸡骨草31~33、田基黄31~33、茵陈蒿31~33、冰草27~29、尖头叶藜27~29、华北大黄27~29、草麻黄20~22、榆钱20~22、茶条槭20~22、蛭石13~15、海泡石13~15、利多卡因2.1~2.3、氯丙嗪0.6~0.8。
所述的利多卡因，为质量浓度为4~6%的毛果芸香碱溶液。
所述的氯丙嗪，为口服氯丙嗪。
一种治疗脚气的药物喷剂的制备方法，包括以下步骤：
（1）将狗牙根、马蹄金、鸡骨草、田基黄和茵陈蒿洗净，粉碎，加入狗牙根重量30~40倍量的水，混合均匀，-46~-44℃冷冻12~14小时，得冷冻料；
（2）将冰草、尖头叶藜、华北大黄、草麻黄、榆钱和茶条槭洗净，粉碎，炒至焦香，加入冰草重量50~60倍量的水，加热煮沸至体积为原来的1/2，破坏中药中的有毒成分，避免对皮肤的伤害，得煎煮料；
（3）将冷冻料和煎煮料混合均匀，加入复合酶，使复合酶的体积分数为0.03~0.05%，混合均匀，于39~41℃搅拌酶解90~100分钟，破坏中药的组织结构，促进有效成分浸出，提高原料利用率，节约成本，得酶解料；
（4）向酶解料中加入所有原料重量140~150倍量的水，混合均匀，加热煮沸至体积为原来的1/3，加入蛭石和海泡石，经多次煮沸后能够吸附植物中药的色泽，避免污染鞋袜，同时丰富喷剂中的矿质元素，促进伤口愈合，加快蜕皮，使皮肤光滑细腻，保温浸泡3~4小时，加入所有原料重量160~180倍量的水，煎煮至体积为原来的1/10，过滤，得一次滤渣和一次滤液；
（5）向一次滤渣中加入一次滤渣重量80~90倍量的体积分数为3~5%的醋酸溶液，提取中药中的碱性成分，提高药效，加快灭菌，缓解痒痛，加热煮沸至体积为原来的1/2，过滤，得二次滤渣和二次滤液；
（6）合并一次滤液和二次滤液，加热浓缩至体积为原来的1/3，向浓缩液中加入体积分数为90~92%的酒精溶液，混合均匀，使酒精的最终体积分数为56~58%，静置32~36小时，过滤，除沉淀，去除其中的糖蛋白杂质，抑制杂菌生长，提高药效，延长药物货架期，得提纯液；
（7）将提纯液进行真空旋转蒸发至无酒精，加水，至体积为所有原料重量的90~100倍，加入利多卡因和氯丙嗪，能够减少脚部汗液分泌，减少病菌滋生，缓解溃烂产生的痛痒感，混合均匀，灭菌，过0.22μm的微孔滤膜，得治疗脚气的药物喷剂；
（8）包装，检验，得成品。
所述步骤（3）的复合酶，由以下重量份的原料制成：纤维素酶34~36、半纤维素酶29~31、果胶酶23~25、淀粉酶12~14、脂肪酶7~9。
所述步骤（7）的真空旋转蒸发，温度为44~46℃、转速为57~59转/分钟。
所述步骤（7）的灭菌，温度为121℃、时间为10~15分钟。
所述治疗脚气的药物喷剂的使用方法，对患处直接进行喷雾，每天2~3次，15天为一个疗程，也可喷洒于鞋袜，喷洒量为不影响鞋袜穿用即可。
实施例2
一种治疗脚气的药物喷剂，由以下重量份的原料制成：狗牙根37~39、马蹄金37~39、鸡骨草31~33、田基黄31~33、茵陈蒿31~33、冰草27~29、尖头叶藜27~29、华北大黄27~29、草麻黄20~22、榆钱20~22、茶条槭20~22、蛭石13~15、海泡石13~15、利多卡因2.1~2.3、氯丙嗪0.6~0.8。
所述的利多卡因，为质量浓度为4~6%的毛果芸香碱溶液。
所述的氯丙嗪，为口服氯丙嗪。
制备和使用方法同实施例1。
实施例3
一种治疗脚气的药物喷剂，由以下重量份的原料制成：狗牙根37~39、马蹄金37~39、鸡骨草31~33、田基黄31~33、茵陈蒿31~33、冰草27~29、尖头叶藜27~29、华北大黄27~29、草麻黄20~22、榆钱20~22、茶条槭20~22、蛭石13~15、海泡石13~15、利多卡因2.1~2.3、氯丙嗪0.6~0.8。
所述的利多卡因，为质量浓度为4~6%的毛果芸香碱溶液。
所述的氯丙嗪，为口服氯丙嗪。
制备和使用方法同实施例1。
对比例1
去除狗牙根和马蹄金，其余制备和使用方法，同实施例1。
对比例2
去除鸡骨草和田基黄，其余制备和使用方法，同实施例1。
对比例3
去除茵陈蒿和冰草，其余制备和使用方法，同实施例1。
对比例4
去除尖头叶藜和华北大黄，其余制备和使用方法，同实施例1。
对比例5
去除榆钱和茶条槭，其余制备和使用方法，同实施例1。
对比例6
去除蛭石和海泡石，其余制备和使用方法，同实施例1。
对比例7
去除利多卡因和氯丙嗪，其余制备和使用方法，同实施例1。
对比例8
去除步骤（1）中的冷冻和步骤（1）中的加热煮沸，其余制备和使用方法，同实施例1。
对比例9
去除步骤（3）中的复合酶，其余制备和使用方法，同实施例1。
对比例10
去除步骤（5）中的醋酸溶液，其余制备和使用方法，同实施例1。
对比例11
去除步骤（6）中的酒精溶液，其余制备和使用方法，同实施例1。
对比例12
现有市售达克宁硝酸咪康唑乳膏。
实施例和对比例脚气药的效果比较：
痊愈：脱皮、瘙痒、糜烂、多汗、脚臭等症状消失；
有效：脱皮、瘙痒、糜烂、多汗、脚臭等症状减轻；
无效：脱皮、瘙痒、糜烂、多汗、脚臭等症状不变或加重。
随机选择1500位脚气症状相当的患者，随机分为15组，每组100人，每位患者每天早晚各用药一次，连续用药15天后，观察脚气状况，计算有效率，停药1年后，计算复发率，实施例和对比例脚气药的效果比较见表1。
表1：实施例和对比例脚气药的效果比较
| 项目 | 总人数 | 痊愈人数 | 好转人数 | 有效率（%） | 复发人数 |
| 实施例1 | 100 | 78 | 19 | 97 | 2 |
| 实施例2 | 100 | 81 | 18 | 99 | 2 |
| 实施例3 | 100 | 79 | 20 | 99 | 3 |
| 对比例1 | 100 | 46 | 13 | 59 | 5 |
| 对比例2 | 100 | 47 | 14 | 61 | 1 |
| 对比例3 | 100 | 39 | 16 | 55 | 5 |
| 对比例4 | 100 | 41 | 11 | 52 | 3 |
| 对比例5 | 100 | 51 | 13 | 64 | 2 |
| 对比例6 | 100 | 53 | 15 | 68 | 2 |
| 对比例7 | 100 | 49 | 13 | 62 | 5 |
| 对比例8 | 100 | 58 | 14 | 72 | 3 |
| 对比例9 | 100 | 63 | 16 | 79 | 5 |
| 对比例10 | 100 | 67 | 15 | 82 | 3 |
| 对比例11 | 100 | 64 | 13 | 77 | 5 |
| 对比例12 | 100 | 24 | 24 | 48 | 9 |
从表1的结果表明，实施例的治疗脚气的药物喷剂，痊愈人数和有效人数明显较对比例多，1年后的复发人数明显较对比例少，说明本发明提供的治疗脚气的药物喷剂具有很好的治疗效果。
Claims (8)
1.一种治疗脚气的药物喷剂，其特征在于，由以下重量份的原料制成：狗牙根37~39、马蹄金37~39、鸡骨草31~33、田基黄31~33、茵陈蒿31~33、冰草27~29、尖头叶藜27~29、华北大黄27~29、草麻黄20~22、榆钱20~22、茶条槭20~22、蛭石13~15、海泡石13~15、利多卡因2.1~2.3、氯丙嗪0.6~0.8。
2.根据权利要求1所述治疗脚气的药物喷剂，其特征在于，所述的利多卡因，为质量浓度为4~6%的毛果芸香碱溶液。
3.根据权利要求1所述治疗脚气的药物喷剂，其特征在于，所述的氯丙嗪，为口服氯丙嗪。
4.一种根据权利要求1所述治疗脚气的药物喷剂的制备方法，其特征在于，包括以下步骤：
（1）将狗牙根、马蹄金、鸡骨草、田基黄和茵陈蒿洗净，粉碎，加入狗牙根重量30~40倍量的水，混合均匀，-46~-44℃冷冻12~14小时，得冷冻料；
（2）将冰草、尖头叶藜、华北大黄、草麻黄、榆钱和茶条槭洗净，粉碎，炒至焦香，加入冰草重量50~60倍量的水，加热煮沸至体积为原来的1/2，得煎煮料；
（3）将冷冻料和煎煮料混合均匀，加入复合酶，使复合酶的体积分数为0.03~0.05%，混合均匀，于39~41℃搅拌酶解90~100分钟，得酶解料；
（4）向酶解料中加入所有原料重量140~150倍量的水，混合均匀，加热煮沸至体积为原来的1/3，加入蛭石和海泡石，保温浸泡3~4小时，加入所有原料重量160~180倍量的水，煎煮至体积为原来的1/10，过滤，得一次滤渣和一次滤液；
（5）向一次滤渣中加入一次滤渣重量80~90倍量的体积分数为3~5%的醋酸溶液，加热煮沸至体积为原来的1/2，过滤，得二次滤渣和二次滤液；
（6）合并一次滤液和二次滤液，加热浓缩至体积为原来的1/3，向浓缩液中加入体积分数为90~92%的酒精溶液，混合均匀，使酒精的最终体积分数为56~58%，静置32~36小时，过滤，除沉淀，得提纯液；
（7）将提纯液进行真空旋转蒸发至无酒精，加水，至体积为所有原料重量的90~100倍，加入利多卡因和氯丙嗪，混合均匀，灭菌，过0.22μm的微孔滤膜，得治疗脚气的药物喷剂；
（8）包装，检验，得成品。
5.根据权利要求4所述治疗脚气的药物喷剂的制备方法，其特征在于，所述步骤（3）的复合酶，由以下重量份的原料制成：纤维素酶34~36、半纤维素酶29~31、果胶酶23~25、淀粉酶12~14、脂肪酶7~9。
6.根据权利要求4所述治疗脚气的药物喷剂的制备方法，其特征在于，所述步骤（7）的真空旋转蒸发，温度为44~46℃、转速为57~59转/分钟。
7.根据权利要求4所述治疗脚气的药物喷剂的制备方法，其特征在于，所述步骤（7）的灭菌，温度为121℃、时间为10~15分钟。
8.根据权利要求1~7任一项所述治疗脚气的药物喷剂的使用方法，其特征在于，对患处直接进行喷雾，每天2~3次，15天为一个疗程，也可喷洒于鞋袜，喷洒量为不影响鞋袜穿用即可。
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