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目的 探讨血竭愈烫喷雾剂的研制开发工艺。方法 根据国家“中药新药研究指导原则”对制剂工艺、质量标准、药理、毒理进行了实验研究 ,并根据“中药新药临床研究指导原则”进行了临床观察。结果 该制剂具有明显抑制二甲苯致小鼠耳廓肿胀作用 ;具有显著的镇痛作用 ;可显著抑制醋酸所致小鼠扭体次数 ;同时该制剂对豚鼠皮肤无致敏作用 ;有显著治愈兔Ⅱ度烧伤的作用 ;皮肤急性毒性实验表明 ,该制剂对豚鼠皮肤无任何毒性反应 ,动物体征无变化。结论 该制剂有如下优点 :止痛效果明显 ,创面愈后快 ,创面渗出少 ,结痂快 ,表皮生长速度快 ,愈后不留疤痕 ,无毒副作用及不良反应 ,携带方便 ,不污染衣物
Objective To study the research and development process of Xueshou Yushang spray. Methods According to the “Guidelines for the Study of New Drugs of Traditional Chinese Medicines” of the State, experimental studies were conducted on the preparation process, quality standards, pharmacology, and toxicology, and clinical observations were conducted according to the “Guiding Principles for the Clinical Research of Traditional Chinese Medicine New Drugs”. RESULTS The preparation had obvious effect of inhibiting xylene-induced ear swelling in mice; it had significant analgesic effect; it could significantly inhibit the number of writhing caused by acetic acid in mice; at the same time, the preparation had no sensitization effect on guinea pig skin; The effect of II degree burns; skin acute toxicity test showed that the preparation had no toxicity to guinea pig skin, and there was no change in animal signs. Conclusion The preparations have the following advantages: Analgesic effect is obvious, the wound surface is faster, the wound surface is less oozing, the scarring is faster, the epidermis grows faster, the epidermis grows faster, leaving no scars, no toxic side effects and adverse reactions, easy to carry, no pollution to clothing