Discussion of Key Problems in the Clinical Use and Preparation of Traditional Chinese Medicine Pulvis in Oral Mucosal Areas
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摘要: 中药散剂使用历史悠久, 以其剂型特色、制法简单、疗效确切成为中药的代表性剂型之一。中药外用散剂在口腔黏膜部位的临床应用历来较为广泛。由于剂型的特殊, 临床用量长期以来没有明确的共识, 而外用散剂处方中多含矿物类生药, 因此会带来一定的安全性隐患; 随着制剂工艺的不断发展更新, 一些新的粉碎工艺也不断应用于散剂制剂工艺中, 但同时带来的相关问题也值得讨论。对上述中药外用散剂的剂量、安全性、工艺合理性等方面的关键问题进行梳理和探讨, 为其规范临床应用、确保用药安全、进一步新药开发等提供启发。Abstract: Traditional Chinese medicine pulvis has a long history of application and has become one of the representative dosage forms of Chinese medicine with its distinctive dosage form, simple preparation and precise efficacy.Topical Chinese medicine bulking agents have been more widely used in the clinical application of oral mucosal areas.Due to the special dosage form, there is no clear consensus on the clinical dosage for a long time, and the prescription of topical dispersant mostly contains mineral raw drugs, so it will bring certain safety risks; with the continuous development and update of preparation process, some new crushing processes have been applied to the preparation process of dispersant, but at the same time, the related problems brought about are also worth discussing.This paper sorts out and discusses the key problems of dosage, safety and process rationality of the above-mentioned topical Chinese medicine dispensers to provide inspiration for their standardized clinical application, ensure medication safety and further new drug development.
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Key words:
- traditional Chinese medicine pulvis /
- oral mucosal /
- dosage /
- security /
- ultra-micro pulverization /
- processing
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表 1 文献报道的中药外用散剂以及说明书上用法用量
Table 1. Traditional Chinese medicine pulvis for oral mucosal areas use reported in the literature and its clinical dosage as well as usage in the instructions
药品名称 使用对象 文献报道用法用量 说明书用法用量 参考文献 锡类散 人 吹少许敷于患处[12]采用无菌棉签蘸取锡类散少许外敷于溃疡处, 3次/d[13]用少许均匀地吹敷患处[14] 每用少许, 吹敷患处, 每日1~2次 [12-14] 黄氏生肌散 大鼠 取制剂2 mg喷洒于大鼠颊部溃疡[15] / [15] 冰硼散 人 应用冰硼散浸泡医用纱布, 将其敷于患者的溃疡表面[16]按照4∶3比例取1 g蒙脱石散, 0.6 g冰硼散充分混合, 以无菌棉签蘸取适量混合药物, 均匀涂抹于溃疡处皮肤表面[17] 吹敷患处, 每次少量, 一日数次 [16-17] 桂林西瓜霜 人/大鼠 给予0.2 g·kg-1桂林西瓜霜, 直接取药粉(约1/4剂量)涂于大鼠口腔溃疡创面上[18]取适量甲硝唑片粉末和西瓜霜喷剂混合, 调成糊状, 然后将混合药物涂抹在患者口腔溃疡的创面上[19] 外用, 喷、吹或敷于患处, 一次适量, 一日数次; 重症者兼服, 一次1~2 g, 一日3次 [18-19] 碧雪散 人 取少许药粉(约0.3 g), 外敷于溃疡处, 每日3次[20] / [20] 口腔溃疡散 大鼠 利用消毒棉签涂抹1 mL的口腔溃疡散混悬液(6%), 每日1次[21] 用消毒棉球蘸药擦患处, 一日2~3次 [21] 表 2 口腔溃疡数目与溃疡面积数据统计(x±s)
Table 2. Statistic summary about numbers and area of human oral ulcer(x±s)
年龄 溃疡个数 溃疡面积/mm2 参考文献 30.82±5.36 / 2.04±0.28 [23] 41.40±2.92 / 6.30±1.89 [24] 28.79±3.55 / 6.19±1.25 [25] 43.93±9.92 1.90±0.56 1.80±0.46 [26] 38.26±6.26 / 9.47±2.54 [27] 38.42±5.45 / 3.34±0.83 [28] 27.05±3.44 / 4.98±1.25 [29] 34.9±6.9 / 15.64±3.52 [30] 45.89±3.25 11.26±1.45 3.68±0.95 [31] 39.11±10.25 2.29±1.24 2.06±0.81 [32] 47.96±12.04 2.21±0.71 2.01±0.34 [33] 18~65 2.22±0.77 26.17±10.21 [34] 55.3±3.6 / 8.4±1.6 [35] 38.4±5.3 / 2.90±1.21 [36] -
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