Review on the Application of Common Formulations and Generic Techniques of Children's Chinese Medicine Preparations
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摘要: 目前儿童中药制剂剂型选择、辅料优选、工艺设计、包装装置等成人化倾向比较普遍, 导致给药剂量不准、患儿用药顺应性差, 药物有效性和安全性难以保证, 药品不良反应事件频发。因此, 研究开发符合儿童用药特点的制剂, 突破儿童制剂关键技术迫在眉睫。分析了口服液、糖浆剂、颗粒剂等常用剂型, 探讨其在儿童中药制剂中的应用情况, 并针对儿童中药制剂中存在的药物溶解度低、服用口感差、给药剂量不准确等问题, 探讨增溶、掩味和定量给药等共性技术的特点及应用, 以期为儿童中药制剂的研发奠定基础并提供依据。Abstract: Currently, adultification phenomenon in formulation selection, excipient optimization, process design, package equipment of children's Chinese medicine preparations are common, resulting in inaccurate dosage, poor medication compliance, difficulties in ensurance of drug's effectiveness and safety, as well as frequent adverse drug reactions. Therefore, it is urgent to investigate the preparations that conform to the characteristics of children's medication and break through the key technologies of children's preparations. This article analyzes the oral liquid, syrup, granule and other dosage forms, meanwhile discusses their application in Chinese medicine preparations for children. At the same time, on the issues of low solubility, poor taste and inaccurate dosage in children's Chinese medicine preparations, the characteristics and utilization of generic technologies such as solubility enhancement, taste masking and quantitative administration are discussed. The review aims to lay a foundation and provide a basis for the research and development of children's Chinese medicine preparations.
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Key words:
- Chinese medicine /
- preparations for children /
- formulations /
- generic techniques
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图 1 《中国药典》2020年版中儿童制剂剂型分布
Figure 1. Distribution of dosage forms of children's preparations in Chinese Pharmacopoeia (2020)
表 1 增溶技术的优缺点
Table 1. Advantages and disadvantages of solubilization technology
增溶技术 增溶原理 优点 缺点 固体分散技术 抑制药物结晶、提高分散度、增加药物可润湿性 工艺简单、增溶效果好 稳定性差、久贮易产生老化现象 自微乳化技术 形成纳米级别的O/W型或W/O型乳滴 增加药物的淋巴转运、减少肝脏首过效应 生产成本高、辅料用量大、稳定性差 脂质体技术 利用脂质体的两亲性包裹水难溶性或脂难溶性药物 增强药物靶向性、降低药物毒副作用 载药量低、包封率低、磷脂易氧化 
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表 2 掩味技术的优缺点
Table 2. Advantages and disadvantages of taste masking technology
掩味技术 掩味原理 优点 缺点 添加矫味剂 混淆大脑味觉、嗅觉感受 操作简单, 价格低廉 对极苦药物掩味效果不佳; 安全性较低 进行薄膜包衣 利用衣层隔断药物与味蕾的接触 不影响生物利用度; 辅料易获得; 适用范围较广; 载药量较高 制备难度和制备成本相对较高; 工艺较复杂 制成微囊/微球 隔断药物与味蕾的接触 粒径小; 可作为制剂中间体、加工成多种剂型 成本较高; 药物包封率低 形成离子交换树脂复合物 改变化合物本身性质, 消除苦味 掩味效果佳; 改善药物稳定性; 无毒副作用 药物需与离子交换树脂带相反电荷; 长期服用影响胃肠道离子平衡
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表 3 定量给药装置的优缺点
Table 3. Advantages and disadvantages of dosing device
给药途径 给药装置 优点 缺点 口服制剂 量匙 使用广泛; 操作简便 剂量多样性差(一般只有5 mL); 重复性差; 药液易洒出 量杯 操作简便; 价格低廉 计量准确性差; 容器的开口大、不适宜婴幼儿直接服用 滴管 测量标示准确, 适用于小剂量给药 大剂量给药时的喂药次数多, 易使儿童产生抗拒行为; 必须垂直吸取药液以保证给药准确性 口腔注射器 剂量准确; 灵活 价格较昂贵 吸入制剂 加压定量吸入装置 使用广泛; 成本低 对患者的呼吸协调性要求高; 口咽部气溶胶沉积多, 易产生副作用 雾化吸入器 对呼吸协调性要求低; 操作简便 价格昂贵; 单次给药所需时间长 软雾吸入器 对患者的呼吸协调性要求低; 雾化效率高 价格较昂贵 干粉吸入器 对呼吸协调性要求低 操作步骤繁多、易用性差; < 4岁儿童和哮喘患者不适用 直肠制剂 预充式注射器 使用方便; 可避免药物交叉污染, 实现药械一体化 对灭菌过程要求高 一次性直肠给药注射器接灌肠管装置 装置简单; 操作方便、无痛; 单剂量给药成本低 灌肠管与注射器的乳突连接不紧密易导致灌肠液外漏, 浪费药物 直肠滴注装置 装置简单、器具易得; 给药容量大、剂量大 输液管与肛管连接不紧密, 输液过程中可能出现脱管
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