Ensuring that injectable bicarbonate-buffered lidocaine-epinephrine complies with 2015 United States Pharmacopeia (USP) compounding provisions.
Ensuring that injectable bicarbonate-buffered lidocaine-epinephrine complies with 2015 United States Pharmacopeia (USP) compounding provisions.
复制标题
确保注射用碳酸氢盐缓冲利多卡因肾上腺素符合 2015 年美国药典 (USP) 的配制规定。
DOI：
10.1016/j.jaad.2016.03.051
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发表时间：
2016
影响因子：
13.8
通讯作者：
Aires,Daniel
中科院分区：
文献类型：
--
作者：
Isedeh,Prescilia;Forrest,MLaird;Liu,Deede;Aires,Daniel
常按1：10万或1：20万添加肾上腺素，以收缩血管，从而延长麻醉时间。由于肾上腺素仅在酸性环境中稳定，因此通过酸性防腐剂将利多卡因-肾上腺素的pH值降低至3.5至5.5。 1 这可能会导致注射部位疼痛，并延迟麻醉起效。 1 通过将 1 份 8.4% 碳酸氢钠添加到 10 份利多卡因-肾上腺素中进行“缓冲”，可以提高 pH 值，从而缓解疼痛和延迟。 1, 2 其他不太常用的局部麻醉剂如布比卡因和甲哌卡因也可以进行缓冲。 3 在单个注射器中组合 2 种药物（例如利多卡因-肾上腺素 + 碳酸氢盐）被视为“复合”，定义为组合、混合或改变 2 种或多种药物的成分，以创建适合个体患者需求的药物。 4 由于肾上腺素活性在碱性或中性环境中每周下降 25%，因此标准文本建议在初次制备后 1 至 2 周内使用。 1, 2, 5, 6 由于尚未报道因办公室内混合利多卡因-肾上腺素+碳酸氢盐而引起的感染，因此教科书指南基于肾上腺素活性的丧失，而不是潜在的感染风险。美国药典 (USP) 公约制定并发布了 USP 国家处方集中的原料药、药品、赋形剂和膳食补充剂的标准。 USP 药品标准在美国由食品和药物管理局 (FDA) 强制执行，这些标准在 140 多个国家/地区使用。 7 USP – 复合制剂的国家处方集标准可由美国药典和美国药典双方共同执行。
Epinephrine is often added at 1: 100,000 or 1: 200,000 to constrict blood vessels, thus prolonging the duration of anesthesia. Because epinephrine is stable only in acidic environments, pH of lidocaine-epinephrine is lowered to 3.5 to 5.5 via acidic preservatives. 1 This can cause injection site pain, and delay anesthesia onset. 1 “Buffering” by adding 1 part 8.4% sodium bicarbonate to 10 parts lidocaine-epinephrine can raise pH to address both pain and delay. 1, 2 Other less commonly used local anesthetics such as bupivacaine and mepivacaine can also be buffered. 3 Combining 2 medicines, such as lidocaine-epinephrine+ bicarbonate, in a single syringe, is considered to be “compounding,” defined as combining, mixing, or altering ingredients of 2 or more drugs to create a medication tailored to the needs of an individual patient. 4 Because epinephrine activity declines at 25% per week in alkaline or neutral environments, standard texts recommend that it be used within 1 to 2 weeks after initial preparation. 1, 2, 5, 6 Because infections from in-office compounding of lidocaine-epinephrine+ bicarbonate have not been reported, textbook guidelines are based on the loss of epinephrine activity rather than the potential infection risk.The United States Pharmacopeia (USP) Convention develops and publishes standards for drug substances, drug products, excipients, and dietary supplements in the USP–National Formulary. USP drug standards are enforceable in the United States by the Food and Drug Administration (FDA), and these standards are used in more than 140 countries. 7 USP–National Formulary standards for compounded preparations may be enforced by both the