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首页> 外文期刊>Journal of Clinical Pharmacy and Therapeutics >A stability indicating assay for a combination of morphine sulphate with levomepromazine hydrochloride used in palliative care
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A stability indicating assay for a combination of morphine sulphate with levomepromazine hydrochloride used in palliative care

机译：用于姑息治疗的硫酸吗啡与盐酸左丙嗪的组合的稳定性指示试验

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摘要

What is known and objective: Morphine is used routinely in clinical practice to manage moderate to severe pain, whereas levomepromazine is commonly used at low doses to manage intractable nausea and vomiting. While it has been reported that an injection combination of morphine sulphate (0·5 mg/mL) and levomepromazine (0·1 mg/mL) was physically compatible, data on the chemical stability of combinations of these drugs has not been reported. Thus, a method was required for the assessment of the stability of morphine sulphate/levomepromazine hydrochloride combinations. Methods: A high-performance liquid chromatography (HPLC) method was developed to assess the stability of the combinations. The injections were stored at 4 °C in the dark at room temperature under natural light and at 37 °C under artificial lighting. Results and Discussion: Morphine sulphate was stable under all storage conditions, but the degree of degradation of levomepromazine hydrochloride increased as the storage temperature increased. The disappearance of levomepromazine hydrochloride was correlated with the appearance of a sulphoxide degradant. What is new Conclusion: The injection combinations of morphine sulphate and levomepromazine hydrochloride were shown in the current study to have a limited storage life with respect to their levomepromazine hydrochloride content.
机译：已知的和客观的：吗啡在临床实践中通常用于治疗中度至重度疼痛，而左丙丙嗪通常在低剂量时用于治疗顽固的恶心和呕吐。据报道，吗啡硫酸盐（0·5 mg / mL）和左氧丙嗪（0·1 mg / mL）的注射剂组合具有物理相容性，但尚未报道这些药物组合的化学稳定性数据。因此，需要一种方法来评估硫酸吗啡/盐酸左氧丙嗪组合的稳定性。方法：开发了一种高效液相色谱（HPLC）方法来评估组合的稳定性。将注射液在室温，自然光下于4°C的黑暗条件下以及在人工照明下于37°C的条件下存储。结果与讨论：吗啡硫酸盐在所有储存条件下均稳定，但盐酸左氧丙嗪的降解程度随储存温度的升高而增加。盐酸左旋丙嗪的消失与亚砜降解物的出现有关。有何新结论：当前研究显示，硫酸吗啡和盐酸左旋丙嗪的注射组合相对于盐酸左旋丙嗪的含量具有有限的储存寿命。

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