Page 84 - 《中国药房》2021年10期

葡萄糖酸钙注射液与不同溶媒配伍的稳定性考察 Δ

张文佳 ，孙德清（山东大学第二医院药品供应科，济南 250033）
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中图分类号 R917 文献标志码 A 文章编号 1001-0408（2021）10-1230-06
DOI 10.6039/j.issn.1001-0408.2021.10.12

摘 要 目的：考察葡萄糖酸钙注射液与不同溶媒配伍24 h内的稳定性，为临床用药提供参考。方法：将10％葡萄糖酸钙注射液
分别均按体积比10∶100、30∶100、50∶100与0.9％氯化钠注射液、5％葡萄糖注射液混合，作为试验组输液；将其与10％葡萄糖注射
液同比例混合，作为对照组输液；将水分别与0.9％氯化钠注射液、5％葡萄糖注射液、10％葡萄糖注射液同比例混合，作为空白对
照组输液；于配制后24 h内观察试验组输液和对照组输液的外观，检测两者pH值、不溶性微粒数量并与空白对照组进行比较。采
用紫外分光光度法测定5-羟甲基糠醛含量及紫外吸收光谱的变化情况。结果：与同一时间的空白对照组输液比较，试验组输液和
对照组输液在24 h内均为无色、澄清溶液，无可见异物，且试验组输液与对照组输液的pH值无明显变化。在配制后的24 h内，3组
输液中≥10、≥25 μm的不溶性微粒数虽有波动，但符合药典标准；小粒径（5～10 μm）不溶性微粒数量有随时间的延长略呈上升
趋势，但试验组输液、对照组输液和空白对照组输液无明显差异。5-羟甲基糠醛检测质量浓度的线性范围为0.149～4.751 µg/mL
2
（R ＝0.999 9）；定量限为 0.013 µg/mL；精密度、重复性、稳定性（24 h）试验的 RSD 均小于 2％；平均回收率为 105.23％（RSD＝
1.08％，n＝9）。试验组输液与对照组输液中5-羟甲基糠醛的含量以及其紫外吸收图谱在24 h内均无明显变化；于284 nm波长处
测定的吸光度符合药典规定。结论：葡萄糖酸钙注射液与0.9％氯化钠注射液、5％葡萄糖注射液配伍后所得输液在24 h内稳定性
良好，可根据临床需要配伍使用。
关键词 葡萄糖酸钙注射液；溶媒；稳定性；配伍
Investigation on Compatibility Stability of Calcium Gluconate Injection with Different Solvents
ZHANG Wenjia，SUN Deqing（Dept. of Drug Supply，the Second Hospital of Shandong University，Jinan 250033，
China）

ABSTRACT OBJECTIVE：To investigate the compatibility stability of Calcium gluconate injection with different solvents within
24 h，and to provide reference for clinical drug use. METHODS：10％ Calcium gluconate injection was mixed with 0.9％ Sodium
chloride injection and 5％ Glucose injection in the proportion of 10 ∶ 100，30 ∶ 100 and 50 ∶ 100（v/v）as trial group，and mixed with
10％ Glucose injection in the same proportion as control group. The water was mixed with 0.9％ Sodium chloride injection，5％
Glucose injection and 10％ Glucose injection in the same proportion as the blank control group. The appearance of the infusion in
the trial group and the control group was observed within 24 h after preparation. pH value and the number of insoluble particles
were detected and compared with the blank control group. The content of 5-hydroxymethylfurfural and the change of UV absorption
spectrum were determined by UV spectrophotometry. RESULTS：Compared with the blank control group infusion at the same time，
the infusion of trial group and the control group were colorless，clear solution，no visible foreign body，and the pH value of the
infusion of trial group and the control group had no significant change within 24 h. Within 24 h after preparation，the number of
insoluble particles≥10 and ≥25 μm in 3 groups fluctuated but met the pharmacopoeia standard；the number of insoluble particles
with small particle size（5-10 μm）increased slightly with time，but there was no significant difference between trial group，control
2
group and blank control group. The linear range of 5-HMF was 0.149-4.751 μg/mL（R ＝0.999 9）；the limit of quantitation was
0.013 μ g/mL；RSDs of precision，repeatability and stability tests （24 h） were less than 2％ ；average recovery was 105.23％
（RSD＝1.08％，n＝9）. The content of 5-HMF and the UV absorption spectrum had no significant change in 2 groups within 24 h.
The absorbance of UV measured at 284 nm was in line with the pharmacopeia. CONCLUSIONS：Calcium gluconate injection，
0.9％ Sodium chloride injection and 5％ Glucose injection have good stability within 24 h，and can be used according to clinical needs.
KEYWORDS Calcium gluconate injection；Solvent；Stability；Compatibility

[1]
葡萄糖酸钙注射液为钙补充剂，现已被广泛应用于 救等 。目前，国内 10％葡萄糖酸钙注射液药品说明书
钙缺乏、手足搐搦症、过敏性疾病的临床治疗，以及镁、 规定其用法为将其稀释于 10％葡萄糖注射液中并缓慢
氟中毒，高血钾、低血钙、钙通道阻滞致心功能异常的解 静脉注射。但在临床实际应用过程中，因10％葡萄糖注
射液与10％葡萄糖酸钙注射液均为高渗溶液，配伍应用
Δ 基金项目：山东省重点研发计划项目（No.2018GSF118024）
易对局部血管造成损伤，引起红肿、疼痛等不适，部分患
＊药师，硕士。研究方向：临床药学。电话：0531-85875507。E-
者无法耐受 ；且对于低氯性代谢性碱中毒的患者，因其
[2]
mail：421083365@qq.com
2+
体内血清蛋白结合钙离子（Ca ）浓度增加，使游离 Ca 2+
# 通信作者：主任药师，博士。研究方向：临床药学、药理学。电
话：0531-85875290。E-mail：sundq0405@126.com 浓度降低，同时伴有肌肉抽动、手足搐搦等症状，故需静
·1230 · China Pharmacy 2021 Vol. 32 No. 10 中国药房 2021年第32卷第10期