目的：鈣磷相容性是靜脈營養輸液 (parenteral nutrition, PN) 調配時的重要議題，文獻指出調製PN 使用有機磷酸鹽較不易產生鈣磷沉澱，但用於調製成人PN 的文獻及研究並不多，因此需要相關的試驗來支持臨床上的使用。

方法：此次試驗濃度選擇1% 胺基酸及10% 葡萄糖，鈣25 mEq/L、磷50 mmol/L。原料分別為市面上常見之不同廠牌的胺基酸輸注液、50% 葡萄糖輸注液、葡萄糖酸鈣 (calcium gluconate)、磷則分為試驗組甘油磷酸鈉 (sodium glycerophosphate, NaGP) 與對照組磷酸鉀。於調配完成時及室溫一天、2 ~ 8°C 2 天室溫1 天以及2 ~ 8°C9 天室溫1 天以上模擬臨床使用情境進行檢測溶液所含微粒物質數，並測定pH 值。

結果：使用磷酸鉀調配，在完成時即有肉眼可見之沉澱，以顆粒計數儀測定也超過中華藥典第八版的合格標準。以NaGP 調配，無論胺基酸原料的廠牌，在調配完成時、或是冷藏後再置於室溫之各時間點，所測出的微粒物質數每毫升直徑 ≥ 10 μm 與≥ 25 μm 微粒顆數均符合中華藥典之標準。

結論：調製1% 胺基酸及10% 葡萄糖，以calcium gluconate 與NaGP 調配達到鈣25 mEq/L、磷50 mmol/L 之靜脈營養輸液，於模擬臨床使用的時間與儲存溫度，均符合中華藥典規範的微粒物質數標準，具有良好的相容性。

 

Objective: The compatibility of calcium and phosphorus has always been an important issue in the preparation of parenteral nutrition. Current studies show that the use of the organic form of phosphorus salts is less likely to produce calcium and phosphorus precipitates. Sodium glycerophosphate has considerable experience in the preparation of PN for neonates, but there are not many studies for adults; thus, more studies are needed to support its clinical use.

Method: PN solutions were composed of 1% amino acid with different brands, 10% dextrose, calcium gluconate at 25 mEq/L, either sodium glycerophosphate or potassium phosphate at 50 mmol/L. The PN solutions were evaluated by a light obscuration particulate count test and pH measurement after compounding and under the following storage conditions simulating clinical use: at room temperature for 1 day, at 2~8°C for 2 or 9 days subsequently at room temperature for 1 day.

Result: Visible precipitation was noted in the solutions using potassium phosphate after formulation, and the particle count also exceeded the criteria of physical compatibility. There was no visible precipitate in the solutions using sodium glycerophosphate, and the particle count met the criteria of the pharmacopoeia under any storage condition.

Conclusion: PN solutions composed of 1% amino acid, 10% dextrose, calcium gluconate at 25 mEq/L and sodium glycerophosphate at 50 mmol/L have good compatibility under any stored condition simulating the clinical use.

 

 

Submitted for publication: 2023.1.31; Accepted for publication: 2024.3.1