The Quality Research Of Hydroxyethyl Starch Injection

Hydroxyethyl starch 480/0.7(HES480/0.7) lactate injection, a kind of high molecular weight artificial plasma substitutes with long expansion effect, which can be used for treatment of hemorrhage or shock caused by massive bleeding, burn or other injury, is a widely used plasma substitute in the United States. Based on the injection formula of the product, this paper has focused on establishing the methodology of various components in the HES480/0.7 lactate injection. The mainly results are as follows:(1) HPLC method was used for the determination of sodium lactate in the HES480/0.7 lactate injection. HPLC separation was carried out on a C18 column (ODS HYPERSIL 200mm×4.6mm lichrospher) with the mobile phase consisting of 0.1% formic acid and 0.1% dicyclohexylamine in water. The results showed that the calibration curve was linear in the concentration range of 0.1 mg/mL to 1.2 mg/mL and the detection limit was 0.25μg. Other components in the HES480 preparation showed no interference. The average recovery was 101 % with RSD of 1.04 %. Light, heat, acid and alkali showed no impact to the main peak of lactate sodium.(2) HPLC method was established for the determination of glucose in the HES480/0.7 lactate injection. The analysis was conducted with a NH2 column (4.6mmID B115 Y525) and a RID detector, and the mobile phase was methanol-water (80:20). The results indicated that the glucose was linear over the range of 0.04 mg/mL to 0.4 mg/mL and the detection limit was 0.80μg. The sample solution was stable and the mean recovery was 100.5 % with RSD of 1. 4 %.(3) Polarimetry analysis was used to determine the hydroxyethyl starch in HES480/0.7 lactate injection. The linear relationship of HES content was good over the range of 10 mg/mL to 90 mg/mL and the blank solution showed no interruption. The average recovery was 99.8 % with RSD of 0.38 %.(4) Atomic absorption spectrophotometry was carried out for determination of CaCl₂ and MgCl₂ in HES480/0.7 lactate injection. . The calibration curve was good linear in the range of 1μg/mL～5μg/mL for Ca²⁺ and Mg²⁺ . The average recovery of Ca²⁺ was 101% with RSD of 1.2%, and 101.5% of Mg²⁺ with RSD of 0.9 %. (5) All of the components in HES480/0.7 lactate injection were identified according to the Pharmacopoeia, and the results are in line with the requirements.