What is the storage temperature of insulin

Drugs like insulin still have some storage temperature restrictions. If they are not stored strictly according to the storage temperature, the drug will deteriorate or lose its efficacy. In this case, it must not be injected into the human body. Otherwise, it will cause great harm to the human body. If you are not careful, it will directly endanger your life. It must be refrigerated.

Determined by high performance liquid chromatography (Appendix Ⅴ D of Part II of the Pharmacopoeia 2010 edition).

Chromatographic conditions and system suitability test

Octadecylsilane bonded silica gel was used as filler (5-10 μm); 0.2 mol/L sulfate buffer (take 28.4 g of anhydrous sodium sulfate, dissolve it in water, add 2.7 ml of phosphoric acid, adjust the pH value to 2.3 with ethanolamine, and add water to 1000 ml)-acetonitrile (74:26) was used as mobile phase; the column temperature was 40°C; the detection wavelength was 214 nm.

Take 20 μl of system suitability test solution (take insulin reference substance, use 0.01 mol/L hydrochloric acid solution to make a solution containing about 40 units per 1 ml, and leave it at room temperature for at least 24 hours), inject it into liquid chromatograph, and record the chromatogram. The separation between the insulin peak and the A21 deaminated insulin peak (the relative retention time with the insulin peak is about 1.2) should be not less than 1.8, and the tailing factor should be not more than 1.8.

Determination method

Take an appropriate amount of this product, weigh it accurately, add 0.01 mol/L hydrochloric acid solution to dissolve and quantitatively dilute to make a solution containing about 40 units per 1 ml (prepare fresh before use, store at 2-4°C, and use within 48 hours). Accurately measure 20 μl and inject it into the liquid chromatograph, and record the chromatogram; take an appropriate amount of insulin reference substance and determine it in the same way. Calculate by external standard method using the sum of the insulin peak area and the A21 desamino insulin peak area.

category

Blood sugar lowering medication.

Storage

Keep in a dark place and sealed at a temperature below -15℃.

preparation

(1) Neutral insulin injection (2) Protamine zinc insulin injection

Most of the insulin secreted from pancreatic beta cells is inactivated in the liver and kidneys, of which about 40% to 50% enters the liver through the portal vein and is inactivated. Therefore, the state of liver and kidney function, especially liver function, is an important factor affecting the level of insulin in circulating blood. Diabetic patients often produce insulin anti-antibodies in their bodies after using insulin, especially animal insulin. Since insulin and insulin anti-antibodies can produce a high immune response, they can affect the determination of plasma pancreatic insulin.

In addition, the levels of proinsulin and preproinsulin in the blood, endocrine system diseases such as the anterior pituitary gland, adrenal cortex, hyperthyroidism, various drugs such as thiazide diuretics and glucocorticoids, and stress states such as infection, fever, and surgery are all common factors affecting insulin determination.