Calcium gluconate injection and preparation method thereof
A technology of calcium gluconate and sodium gluconate, applied in the field of medicine, can solve problems such as reduced solubility, and achieve the effects of enhancing stability, increasing the effect of solubilization, and maintaining stable quality.
Inactive Publication Date: 2009-09-02
HEBEI TIANCHENG PHARMA
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AI Technical Summary
Problems solved by technology
In traditional prescriptions, lactic acid and calcium hydroxide produce calcium lactate, which can help dissolve calcium gluconate to a certain extent, but it can only prevent calcium gluconate from crystallizing in a short period of time. , especially under low temperature conditions, the solubility of calcium gluconate gradually decreases, so that saturated calcium gluconate gradually precipitates and crystallizes
Method used
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Experimental program
Comparison scheme
Effect test
Embodiment
[0010] 1. Weigh 1000g of calcium gluconate, 15g of sodium gluconate, 2g of calcium hydroxide and 85g of lactic acid;
[0011] 2. Measure 70% of the water for injection, heat to boil, add calcium gluconate and stir to dissolve, then add sodium gluconate, calcium hydroxide and lactic acid in turn, heat to boil, stir to dissolve;
[0012] 3. Add sodium hydroxide solution to adjust the pH value to 4.0-7.5;
[0013] 4. Add 1‰ activated carbon, stir evenly, let stand, filter, then add water for injection to 10000ml, fine filter until qualified;
[0014] 5. Potting, autoclaving, light inspection, printing, packaging.
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The invention discloses a calcium gluconate injection, each liter of which contains 90 to 110g of calcium gluconate, 5 to 9g of lactic acid, 0.2 to 0.5g of calcium hydroxide, 9 to 11g of sodium hydroxide, 0.5 to 5g of sodium gluconate and the balance water for injection. The calcium gluconate injection is prepared according to the following steps: taking and boiling the water for injection; adding and stirring calcium gluconate to the water to dissolve; adding sodium gluconate, calcium hydroxide and lactic acid in turn; heating the mixture to boil and stirring to dissolve; adding the sodium hydroxide solution for adjusting the pH value; adding activated carbon; stirring the activated carbon evenly; standing and filtering the resultant ; adding the full quality of water for injection to the resultant; finely filtering the resultant to qualify; and encapsulating and sterilizing the resultant under high pressure. The calcium gluconate injection has strong stability and stable quality, and basically does not generate crystals within the storage period at low temperature.
Description
[0001] The technical field [0002] The invention belongs to the field of medicine, in particular to a calcium gluconate injection and a preparation method thereof. Background technique [0003] In the prior art, calcium gluconate injection is a small-volume injection product, the solubility of calcium gluconate in water is 3.33%, and the product specification is 10% concentration, which is a supersaturated solution. Therefore, crystallization tends to occur during storage. In traditional prescriptions, lactic acid and calcium hydroxide produce calcium lactate, which can help dissolve calcium gluconate to a certain extent, but it can only prevent calcium gluconate from crystallizing in a short period of time. , especially under low temperature conditions, the solubility of calcium gluconate gradually decreases, so that saturated calcium gluconate gradually precipitates and crystallizes. Contents of the invention [0004] The purpose of the present invention is to overcome ...
Claims
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IPC IPC(8): A61K9/08A61K31/191A61K47/12A61P3/02
Inventor 杨金庆彭琳璟王振刚
Owner HEBEI TIANCHENG PHARMA
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