Compound calcium gluconate oral solution and preparation method thereof
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A technology of calcium gluconate and oral solution, which is applied in the field of medicine, can solve problems such as inability to store for a long time, high calcium content, and easy precipitation, and achieve the effects of reducing crystallization rate, promoting dissolution, and improving stability
Pending Publication Date: 2022-01-04
KUNMING YUANRUI PHARMA
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[0003] The prescription of compound calcium gluconate oral solution in the prior art is: calcium gluconate, calcium lactate, lactic acid, sucrose, glucose and essence, have used a large amount of calcium gluconate and calcium lactate in the prescription, and calcium content is high, and solution is too high. In saturated state, there is a problem of easy precipitation at low temperature, and it cannot be stored for a long time at low temperature
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[0040] The present invention also provides the preparation method of the compound calcium gluconate oral solution described in the above-mentioned technical scheme, comprises the following steps:
[0041] Part of the water is first mixed with calcium gluconate to obtain a first solution;
[0042] performing second mixing of the first solution and calcium lactate to obtain a second solution;
[0043] performing a third mixing of the second solution and lactic acid to obtain a third solution;
[0044] The third solution, mannitol, sweetener, citric acid, essence and remaining water are mixed for the fourth to obtain the compound calcium gluconate oral solution.
[0045] In the present invention, the temperature of the first mixing is preferably 60-70°C.
[0046] In the present invention, the temperature of the third mixing is preferably 40-50°C.
[0047] In the present invention, the volume ratio of the part of water to the remaining water is preferably 4:1.
[0048] In the ...
Embodiment
[0055] EXAMPLES The formulations of Examples 1 to 3 are shown in Table 1.
[0056] The formula of table 1 embodiment 1~3
[0057]
[0058] Preparation Process
[0059] Take 80vol% purified water of the prescription, heat to 60°C, add calcium gluconate and stir to dissolve;
[0060] Add calcium lactate, stir to dissolve, stop heating;
[0061] Cool, add lactic acid when the temperature reaches 40°C, and stir thoroughly for 30 minutes;
[0062] Add mannitol, sucralose, citric acid, essence, stir to dissolve, cool to room temperature, add remaining purified water;
[0063] After stirring and mixing evenly, the solution was filtered with a 0.2 μm filter membrane, and after filtration, it was potted, sterilized at 105°C for 45 minutes, and vacuum leak tested.
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Abstract
The invention provides a compound calcium gluconate oral solution and a preparation method thereof, and belongs to the technical field of medicines. The compound calcium gluconate oral solution contains the mannitol and the citric acid, the freezing point of the oral solution is reduced by adding the mannitol, a good effect of delaying low-temperature precipitation is achieved, the lactic acid serves as a pH regulator, the stability of the oral solution can be effectively improved, the crystallization rate is reduced, however, after the lactic acid is excessive, the lactate content and the pH value can exceed the quality control range, and the lactic acid is not suitable for practical application, the citric acid in the invention increases the acidity of the solution on the premise of not increasing the lactate content, makes up for the deficiency of the lactic acid, and further promotes the dissolution of calcium ions. Data of the embodiment shows that the compound calcium gluconate oral solution provided by the invention can be stably stored at 2-8 DEG C.
Description
technical field [0001] The invention relates to the technical field of medicines, in particular to a compound calcium gluconate oral solution and a preparation method thereof. Background technique [0002] Compound calcium gluconate oral solution is used for the prevention and treatment of calcium deficiency, such as osteoporosis, tetany, bone hypoplasia, rickets, and calcium supplementation for children, pregnant and lactating women, menopausal women, and the elderly. [0003] The prescription of compound calcium gluconate oral solution in the prior art is: calcium gluconate, calcium lactate, lactic acid, sucrose, glucose and essence, have used a large amount of calcium gluconate and calcium lactate in the prescription, and calcium content is high, and solution is too high. In saturated state, there is the problem of easy precipitation at low temperature, and it cannot be stored for a long time at low temperature. Contents of the invention [0004] In view of this, the o...
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