A kind of preparation method of nicorandil freeze-dried preparation with good stability
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A technology for nicorandil and freeze-dried preparations, which is applied in the field of preparation of nicorandil freeze-dried preparations and can solve problems such as acute clinical consequences
Active Publication Date: 2019-02-26
BEIJING SIHUAN KEBAO PHARM CO LTD
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Problems solved by technology
For injections administered by injection, if the active ingredient degrades to produce side effects products, it will bring serious and acute clinical consequences
Method used
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Embodiment 1
[0049] The preparation of embodiment 1 nicorandil solution
[0050] prescription
[0051]
[0052] Preparation:
[0053] ① Take about 40% of the prescribed amount of water for injection, add mannitol to dissolve it completely;
[0054] ② Add ethanol (95%) to the stainless steel bucket, then add about 3L water for injection, stir and mix to prepare about 50% ethanol solution, set aside;
[0055] ③Take the Nicorandil raw material, add it to the cooled 50% ethanol solution, stir to dissolve, pour this solution into the mannitol solution, rinse the stainless steel bucket with water for injection, and pour the washing solution into the mannitol solution, stir evenly;
[0056] ④Add sodium citrate-citric acid solution to the above mixed solution to adjust the pH to 6.8, add water for injection to 15L, and obtain Nicorandil solution;
[0057] ⑤ The solution is sterilized and filtered, and filled.
Embodiment 2
[0058] The preparation of embodiment 2 nicorandil solution
[0059] prescription
[0060]
[0061] The preparation method is the same as in Example 1, wherein the 95% ethanol solution is prepared into a 40% ethanol solution, and the pH of the nicorandil solution is adjusted to 7.2.
Embodiment 3
[0062] The preparation of embodiment 3 nicorandil solution
[0063] prescription
[0064]
[0065] The preparation method is the same as in Example 1, wherein the 95% ethanol solution is prepared into a 30% ethanol solution, and the pH of the nicorandil solution is adjusted to 6.5.
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Abstract
The invention provides a preparation method of a nicorandil freeze-drying preparation with the good stability. The preparation method is characterized by comprising the following steps of a, preparing a nicorandil solution, wherein the nicorandil solution is dissolved into an ethanol solution to be mixed with an excipient solution, and an acid-base adjusting agent is added for adjusting the pH to obtain the nicorandil solution; b, conducting freeze drying. Observation is performed for 6 months through acceleration test conditions and observation is performed for 24 months through long-term test conditions, so that the result shows that freeze-drying preparation related substances, the pH and the content meet the requirement, and the nicorandil freeze-drying preparation has the good stability.
Description
technical field [0001] The invention relates to a preparation method of a nicorandil freeze-dried preparation, which belongs to the field of medicine. Background technique [0002] Nicorandil is an antiangina pectoris drug, which belongs to nitrate ester compound. It has the functions of preventing the dissociation of intracellular calcium ions, enhancing the permeability of cell membranes to potassium ions, dilating tubular blood vessels, continuously enhancing coronary blood flow, and inhibiting coronary artery spasm. The effect of dilating blood vessels does not affect blood pressure, heart rate, myocardial contractility and myocardial oxygen consumption. Nicorandil also has the effect of inhibiting platelet aggregation and preventing thrombosis. Nicorandil is a drug that is unstable to heat. Studies have shown that Nicorandil will degrade at 25°C, and the degraded substances can reach 5%-8% after 1 hour at 60°C, and more than 10% at 100°C for 1 hour. . For injections ...
Claims
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Application Information
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