Cefquinome sulfate injection and low-temperature high-shear preparation method thereof
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A technology for cefquinoxime sulfate and injection, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. and other problems, to achieve the effect of simple preparation steps and easy operation
Active Publication Date: 2017-11-10
GUANGDONG WENS DAHUANONG BIOTECH
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However, when the rotor rotates at high speed, a large amount of heat will be generated, which will cause the temperature of the liquid medicine to rise rapidly; the active ingredient of cefquinome sulfate will degrade rapidly in a high temperature environment above 60°C, the potency will decrease, the properties will change, and the yield of the product will decrease. At the same time, it also caused the related substances in the finished product to exceed the standard
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Embodiment 1
[0035] Prepare cefquinome sulfate injection, comprising the steps:
[0036] (1) Weigh each component according to the following mass percentage, and set aside;
[0037] Cefquinome Sulfate 2.3%,
[0038] Lecithin 1.0%,
[0039] Aluminum stearate 2.0%,
[0040] The balance is ethyl oleate;
[0041] (2) High temperature sterilization and cooling of auxiliary materials;
[0042] Add 85% ethyl oleate into the liquid mixing tank, then add the formulated amount of aluminum stearate and lecithin, and stir evenly; heat to 121°C, keep constant temperature, and continue stirring for 30 minutes (the maximum temperature should not exceed 130°C) ; Circulate cold water into the interlayer of the liquid distribution tank, after cooling down to 50°C, slowly add the prescribed amount of cefquinoxime sulfate, and stir until uniform while adding; then use ethyl oleate to make up the volume, and stir evenly;
[0043] (3) Cefquinome sulfate is subjected to low temperature and high shear to obt...
Embodiment 2
[0048] Prepare cefquinome sulfate injection, take each component by the following mass percentages, and set aside;
[0049] Cefquinome Sulfate 2.4%,
[0050] Lecithin 1.0%,
[0051] Aluminum stearate 2.0%,
[0052] Add ethyl oleate to the full amount;
[0053] All the other preparation methods are the same as in Example 1.
Embodiment 3
[0055] Prepare cefquinome sulfate injection, take each component by the following mass percentages, and set aside;
[0056] Cefquinome Sulfate 2.5%,
[0057] Lecithin 1.0%,
[0058] Aluminum stearate 2.0%,
[0059]Add ethyl oleate to the full amount;
[0060] All the other preparation methods are the same as in Example 1.
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Abstract
The invention discloses a cefquinome sulfate injection and a low-temperature high-shear preparation method thereof, wherein the cefquinome sulfate injection comprises, by mass, 2.25-2.75% of cefquinome sulphate, 0.9-1.1% of lecithin, 1.8-2.2% of aluminum stearate, and the balance of ethyl oleate. The preparation method comprises: carrying out low-temperature high shear on cefquinome sulfate to obtain an ultra-fine suspension, and homogenizing by using a colloid mill to finally prepare the cefquinome sulfate injection. Compared to the preparation method in the prior art, the preparation method of the present invention has the following advantages that the drug liquid temperature is controlled at 2-8 DEG C during the shear, the finally obtained product is detected according to the quality standard, various detection indexes meet the regulations, the sum of various impurity peak area in the related substance detection is 3 times (3.0%) less than the main peak area of the control solution, the yield of the product is high, and the preparation steps are simple and are easy to operate.
Description
technical field [0001] The invention relates to the field of biomedicine, in particular to a cefquinome sulfate injection and a low-temperature, high-shear preparation method thereof. Background technique [0002] The molecular formula of cefquinome is C 23 h 24 N 6 o 5 S 2 , molecular weight 528.60, white or off-white crystalline powder, slightly soluble in water, solubility at pH 7.0 is 11-12mg / mL, unstable and easy to decompose in high temperature and humid environment. Its chemical structure is as follows, [0003] [0004] The characteristics of the structural formula of cefquinome are: there is a quaternary nitrogen positive charge on the 3rd position of the molecule, which can form zwitterions; , which can prevent the enzyme from acting on the mother nucleus and improve the stability of β-lactamase, and at the same time, most of the α-carbons at the 7-position can be substituted to reduce the access of β-lactamase. [0005] Cefquinome is a cephalosporin anti...
Claims
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