Preparation method of lidocaine hydrochloride injection
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A technology for preparing lidocaine hydrochloride and injection, which is applied in the field of medicinal chemistry, can solve the problems that sterility cannot be effectively guaranteed, medication safety cannot be effectively guaranteed, product sterility inspection is unqualified, etc. Great application value, simple method effect
Active Publication Date: 2015-06-10
SHANGHAI ZHAOHUI PHARMA
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[0017] However, the sterility test of the product prepared by the above method failed
Due to the special route of administration of injection products, the high risk of this type of produc...
Method used
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Embodiment 1
[0040] Example 1 Preparation of lidocaine hydrochloride injection:
[0041]
Ingredients
Per 10,000 ml prescription
1
Lidocaine hydrochloride
218.4g
2
Sodium chloride
85g
3
Medicinal charcoal
49g
4
Water for Injection
Add to 10,000 ml
[0042] 1 Put 80kg of water for injection (30℃) into the dissolution tank, and add the prescribed amount of sodium chloride.
[0043] 2 Put the prescription amount of lidocaine hydrochloride into the dissolution tank and stir.
[0044] 3 Add the weighed medicinal charcoal and stir.
[0045] 4 Add water for injection to full volume and stir.
[0046] 5 The solution is filtered with a titanium filter first, and then through 0.45μm and 0.2μm microporous membrane cartridge filters.
[0047] 6 Adjust the pH value to the range of 4.0-5.0.
[0048] 7 Determine the intermediate product content and pH value.
[0049] 8 Fill and seal into 5ml ampoule.
[0050] 9 Sterilize at 116°C for 30 minutes.
[0051] 10 light inspection.
[0052] 11 Printing, packa...
Embodiment 2
[0054] Example 2 Preparation of lidocaine hydrochloride injection
[0055] The composition and preparation method are the same as in Example 1, but the water temperature of the water for injection in step (1) is 40°C.
Embodiment 3
[0056] Example 3 Preparation of lidocaine hydrochloride injection
[0057] The composition and preparation are the same as in Example 1, but the water temperature of the water for injection in step (1) is 50°C; the sterilization conditions in step (9) are 116°C for 40 min.
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Abstract
The invention provides a preparation method of a lidocaine hydrochloride injection. The method provided by the invention is improved as follows: the sterilization condition is improved to 116 DEG C for 30-40 minutes from 100 DEG C for 30 minutes; and the temperature of liquid-dosing injection water is improved to 30-50 DEG C from 70-80 DEG C. The defects of an existing method are overcome; by virtue of test research on the prepared lidocaine hydrochloride injection, the indexes such as sterile detection, related substances and content reach the quality standard of the second part lidocaine hydrochloride injection of the Chinese pharmacopoeia 2010; the quality risk of the product and the medication risk of patients are relatively well reduced. By virtue of an accelerated test and a long-term stability test, the result shows that the lidocaine hydrochloride injection prepared by the method provided by the invention is good in stability. The method provided by the invention is simple; new cost is not increased; and the method is suitable for large-scale industrial production, and has relatively great application value.
Description
Technical field [0001] The present invention relates to medicinal chemistry. Specifically, it relates to a preparation method of lidocaine hydrochloride injection. Background technique [0002] Lidoca is a local anesthetic and antiarrhythmic drug. Mainly used for infiltration anesthesia, epidural anesthesia, surface anesthesia (including mucosal anesthesia during thoracoscopy or abdominal surgery) and nerve conduction block. It can also be used for ventricular premature beats and ventricular tachycardia after acute myocardial infarction, as well as for ventricular arrhythmias caused by digitalis poisoning, cardiac surgery and cardiac catheterization. The preparation form used clinically is lidocaine hydrochloride injection. [0003] The composition of lidocaine hydrochloride injection is as follows: [0004] Ingredients Per 10,000 ml prescription 1 Lidocaine hydrochloride 218.4g 2 Sodium chloride 85g 3 Medicinal charcoal 49g 4 Water for Injection Add to 10,000 m...
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