Levocarnitine for injection and preparation method thereof

A technology for injection and water for injection, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas. It can solve problems affecting drug quality, avoid API degradation, and achieve high safety. The effect of reducing the amount of excipients

Active Publication Date: 2012-01-11
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention also discloses the preparation method of the above-mentioned levocarnitine for injection, which solves the problems that the active ingredients of the existing levocarnitine preparations are degraded during the process of preparation, which affects the quality of the medicine and the safety of the medicine.

Method used

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  • Levocarnitine for injection and preparation method thereof
  • Levocarnitine for injection and preparation method thereof
  • Levocarnitine for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 2

[0044] 25g of sodium dihydrogen phosphate and 2.5g of sodium hydroxide were prepared into 5000g of buffer solution, 100g of levocarnitine and 100g of mannitol were dissolved in the above buffer solution, and 0.1% (g / ml) needle activated carbon was added and stirred evenly. Stir and adsorb for 30 minutes, and filter to remove carbon (0.45μm membrane filtration). Use a 0.22μm microporous filter membrane for fine filtration. After passing the intermediate inspection, the filtrate is filled in a 15ml vial with 5ml / bottle (the liquid should be used up within 6 hours after sterilization), half-tightened, freeze-dried, Capping, visual inspection, labeling, finished product packaging.

Embodiment 3

[0046] 25g of sodium dihydrogen phosphate and 2.5g of sodium hydroxide were prepared into 5000g of buffer solution, 200g of levocarnitine and 200g of mannitol were dissolved in the above buffer solution, and 0.1% (g / ml) needle activated carbon was added and stirred evenly. Stir and adsorb for 30 minutes, and filter to remove carbon (0.45μm membrane filtration). Use a 0.22μm microporous filter membrane for fine filtration. After passing the intermediate inspection, the filtrate is filled in a 15ml vial with 5ml / bottle (the liquid should be used up within 6 hours after sterilization), half-tightened, freeze-dried, Capping, visual inspection, labeling, finished product packaging.

Embodiment 4

[0048] 25g of sodium dihydrogen phosphate and 2.5g of sodium hydroxide were prepared into 5000g of buffer solution, 100g of levocarnitine and 200g of mannitol were dissolved in the above buffer solution, and 0.1% (g / ml) needle activated carbon was added and stirred evenly. Stir and adsorb for 30 minutes, and filter to remove carbon (0.45μm membrane filtration). Use a 0.22μm microporous filter membrane for fine filtration. After passing the intermediate inspection, the filtrate is filled in a 15ml vial with 5ml / bottle (the liquid should be used up within 6 hours after sterilization), half-tightened, freeze-dried, Capping, visual inspection, labeling, finished product packaging.

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Abstract

The invention discloses a levocarnitine for injection and a preparation method thereof. The preparation method comprises the following steps: weighing sodium dihydrogen phosphate and sodium hydroxide, using injection water to dissolve the weighed sodium dihydrogen phosphate and sodium hydroxide and diluting and uniformly mixing, dissolving levocarnitine and mannitol in the buffer solution, addingneedle active carbon and stirring uniformly, stirring for adsorption, and using filtering membrane for filtering and removing carbon; carrying out fine filtration through 0.22 mum microporous membrane, after the intermediate passed the inspection, filling the filtrate with the amount of 5 ml in 15 ml penicillin bottle (using up the liquor in 6 h after degerming), and carrying out half-plug pressing, freeze-drying, capping, visual inspection, labeling, and packaging. According to the invention, buffer salts (the buffer salt ion pair consisting of sodium dihydrogen phosphate and sodium hydroxide) with buffer effect are used in stead of traditional hydrochloric acid to regulate the pH value of the levocarnitine solution, so that the main drug is always in a stable pH environment in the wholepreparation process, and the API degradation caused by violent change of pH value of levocarnitine is avoided. Compared with the similar kind products, the levocarnitine disclosed in the invention has higher effectiveness and higher safety.

Description

technical field [0001] The invention discloses levocarnitine for injection and a preparation method thereof, which are used for treating a series of complications caused by secondary carnitine deficiency in patients with chronic renal failure and long-term hemodialysis, such as cardiomyopathy, skeletal muscle disease, Arrhythmia, hyperlipidemia, and hypotension and muscle spasms during dialysis. It belongs to the technical field of medical pharmaceutical preparations. Background technique [0002] L-carnitine is a biologically active natural compound that exists in animals. This product is optically active and can be divided into left-handed and right-handed photobodies, and only left-handed has beneficial physiological or pharmacological effects on the human body. The traditional preparation process of levocarnitine for injection only uses 1mol / L hydrochloric acid to adjust the pH. There are no other auxiliary materials and special preparation process, and the process is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/205A61K47/04A61P9/10A61P19/00A61P9/06A61P3/06A61P21/02
Inventor 姜波李华王梅袁春玲董伟吕爽
Owner 长春海悦药业股份有限公司
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