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Lobaplatin pharmaceutical composition for injection and preparation method thereof

A technology for composition and injection, which is applied in the direction of drug combinations, pharmaceutical formulas, active ingredients of heavy metal compounds, etc., can solve the problems of high content of related substances and moisture in freeze-dried finished products, long preparation process time, and large damage to production equipment. The effect of reducing complicated operation process, improving appearance and reducing production cost

Active Publication Date: 2014-02-26
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The patent application CN101953805A of Guizhou Yibai Pharmaceutical Co., Ltd. discloses a preparation method of lobaplatin freeze-dried powder injection with low moisture content, which not only requires strict and complicated control of the freeze-drying curve, but also The content of related substances and moisture are high, which increases the risk in clinical use
[0008] The above prior art uses a relatively cumbersome preparation method to prepare lobaplatin preparations, resulting in a longer preparation process, and this process results in a longer freeze-drying process and greater damage to production equipment

Method used

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  • Lobaplatin pharmaceutical composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription

[0042] Loba5g lactose15g Water for Injection Volume up to 300ml

[0043] Preparation Process:

[0044] 1. Weigh 15g of lactose, add 240ml of water for injection at room temperature, and stir until completely dissolved;

[0045] 2. Weigh 5 g of lobaplatin trihydrate, add it to the lactose solution, and stir until completely dissolved;

[0046] 3. Add 0.15g of activated carbon to the solution, decarburize at 40°C for half an hour, filter and decarburize; add water for injection to the full amount, and mix well;

[0047] 4. Fill the liquid medicine in a unit vial and send it to the freeze-drying box for freeze-drying;

[0048] 5. After the product enters the box, it is cooled to about -45°C and pre-frozen and kept for 2.5 hours; the cold trap is opened and the vacuum is turned on; the temperature is raised to 35°C and then kept for 20 hours;

[0049] The finished product has 1.7% related substances, 0.9% moisture and 98.5% content.

Embodiment 2

[0051] prescription

[0052] Loba10g Mannitol1g Water for Injection Constant volume to 100ml

[0053] Preparation Process:

[0054] 1. Weigh 1g of mannitol, add 70ml of water for injection at room temperature, and stir until completely dissolved;

[0055] 2. Weigh 10g of lobaplatin, add it to the mannitol solution, and stir until completely dissolved;

[0056] 3. Add 0.1g activated carbon to the solution, decarburize at 30°C for half an hour, filter and decarburize; add water for injection to the full amount, and mix well;

[0057] 4. Fill the liquid medicine in a unit vial and send it to the freeze-drying box for freeze-drying;

[0058] 5. After the product enters the box, it is cooled to about -45°C and pre-frozen and kept for 2.5 hours; the cold trap is opened and the vacuum is turned on; the temperature is raised to 35°C and then kept for 18 hours;

[0059] The finished product has 1.4% related substances, 0.8% moisture and 99.2% content.

Embodiment 3

[0061] prescription

[0062] Loba10g glucose50g Water for Injection Volume up to 200ml

[0063] Preparation Process:

[0064] 1. Weigh 50g glucose, add 140ml water for injection at room temperature, and stir until completely dissolved;

[0065] 2. Weigh 10g lobaplatin, add it to the glucose solution, and stir until it is completely dissolved;

[0066] 3. Add 0.06g of activated carbon to the solution, decarburize at 50°C for half an hour, filter and decarburize; add water for injection to the full amount and mix well;

[0067] 4. Fill the liquid medicine in a unit vial and send it to the freeze-drying box for freeze-drying;

[0068] 5. After the product enters the box, cool down to about -45°C and pre-freeze and keep it for 2.5 hours; open the cold trap and open the vacuum; increase the temperature to 5°C and then keep it for 10 hours; increase the temperature to 38°C and keep it warm for 15 hours; , Get the finished product out of the box.

[0069] The finished product has 1.5% rel...

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PUM

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Abstract

The invention belongs to the chemical pharmaceuticals field, and specifically provides a lobaplatin pharmaceutical composition for injection and a preparation method thereof. The lobaplatin pharmaceutical composition comprises lobaplatin and an excipient in a mass ratio of 1:(0.1-5), wherein the excipient can be selected from monosaccharide, disaccharide, polysaccharide, polyhydric alcohols, amino acids and the like, and preferably selected from polysaccharide. The lobaplatin pharmaceutical composition for injection provided by the invention is less in content of related substances, low in water content and good in stability, and compared with the quality of a finished product prepared in the prior art, the quality is improved to a great extent.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a lobaplatin pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Lobaplatin (D19466), whose chemical name is 1,2-diaminomethyl-cyclobutane-lactate platinum, is the third-generation platinum antineoplastic drug after cisplatin and carboplatin. Shown in chemical formula I is the structure of lobaplatin trihydrate: [0003] [0004] I [0005] Lobaplatin was developed by Asta Medica AG of Germany. In 2003, the State Food and Drug Administration approved Lobaplatin as a national first-class new drug. Lobaplatin is an alkylating agent, which has definite cytotoxic effect on various animal and human tumor cell lines, similar and strong antitumor effect to cisplatin, and still has a certain cytotoxic effect on cisplatin-resistant cell lines , which is less toxic, has good solubility and is stable in water. Mainly fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/282A61K47/36A61K47/34A61K47/26A61K47/10A61K47/18A61P35/00
Inventor 陈庆财陈祥峰李晓昕贾元超
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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