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A kind of carrimycin freeze-dried powder preparation and preparation method thereof

A technology of freeze-dried powder injection and carrimycin, which is applied in the field of medicine, can solve the problems of low bioavailability, and achieve the effects of short reconstitution time, outstanding curative effect, and less insoluble particles

Active Publication Date: 2022-06-21
沈阳信达泰康医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In the prior art, there are only ordinary tablets and enteric-coated tablets in the preparations containing corimycin, and their bioavailability is very low, and there is no injection in the existing preparations, so the application of corimycin is limited

Method used

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  • A kind of carrimycin freeze-dried powder preparation and preparation method thereof
  • A kind of carrimycin freeze-dried powder preparation and preparation method thereof
  • A kind of carrimycin freeze-dried powder preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1: Screening and optimization of freeze-dried powder for injection

[0039] Appearance and Clarity: Visually inspect the appearance; dissolve the freeze-dried powder injection with sodium chloride injection before checking, and visually inspect its clarity.

[0040] (1) Comparison of the solubility of carrimycin and organic or inorganic acids in water

[0041]

[0042] The above solubility test is based on the solubility of 100 mg of carrimycin in water at 25 °C as an indicator;

[0043] Slightly soluble: 100mg of carrimycin is dissolved in 10-100ml of water;

[0044] More soluble: 100mg of carrimycin is dissolved in 2-3ml of water;

[0045] Soluble: 100mg of carrimycin is dissolved in 0.1-1ml of water;

[0046] The test results show that the solubility of canrimycin is improved to different degrees after mixing with different acids. The solubility of mycin component is better, but when canrimycin is combined with sulfuric acid, its pH is less than 2 and ...

Embodiment 2

[0089] prescription:

[0090]

[0091] Preparation method: take a certain proportion of the prescribed amount of water for injection, add the prescribed amount of mannitol, after it is completely dissolved, add the prescribed amount of anhydrous citric acid and karimycin, and add the remaining amount of water for injection, wait until it is completely dissolved. After dissolving, the intermediate medicinal liquid is obtained, which is then filtered through a filter membrane. Put it in a freeze-drying box, the temperature is -40℃, pre-freeze for 5h, the sublimation temperature is -20℃, the vacuum is ≤20Pa, the sublimation time is about 10h, and then it is heated and dried, the drying temperature is 10℃, the time is 4h, and the temperature is 25°C for 4 hours.

Embodiment 3

[0093] prescription:

[0094]

[0095] Preparation method: take a certain proportion of the prescribed amount of water for injection, add the prescribed amount of mannitol, after it is completely dissolved, add the prescribed amount of anhydrous citric acid and karimycin, and add the remaining amount of water for injection, wait until it is completely dissolved. After dissolving, the intermediate medicinal liquid is obtained, which is then filtered through a filter membrane. Put it in a freeze-drying box, the temperature is -40℃, pre-freeze for 5h, the sublimation temperature is -20℃, the vacuum is ≤20Pa, the sublimation time is about 10h, and then it is heated and dried, the drying temperature is 10℃, the time is 4h, and the temperature is 25°C for 4 hours.

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Abstract

The invention belongs to the technical field of medicine, and relates to a corimycin freeze-dried powder preparation and a preparation method thereof. The freeze-dried powder preparation is prepared by corimycin, an organic acid or an inorganic acid, a proppant and water for injection. to make. Wherein, every 1000ml of water for injection contains 40-115g of corimycin, 20-100g of organic acid or inorganic acid, and 15-30g of proppant. The weight ratio of carrimycin, organic acid or inorganic acid is: 1:1-5:1, preferably 2:1-4:1. Inorganic acid includes hydrochloric acid, sulfuric acid or phosphoric acid; described organic acid includes citric acid, anhydrous citric acid, maleic acid, adipic acid, acetic acid, methanesulfonic acid, ethanesulfonic acid, fumaric acid, tartaric acid, apple Acid, pyroglutamic acid, lactic acid, succinic acid or C1-C4 straight chain or branched chain alkane sulfonate unsubstituted or substituted by any position of 1-3 hydroxyl groups. The freeze-dried powder injection of the invention has the characteristics of short reconstitution time, few insoluble particles, easy preparation and relatively stable characteristics.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a lyophilized powder preparation of canrimycin and a preparation method thereof. Background technique [0002] Cilimycin is a new type of spiramycin derivative researched by genetic engineering technology. According to the "Nomenclature Principles for Common Names of Chinese Medicines", after technical review and research by the State Pharmacopoeia Committee, the Chinese generic name of Bitespiramycin was changed to Calimycin, and the English name was Calimycin. [0003] Carrimycin is effective against Gram-positive bacteria, especially some drug-resistant bacteria (such as β-lactam-resistant Staphylococcus aureus, erythromycin-resistant Staphylococcus aureus, etc.), and has no obvious cross-resistance with similar drugs. At the same time, it has good antibacterial activity against mycoplasma and chlamydia, and also has antibacterial activity against some gram-negative bacteria...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7048A61K47/02A61K47/10A61K47/12A61K47/26A61P11/00A61P31/04A61P31/14
CPCA61K31/7048A61K9/19A61K47/02A61K47/12A61K47/10A61K47/26A61P31/14A61P11/00A61P31/04
Inventor 刘洪卓刘琦何仲贵马宏达赵小峰杨生武姜琪坤
Owner 沈阳信达泰康医药科技有限公司
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