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A kind of ertapenem sodium pharmaceutical composition and preparation method thereof

A technology of ertapenem sodium and composition, applied in the field of medicine, can solve problems such as affecting the antibacterial activity of preparations, and achieve the effects of high treatment efficiency and cure rate, reduced treatment cost and short treatment time

Active Publication Date: 2018-11-27
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventors found in the research that the final preparation of ertapenem sodium contains a certain proportion of the compound of formula 2, although the stability of the final preparation is ensured, it will also affect the antibacterial activity of the preparation

Method used

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  • A kind of ertapenem sodium pharmaceutical composition and preparation method thereof
  • A kind of ertapenem sodium pharmaceutical composition and preparation method thereof
  • A kind of ertapenem sodium pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Preparation of ertapenem sodium solid pharmaceutical composition

[0044] Table 1: Ertapenem sodium solid pharmaceutical composition prescription (1000 bottles, specification: 1g)

[0045] Name of raw material

Dosage (g)

Ertapenem Sodium

1046g

sodium bicarbonate

185g

sodium hydroxide

Appropriate amount

Water for Injection

Add to 11000g

Packed according to 11g per bottle, making 1000 bottles in total

[0046] Preparation Process:

[0047] ① Dissolve the prescribed amount of sodium bicarbonate in 1L of water for injection, cool to 0-5°C, and set aside;

[0048] ②Add 50% of the prescription amount of ertapenem sodium raw material into 7L of water for injection at 0-5°C, and stir to dissolve;

[0049] 3. At 0-5°C, add the sodium bicarbonate solution of step 1 to the solution obtained in step 2;

[0050] ④At 0-5°C, slowly add the remaining 50% of the prescription amount of ertapenem sodium raw material ...

Embodiment 2～6

[0060] Examples 2-6: Preparation of Ertapenem Sodium Solid Pharmaceutical Composition (Investigation on the Dosage of Sodium Bicarbonate)

[0061] With reference to the prescription technology of embodiment 1, just change the consumption of sodium bicarbonate in the step (1), experimental result sees the following table:

[0062] The experimental result of table 3 embodiment 2~6

[0063]

[0064] The experimental results show that the molar ratio of sodium bicarbonate to ertapenem sodium is between 0.5 and 2.0, and the ratio of carbamate to ertapenem sodium in the final freeze-dried product ranges from 20:80 to 70:30.

Embodiment 7～13

[0065]Examples 7-13: Preparation of ertapenem sodium solid pharmaceutical composition (investigation on the initial dosage of ertapenem sodium raw materials)

[0066] Referring to the prescription process of Example 1, only the initial dosage of ertapenem sodium raw material in step ② was changed, and the experimental results are shown in the following table:

[0067] Table 4 embodiment 7~13 experimental results

[0068]

[0069] The experimental results show that the initial dosage of ertapenem sodium in step ② is between 30% and 70%, and the ratio of carbamate to ertapenem sodium in the final freeze-dried product ranges from 20:80 to 70: 30.

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PUM

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Abstract

The present invention relates to a solid pharmaceutical composition of ertapenem sodium and a preparation method thereof. The pharmaceutical composition contains ertapenem sodium represented by formula 1, and a compound represented by formula 2 or its sodium salt or hydrate Or solvates, and pharmaceutically acceptable excipients. In the solid pharmaceutical composition of ertapenem sodium provided by the present invention, the compound of formula 2 or its pharmaceutically acceptable salt, hydrate or solvate accounts for less than 70%, which ensures the therapeutic effectiveness of the final formulation of ertapenem sodium.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a pharmaceutical composition of ertapenem sodium and a preparation method thereof. Background technique [0002] Ertapenem sodium (Ertapenem sodium, structural formula as formula 1), chemical name: [0003] (1R,5S,6S,8R,2S*,4S*)-2-[2-[3-Carboxyl-phenylcarbamoyl]-pyrrolidinyl-4-thio]-6-(1-hydroxyethyl Base)-1-methylcarbapenem-3-carboxylic acid monosodium salt, a new type of broad-spectrum carbapenem antibiotics jointly developed by Merck and AstraZeneca, including Gram-positive bacteria and Gram-negative bacteria Both aerobic and anaerobic bacteria have good antibacterial activity. [0004] [0005] The trade name of Ertapenem Sodium’s listed preparation product is “Yiwanzhi”, which is a sterile freeze-dried powder. Each unit of ertapenem sodium preparation also contains 175 mg of sodium bicarbonate, and the pH is adjusted to 7.5 with sodium hydroxide. [0006] CN1198162...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/407A61P31/04
Inventor 申东民马玉秀米毅赫玉霞周付刚
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD