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Ethylenediamine diaceturate freeze-dried powder for injection and preparation method thereof

A technology of ethylenediamine diacetamidoacetic acid and freeze-dried powder, which is applied in freeze-dried transportation, powder transportation, blood diseases, etc., and can solve the problem of unstable quality and increased side effects The risk of large clinical use, the step control process is not very standardized, etc., to achieve the effect of improving clinical use safety, high clinical use safety, and avoiding side effects

Inactive Publication Date: 2015-02-18
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, ethylenediamine diacetamidoacetic acid for injection is mainly stored in the form of lyophilized powder. However, in the preparation process of ethylenediamine diacetamidoacetic acid ethylenediamine lyophilized powder for injection, the step control process is not very standardized, and the parameter control Inaccurate and other problems lead to unstable quality of the obtained freeze-dried powder of ethylenediamine diacetamidoacetic acid for injection, so the shelf life has a large fluctuation range, and the risk of clinical use is relatively high. In addition, in order to improve the stability of drug performance, The side effects caused by adding a variety of excipients also increase the risk of clinical use

Method used

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  • Ethylenediamine diaceturate freeze-dried powder for injection and preparation method thereof
  • Ethylenediamine diaceturate freeze-dried powder for injection and preparation method thereof
  • Ethylenediamine diaceturate freeze-dried powder for injection and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0038] The invention provides a freeze-dried powder of ethylenediamine diacetamide for injection, which comprises 400 g of ethylenediamine diacetamide and 60 g of lactose, and the weight ratio of ethylenediamine diacetamide:lactose is 20:3.

[0039] The preparation method of diacetamidoacetic acid ethylenediamine freeze-dried powder for injection comprises the following steps:

[0040] S1 formula preparation;

[0041] S2 liquid preparation:

[0042] S2-1: Disperse ethylenediamine diacetamidoacetic acid and lactose in water for injection, stir until completely dissolved to obtain a clear liquid;

[0043] S2-2: Add medicinal activated carbon, stir for 30 minutes to make it evenly dispersed, successively pass through a 0.45 μm microporous membrane for filtration decarbonization, and pass through a 0.22 μm microporous membrane for fine filtration and decarbonization, and pass through coarse filtration and fine filtration The multi-level filtration method of filtration can improv...

Embodiment 2 Embodiment 5

[0058] In Example 1 to Example 5, the composition formula of ethylenediamine diacetamidoacetic acid lyophilized powder for injection is shown in Table 1, and its preparation method is the same as Example 1, and the finished product obtained in Example 1 to Example 5 Stability studies were continued at room temperature. As can be seen from the data in Table 1, the resulting ethylenediamine diacetamidoacetic acid freeze-dried powder for injection has high quality, good stability, low water content in the finished product, and a shelf life of 28 days. more than a month. Especially in Example 1, when the weight ratio of ethylenediamine diacetamide: lactose was 20:3, the stability of the ethylenediamine lyophilized powder for injection obtained was the best, and the shelf life could reach 36 months.

[0059] Table 1 Diacetylethylenediamine lyophilized powder for injection with different formulations

[0060]

[0061]

Embodiment 6 8

[0063] In Embodiment 6 to Embodiment 8, the composition formula of ethylenediamine diacetamidoacetic acid lyophilized powder for injection is the same as that of Embodiment 1, and the preparation method is to reduce the temperature in steps S4-1 to S4-4, the first The temperature rise, temperature rise rate, heat preservation temperature, heat preservation time and vacuum degree of temperature rise for the second time are replaced with the numerical values ​​shown in Table 2, and the stability study is continued on the resulting finished product at room temperature, and the results are as shown in Table 2. Compared with the prior art, the method of the present invention adopts a vacuum low-temperature freeze-drying process to prepare medicines in airtight containers to ensure that the medicines are not easy to oxidize and deteriorate, and overcome the problem of medicine decomposition caused by high temperature in the production process. The obtained diacetyl diacetyl Ethylened...

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Abstract

The invention provides ethylenediamine diaceturate freeze-dried powder for injection. The ethylenediamine diaceturate freeze-dried powder comprises ethylenediamine diaceturate and lactose in the weight ratio of (16-27):3. According to the ethylenediamine diaceturate freeze-dried powder, the formula is simple, the kind of the auxiliary materials is fewer, the freeze-dried powder is applicable to popularization, side effects caused by excessive addition of auxiliary materials are avoided, and the safety of clinical use is improved. The invention further provides a preparation method of the ethylenediamine diaceturate freeze-dried powder for injection. Through accurate control on parameters, such as the heating speed, the holding temperature, the holding time, the pressure and the like, of freeze-drying process steps, the obtained ethylenediamine diaceturate freeze-dried powder for injection is more normative in preparation course, good in product quality and high in stability.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a freeze-dried powder of ethylenediamine diacetamidoacetic acid for injection and a preparation method thereof. Background technique [0002] Ethylenediamine diacetylaminoacetate, the main feature is that it can promote fibrinogen to fibrin, accelerate blood coagulation, promote platelets to release coagulation active substances, enhance platelet aggregation and adhesion, shorten coagulation time, and produce hemostatic effect. Drip injection, push injection or intramuscular injection, easy to use and widely used in gastrointestinal bleeding, eye and nose bleeding, gynecological bleeding, hemorrhoid bleeding, surgical bleeding, etc., suitable for various departments of the hospital Features: rapid hemostasis, long-lasting effect. Pharmacological toxicity: (1) Inhibit plasminogen activator, so that plasminogen cannot be activated into plasmin, thereby inhibiting the dissolution of fibrin a...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/197A61P7/04
Inventor 王志涛林小雪张丽华
Owner HAINAN GENERAL & KANGLI PHARMA
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