Method for preparing powder injection using superfine communication technique and prepared products

A kind of superfine pulverization technology and technology, which is applied in the field of preparation of powder injections and products prepared by superfine pulverization technology, which can solve the stability problem that has not been completely solved, the freeze-dried powder injection process is complicated, the application of superfine pulverization technology, etc. problem, to achieve the effect of facilitating packaging, good clarity and reducing irritation

Inactive Publication Date: 2008-12-31
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the routinely used preparation of sterile powder for injection such as freeze-dried powder injection has the following disadvantages: the freeze-dried powder is uneven, the color is poor, there is a difference in pure loading, there is a problem in clarity, the prepared product has low purity, and the stability of the substance The sex problem has not been completely solved, and it is still not easy to store for a long time, etc., and the process of freeze-dried powder injection is more complicated and the cost is higher
But at present, technicians in the pharmaceutical field mainly apply ultrafine pulverization technology to traditional Chinese medicine. So far, there is almost no application of superfine pulverization technology to chemical medicines and western medicines to improve the defects in the preparation of chemical medicines.

Method used

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  • Method for preparing powder injection using superfine communication technique and prepared products
  • Method for preparing powder injection using superfine communication technique and prepared products
  • Method for preparing powder injection using superfine communication technique and prepared products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Preparation of Invert Sugar Sterile Powder for Injection

[0033] prescription

[0034] Fructose 6250g

[0035] Glucose 6250g

[0036] Preparation steps:

[0037] 1. Aseptic pretreatment of chemical drugs fructose and glucose

[0038] a. In the 10,000-class clean area, put fructose: ethanol which is 1:8 by weight to volume ratio; glucose: 80% ethanol which is 1:4 by weight to volume ratio, and put into two reaction tanks respectively, and slowly heat up to 70 ℃, stir separately to dissolve, add medicinal charcoal with a dosing volume of 0.2-0.5% (g / ml), stir for 30 minutes, filter to remove charcoal while it is hot, then fine filter through a 0.22μm filter membrane, and cool to 25±5 ℃, add appropriate amount of fructose and glucose seed crystals respectively, stir and crystallize for 10-30 hours (preferably 12-18 hours);

[0039] b. Transfer the crystallized drug solution to a sterile room, filter, and wash with ethanol approximately equivalent to 0.15-0.25 t...

Embodiment 2

[0045] Preparation of Clindamycin Phosphate Sterile Powder for Injection

[0046] Preparation steps:

[0047] 1. Aseptic pretreatment of the chemical drug clindamycin phosphate

[0048]a. In the 10,000-class clean area, put 900g of clindamycin phosphate and water for injection into the reaction tank at a weight / volume ratio of 1:1~2, slowly raise the temperature to 50°C, stir to dissolve, and add a dosing amount of 0.1~ 0.3% (g / ml) medicinal charcoal, stirred for 10 to 30 minutes, filtered while hot to remove charcoal, then finely filtered through a 0.22 μm filter membrane, cooled to room temperature, added 3 times the volume of the filtrate and mixed evenly, Then add an appropriate amount of clindamycin phosphate seed crystals, stir and crystallize for 8-20 hours (preferably 10-15 hours);

[0049] b. Transfer the crystallized medicinal solution to a sterile room, filter, and wash with an amount of absolute ethanol approximately equivalent to 0.1 to 0.3 times the volume ...

Embodiment 3

[0055] Preparation of sterile powder for injection of cefpiramide sodium

[0056] Preparation steps:

[0057] 1. Use 2000g of cefpiramide sodium aseptic raw material powder, purchased from Shandong Lukang Pharmaceutical Co., Ltd., without aseptic treatment.

[0058] 2. Pre-crushing the above-mentioned cefpiramide sodium sterile raw material powder through mortar grinding, and pulverizing into coarse particles that all pass through 80 meshes;

[0059] 3. Use QWJ-5 airflow vortex pulverizer to superfine the above coarse particles respectively, and pulverize them into superfine powders that all pass 1340 mesh;

[0060] Grinding conditions: the air temperature after freeze-drying is 0°C, the water content is 0.6%, the pressure is 1.5MP when injected into the ultrafine pulverizer, the working pressure of the ultrafine pulverizer is 1.5MP, the working temperature is 4°C, and the pulverization time is 60min .

[0061] 4. Dispense the above ultrafine powder into antibiotic glas...

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Abstract

The present invention relates to a method of using a superfine pulverizing technology to prepare sterile powder for injection (powder injection) of chemical medicine and the prepared medicine powder injection. Invert sugar, clindamycin phosphate, cefpiramide sodium, cefepime hydrochloride, latamoxef sodium or cefmetazole sodium are preferable as the chemical medicine.

Description

technical field [0001] The application relates to a method for preparing a pharmaceutical dosage form by using ultrafine pulverization technology and the prepared product, more particularly, the application relates to a method for preparing sterile powder for injection (powder injection) of a chemical drug by using ultrafine pulverization technology and the prepared drug powder injection. Background technique [0002] Sterile powder for injection, referred to as powder injection, is a dosage form prepared for drugs that are unstable in water. It is usually prepared by freeze-drying method, that is, the drug solution to be dried is pre-frozen into a solid, and then under low temperature and low pressure conditions, a drying method is used to remove water from the frozen state without sublimation. Unstable drugs. However, the routinely used preparation of sterile powder for injection such as freeze-dried powder injection has the following disadvantages: the freeze-dried powd...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/546A61K31/7004A61K31/7056A61J3/02A61P3/02A61P31/04
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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