Cimetidine sodium chloride injection production method capable of preventing impurities from exceeding standard

A technology of cimetidine sodium chloride and titin sodium chloride, which is applied in the field of medicine, can solve problems such as immature production process conditions, low product qualification rate, and excessive impurities in liquid medicine, so as to prevent the degradation of impurities from exceeding the standard, The effect of ensuring the quality of medicines and improving the qualified rate

Inactive Publication Date: 2019-03-08
SHANXI NUOCHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The purpose of the present invention is to adopt non-PVC co-extruded film soft bag to exist production process condition immature in the cimetidine sodium chloride injection that adopts non-PVC co-extrusion film soft bag, the finished product that produces has medicinal liquid impurity to exceed standard, quality is not stable, product qualified rate is not high etc. Problem, to provide a production method of cimetidine sodium chloride injection with stable liquid quality and high product qualification rate to prevent impurities from exceeding the standard

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A kind of cimetidine sodium chloride injection production method that prevents impurity from exceeding the standard may further comprise the steps:

[0019] 1) Strong blend:

[0020] a. Add 500L of water for injection to the concentrated preparation tank, open the cooling water valve of the concentrated preparation tank to lower the temperature of the concentrated preparation tank to 60°C;

[0021] b. Turn on the stirring, and the stirring rate is controlled at 64r / min;

[0022] c, drop into 2 kilograms of cimetidine, 9 kilograms of sodium chloride, stir and dissolve for 10-15 minutes;

[0023] d. After confirming that all the raw materials are dissolved, open the liquid outlet valve of the thick dispensing tank and the liquid inlet valve of the dilute dispensing tank, start the circulation pump, and pour the liquid medicine into the dilute dispensing tank;

[0024] e. After all the liquid medicine in the concentrated preparation tank is injected into the thin prepara...

Embodiment 2

[0048] A kind of cimetidine sodium chloride injection production method that prevents impurity from exceeding the standard may further comprise the steps:

[0049] 1) Strong blend:

[0050] a. Add 800L of water for injection to the concentrated preparation tank, open the cooling water valve of the concentrated preparation tank to reduce the temperature of the concentrated preparation tank to 70°C

[0051] b. Turn on the stirring device, and the stirring rate is controlled at 80r / min;

[0052] c, drop into 2 kilograms of cimetidine, 9 kilograms of sodium chloride, stir and dissolve for 10-15 minutes;

[0053] d. After confirming that all the raw materials are dissolved, open the liquid outlet valve of the thick dispensing tank and the liquid inlet valve of the dilute dispensing tank, start the circulation pump, and pour the liquid medicine into the dilute dispensing tank;

[0054] e. After all the liquid medicine in the concentrated preparation tank is injected into the thin ...

Embodiment 3

[0078] A kind of cimetidine sodium chloride injection production method that prevents impurity from exceeding the standard may further comprise the steps:

[0079] 1) Strong blend:

[0080] a. Add 1000L of water for injection to the concentrated preparation tank, open the cooling water valve of the concentrated preparation tank to lower the temperature of the concentrated preparation tank to 80°C;

[0081] b. Turn on the stirring device, and the stirring rate is controlled at 110r / min;

[0082] c, drop into 2 kilograms of cimetidine, 9 kilograms of sodium chloride, stir and dissolve for 10-15 minutes;

[0083] d. After confirming that all the raw materials are dissolved, open the liquid outlet valve of the thick dispensing tank and the liquid inlet valve of the dilute dispensing tank, start the circulation pump, and pour the liquid medicine into the dilute dispensing tank;

[0084] e. After all the liquid medicine in the concentrated preparation tank is injected into the thi...

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PUM

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Abstract

The invention provides a cimetidine sodium chloride injection production method capable of preventing impurities from exceeding the standard, belongs to the technical field of medicines and mainly solves the problem that impurities in finished cimetidine sodium chloride injection products in the prior art exceed the standard. The method is characterized by comprising the three following steps: 1)concentrated preparation; 2) diluted preparation; 3) sterilization. The method specifically comprises the following steps: injecting injection water into a concentrated preparation tank, putting 2 kgof cimetidine and 9 kg of sodium chloride, performing stirring, starting a circulating pump in a diluted preparation tank, circulating a solution by a fine filter provided with a 0.45 mu m polyether sulfone filter element, adjusting the pH by a hydrochloric acid solution with concentration being 1 mol / L, finally, circularly sending the solution into a filling procedure after the solution passes through the fine filter provided with the 0.45 mu m polyether sulfone filter element, putting the solution in a non-PVC co-extrusion infusion bag according to the dosage, setting specific control sterilization parameters in a high-temperature superheated water shower manner during sterilization, and performing lamp inspection and packaging after sterilization to obtain the cimetidine sodium chlorideinjection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a production method of cimetidine sodium chloride injection for preventing impurities from exceeding the standard. Background technique [0002] The cimetidine sodium chloride injection currently produced is a small-volume injection, all packaged in low-borosilicate glass ampoules. Because the glass ampoules are often damaged in the clinical medication due to nurses’ misoperation or other reasons, the drug There are glass shavings in the liquid, and the glass shavings will enter the human body during the intravenous infusion, causing additional harm to the patient; and the small-volume injection requires secondary dispensing in clinical use, which is likely to cause contamination of the drug solution and bring infusion risks ; In addition, glass ampoules often break due to collisions during transportation; therefore, cimetidine sodium chloride injection packaged in n...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K31/4164
CPCA61K9/0019A61K9/08A61K31/4164A61K47/02
Inventor 张志英李建军
Owner SHANXI NUOCHENG PHARMA
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