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Ganciclovir lactated ringer solution and preparation method

A technology of Ringer Injection and Lowe Sodium Lactate, applied in the direction of antiviral agents, active ingredients of heterocyclic compounds, etc., can solve the problems of easy decomposition, poor solubility, and inability to fully satisfy the solubility and stability of the main drug, and achieve Reduce irritation, ensure stability, and ensure safety

Inactive Publication Date: 2006-02-01
HUBEI LIYI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Among the diluents commonly used in clinical practice, the pH value of glucose injection is 3.2-5.5, similar to that of glucose sodium chloride injection. The main drug ganciclovir has poor solubility in the above two diluents and is easy to decompose; The pH value of sodium injection is 4.5-7.0, which still cannot fully meet the solubility and stability of the main drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Specification: 100ml: 100mg

[0015] Ganciclovir 10g

[0016] Sodium Lactate 31g

[0017] Sodium chloride 60g

[0018] Potassium chloride 3g

[0019] Calcium chloride 2g

[0020] Add water for injection to 10L

[0021] Filling 100 bottles

[0022] Preparation method: (1) prepare water for injection; (2) dissolve the medicinal carrier with water for injection, and prepare isotonic solution (I); (3) add active raw material ganciclovir to the above-mentioned solution I, add water for injection to a sufficient amount, stir and dissolve, and prepare drug solution II; (4) adjust the pH value of solution II to 6.0 to 8.5; (5) add water for injection to the full amount; (6) pass through a charcoal layer to remove pyrogens; (7) divide After packing, autoclave; (8) check the package.

Embodiment 2

[0024] Specification: 100ml: 100mg

[0025] Ganciclovir 10g

[0026] Sodium Lactate 31g

[0027] Sodium chloride 60g

[0028] Potassium chloride 3g

[0029] Calcium chloride 2g

[0030] Add water for injection to 10L

[0031] Filling 100 bottles

[0032] Preparation method: (1) prepare water for injection; (2) dissolve the medicinal carrier with water for injection, and prepare isotonic solution (I); (3) add active raw material ganciclovir to the above-mentioned solution I, add water for injection to a sufficient amount, stir and dissolve, and prepare drug solution II; (4) adjust the pH value of solution II to 6.0 to 8.5; (5) add water for injection to the full amount; (6) remove pyrogens with an ultrafilter; (7) After subpackaging, autoclave; (8) check the packaging.

Embodiment 3

[0034] Specification: 250ml: 250mg

[0035] Ganciclovir 25g

[0036] Sodium Lactate 77.5g

[0037] Sodium chloride 150g

[0038] Potassium chloride 7.5g

[0039] Calcium chloride 5g

[0040] Add water for injection to 25L

[0041] Filling 100 bottles

[0042] Preparation method: (1) prepare water for injection; (2) dissolve the medicinal carrier with water for injection, and prepare isotonic solution (I); (3) add active raw material ganciclovir to the above-mentioned solution I, add water for injection to a sufficient amount, stir and dissolve, and prepare drug solution II; (4) adjust the pH of solution II to 6.0 to 8.5; (5) add water for injection to the full amount; (6) pass through a charcoal layer to remove pyrogens;

[0043] (7) After subpackaging, autoclave; (8) Check the packaging.

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PUM

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Abstract

A ganciclovir-sodium lactate liquid injection is proportionally prepared from ganciclovir or its derivative or its medicinal salt, sodium lactate, sodium chloride, potassium chloride, calcium chloride and the water for injection through dissolving carrier in the water for injection to obtain isotonic solution, dissolving ganciclovir in it, adding the water for injection, stirring, regulating pH=6.0-8.5, adding the water for injection, ultrafiltering to remove heat source, and high-pressure sterilizing.

Description

technical field [0001] The invention relates to Ganciclovir Lactated Sodium Ringer Injection and a preparation method thereof. The invention belongs to the production method of medicine infusion, in particular to the production method of Ganciclovir Lactated Sodium Ringer Injection. Background technique [0002] Ganciclovir is a broad-spectrum anti-herpes virus drug, especially active against human cytomegalovirus, and has become the drug of choice for the prevention and treatment of cytomegalovirus infection. The main purpose is to prevent and treat: cytomegalovirus infection secondary to organ transplantation; cytomegalovirus infection secondary to leukemia patients receiving bone marrow transplantation; cytomegalovirus infection secondary to tumor patients receiving radiotherapy and chemotherapy; AIDS patients with cytomegalovirus infection; experimental For giant cell inclusion body disease in infants and young children, refractory genital herpes and refractory hepatiti...

Claims

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Application Information

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IPC IPC(8): A61K31/522A61P31/22
Inventor 刘红王登美陈历胜潘经媛吴迪
Owner HUBEI LIYI PHARM TECH CO LTD
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