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Ganciclovir composition freeze-dried powder for injection

A technology of ganciclovir and freeze-dried powder injection, which is applied in the field of ganciclovir composition freeze-dried powder injection for injection, which can solve problems such as abnormal liver function, white blood cell and thrombocytopenia, and achieve weakening of toxic effects and elimination of activity Effect, the effect of enhancing anti-human cytomegalovirus activity

Inactive Publication Date: 2014-01-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, during its use, there may be various degrees of leukopenia and thrombocytopenia, abnormal liver function and other toxic and side effects, and even potential dangers. Both clinicians and patients have certain doubts about the use of this drug.

Method used

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  • Ganciclovir composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1, preparation of ganciclovir composition freeze-dried powder for injection, in 1000 pieces.

[0036] prescription:

[0037] Ganciclovir 100g

[0038] Chitosan Nanoparticles 70g

[0039] Water for injection 2000ml

[0040] 2. Preparation process:

[0041] The chitosan nanoparticle that takes by weighing 70g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0042] Add 100 g of Ganciclovir and stir to dissolve until clear.

[0043] Adjust the pH to 5.1 with the buffer salt of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to the ganciclovir 0.1g per bottle to calculate the loading.

[0044] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C...

Embodiment 2

[0045] Embodiment 2, preparation of ganciclovir composition freeze-dried powder for injection, in 1000 pieces.

[0046] 1. Prescription:

[0047] Ganciclovir 100g

[0048] Chitosan Nanoparticles 61g

[0049] Water for injection 2000ml

[0050] 2. Preparation process:

[0051] The chitosan nanoparticle that takes by weighing 61g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0052] Add 100 g of Ganciclovir and stir to dissolve until clear.

[0053] Adjust the pH to 5.1 with the buffer salt of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to the ganciclovir 0.1g per bottle to calculate the loading.

[0054] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C, k...

Embodiment 3

[0055] Embodiment 3, preparation of ganciclovir composition freeze-dried powder for injection, in 1000 pieces.

[0056] prescription:

[0057] Ganciclovir 100g

[0058] Chitosan Nanoparticles 82g

[0059] Water for injection 2000ml

[0060] 2. Preparation process:

[0061] The chitosan nanoparticle that takes by weighing 82g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0062] Add 100 g of Ganciclovir and stir to dissolve until clear.

[0063]Adjust the pH to 5.1 with the buffer salt of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to the ganciclovir 0.1g per bottle to calculate the loading.

[0064] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C,...

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Abstract

The invention provides a ganciclovir composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The ganciclovir composition freeze-dried powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of ganciclovir, 5.15 to 6.56 parts of chitosan nanoparticle, and 80.34 to 87.10 parts of injection water. Advantages of the ganciclovir composition freeze-dried powder are that: 1) toxic effect of the ganciclovir composition freeze-dried powder on cells is reduced; 2) the ganciclovir composition freeze-dried powder is capable of avoiding phagocytosis of mononuclear macrophage on ganciclovir, contact area of ganciclovir with action sites is enlarged, and per unit area medicine concentration is increased; 3) human cytomegalovirus resistance is increased significantly, and medication cycle of patients is shortened, so that occurrence likelihood of adverse drug reaction caused by accumulation of ganciclovir is reduced; 4) no hemolysis, agglutination reaction, stimulus response or anaphylactic reaction is observed in special safety tests such as allergic test, hemolytic test and vascular stimulation test; 5) the chitosan nanoparticle is used as a freeze-dried skeleton agent of the freeze-dried powder injection instead of mannitol, so that active effects of mannitol on human bodies are avoided.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a ganciclovir composition freeze-dried powder for injection. Background technique: [0002] Ganciclovir chemical name: 9-(1,3-dihydroxy-2-propoxymethyl)guanine, this product is slightly soluble in water, almost insoluble in methanol, insoluble in dichloromethane, its structural formula is as follows : [0003] [0004] Human cytomegalovirus belongs to the B subfamily of the Herpesviridae family, and is commonly infected in the Chinese population. It is one of the most common pathogens for intrauterine and postpartum infection of mothers and infants, and can cause stillbirth, fetal malformation, miscarriage, developmental delay, and abnormal liver function. Pathological damage is the main pathogen that causes serious diseases such as congenital malformations, nervous system developmental delay, hearing and vision impairment, blood system lesions and ...

Claims

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Application Information

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IPC IPC(8): A61K31/722A61K47/36A61K9/19A61P31/22A61K31/522
Inventor 汪六一汪金灿胡珍珍
Owner HAINAN WEI KANG PHARMA QIANSHAN
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