Meptazinol hydrochloride injection medicine composition and preparation method thereof

A technology of meptafol hydrochloride and meptafol, which is applied in the field of medicine, can solve problems such as patient irritation, hemolysis risk, and safety hazards, and achieve the effects of avoiding degradation, improving product quality, and ensuring safety

Inactive Publication Date: 2016-03-02
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Two kinds of antioxidants are added to the prescription of this product, especially calcium sodium edetate. Irritation in patients and risk of hemolysis

Method used

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  • Meptazinol hydrochloride injection medicine composition and preparation method thereof
  • Meptazinol hydrochloride injection medicine composition and preparation method thereof
  • Meptazinol hydrochloride injection medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1 Mebutamol Hydrochloride Injection Prescription (in 1000 pieces)

[0046] prescription

Dosage

Mebutamol Hydrochloride (calculated as Mebutaol)

100g

glucose

50g

Acetic acid

1ml

Sodium acetate

1g

Water for Injection

Add to 1000ml

[0047] Preparation Process:

[0048]Take 800ml of water for injection, control the temperature of the water for injection at 40°C, fill with nitrogen until the dissolved oxygen content of the water for injection is lower than 2.0mg / L, add 100g of meptafol hydrochloride (calculated as meptafol), 50g of glucose, 1ml acetic acid and 1g sodium acetate, stirred to dissolve completely, added water for injection to 1000ml; then added 0.3g activated carbon, stirred and adsorbed for 20min; "Membrane" series-connected sterilizing filter for fine filtration; control the filling nitrogen flow rate to 15L / min, and fill each 1.0ml bottle into a 1ml low borosilicate glas...

Embodiment 2

[0049] Example 2 Mebutamol Hydrochloride Injection Prescription (in 1000 pieces)

[0050] prescription

Dosage

Mebutamol Hydrochloride (calculated as Mebutaol)

100g

glucose

50g

Acetic acid

1ml

Sodium acetate

5g

Water for Injection

Add to 1000ml

[0051] Preparation Process:

[0052] Take 800ml of water for injection, control the temperature of the water for injection at 40°C, fill with nitrogen until the dissolved oxygen content of the water for injection is lower than 2.0mg / L, add 100g of meptafol hydrochloride (calculated as meptafol), 50g of glucose, 1ml acetic acid and 5g sodium acetate, stirred to dissolve completely, added water for injection to 1000ml; then added 0.3g activated carbon, stirred and adsorbed for 20min; "Membrane" in series with sterilizing filter for fine filtration; control the nitrogen flow rate of potting to 14L / min, and pot each 1.0ml into a 1ml low borosilicate glass ampoule...

Embodiment 3

[0053] Example 3 Mebutamol Hydrochloride Injection Prescription (in 1000 pieces)

[0054] prescription

Dosage

Mebutamol Hydrochloride (calculated as Mebutaol)

100g

glucose

50g

Acetic acid

2ml

Sodium acetate

3g

Water for Injection

Add to 1000ml

[0055] Preparation Process:

[0056] Take 800ml of water for injection, control the temperature of the water for injection at 45°C, fill with nitrogen until the dissolved oxygen content of the water for injection is lower than 2.0mg / L, add 100g of meptafol hydrochloride (calculated as meptafol), 50g of glucose, 2ml acetic acid and 3g sodium acetate, stirred to dissolve completely, added water for injection to 1000ml; then added 0.3g activated carbon, stirred and adsorbed for 20min; "Membrane" in series with the sterilization filter for fine filtration; control the flow rate of nitrogen gas for potting to 12L / min, and fill each 1.0ml bottle into a 1ml low boro...

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Abstract

The invention provides a meptazinol hydrochloride injection medicine composition and a preparation method thereof. Only a small amount of acetic acid-sodium acetate is used to serve as a buffer system in the prescription, the pH value of liquid medicine can be controlled within the reasonable range, meanwhile, meptazinol hydrochloride injection is prevented from being degraded in the placement process, and product quality is remarkably improved; meanwhile, use of antioxidant is omitted, adverse reaction caused by sodium calcium edetate is avoided, and safety is guaranteed; a preparation process of introducing nitrogen twice is adopted, and product stability is greatly improved.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a pharmaceutical composition of meptafol hydrochloride injection and a preparation method thereof. Background technique [0002] Meptazinol hydrochloride, the English name is Meptazinolhydrochloride, and its structural formula is: [0003] [0004] Meprotamol hydrochloride is a powerful analgesic, its structure is similar to morphine, it is an agonist of opioid μ receptor, and it is also an antagonist of μ receptor. Compared with other analgesics, meprotamol hydrochloride Non-addictive, with few side effects. [0005] The Chinese patent application number 201110172372.9 discloses a meptafol hydrochloride injection, the prescription contains meptafol hydrochloride, sodium bisulfite, calcium sodium edetate and water for injection. Two kinds of antioxidants are added to the prescription of this product, especially calcium sodium edetate. Irritation in patients and risk of he...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/55A61K47/12A61P29/00A61K47/26
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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