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Lansoprazole sodium suspension preparation for injection and new application thereof

A technology of lansoprazole sodium and suspension preparations, applied in the field of preparation of lansoprazole sodium suspension preparations for injection, can solve the problems of high insoluble particles, easy oxidative degradation, easy precipitation and crystallization, etc. Low cost, low price, good resolubility effect

Inactive Publication Date: 2010-06-30
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The present invention is faced with the problems of the existing marketed preparations of this variety: visible foreign matter after reconstitution, high insoluble particles, easy precipitation and crystallization, easy oxidative degradation, poor stability, complicated process, etc., after referring to many documents A brand-new preparation method obtained by repeatedly summarizing a large number of experiments

Method used

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  • Lansoprazole sodium suspension preparation for injection and new application thereof
  • Lansoprazole sodium suspension preparation for injection and new application thereof
  • Lansoprazole sodium suspension preparation for injection and new application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation of embodiment 1 injection lansoprazole sodium suspension

[0049] Prescription (specification 30mg)

[0050] Lansoprazole Sodium 30g

[0051] Polysorbate 80 7.5g

[0052] Poloxamer 188 15g

[0053] Cellulose acetate 15g

[0054] Butylated Hydroxyanisole 7.5g

[0055] Sodium chloride 22.5g

[0056] Preparation Process:

[0057] A. 7.5g polysorbate 80, 15g poloxamer 188 and 30g lansoprazole sodium are dissolved in 500ml water for injection to form an aqueous phase;

[0058] B. Stir and disperse 15g of cellulose acetate and 7.5g of butyl hydroxyanisole in 50ml of dichloromethane to form an organic phase;

[0059] C. Add the organic phase to the water phase while stirring, then transfer it to a high-pressure homogenizer, fully stir and emulsify for 2 hours, and obtain an emulsion;

[0060] D. add 22.5g sodium chloride in this emulsion, fully stir and mix, carry out sub-packaging in the vial, freeze-drying, obtained the finished product of lansoprazol...

Embodiment 2

[0073] The preparation of embodiment 2 injection lansoprazole sodium suspension

[0074] Prescription (specification 15mg)

[0075] Lansoprazole Sodium 15g

[0076] Glyceryl Stearate 5g

[0077] Poloxamer 188 10g

[0078] Ethylcellulose 15g

[0079] Vitamin E 7.5g

[0080] Mannitol 15g

[0081] Preparation Process:

[0082] A. 5g glyceryl stearate, 10g poloxamer 188 and 15g lansoprazole sodium are dissolved in 700ml water for injection to form an aqueous phase;

[0083] B. Stir and disperse 15g of ethyl cellulose and 7.5g of vitamin E in 70ml of ethyl acetate to form an organic phase;

[0084] C. Add the organic phase to the water phase while stirring, then transfer it to a high-pressure homogenizer, fully stir and emulsify for 2 hours, and obtain an emulsion;

[0085] D. Add 15g mannitol in this emulsion, fully stir and mix, carry out subpackage in the vial, lyophilize, obtained the finished product of lansoprazole sodium suspension preparation.

Embodiment 3

[0098] The preparation of embodiment 3 injection lansoprazole sodium suspension

[0099] Prescription (specification 30mg)

[0100] Lansoprazole Sodium 30g

[0101] Poloxamer 188 30g

[0102] Glyceryl Stearate 7.5g

[0103] Ethylcellulose 19g

[0104] Vitamin E 10.5g

[0105] Lactose 27g

[0106] Preparation Process:

[0107]A. 7.5g glyceryl stearate, 30g poloxamer 188 and 30g lansoprazole sodium are dissolved in 1000ml water for injection to form an aqueous phase;

[0108] B. Stir and disperse 19g ethylcellulose and 10.5g vitamin E in 100ml ethyl acetate to form an organic phase;

[0109] C. Under stirring, add the organic phase to the water phase, then transfer it to a high-pressure homogenizer, fully stir and emulsify for 2.5 hours, and obtain an emulsion;

[0110] D. Add .27g lactose in this emulsion, fully stir and mix, carry out sub-package in the vial, lyophilize, obtained the finished product of lansoprazole sodium suspension preparation.

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Abstract

The invention discloses a Lansoprazole sodium suspension preparation for injection. The suspension preparation is characterized by containing Lansoprazole sodium, an emulsifier, a carrier material, an antioxidant and an excipient, wherein the emulsifier is a compound emulsifier containing two or more than two of poloxamer 188, sorbitan fatty acid 60, polysorbate 80, glyceryl monostearate and glycerin monostearate. Preferably, the Lansoprazole sodium suspension preparation contains 4 parts of Lansoprazole sodium, 3-5 parts of emulsifier, 2-4 parts of carrier material, 1-2 parts of antioxidant and 3-4 parts of excipient, wherein the weight ratio of the poloxamer 188 to the sorbitan fatty acid 60, the polysorbate 80, the glyceryl monostearate or the glycerin monostearate is 4-2:1. The Lansoprazole sodium suspension preparation for injection prepared by the invention has low-content harmful substances and good stability. The new application of the preparation in the initial treatment of erosive esophagitis patients which can not accept oral drug treatment has the satisfactory technical effect.

Description

technical field [0001] The present invention relates to a kind of lansoprazole sodium preparation for injection, specifically relate to a kind of preparation method of lansoprazole sodium suspension preparation for injection, and this preparation is used clinically The invention relates to a new application for initial treatment of patients with sexual esophagitis, belonging to the technical field of medicine. Background technique [0002] Erosive esophagitis is a common clinical disease. It is mainly caused by swallowing or eating corrosive agents, such as strong acids such as sulfuric acid, hydrochloric acid, nitric acid, and carbolic acid, and strong alkalis such as brine, ammonia, and lime. Medications can also damage the esophagus. According to literature reports, there are hundreds of known drugs that can cause esophagitis, among which esophagitis caused by antibiotics accounts for more than 50-60%, followed by cold capsules, granular non-steroidal anti-inflammatory ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/4439A61K47/34A61K47/14A61K47/38A61P1/00A61K47/10A61K47/26
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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