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Rabeprazole sodium liposome enteric-coated tablets

A technology of rabeprazole sodium lipid and beprazole sodium lipid, which is applied in the field of medicine, can solve the problems of poor stability and encapsulation efficiency of rabeprazole sodium, and solve discoloration when heated, improve stability, The effect of simple production process

Inactive Publication Date: 2011-02-09
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After a long period of serious research, the inventors found that the three materials, dioleoylphosphatidylcholine, cholesterol and sodium glycocholate, were combined according to a specific ratio, and prepared into a liposome with rabeprazole sodium according to a certain ratio. Plastids, and then prepare the liposomes with alkaline substances and other solid common excipients into solid preparations, which can solve the technical problems of rabeprazole sodium stability and poor encapsulation efficiency, and obtain unexpected preparation effects. thus providing formulations of good quality

Method used

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  • Rabeprazole sodium liposome enteric-coated tablets
  • Rabeprazole sodium liposome enteric-coated tablets
  • Rabeprazole sodium liposome enteric-coated tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of embodiment 1 rabeprazole sodium liposome enteric-coated tablet

[0031] Prescription: (1000 tablets)

[0032]Component Dosage

[0033] Rabeprazole Sodium 10g

[0034] Dioleoyl Phosphatidylcholine 40g

[0035] Cholesterol 15g

[0036] Sodium Glycocholate 8g

[0037] Mannitol 70g

[0038] Crospovidone 8g

[0039] Magnesium oxide 7g

[0040] Highly substituted hydroxypropyl cellulose 1g

[0041] Magnesium Stearate 2g

[0042] Talc powder 6.8g

[0043] Povidone K30 1.7g

[0044] Ruitai ES-H Coating Agent 15.8g

[0045] Preparation Process

[0046] (1) Add 40g of dioleoylphosphatidylcholine, 15g of cholesterol and 8g of sodium glycocholate into 600ml of purified water, then add 10g of rabeprazole sodium and mix evenly, heat and stir in a water bath at 90°C for 30min until molten , using a tissue masher to shear and stir 5 times, 5 minutes each time, with a rotating speed of 8000r / min, to obtain the primary emulsion, and then circulate and emul...

Embodiment 2

[0049] The preparation of embodiment 2 rabeprazole sodium liposomal enteric-coated tablets

[0050] Prescription: (1000 tablets)

[0051] Component Content

[0052] Rabeprazole Sodium 20g

[0053] Dioleoyl Phosphatidylcholine 90g

[0054] Cholesterol 50g

[0055] Sodium Glycocholate 30g

[0056] Mannitol 80g

[0057] Crospovidone 10g

[0058] Magnesium oxide 10g

[0059] Highly substituted hydroxypropyl cellulose 2g

[0060] Magnesium Stearate 3g

[0061] Talc powder 18g

[0062] Povidone K30 4.5g

[0063] Ruitai ES-H Coating Agent 30g

[0064] Preparation Process

[0065] (1) Add 90g of dioleoylphosphatidylcholine, 50g of cholesterol and 30g of sodium glycocholate into 1500ml of purified water, then add 20g of rabeprazole sodium and mix well, heat and stir in a water bath at 70°C for 50min until molten , using a tissue masher to shear and stir 5 times, each time for 10min, and a rotating speed of 5000r / min to obtain the first emulsion, then circulate and emulsify...

Embodiment 3

[0068] The preparation of embodiment 3 rabeprazole sodium liposomal enteric-coated tablets

[0069] Prescription: (1000 tablets)

[0070] Component Content

[0071] Rabeprazole Sodium 10g

[0072] Dioleoyl Phosphatidylcholine 90g

[0073] Cholesterol 50g

[0074] Sodium Glycocholate 30g

[0075] Mannitol 45g

[0076] Lactose 30g

[0077] Low-substituted hydroxypropyl cellulose 15g

[0078] Magnesium hydroxide 8g

[0079] Povidone K30 5g

[0080] Magnesium Stearate 3g

[0081] Talc powder 6g+17.7g

[0082] Povidone K30 4.4g

[0083] Aileyi EOQL55 Coating Agent 28.6g

[0084] Preparation Process

[0085] (1) Add 90g of dioleoylphosphatidylcholine, 50g of cholesterol and 30g of sodium glycocholate into 1500ml of purified water, then add 10g of rabeprazole sodium and mix well, heat and stir in a water bath at 80°C for 40min until molten , using a tissue masher to shear and stir 5 times, each time for 8min, and a rotating speed of 6000r / min to obtain the first emulsio...

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Abstract

The invention discloses rabeprazole sodium liposome enteric-coated tablets and a preparation method and application thereof to treating gastroesophageal reflux disease (GERD). The rabeprazole sodium liposome enteric-coated tablets comprise rabeprazole sodium liposome solid, alkaline substances and other common auxiliary materials for a solid preparation, wherein the rabeprazole sodium liposome solid comprises the following components in part by weight: 10 to 20 parts of rabeprazole sodium, 40 to 90 parts of dioleoyl phosphatidylcholine, 15 to 50 parts of cholesterol and 8 to 30 parts of sodium glycocholate. The rabeprazole sodium liposome enteric-coated tablets have the advantages of improving stability, increasing dissolution, solving the problem of color change when being heated, and the like, and when the rabeprazole sodium liposome enteric-coated tablets are used for treating the GERD, the curative ratio is higher, the total effective rate is higher, and the clinical superiority is more obvious.

Description

technical field [0001] The invention relates to a rabeprazole sodium liposome enteric-coated tablet and a preparation method thereof, as well as its application in the treatment of gastroesophageal reflux disease, belonging to the technical field of medicine. Background technique [0002] With the change of people's eating habits, the incidence of gastroesophageal reflux disease (GERD) patients is increasing year by year. Gastroesophageal reflux disease (GERD) refers to the inflammation, erosion, ulcer and fibrosis of the esophageal mucosa caused by the reflux of gastric and duodenal contents into the esophagus. The clinical manifestations are burning sensation in the stomach, chest pain, dysphagia and other symptoms, and some GERD patients have no endoscopic manifestations of esophagitis. Gastroesophageal reflux disease (GERD) is a common digestive system disease in my country. Epidemiological survey results show that the incidence rate of GERD is 5.77%. The main diagnosis...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/4439A61P1/04A61K47/24A61K9/20A61K47/28A61K9/28
Inventor 杨明贵
Owner HAINAN MEILAN SMITH KLINE PHARMA
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