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Lansoprazole enteric preparation and preparation method thereof

A technology of lansoprazole enteric and enteric coating, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of low dissolution rate and low dissolution rate of lansoprazole , low dissolution rate and other issues, to achieve the effects of low economic cost, beneficial to human safety, and simple preparation process

Inactive Publication Date: 2011-01-26
陈敏伟 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the invention is to overcome the low problem of lansoprazole stripping rate, when lansoprazole is prepared micropill, the disintegrant crospovidone commonly used in tablet is used in this preparation, and further disintegrating After the drug is micronized, it is sprayed onto the surface of the inert core together with the drug to form a relatively loose drug layer, which greatly improves the problem of low dissolution rate and small dissolution amount of the lansoprazole preparation

Method used

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  • Lansoprazole enteric preparation and preparation method thereof
  • Lansoprazole enteric preparation and preparation method thereof
  • Lansoprazole enteric preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Drugs and preparatory excipients

[0042] (1) drug layer

[0043] Blank ball core 80.0g

[0044] Lansoprazole 20.0g

[0045] Magnesium oxide 2.5g

[0046] Poloxamer 188 4.0g

[0047] Crospovidone 2.5g

[0048] Polyvinylpyrrolidone 10.0g

[0049] Proper amount of ethanol

[0050] (2) isolation layer

[0051] Talc powder 3.0g

[0052] Titanium dioxide 9.0g

[0053] Polyvinylpyrrolidone 10.0g

[0054] Anhydrous ethanol amount

[0055] (3) Enteric coating layer

[0056] Udrake L100-55 60.0g

[0057] PEG40006.0g

[0058] Talc powder 15.0g

[0059] Anhydrous ethanol amount

[0060] Preparation:

[0061] (1) Drug layer preparation

[0062] Get an appropriate amount of ethanol, slowly add magnesia, polyvinylpyrrolidone, crospovidone and poloxamer that are sieved and mixed, stir evenly, add the lansoprazole crude drug to obtain a drug suspension, and spray the drug suspension to Blank ball core surface, get medicine ball core;

[0063] (2) Isolation gown prepa...

Embodiment 2

[0086] Drugs and preparatory excipients

[0087] (1) drug layer

[0088] Blank ball core 80.0g

[0089] Lansoprazole 20.0g

[0090] Magnesium carbonate 2.5g

[0091] Poloxamer 188 4.0g

[0092] Crospovidone 2.5g

[0093] Polyvinylpyrrolidone 10.0g

[0094] Proper amount of ethanol

[0095] (2) isolation layer

[0096] Talc powder 3.0g

[0097] Titanium dioxide 9.0g

[0098] Polyvinylpyrrolidone 10.0g

[0099] Anhydrous ethanol amount

[0100] (3) Enteric coating layer

[0101] Udrake L100-55 60.0g

[0102] PEG40006.0g

[0103] Talc powder 15.0g

[0104] Anhydrous ethanol amount

[0105] Preparation:

[0106] (1) Drug layer preparation

[0107] Get an appropriate amount of ethanol, slowly add sieved and mixed magnesium carbonate, polyvinylpyrrolidone, crospovidone and poloxamer, stir evenly, add the lansoprazole crude drug to obtain a drug suspension, and spray the drug suspension to Blank ball core surface, get medicine ball core;

[0108] (2) Isolation gown...

Embodiment 3

[0115] Drugs and preparatory excipients

[0116] (1) drug layer

[0117] Blank ball core 80.0g

[0118] Lansoprazole 20.0g

[0119] Magnesium oxide 2.5g

[0120] Poloxamer 188 4.0g

[0121] Crospovidone 2.5g

[0122] Polyvinylpyrrolidone 10.0g

[0123] Proper amount of ethanol

[0124] (2) isolation layer

[0125] Talc powder 3.0g

[0126] Titanium dioxide 9.0g

[0127] Polyvinylpyrrolidone 10.0g

[0128] Anhydrous ethanol amount

[0129] (3) Enteric coating layer

[0130] Udrake L100-55 60.0g

[0131] Triethyl citrate 6.0g

[0132] Talc powder 15.0g

[0133] Anhydrous ethanol amount

[0134] Preparation:

[0135] (1) Drug layer preparation

[0136] Get an appropriate amount of ethanol, slowly add magnesia, polyvinylpyrrolidone, crospovidone and poloxamer that are sieved and mixed, stir evenly, add the lansoprazole crude drug to obtain a drug suspension, and spray the drug suspension to Blank ball core surface, get medicine ball core;

[0137] (2) Isolation ...

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Abstract

The invention relates to the field of medicament preparation, in particular to a lansoprazole enteric preparation and a preparation method thereof. A lansoprazole enteric pellet is provided with an empty pellet core, a medicament layer, an isolation layer and an enteric coating layer in turn from the interior to the exterior, wherein the medicament layer contains lansoprazole, disintegrating agent, compatibilizer and basic stabilizing agent; and the lansoprazole enteric preparation is characterized in that the medicament layer also comprises micronized crosslinked povidone. The lansoprazole enteric preparation and the preparation method thereof have the advantages of higher dissolution rate of enteric pellets, reducing consumption and variety of compatibilizer, saving the preparation cost, reducing the technical difficulty and contributing to human safety.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lansoprazole enteric-coated pellet preparation and a preparation method thereof. technical background [0002] Lansoprazole is a benzimidazole derivative, chemical name: 2-[3-methyl-4-(2,2,2-trifluoroethyl)-2-pyridyl]-methylsulfinyl -1H-benzimidazole, the structural formula is as follows: [0003] [0004] Lansoprazole was first developed by Takeda Corporation of Japan. This product can inhibit gastric acid secretion and is mainly used to treat acid-related digestive system dysfunction diseases. First launched in Japan in 1992, it is the second-generation proton pump inhibitor (PPI) after omeprazole. Compared with omeprazole, it introduces trifluoroethoxy group in its structure, and its lipophilicity increases, so it can penetrate the cell wall more quickly to exert its drug effect, relieve symptoms faster, and have lower treatment cost. The cure rate of intesti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/34A61K47/32A61P1/04A61K47/10
Inventor 陈敏伟李学明周维娜
Owner 陈敏伟
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