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Improved enteric medicine composition with mycophenolate

A technology of mycophenolate mofetil and enteric coating, which is applied in the field of pharmaceutical compositions coated with enteric coating, can solve the problems of improvement, and achieve the effect of excellent drug release

Inactive Publication Date: 2007-06-27
海南澳合医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the release index of the drug prepared by the above-mentioned prior art meets the national standard, with the development of pharmaceutical excipients, the drug composition still has the possibility of improving the release index

Method used

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  • Improved enteric medicine composition with mycophenolate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Tablet core prescription:

[0031] Mycophenolate sodium

180g (based on mycophenolic acid)

Lactose

40g

Crosslinked PVP

12.5g

PVP K30 Aqueous solution

Right amount

Magnesium stearate

1g

production

1000 pieces

[0032] Coating liquid prescription:

[0033] Opadry OY-P type

200g

85% ethanol

1000ml

production

1000ml

[0034] Preparation method: Weigh the prescribed amount of mycophenolate sodium, lactose, and cross-linked PVP, mix well, and use PVP K30 The aqueous solution is granulated, dried, magnesium stearate is added in the prescribed amount, and the tablet core is obtained by pressing after mixing.

[0035] Take the prescription amount of Opadry OY-P and disperse it in the prescription amount of 85% ethanol, and then coat it to increase the weight by about 10%.

Embodiment 2

[0037] Tablet core prescription:

[0038] Mycophenolate sodium

180g (based on mycophenolic acid)

Lactose

40g

Crosslinked PVP

12.5g

PVP K30 Aqueous solution

Right amount

Magnesium stearate

1g

production

1000 pieces

[0039] Coating liquid prescription:

[0040] Hydroxypropyl methylcellulose acetate succinate

200g

Titanium dioxide

50g

80% ethanol

2000ml

production

2000ml

[0041] Preparation method: Weigh the prescribed amount of mycophenolate sodium, lactose, and cross-linked PVP, mix well, and use PVP K30 The aqueous solution is granulated, dried, magnesium stearate is added in the prescribed amount, and the tablet core is obtained by pressing after mixing.

[0042] Dissolve the prescription amount of coating material in 80% ethanol of the prescription amount, and then grind the titanium dioxide to make a coating solution,...

Embodiment 3

[0044] This embodiment provides tablets made according to the relevant parameters provided in the invention patent of CN1104238C.

[0045] Tablet core prescription:

[0046] Mycophenolate sodium

180g (based on mycophenolic acid)

Lactose

40g

Crosslinked PVP

12.5g

PVP K30 Aqueous solution

Right amount

Magnesium stearate

1g

production

1000 pieces

[0047] Coating liquid prescription:

[0048] Acrylic resin No. 2

250g

Diethyl phthalate

100g

Castor oil

75g

Tween 80

35g

Titanium dioxide

50g

95% ethanol

3000ml

production

3000ml

[0049] Preparation method: Weigh the prescribed amount of mycophenolate sodium, lactose, and cross-linked PVP, mix well, and use PVP K30 The aqueous solution is granulated, dried, magnesium stearate is added in the prescribed amount, and the tablet core is ob...

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PUM

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Abstract

The present invention relates to mycophenolic acid, and is especially a kind of improved medicine composition of mycophenolate with enteric coating. The medicine composition includes pharmaceutically acceptable mycophenolate with enteric coating, and the enteric coating includes poly(acetic vinyl phthalate) or acetic succinic hydroxypropyl methyl cellulose. The improved medicine composition of the present invention has excellent medicine releasing property.

Description

Technical field [0001] The present invention relates to mycophenolic acid, in particular to an improved enteric-coated pharmaceutical composition containing mycophenolate. Background technique [0002] Mycophenolic acid, also called MPA in this article, was first isolated in 1896, and extensive research has been conducted on its potential as a drug of commercial interest. It is known to have anti-tumor, anti-viral, immunosuppressive, anti-psoriatic, and anti-inflammatory activities [see: for example, Walee et al., Pharmaceutical Research (1990), 7, p.161-166, and incorporated herein by reference] . Lilly scientists have published articles on MPA as an anticancer agent in publications, see, for example, MJSweeney et al., Cancer Research (1972), 32, 1795-1802, ICI scientists have also published articles in this regard See, for example, GB1157099 and 1203328, and articles as immunosuppressants, see, for example, A. Mitsui et al., Journal of Antibiotics (1969) 22, p.358-363. In the a...

Claims

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Application Information

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IPC IPC(8): A61K47/32A61K47/38A61K31/365A61K9/20A61K9/48A61P35/00A61P31/12A61P29/00A61P17/06A61P37/06
Inventor 谷景斌韩立峰
Owner 海南澳合医药有限公司
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