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Nifedipine microporous osmotic pump core-encapsulating tablet with expanding tablet core and preparation method thereof

A technology of nifedipine and expansion tablets, which is applied in the field of medicine, can solve the problems such as no reports on the technology of nifedipine microporous osmotic pump tablets, and achieve the goals of avoiding blood drug concentration fluctuations, improving safety, and good internal and external correlations Effect

Inactive Publication Date: 2018-03-06
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, there is no technical report on the nifedipine microporous osmotic pump tablet with an expanded tablet core at present.

Method used

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  • Nifedipine microporous osmotic pump core-encapsulating tablet with expanding tablet core and preparation method thereof
  • Nifedipine microporous osmotic pump core-encapsulating tablet with expanding tablet core and preparation method thereof
  • Nifedipine microporous osmotic pump core-encapsulating tablet with expanding tablet core and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Prescription (1000 tablets):

[0031]

[0032]

[0033] Preparation process (see figure 1 ):

[0034] 1. Preparation of expanded tablet core:

[0035] Weigh the prescribed amount of polyoxyethylene-301, lactose T80, and hypromellose E5 and mix them in a micro mixer for 10 minutes, add magnesium stearate and mix them for another 2 minutes, and use a ZP-19 rotary tablet press to compress them with a diameter of 6 mm and a hardness of 30-40N shallow concave core.

[0036] 2. Preparation of nifedipine-coated chips

[0037] Avoid light, weigh the prescribed amount of nifedipine, hypromellose E5, sodium chloride, and lactose T80 and mix them in a micro-mixer for 10 minutes, add magnesium stearate and mix them for another 2 minutes, and then use ZPW20 to pack chips and press them. A tablet machine presses the expanded tablet core obtained above and the drug-containing layer of nifedipine to form a shallow concave tablet with a diameter of 8.5mm and a hardness of 60-80N...

Embodiment 2

[0041] Prescription (1000 tablets):

[0042]

[0043]

[0044] Preparation Process:

[0045] 1. Preparation of expanded tablet core:

[0046] Weigh the prescribed amount of polyoxyethylene-coagulant, microcrystalline cellulose PH102, and hypromellose E5 and mix in a micro mixer for 10 minutes, add magnesium stearate and mix for 2 minutes, and use a ZP-19 rotary tablet press to compress the diameter 6mm, shallow concave core with a hardness of 30-40N.

[0047] 2. Preparation of nifedipine-coated chips

[0048] Avoid light operation, weigh the prescribed amount of nifedipine, hypromellose E5, sodium chloride, microcrystalline cellulose PH102, mannitol and mix in a micro mixer for 10 minutes, add magnesium stearate and mix for 2 minutes, Then use a ZPW20 chip-packed tablet press to press the expanded tablet core obtained above and the drug-containing layer of nifedipine to form a shallow concave tablet with a diameter of 8.5mm and a hardness of 60-80N.

[0049] 3. Semi-...

Embodiment 3

[0052] Prescription (10000 tablets):

[0053]

[0054] Preparation Process:

[0055] 1. Preparation of expanded tablet core:

[0056] Weigh the prescribed amount of polyoxyethylene-301, lactose T80, and hydroxypropyl cellulose SSL and mix in a mixer for 15 minutes, add talcum powder and mix for 2 minutes, and use a ZP-19 rotary tablet press to compress the tablet with a diameter of 6mm and a hardness of 30-40N shallow concave core.

[0057] 2. Preparation of nifedipine-coated chips

[0058] Avoid light operation, weigh the prescribed amount of nifedipine, hydroxypropyl cellulose SSL, sodium chloride, lactose T80 and mix in a mixer for 15 minutes, add talcum powder and mix for another 2 minutes, and then use a ZPW20 chip tablet press The expanded tablet core obtained above is laminated with the drug-containing nifedipine to form a shallow concave tablet with a diameter of 8.5mm and a hardness of 60-80N.

[0059] 3. Semi-permeable membrane coating

[0060] Prepare the co...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a nifedipine microporous osmotic pump core-encapsulating tablet with an expanding tablet core and a preparation method thereof. The expanding tablet core is contained in the microporous osmotic pump core-encapsulating tablet, a nifedipine medicine-containing layer and a semipermeable membrane are sequentially arranged on the surface of the expanding tablet core, and the weight proportion of all the components is: expanding tablet core:nifedipine medicine-containing layer:semipermeable membrane=(5-55):(5-75):(5-30). The nifedipine microporous osmotic pump core-encapsulating tablet containing the expanding tablet core which is prepared by adopting the invention is almost equivalent to a medicine released at a zero-order release rate, moreover, perforation is not required, and the production process is mature, and can be industrially scaled up.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a nifedipine microporous osmotic pump package chip with an expanded tablet core and a preparation method thereof. Background technique [0002] Nifedipine, chemical name: dimethyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate, is calcium One of the ion antagonists, it is the drug of choice for variant angina pectoris. It is clinically suitable for the prevention and treatment of angina pectoris of coronary heart disease. It is suitable for various types of hypertension and has a good effect on intractable and severe hypertension. [0003] Hypertension is one of the most common cardiovascular diseases in the world today, and it is also a major risk factor for cardiovascular and cerebrovascular diseases. The prevalence of hypertension in my country is about 12%, and the existing number of hypertensive patients is more than 100 million, and it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K47/10A61K31/4422A61P9/12
CPCA61K9/2853A61K9/2866A61K9/2886A61K31/4422
Inventor 李普成胡关容丁姣姣赵月芳解雨婷朗悦王美闫忠辉
Owner QINGDAO HUANGHAI PHARM CO LTD
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