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Carvedilol push-pull osmotic pump type controlled release preparation and preparation method thereof

A technology of controlled-release preparations and osmotic pumps, which is applied in pharmaceutical formulations, pill delivery, and medical preparations containing active ingredients. problems, to achieve the effect of reducing the number of medications, improving curative effect and reducing side effects

Inactive Publication Date: 2012-09-19
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, studies have shown that only a small number of patients can continue to take medication for a long time, which is the main obstacle leading to the failure of carvedilol preparations to achieve the desired clinical effect. Frequent medication and tolerance are the main reasons for patients to stop medication

Method used

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  • Carvedilol push-pull osmotic pump type controlled release preparation and preparation method thereof
  • Carvedilol push-pull osmotic pump type controlled release preparation and preparation method thereof
  • Carvedilol push-pull osmotic pump type controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Tablet core drug layer prescription

[0039]

[0040] Tablet core booster layer prescription

[0041]

[0042] Preparation method of tablet core:

[0043] 1. Take carvedilol through an 80 mesh sieve;

[0044] 2. Weigh the main medicine and related auxiliary materials according to the prescription, mix them evenly, add an appropriate amount of 95% ethanol to make the soft material, granulate with a 20-mesh sieve, and dry completely at 40°C with air blowing;

[0045] 3. After the granules are completely dried, use an 18-mesh sieve to size them, add the prescribed amount of magnesium stearate and mix evenly to obtain granules A for use.

[0046] 4. Weigh the auxiliary materials according to the formula of the booster layer, mix them, add an appropriate amount of 100% ethanol to prepare soft materials, granulate with 20 mesh sieve, and dry completely at 40°C; pass through 18 mesh sieve and add the prescribed amount of hard fat Magnesium acid, get granule B for use.

[0047] 5. Select ...

Embodiment 2

[0056] Tablet core prescription:

[0057]

[0058] Tablet core booster layer prescription:

[0059]

[0060] Coating liquid prescription (200ml coating liquid dosage):

[0061]

[0062] According to the tablet core prescription, the tablet core was prepared according to the tablet core preparation method of Example 1. According to the coating liquid prescription, the Carvedil of this example was prepared according to the conventional film coating method and the same aging method and perforating method of Example 1. Luo osmotic pump piece finished product.

Embodiment 3

[0064] Tablet core prescription:

[0065]

[0066]

[0067] Tablet core booster layer prescription

[0068]

[0069] Coating liquid prescription (200ml coating liquid dosage)

[0070]

[0071] According to the tablet core prescription, the tablet core was prepared according to the tablet core preparation method of Example 1. According to the coating liquid prescription, the Carvedil of this example was prepared according to the conventional film coating method and the same aging method and perforating method of Example 1. Luo osmotic pump piece finished product.

[0072] Release determination:

[0073] Take the sample and use the device for the irradiance determination method (the first method of appendix XD of the Chinese Pharmacopoeia 2005 edition) and the device of the dissolution test method (the second appendix XC method of the Chinese Pharmacopoeia 2005 edition) with a hydrochloric acid solution (9→1000 ) 900ml is the dissolution medium, the measuring temperature is (37±0.5)℃, t...

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Abstract

The invention relates to a carvedilol push-pull osmotic pump type controlled release preparation. The carvedilol push-pull osmotic pump type controlled release preparation comprises a medicine-containing layer tablet core, a boosting layer tablet core, a coating film and a single medicine releasing pore on the surface of a controlled release tablet on one side of the medicine-containing layer tablet core. According to the carvedilol push-pull osmotic pump type controlled release tablet disclosed by the invention, the medicine release accords with the zero-order release process and is basically complete, the administration frequencies of patients can be reduced and the peak-to-valley phenomenon which occurs after a general preparation is administrated is avoided; and plasma drug stability and durable curative effect in the release process of medicaments are obtained, and thus the safety and the effectiveness are improved.

Description

Technical field [0001] The invention relates to a beta receptor blocker carvedilol (Carvedilol) controlled release preparation and a preparation method thereof technical background [0002] Carvedilol (carvedilol) is a non-selective third-generation β-receptor blocker with no intrinsic sympathomimetic activity. It can completely block α1, β1 and β2 receptors. In addition, there are calcium channel block, inhibition of smooth muscle cell proliferation, anti-inflammatory, anti-oxidation, and inhibition of the vasoconstrictor effect of prostate F1α. Large-scale clinical comparative treatment data abroad show that this product has a unique effect on the treatment of essential hypertension, heart failure, angina pectoris and myocardial infarction. It is mainly used clinically for mild and moderate hypertension, heart failure and coronary heart disease. . [0003] Carvedilol (carvedilol) is a lipophilic aromatic oxypropanol compound. Oral absorption is rapid and complete. The drug reac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K31/403A61K9/32A61K9/36A61P9/04A61P9/10A61P9/12
Inventor 王柏胡君寅
Owner CHINA PHARM UNIV
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