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Compound sustained-release preparation and preparation method thereof

The technology of a sustained-release preparation and a compound formula, which is applied to the compound sustained-release preparation composed of aplite and terazosin hydrochloride and the field of preparation thereof, can solve the problem that there are no compound eplite sustained-release preparations, patients and doctors have not yet seen. Inconvenience, failure to achieve treatment and other problems, to achieve obvious clinical application advantages, improve drug safety and effectiveness

Inactive Publication Date: 2010-07-21
JIANGSU LIANHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In addition, the treatment of benign prostatic hyperplasia with Apuletide requires long-term medication, multiple doses per day, and the general course of treatment is 4 months, which not only brings inconvenience to patients and doctors, but once there is a mistake in medication, it will fail good treatment
[0009] At present, the Chinese patents related to Apulet preparations include: 1. A controlled-release pellet for the treatment of benign prostatic hyperplasia and its preparation method (patent number: 99117214.0); 2. Apulet dripping pills and its preparation method ( Application No.: 200410030368.0); 3. Aprilide Sustained-release Preparation (Patent No. 200610041255.8), but there is no patent for Compound Aprelide Sustained-release Preparation and its related literature reports and published literature

Method used

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  • Compound sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Compound Apretide Double Layer Sustained Release Tablets

[0036] Sustained release part:

[0037] Aprilite 10g

[0038] Lactose 100g

[0039] Microcrystalline Cellulose 60g

[0040] Hypromellose (K15M) 30g

[0041] Ethanol 150ml

[0042] Magnesium Stearate Appropriate amount

[0043] Regular part:

[0044] Terazosin hydrochloride 2g (calculated as terazosin)

[0045] Sodium carboxymethyl starch 2.5g

[0046] Microcrystalline Cellulose 50g

[0047] Starch 40g

[0048] Lactose 30g

[0049] Hypromellose (4% aqueous solution) 50g

[0050] Magnesium Stearate Appropriate amount

[0051] Preparation process operation is as follows:

[0052]The raw and auxiliary materials are crushed through a 100-mesh sieve, and the sustained-release part of Eprelate, lactose, microcrystalline cellulose, and hypromellose (K15M) is weighed according to the prescription. granules, dried at 50-60°C, granulated with 24 mesh sieve, added magnesium stearate and mixed evenly, and set a...

Embodiment 2

[0054] Compound Aprelate Film Coated Sustained Release Tablets

[0055] Applet chip

[0056] Aprilite 10g

[0057] Lactose 110g

[0058] Microcrystalline Cellulose 80g

[0059] Ethanol 150ml

[0060] Magnesium Stearate Appropriate amount

[0061] Coating solution containing terazosin hydrochloride

[0062] Terazosin hydrochloride 2g (calculated as terazosin)

[0063] Ethylcellulose 25g

[0064] Acrylic II 10g

[0065] Macrogol 6000 5g

[0066] Absolute ethanol 500ml

[0067] Preparation process operation is as follows:

[0068] The raw and auxiliary materials are crushed and passed through a 100-mesh sieve, and weighed according to the prescription, eprelate, lactose, and microcrystalline cellulose. After mixing, use ethanol as a soft material, granulate with a 24-mesh sieve, dry at 50-60°C, and sieve through a 24-mesh sieve. Add magnesium stearate and mix evenly, press into tablets, and set aside; weigh ethyl cellulose, acrylic resin II, and polyethylene glycol 600...

Embodiment 3

[0070] Compound Epulet Sustained-release Granules

[0071] Epulet Sustained Release Pellets

[0072] Aprilite 10g

[0073] Terazosin hydrochloride 2g (calculated as terazosin)

[0074] Cetyl Alcohol 80g

[0075] Lactose 80g

[0076] Microcrystalline Cellulose 100g

[0077] Povidone K30 20g

[0078] 50% ethanol solution appropriate amount

[0079] 2% HPMC aqueous solution appropriate amount

[0080] Magnesium Stearate Appropriate amount

[0081] Preparation process operation is as follows:

[0082] The raw and auxiliary materials are crushed through a 100-mesh sieve, weighed Apret according to the prescription, added to the molten cetyl alcohol and stirred evenly, and then added povidone K30 as a porogen and mixed evenly, cooled and solidified, crushed, and added 50g Mix microcrystalline cellulose and 50g lactose evenly, make soft material with 50% ethanol solution, granulate with 12-18 mesh sieve, dry at 50-60°C, and set aside; weigh terazosin hydrochloride according ...

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Abstract

The invention relates to a compound sustained-release preparation and a preparation method thereof, and the compound sustained-release preparation comprises Epristeride, terazosin hydrochloride and pharmaceutically acceptable auxiliary materials, wherein the Epristeride and the terazosin hydrochloride are used as the active components, the Epristeride is prepared into a sustained-release part, and the terazosin hydrochloride is prepared into an ordinary-release part, so that the two medicines are kept in an effective blood concentration range in vivo, the adverse effect of the medicines and the administration frequency are reduced, and the safety and effectiveness of pharmacy and the compliance of patients are improved.

Description

technical field [0001] The invention relates to a compound sustained-release preparation and a preparation method thereof, in particular to a compound sustained-release preparation composed of aprellide and terazosin hydrochloride and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) is a common and frequently-occurring disease in elderly men. It is manifested in abnormal urination, such as dysuria, frequent urination, urgency, thinning urine line, increased nocturia, and endless urination, etc., which threatens the health of elderly men. health, significantly affecting their quality of life. Abnormal urination caused by benign prostatic hyperplasia is composed of two factors: one is the static factor caused by the compression of the prostatic urethra by the prostatic tissue; the other is the dynamic factor related to the sympathomimetic nerve excitation. Drug therapy plays an important role in the treatment of BPH. At present, o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/16A61K9/52A61K31/56A61P13/08A61K31/517
Inventor 张德伟游余文褚青松秦雄剑
Owner JIANGSU LIANHUAN PHARMA
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