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Medicine solid compound preparation and preparation method thereof

A technology of compound preparations and medicines, which is applied in the field of compound preparations and preparations in which active drugs are wrapped with isolation gowns and drug coats. Inhomogeneity and other problems, to achieve the effect of improving bioavailability, improving storage stability, and avoiding uneven drug content

Inactive Publication Date: 2009-12-16
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, it is difficult to hold the largest 000 capsules, and it is necessary to increase the number of capsules to be taken, but this will inevitably increase the cost
[0016] 2. The problem of content uniformity when filling capsules with rifampicin pellets and isoniazid pellets. If the two are mixed and then loaded into capsules, it is difficult to mix the pellets and pellets evenly. The density of the capsules is different, causing the heavy ones to enter the capsules first, and the lighter capsules to enter the capsules later, which will also cause the drug content of the capsules to be uneven; For micro-pills, the amount of loading must also be controlled, which requires high equipment and is difficult and complicated for the encapsulation process.
[0029] Although the above methods are correct in thinking, the actual operation is complicated and difficult, which has special requirements for equipment and high cost
Therefore, these methods have not been adopted in actual production at home and abroad at present, and most of the preparations have only relatively extended the validity period, but have not fundamentally solved the stability problem of solid compound preparations during storage; of course, the bioavailability problem has not been solved.

Method used

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  • Medicine solid compound preparation and preparation method thereof
  • Medicine solid compound preparation and preparation method thereof
  • Medicine solid compound preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] The preparation of embodiment 1 rifampicin-isoniazid double tablet (with rifampicin as tablet core)

[0088] (A) Rifampicin tablet core formula and preparation process

[0089] formula:

[0090] Rifampicin 150g

[0091] Microcrystalline Cellulose KG802 180g

[0092] povidone s630 40g

[0093] Cross-linked polyvinylpyrrolidone 30g

[0094] Magnesium Stearate 1%

[0095] A total of 1000 pieces

[0096] Preparation Process:

[0097] The above-mentioned raw and auxiliary materials are weighed according to the formula, mixed, passed through a 100-mesh sieve three times, mixed evenly, and the powder is directly compressed into tablets. The diameter of the tablet is 10mm, the hardness is controlled at 10-12kg, the tablet weight is controlled between 405mg-420mg, and the average tablet weight is 410.6mg.

[0098] (B) Formula and preparation process of tablet core isolation coat coating liquid

[0099] formula:

[0100]Hypromellose E5LV 6g

[0101] Polyethylene glycol...

Embodiment 2

[0128] Example 2 Preparation of Rifampicin-ISoniazid Dual Tablets (with Isoniazid as tablet core)

[0129] (A) Formula and preparation process of isoniazid tablet core

[0130] formula:

[0131] Isoniazid 75g

[0132] Microcrystalline Cellulose KG802 180g

[0133] Starch 230g

[0134] povidone s630 40g

[0135] Low-substituted hydroxypropyl cellulose 20g

[0136] Sodium Carboxymethyl Cellulose (2%) 10%

[0137] Magnesium Stearate 1%

[0138] A total of 1000 pieces

[0139] Preparation Process:

[0140] Weigh 2 g of sodium carboxymethyl cellulose and dissolve it in 100 ml of purified water. The above-mentioned raw and auxiliary materials are weighed according to the formula, mixed, passed through a 100 mesh sieve three times, and mixed uniformly to obtain 548g of powder, adding 54.8g of a binder with a concentration of 2%, making a soft material, passing through a 24 mesh sieve for granulation. The wet granules were dried in an oven at 60°C for 3 hours, tak...

Embodiment 3

[0158] Example 3 Preparation of Rifampin-ISoniazid Dual Capsules (Rifampicin as the core of the pellet)

[0159] (A) formula and preparation process of rifampicin ball core

[0160] formula:

[0161] Rifampicin 150g

[0162] Microcrystalline Cellulose KG802 85g

[0163] Low-substituted hydroxypropyl cellulose 15g

[0164] Povidone K30 (15%) 20%

[0165] A total of 1000 capsules

[0166] Preparation Process:

[0167] Weigh 15 g of povidone and dissolve it in 100 ml of 70% ethanol. Weigh the rifampicin, microcrystalline cellulose KG802, and low-substituted hydroxypropyl cellulose in the formula, pass through a 100-mesh sieve, and mix evenly; add 57ml of 15% povidone solution, make a soft material, pass through a 32-mesh sieve for granulation . Put the granules in the coating pot, turn the coating pot at a speed of 80-110 rpm, and rotate for 45 minutes; take out the pellet core and dry it in an oven at 60°C for 3 hours to obtain the product.

[0168] (B) Formula and prep...

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Abstract

The invention relates to a medicine solid compound preparation which contains a medicine inner core prepared of one or more active medicines, and a medicine cover prepared by one or more active medicines, wherein the medicine cover is covered on the medicine inner core. The medicines reacted mutually in the compound preparation are separated and are positioned in different layers in the preparation so as to avoid the interaction. The invention also discloses a preparation method of the medicine solid compound preparation.

Description

Technical field: [0001] The invention relates to a medicine solid compound preparation and a preparation method thereof, in particular to a compound preparation in which an active drug in the preparation is wrapped with an isolation coat and a drug coat and a preparation method thereof. Background technique: [0002] The compound preparation of multiple active drugs has the advantages of simple formula, convenient medication, accurate dosage, fixed treatment plan, no missed or wrong dose, and prevention of secondary drug resistance in the treatment of diseases. For example, in the drug treatment of tuberculosis, WHO recommends the use of solid compound preparations of anti-tuberculosis drugs that are compatible with multiple drugs. [0003] However, chemical reactions may occur among multiple active drugs in some compound preparations, resulting in the degradation or deterioration of active drugs during the production, storage and administration of compound preparations, res...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/28A61K9/56A61K31/496A61K31/4409A61K31/4965A61K31/133
Inventor 徐飞刘均胜
Owner CHONGQING HUAPONT PHARMA
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