DC (Directly compressible)-xylitol and preparation method thereof

A xylitol and wet granulation technology, which is used in pharmaceutical formulations, medical preparations with inactive ingredients, and pill delivery, etc., can solve the problems of unfitness, high friability, low tablet hardness, etc. quality, overcoming strong hygroscopicity, and the effect of a wide range of applications

Inactive Publication Date: 2012-05-02
SHANDONG LINUO KEFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method adopts natural adhesives, hot water is used to dissolve the adhesives during preparation, which is not easy to compress, and the prepared granules have low bulk density, low hardness and high friability of directly compressed tablets.
[0007] It can be seen from the above patents that most of the current DC-xylitol preparation prescriptions have added polyvinylpyrrolidone and other chemicals as adhesives, which are not suitable for the body. Low bulk density of granules, low hardness and high friability of direct compression tablets

Method used

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  • DC (Directly compressible)-xylitol and preparation method thereof
  • DC (Directly compressible)-xylitol and preparation method thereof
  • DC (Directly compressible)-xylitol and preparation method thereof

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Effect test

Embodiment 1

[0030] DC-xylitol of the present invention mainly comprises main material xylitol, binder carboxymethylcellulose sodium (CMC-Na) and wetting agent ethanol solution, and the concentration of described ethanol solution is 70% (w / w), wherein, the consumption of binding agent and wetting agent sees the following table, prepare DC-xylitol according to following preparation method, compress tablet and detect its hardness and friability:

[0031] 1. Raw material preparation: Grind and sieve the xylitol main material and the binder sodium carboxymethyl cellulose to 80 mesh respectively, and set aside;

[0032] 2. Wet granulation: Mix the treated raw materials and binders evenly in a wet granulator for about 3 minutes, then add 70% ethanol solution, stir at low speed for 5-10 minutes, then stir at high speed Cut for 5-10 minutes, then granulate twice with a 30-mesh sieve in a swing granulator, and dry at 45°C until the moisture content is less than 0.5% (w / w);

[0033] 3. Tablet pres...

Embodiment 2

[0036] 500g of xylitol, 16g of sodium carboxymethylcellulose, and 119.7g of 70% ethanol solution are made into granules and compressed according to the following methods:

[0037] 1. Raw material preparation: Grind and sieve the xylitol main material and the binder sodium carboxymethyl cellulose to 80 mesh respectively, and set aside;

[0038] 2. Wet granulation: Mix the treated raw materials and binder in a wet granulator for about 3 minutes, then add 70% ethanol solution, first stir at low speed for 5 minutes, then stir at high speed for 5 minutes, then Granulate twice with a 30-mesh sieve in a swing granulator, and dry at 45°C until the moisture content is less than 0.5% (w / w).

[0039] 3. Screening and tabletting: pass the dried particles through a 24-mesh sieve, and discard a small amount of products that fail to pass the 24-mesh sieve to obtain DC-xylitol with uniform thickness, and perform tabletting according to conventional operations to obtain xylose Alcohol Tablets...

Embodiment 3

[0042] 500g of xylitol, 20g of sodium carboxymethylcellulose, and 115g of 70% ethanol solution are made into granules and compressed according to the following methods:

[0043] 1. Raw material preparation: Grind and sieve the xylitol main material and the binder sodium carboxymethyl cellulose to 80 mesh respectively, and set aside;

[0044] 2. Wet granulation: Mix the treated raw materials and binders evenly in a wet granulator for about 3 minutes, then add 70% ethanol solution, first stir at low speed for 6 minutes, and then stir at high speed for 6 minutes. Then granulate twice with a 30-mesh sieve in a swing granulator, and dry at 45°C until the moisture content is less than 0.5% (w / w).

[0045] 3. Screening and tabletting: pass the dried particles through a 24-mesh sieve, and discard a small amount of products that fail to pass the 24-mesh sieve to obtain DC-xylitol with uniform thickness, and perform tabletting according to conventional operations to obtain xylose Alcoh...

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Abstract

The invention discloses DC (Directly compressible)-xylitol, which mainly comprises xylitol, sodium carboxymethylcellulose adhesive and 70% (w/w) ethanol solution wetting agent, wherein sodium carboxymethylcellulose accounts for 3-10% the weight of a mother batch and the ethanol solution accounts for 20-40% the weight of the mother batch. The invention also discloses a preparation method of DC-xylitol. In the preparation method disclosed by the invention, high-concentration ethanol is used as a wetting agent, so as to reduce the viscosity during granulating; and the adhesive is added in an internal addition manner, the problem that granulation is not easy due to over-high use amount and ultrahigh viscosity of the adhesive is overcome. Through the matching of the adhesive and wetting agent,the prepared DC-xylitol is directly compressible, the bulk density of the obtained particle is maximally up to 0.7 g/mL, the hardness of the tablet is more than 140 N, and the friability of the tablet is reduced to 0%.

Description

technical field [0001] The invention relates to DC-xylitol and a preparation method thereof, in particular to DC-xylitol which is easy to be directly compressed into tablets, has high tablet hardness and 0% friability and a preparation method thereof. Background technique [0002] Xylitol is a new type of pure natural sweetener extracted from corncobs, bagasse and other substances. It is an intermediate in the metabolism of carbohydrates in the human body and widely exists in nature, especially in vegetables, fruits, and natural mushrooms. Rich in edible fungi. In the case of the lack of insulin in the human body affecting glucose metabolism, xylitol can also be absorbed and utilized by tissues through the cell membrane without insulin promotion, and can promote the synthesis of glycogen in the liver and improve liver function. It is an ideal drug for patients with diabetes and hepatitis complications. . At the same time, this product is not used by bacteria that produce d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/16A61K47/38A61K31/047A61P1/02A61P1/16A61P27/16
Inventor 常鸿彦张汝德
Owner SHANDONG LINUO KEFENG PHARMA
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