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Sucralfate oral preparation and preparation method thereof

An oral preparation, sucralfate technology, applied in the field of oral sucralfate preparation and its preparation, can solve the problems of limitation, low bioavailability, unsatisfactory treatment effect, etc., achieve good gastric retention characteristics, prolong the repair of ulcers, product Stable and controllable quality

Active Publication Date: 2022-07-29
海南久常制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the effect of gastric emptying, sucralfate usually does not stay in the stomach for a long time, resulting in unsatisfactory therapeutic effect and low bioavailability, and the dissolution of sucralfate requires low acid conditions, which is subject to certain restrictions

Method used

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  • Sucralfate oral preparation and preparation method thereof
  • Sucralfate oral preparation and preparation method thereof
  • Sucralfate oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A sucralfate oral preparation, the prescription is as follows:

[0030] serial number Material composition Proportion (g) 1 Sucralfate 350 2 sucrose 250 3 Mannitol 150 4 Porous starch 50 5 Sodium carboxymethyl cellulose Moderate 6 peppermint 7.4 7 orange essence Moderate 8 Thioglycerol 50 9 Poloxamer 15 10 Galactomannan 80 11 xylo-oligosaccharide 37

[0031] (1) Preparation of raw materials: The porous film material is a mixture of poloxamer and galactomannan in a mass ratio of 0.3:1.6, and is irradiated with 630 nm red light to obtain a porous film material with a pore size of 1.0 μm.

[0032] (2) the preparation method of sucralfate oral preparation, comprises the steps:

[0033] Step S1: respectively pass sucralfate and diluent through 80 mesh sieves to obtain premix 1, and pass aromatic correctives through 100 mesh sieves to obtain premix 2;

[0034] Step S2: Add binder...

Embodiment 2-5

[0043] A sucralfate oral preparation, the prescription is as follows:

[0044]

[0045] (1) Preparation of raw materials: the porous film material is poloxamer and galactomannan irradiated with 630 nm red light to obtain a porous film material with a pore size of 1.0 μm.

[0046] (2) the preparation method of above-mentioned embodiment 2-5 sucralfate oral preparation, comprises the steps:

[0047] Step S1: respectively pass sucralfate and diluent through 80 mesh sieves to obtain premix 1, and pass aromatic correctives through 100 mesh sieves to obtain premix 2;

[0048] Step S2: Add binder and absorbent to premix 1, make soft material, add cosolvent and porous film material, stir at 25°C for 30min, sonicate at 700W for 40min, pass through a 20-mesh sieve, granulate at 50 ℃ drying to moisture content ≤ 3.0% to obtain particulate matter;

[0049] Step S301: take the granules, pass through a 20-mesh sieve, granulate, add premix 2, sodium carboxymethyl starch and magnesium stea...

Embodiment 6

[0057] The difference between this example and Example 1 is that the preparation methods of oral sucralfate preparations are different, and the specific steps are:

[0058] Step S1: respectively pass sucralfate and diluent through a 70-mesh sieve to obtain premix 1, and pass the aromatic correctives through a 100-mesh sieve to obtain premix 2;

[0059] Step S2: Add binder and absorbent to premix 1, make soft material, add cosolvent and porous film material, stir at 25°C for 30min, 800W ultrasonic for 60min, pass through a 20-mesh sieve, granulate at 50 ℃ drying to moisture content ≤ 3.0% to obtain particulate matter;

[0060] Step S3: take the granules, pass through a 20-mesh sieve, granulate, add premix 2, sodium carboxymethyl starch and magnesium stearate, mix, and press with a 9mm diameter flat arc punch to obtain a sucralfate oral preparation.

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Abstract

The invention provides a sucralfate oral preparation and a preparation method thereof, the sucralfate oral preparation comprises the following components by mass: 30-55 wt% of sucralfate, 28-50 wt% of a diluent, 0.2-2.2 wt% of an aromatic flavoring agent, 3-11 wt% of a cosolvent, 8-17 wt% of porous film materials and 2-20 wt% of an adhesive, the cosolvent is thioglycerol, the porous film materials comprise poloxamer and galactomannan, and the adhesive is a mixture of sodium alginate and sodium alginate. The mass ratio of the poloxamer to the galactomannan is (0.2 to 0.3) to (0.8 to 1.6). The invention also provides a preparation method of the sucralfate oral preparation. The sucralfate oral preparation obtained by the invention has an accumulative release rate up to 18 hours, has excellent properties such as quick response, stable effect persistence, high dissolution property and the like, and meanwhile, has high adhesive force on gastric mucosa and in-vitro biological adhesive force up to 28.72 g / cm < 2 >.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical oral preparations, in particular to a sucralfate oral preparation and a preparation method thereof. Background technique [0002] Stomach ulcer is a type of peptic ulcer. When the gastric mucosa is damaged, ulcers are prone to occur in this area, that is, gastric ulcers are formed. Sucralfate is one of the effective drugs for the treatment of gastric ulcer, which can protect the ulcer surface and promote ulcer healing. Its mechanism of action is: in an acidic environment, sucralfate can dissociate sucrose sulfate complex ions, and the complex ions aggregate into insoluble negatively charged colloids, which can combine with positively charged protein exudates on the ulcer surface to form A protective film covers the ulcer surface to promote ulcer healing. However, due to gastric emptying, sucralfate usually does not stay in the stomach for a long time, resulting in unsatisfactory therapeut...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/70A61K47/20A61K47/26A61K47/10A61K47/36A61P1/04
CPCA61K31/70A61K9/0053A61K9/2013A61K9/2018A61K9/205A61P1/04Y02A50/30
Inventor 魏雪纹戴宏旭吴海锋彭琪王宗达纪新明许宇丽
Owner 海南久常制药有限公司
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