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Novel coated aldehyde oxystarch sustained-release capsule and preparation method thereof

A new type of technology including aldehyde oxygen starch, which is applied in the field of medicine, can solve the problems of urea adsorption capacity attenuation, etc., and achieve the effects of long action time, convenient taking of medicine, and improvement of medication compliance

Inactive Publication Date: 2018-03-13
TIANJIN PACIFIC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the presence of amino groups in a large number of beneficial substances such as protein and amino acids in human body fluids, the aldehyde-oxygen-coated starch as an adsorbent will inevitably combine with these substances when it is taken orally, so that the adsorption capacity of the adsorbent for urea will be attenuated.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: Take by weighing 550g of aldehyde-containing oxygenated starch, 250g of sodium alginate, and 150g of human albumin, mix uniformly, grind with 500ml of 1% sodium alginate aqueous solution, measure the particle size, granulate, dry in a freeze dryer, and control The moisture content of the granules is ≤1%, and 982g of granules of 20-40nm are obtained in total. Take 300g of granules and 3g of magnesium stearate, mix them uniformly and fill them into enteric-coated capsules, 0.25g / granule, to obtain 1170 aldehyde-oxygenated starch capsules.

Embodiment 2

[0027] Embodiment 2: rat frozen kidney chronic renal failure model, rat mercuric chloride renal acute renal failure model, feeding capsules in the present invention, feeding and administering this oral preparation 3g preparation / 100g body weight, 1g preparation / 100g body weight, 0.5g preparation / 100g body weight dose, 2 times a day, blood biochemical detection rat serum urea nitrogen (BUN), creatinine (Scr) all have different degrees of decrease after 1 week continuously (P<0.05), rat urine The protein content in the solution was also significantly reduced (P<0.05). It is suggested that the preparation can improve various acute and chronic kidney injuries and antagonize the development of renal failure in rats.

Embodiment 3

[0028] Embodiment 3: Grouping rat frozen renal chronic failure models, single administration of the same dose (2.5g preparation / 100g body weight) of the preparation, wherein the administration group I is the sustained-release preparation of the present invention, and the administration group II is the aldehyde oxygen-containing preparation. Common oral preparations of starch, and a blank control group were set at the same time, blood samples and urine samples were obtained from rats at 1 hour, 4 hours, 8 hours, 24 hours, and 48 hours respectively. The test showed that, compared with the blank control group, the two administration groups There was no significant difference in BUN and Scr at 1 hour and 4 hours after administration (P>0.05), but BUN and Scr were significantly reduced at 8 hours, 24 hours and 48 hours (P0.05). Comparing the two administration groups with each other, there was no significant difference in BUN and Scr 1 hour, 4 hours, and 8 hours after administration...

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PUM

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Abstract

The invention provides a novel coated aldehyde oxystarch sustained-release capsule and a preparation method thereof. 0.5-0.6 kg of an enteric coating is added in an auxiliary material in the preparation process, and the particle diameter of the prepared particles is 20-40 nm. The novel coated aldehyde oxystarch sustained-release capsule has the beneficial effects that the product provided by the invention is simple in preparation process and is suitable for large-scale mass production; the product can be accepted by the vast number of patients; the product has fewer taking times, and is convenient to use. The enteric sustained-release capsule is orally taken for two to three times a day with two to three grains each time; and the medication compliance of the patients is greatly improved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a novel aldehyde-oxygen-coated starch capsule and a preparation method thereof. Background technique [0002] The kidney is an important excretory organ of the human body. It has the functions of excreting metabolites, drugs, poisons and detoxification products in the body, and regulating the water, electrolyte, and acid-base balance in the body. In addition, the kidney can also secrete renin, prostaglandin, erythropoietin, 1,25-dihydroxyvitamin D3, etc., so as to regulate the important physiological functions of the body. Therefore, the kidney is a multifunctional organ, which plays an important role in maintaining the stability of the internal environment of the human body. When various etiologies cause serious impairment of renal function, the internal environment of the human body will be disturbed, which is mainly manifested in the accumulation of metabolites in the body...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K9/22A61K31/718A61K47/42A61P13/12A61K9/19
CPCA61K9/1658A61K9/0002A61K9/19A61K9/2063A61K31/718
Inventor 宋德成
Owner TIANJIN PACIFIC PHARMA