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Drug excipient and preparation method thereof

An excipient and a technology for preparing medicines, applied in the field of starch modification and application, can solve the problems of many additives and side effects, and achieve the effect of reducing application, reducing side effects and good fluidity

Active Publication Date: 2015-01-07
SOUTH CHINA UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current cross-linked modified starch uses many additives in the modification process, which may cause some side effects when used as a pharmaceutical excipient

Method used

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  • Drug excipient and preparation method thereof
  • Drug excipient and preparation method thereof
  • Drug excipient and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] A pharmaceutical excipient, prepared by cross-linking and cooperating enzymatic hydrolysis of starch, the preparation method is as follows:

[0042] (1) Adjust the waxy rice starch into starch milk with a mass fraction of 20% with distilled water, and add Na 2 CO 3 ;

[0043] (2) Regulate the pH of the starch milk to 11 with the NaOH solution of 1mol / L, add sodium trimetaphosphate equivalent to 3% of the waxy rice starch quality;

[0044] (3) stirring and reacting at 40° C. for 3 h, adjusting the pH to 6.5 with 1 mol / L HCl solution to complete the reaction, and obtaining the reacted starch milk;

[0045] (4) Add 95% ethanol to the reacted starch milk to carry out suction filtration, wash 5 times, then wash 2 times with NaCl solution with a mass fraction of 2.5%, then dry the washed product in a blast drying oven at 45°C , pulverized, and passed through a 100-mesh standard sieve to obtain cross-linked starch;

[0046] (5) Take the above-mentioned cross-linked starch ...

Embodiment 2

[0066] A pharmaceutical excipient, prepared by cross-linking and cooperating enzymatic hydrolysis of starch, the preparation method is as follows:

[0067] (1) With distilled water, cornstarch is adjusted into starch milk with a mass fraction of 20%, and Na 2 CO 3 ;

[0068] (2) Regulate the pH of starch milk to 10 with the NaOH solution of 0.1mol / L, add the sodium trimetaphosphate equivalent to 4% of cornstarch quality;

[0069] (3) stirring and reacting at 45° C. for 2 h, adjusting the pH to 7 with 1 mol / L HCl solution to complete the reaction, and obtaining starch milk after reaction;

[0070] (4) Add 95% ethanol to the reacted starch milk for suction filtration, wash 5 times, then wash 3 times with 2.5% NaCl solution by mass fraction, then dry the washed product in a blast drying oven at 45°C , pulverized, and passed through a 100-mesh standard sieve to obtain cross-linked starch;

[0071] (5) Take the above-mentioned cross-linked starch and use an acetic acid-sodium a...

Embodiment 3

[0079] A pharmaceutical excipient, prepared by cross-linking and cooperating enzymatic hydrolysis of starch, the preparation method is as follows:

[0080] (1) Use distilled water to adjust the pea starch into starch milk with a mass fraction of 25%, and add Na 2 CO 3 ;

[0081] (2) Regulate the pH of starch milk to 9 with the NaOH solution of 1mol / L, add sodium trimetaphosphate equivalent to 5% of pea starch quality;

[0082] (3) stirring and reacting at 50° C. for 1 h, adjusting the pH to 6 with 1 mol / L HCl solution to complete the reaction, and obtaining the reacted starch milk;

[0083] (4) Add 95% ethanol to the reacted starch milk to carry out suction filtration, wash 4 times, then wash 2 times with NaCl solution with a mass fraction of 2.5%, and then dry the washed product in a blast drying oven at 45°C , pulverized, and passed through a 100-mesh standard sieve to obtain cross-linked starch;

[0084] (5) Take the above-mentioned cross-linked starch and use an acetic...

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Abstract

The invention belongs to the field of starch modification and application, and discloses a drug excipient prepared through the synergistic effects of chemical modification and enzymolysis on starch. The preparation method comprises the following steps: at first, adding sodium trimetaphosphate into the starch for reaction under the alkaline condition, regulating the obtained product to be neutral, and obtaining crosslinked starch after pumping washing and washing; then, preparing the crosslinked starch into crosslinked starch milk by using an acetic acid-sodium acetate buffer solution, adding beta-amylase into the crosslinked starch milk after high-temperature gelatinization for enzymatic hydrolysis, and performing high-temperature enzyme deactivation, alcohol dissolution, centrifuging, drying, crushing and screening to obtain solid powder which is the drug excipient. The drug excipient overcomes the defects of native starch and single modified starch, and the quantity of the other matters added in tablets as auxiliary materials is minimized, so that the drug preparation cost can be lowered, side effects of the drug are reduced, and the drug effect can be improved.

Description

technical field [0001] The invention belongs to the field of starch modification and application, and relates to a pharmaceutical excipient and a preparation method thereof, in particular to a pharmaceutical excipient prepared by synergistically chemically modifying starch and enzymatic hydrolysis and a preparation method thereof. Background technique [0002] Excipients are additives in pharmaceutical preparations other than the main drug, also known as excipients. Pharmaceutical excipients are the key components of tablets, and have an important relationship with the relationship between excipients and dosage forms, excipients and absorption. Drugs and excipients interact with each other, and excipients play a positive and key role in the actual application and curative effect of drugs. Starch is the most commonly used excipient in tablet production. It can be used as diluent and absorbent, as well as binder and disintegrant. There are many types of starch, mainly includi...

Claims

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Application Information

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IPC IPC(8): C12P19/22C08B31/00A61K47/36
Inventor 高群玉雷俊华
Owner SOUTH CHINA UNIV OF TECH
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