Pharmaceutical composition and preparation method thereof

A composition and drug technology, applied in the field of oral stable pharmaceutical composition and preparation, can solve the problems of complicated preparation process, influence drug safety, influence product quality, etc. The effect of reducing the economic burden

Active Publication Date: 2017-07-04
WATERSTONE PHARMA WUHAN
4 Cites 3 Cited by

AI-Extracted Technical Summary

Problems solved by technology

However, changing the crystal form of the raw material may cause quality problems in other aspects of the drug, such as the dissolution rate, thereby affecting the product qu...
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Method used

As can be seen from table 2, test result, add auxiliary material fumaric acid and be respectively 1,3, the embodiment 3-5 of 5 weight parts place temperature 40 ℃, place 6 months under the accelerated condition of 75% relative humi...
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Abstract

The invention relates to a pharmaceutical composition and a preparation method thereof. The pharmaceutical composition comprises a first component and a second component, wherein the first component is at least one selected from a group consisting of vonoprazan fumarate, a pharmaceutical salt thereof and a solvate of vonoprazan fumarate, and the second component is at least one selected from a group consisting of polaprezinc, a pharmaceutical salt thereof and a solvate of polaprezinc. The pharmaceutical composition is advanced in prescription, and the preparation method is simple in process and easy to operate, saves production cost and can guarantee more stable product quality.

Application Domain

Technology Topic

ChemistryPolaprezinc

Image

  • Pharmaceutical composition and preparation method thereof
  • Pharmaceutical composition and preparation method thereof
  • Pharmaceutical composition and preparation method thereof

Examples

  • Experimental program(9)

Example Embodiment

[0047] Example 1
[0048]
[0049] Preparation method: Weigh the raw and auxiliary materials in the prescription amount, crush them, sieving them for later use; mix the fumaric acid and voronolazan fumaric acid evenly to obtain the mixture ①; the mixture ①, polyprezinc, and hardened Other auxiliary materials other than magnesium fatty acid are put into the high-efficiency wet granulator and premixed for 15 minutes; into the high-efficiency wet granulator, slowly add 50% by volume ethanol solution to make soft materials; use the swing granulator to The prepared soft material is granulated with a 24-mesh sieve; the prepared wet granules are put into a hot-air circulating oven and dried at 55-65℃ until the moisture content is ≤1.0%; the dried granules are sieved with 16 mesh and 80 mesh respectively Sieve, collect particles below 16 mesh and above 80 mesh; sizing particles above 16 mesh with 18 mesh sieve, collect particles below 16 mesh sieve and above 80 mesh sieve; mix the particles with magnesium stearate 10min, subpackage.

Example Embodiment

[0050] Example 2
[0051]
[0052] Preparation method: Weigh the raw and auxiliary materials in the prescription amount, crush them, sieving them for later use; mix the fumaric acid and voronolazan fumaric acid evenly to obtain the mixture ①; the mixture ①, polyprezinc, and hardened Other auxiliary materials other than magnesium fatty acid are put into the high-efficiency wet granulator and premixed for 15 minutes; into the high-efficiency wet granulator, slowly add 50% by volume ethanol solution to make soft materials; use the swing granulator to The prepared soft material is granulated with a 24-mesh sieve; the prepared wet granules are put into a hot-air circulating oven and dried at 55-65℃ until the moisture content is ≤1.0%; the dried granules are sieved with 16 mesh and 80 mesh respectively Sieve, collect particles below 16 mesh and above 80 mesh; sizing particles above 16 mesh with 18 mesh sieve, collect particles below 16 mesh sieve and above 80 mesh sieve; mix the particles with magnesium stearate 10min, subpackage.

Example Embodiment

[0053] Example 3
[0054]
[0055] Preparation method: Weigh the raw and auxiliary materials in the prescription amount, crush them, sieving them for later use; mix the fumaric acid and voronolazan fumaric acid evenly to obtain the mixture ①; the mixture ①, polyprezinc, and hardened Other auxiliary materials other than magnesium fatty acid are put into the high-efficiency wet granulator and premixed for 15 minutes; into the high-efficiency wet granulator, slowly add 50% by volume ethanol solution to make soft materials; use the swing granulator to The prepared soft material is granulated with a 24-mesh sieve; the prepared wet granules are put into a hot-air circulating oven and dried at 55-65℃ until the moisture content is ≤1.0%; the dried granules are sieved with 16 mesh and 80 mesh respectively Sieve, collect particles below 16 mesh and above 80 mesh; sizing particles above 16 mesh with 18 mesh sieve, collect particles below 16 mesh sieve and above 80 mesh sieve; mix the particles with magnesium stearate 10min, subpackage.
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Description & Claims & Application Information

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