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Sitagliptin phosphate composition tablet and preparation method thereof

A technology of sitagliptin phosphate and composition, which is applied in the field of sitagliptin phosphate composition tablet and its preparation, can solve the problems of inconvenient use, slow disintegration speed, low dissolution rate, etc., and achieve easy portability, The effect of fast disintegration speed and high dissolution rate

Inactive Publication Date: 2015-05-27
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] It was first produced by Merck, but it has the disadvantages of slow disintegration, low dissolution rate and inconvenient use

Method used

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  • Sitagliptin phosphate composition tablet and preparation method thereof
  • Sitagliptin phosphate composition tablet and preparation method thereof
  • Sitagliptin phosphate composition tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Production of 1000 specifications is 100mg sitagliptin phosphate composition tablets, the active ingredients of the sitagliptin phosphate composition tablet are sitagliptin phosphate, mannitol, microcrystalline cellulose, cross-linked carboxylate The amounts of sodium methylcellulose, magnesium stearate and 5% aqueous hydroxypropylcellulose solution are shown in Table 1.

[0031]

[0032] Concrete preparation steps are as follows:

[0033] The first step: sieve, pass sitagliptin phosphate through a 100-mesh sieve, and pass mannitol, microcrystalline cellulose and croscarmellose sodium through a 80-mesh sieve;

[0034] The second step: mixing, mixing sitagliptin phosphate, mannitol, microcrystalline cellulose and cross-linked carboxymethyl cellulose sodium after sieving to obtain the first mixture, set aside;

[0035] The third step: granulation, add the weighed 5% hydroxypropyl cellulose aqueous solution to the first mixture to make soft material, pass through a ...

Embodiment 2

[0042] Adopt the formula of embodiment 1 to carry out scale-up test, the concrete consumption of raw material is as follows:

[0043] Table 3 specification is 100mg sitagliptin phosphate composition tablet scale-up test raw material consumption

[0044]

[0045] The control parameters in the specific process are shown in Table 4:

[0046] Table 4 key process parameter control table

[0047]

[0048] The results show that during the scale-up process, the prescription process of this specification preparation is practical and feasible, and the process is stable. The indexes of the prepared samples were inspected with reference to Example 2, and all the indexes met the quality standards for clinical research.

[0049] The detection instrument and detection method thereof used in above embodiment 1, embodiment 2 technology are summed up as follows:

[0050] 1. Moisture content of granules: Use the Karl Fischer Moisture Analyzer to measure the moisture content of granules ...

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Abstract

The invention relates to the field of pharmacy, and discloses a sitagliptin phosphate composition tablet and a preparation method thereof. The sitagliptin phosphate composition tablet disclosed by the invention comprises the following effective components: sitagliptin phosphate, mannitol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate and 5% hydroxy propyl cellulose. The sitagliptin phosphate composition tablet is available in synthesis materials, low in cost, high in disintegrating speed, high in dissolution rate, good in stability, accurate in dosage, convenient to take and convenient to carry. The method for preparing the sitagliptin phosphate composition tablet is simple in steps, short in production cycle, low in production cost and suitable for industrialized application; and the technological process is easy to control.

Description

technical field [0001] The invention relates to the medical field, and discloses a sitagliptin phosphate composition tablet and a preparation method thereof. Background technique [0002] Diabetes is a combination of sugar, protein, fat, water and electrolytes caused by genetic factors, immune dysfunction, microbial infection and its toxins, free radical toxins, mental factors and other pathogenic factors acting on the body to cause hypofunction of pancreatic islets. A series of metabolic disorder syndromes, clinically characterized by hyperglycemia, typical cases may appear polyuria, polydipsia, polyphagia, weight loss and other manifestations, that is, "three more and one less" symptoms. Among them, type 1 diabetes mostly occurs in adolescents. Due to the lack of insulin secretion, they must rely on exogenous insulin supplements to maintain life. Among them, type 1 diabetes mostly occurs in adolescents, who must rely on exogenous insulin supplementation to maintain life ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4985A61K47/38A61K47/26A61P3/10
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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