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Compound preparation for treating II type diabetes mellitus and preparation method of compound preparation

A technology for type 2 diabetes and compound preparations, which are applied in the field of compound preparations for the treatment of type 2 diabetes, compound preparations for the treatment of type 2 diabetes and their preparation, can solve the problems of low dissolution rate, unstable quality, and required particle size and the like , to achieve the effect of good efficacy, high drug dissolution and good stability

Inactive Publication Date: 2015-04-01
CHANGSHA BAISHUN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Since Ipagliflozin is a poorly water-soluble drug, the absorption of the drug mainly depends on the dissolution rate of the drug. The existing Ipagliflozin preparations have defects such as unstable quality, low dissolution rate, and requirements for particle size.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Ipagliflozin Metformin Tablet Core Prescription: (Specifications: Ipagliflozin 25mg, Metformin Hydrochloride 0.25g)

[0037] Ipagliflozin 25.0 g

[0038] Metformin Hydrochloride 250.0 g

[0039] Microcrystalline Cellulose 100.0 g

[0040] Crospovidone 20.0 g

[0041] Magnesium stearate 2.0 g

[0042] 4% hydroxypropyl cellulose aqueous solution appropriate amount

[0043] A total of 1000 pieces were made

[0044] Coating Solution Prescription:

[0045] Opadry II 85F18422 20.0 g

[0046] Purified water 180.0 g

[0047] Preparation:

[0048] 1. Preparation of drug-containing tablet cores

[0049] Processing of raw and auxiliary materials: Pass Ipagliflozin and metformin hydrochloride through a 100-mesh standard sieve, and microcrystalline cellulose and crospovidone through a 60-mesh standard sieve for later use;

[0050] ② Weigh 8g of hydroxypropyl cellulose and add it to 192g of purified water in stages, and stir until ...

Embodiment 2

[0061] Prescription of Ipagliflozin and Metformin Tablets: (Specification: Ipagliflozin 50mg, Metformin Hydrochloride 0.5g)

[0062] Proline Ipagliflozin 50.0 g (calculated as Ipagliflozin)

[0063] Metformin Hydrochloride 500.0 g

[0064] Mannitol 200.0 g

[0065] Croscarmellose Sodium 42.0 g

[0066] Micronized silica gel 8.0 g

[0067] 2% hypromellose aqueous solution appropriate amount

[0068] A total of 1000 pieces were made

[0069] Coating Solution Prescription:

[0070] Opadry II 85F42129 40.0 g

[0071] 70% ethanol 460.0 g

[0072] Preparation:

[0073] 1. Preparation of drug-containing tablet cores

[0074] Processing of raw and auxiliary materials: pass proline ipagliflozin and metformin hydrochloride through a 100-mesh standard sieve, sieve mannitol and croscarmellose sodium through a 80-mesh sieve for later use;

[0075] ②Weigh 8g of hypromellose E15 and add it to 392g of purified water, stir until completely d...

Embodiment 3

[0086] Ipagliflozin Metformin Tablet Core Prescription (Specification: Ipagliflozin 25mg Metformin Hydrochloride 0.85g):

[0087] Ipagliflozin Glutamate 25.0 g (calculated as Ipagliflozin)

[0088] Metformin Hydrochloride 850.0 g

[0089] Anhydrous lactose 250.0 g

[0090] Sodium starch glycolate 80.0 g

[0091] Magnesium Stearate 10.0g

[0092] 8% povidone K30 aqueous solution appropriate amount

[0093] A total of 1000 pieces were made

[0094] Coating Solution Prescription:

[0095] Opadry II 85F18422 60.0 g

[0096] 75% ethanol 940.0 g

[0097] Preparation:

[0098] 1. Preparation of drug-containing tablet cores

[0099] Processing of raw and auxiliary materials: Pass Ipagliflozin glutamic acid and metformin hydrochloride through a 100-mesh standard sieve, and anhydrous lactose and carboxymethyl starch sodium pass through a 60-mesh standard sieve for later use;

[0100] ② Add 40g of povidone K30 to 460g of purified water...

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PUM

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Abstract

The invention provides a compound preparation for treating II type diabetes mellitus and a preparation method of the compound preparation. The pharmaceutical composition for treating II type diabetes mellitus is prepared from active components ipragliflozin and metformin hydrochloride as well as pharmaceutical adjuvants including a filler, an adhesive, a disintegrant and a lubricant. The compound preparation for treating II type diabetes mellitus prepared by the method has no special requirements on particle sizes of the active components, is free of superfine grinding, low in energy consumption, high in dissolution rate and high in bioavailability, and has a market development prospect; and the defects of poor dissolution rate and low bioavailability of the active components are solved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a compound preparation for treating type 2 diabetes and a preparation method thereof. The invention also provides a compound preparation for treating type 2 diabetes with safe quality and good stability. Background technique [0002] According to the statistics of the International Diabetes Federation, there were 151 million diabetic patients in the world in 2000, and currently there are 285 million diabetic patients in the world. If the current growth rate is maintained, it is estimated that by 2030, nearly 500 million people worldwide will suffer from diabetes, including type 2 diabetes patients. Accounted for more than 90%. Chronic vascular complications of diabetes pose a great threat to the life and quality of life of patients, and bring heavy economic burdens to families and individuals. [0003] Ipragliflozin was jointly developed by Japan's Astellas and...

Claims

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Application Information

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IPC IPC(8): A61K31/381A61K9/36A61K9/48A61K47/38A61K47/36A61K47/32A61K47/10A61P3/10A61K31/155
Inventor 不公告发明人
Owner CHANGSHA BAISHUN BIOTECH
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