Migltol microcapsule tablet and preparation method thereof

A technology of miglitol and microcapsule tablets, which is applied in the field of medicine, can solve the problems of affecting the stability of drugs, the decrease of dissolution rate, the increase of substances, etc., and achieve the effects of benefiting quality control, improving stability and reducing side effects

Active Publication Date: 2009-11-11
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In view of the miglitol wet-processed granules in the prior art, which are easy to coke at about 70-80°C, the tablets produced by common methods such as direct compression, wet granulation and dry granulation The agent is easy to absorb moisture during storage, which affects the stability of the drug, and there are problems such as content decrease, dissolution rate decrease and related substances increase. This requires a new method to improve the quality of miglitol tablets and prepare a quick-acting product. , Miglitol tablets with high safety to meet clinical needs

Method used

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  • Migltol microcapsule tablet and preparation method thereof
  • Migltol microcapsule tablet and preparation method thereof
  • Migltol microcapsule tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Microcapsule preparation of Miglitol of the present invention

[0035] Name of raw material Amount / g

[0036]

[0037] Miglitol 50

[0038] starch 10

[0039] Type IV Acrylic 30

[0040] MCC 50

[0041] CMS-Na3

[0042] 70% ethanol water solution

[0043]

[0044] A total of 1000 pieces were made

[0045] Preparation Process:

[0046] ① Pass the prescribed amount of Miglitol through a 60-120 mesh sieve, place it in a fluidized bed, and pass hot air into it to suspend and fluidize it. The temperature of the hot air is 45-55°C;

[0047]② Dissolve starch and type IV acrylic resin with an appropriate amount of 70% ethanol aqueous solution to make a 15% capsule material solution, and the capsule material solution is atomized through the nozzle of the fluidized bed and continuously added to the fluidized bed, where the atomization pressure is 0.25-0.30Mpa , the spraying speed is 50...

Embodiment 2

[0050] Microcapsule preparation of Miglitol of the present invention

[0051] Name of raw material Amount / g

[0052]

[0053] Miglitol 50

[0054] Polyethylene glycol 15

[0055] HPMC 20

[0056] Lactose 60

[0057] CMC-Na4

[0058] 70% ethanol water solution

[0059]

[0060] A total of 1000 pieces were made

[0061] Preparation Process:

[0062] ① Pass the prescribed amount of Miglitol through a 60-120 mesh sieve, place it in a fluidized bed, and pass hot air into it to suspend and fluidize it. The temperature of the hot air is 45-55°C;

[0063] ② Dissolve HPMC and polyethylene glycol with an appropriate amount of 70% ethanol aqueous solution to make a 15% capsule material solution, and the capsule material solution is atomized through the nozzle of the fluidized bed and continuously added to the fluidized bed, wherein the atomization pressure is 0.25-0.30Mpa , the spra...

Embodiment 3

[0066] Microcapsule preparation of Miglitol of the present invention

[0067] Name of raw material Amount / g

[0068]

[0069] Miglitol 50

[0070] PvP 35

[0071] Calcium hydrogen phosphate 20

[0072] MCC 40

[0073] Copovidone S-630 4

[0074] 70% ethanol water solution

[0075]

[0076] A total of 1000 pieces were made

[0077] Preparation Process:

[0078] ① Pass the prescribed amount of Miglitol through a 60-120 mesh sieve, place it in a fluidized bed, and pass hot air into it to suspend and fluidize it. The temperature of the hot air is 45-55°C;

[0079] ②Dissolve PVP with an appropriate amount of 70% ethanol aqueous solution to make a 20% capsule material solution. The capsule material solution is atomized and continuously added to the fluidized bed through the nozzle of the fluidized bed, wherein the atomization pressure is 0.25-0.30Mpa, and the spraying speed is 50 ~...

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Abstract

The invention relates to a migltol microcapsule tablet and preparation method thereof. Migltol is put in a fluidized bed; then capsule solution is continuously added to the fluidized bed after atomized by the nozzle of the fluidized bed, and migltol microcapsules are produced; the migltol microcapsule, disintegrating agent and thinner of the unit formula are uniformly mixed, and the mixture is tabletted according to routine techniques to produce the migltol microcapsule tablet. The preparation method of the invention can remarkably increase the stability of migltol, thus being more suitable for commercial process. The migltol microcapsule tablet of the invention can be steadily and rapidly released in bodies to perform the diabetes-treating function of migltol.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a microencapsulated tablet of diabetes drug miglitol and a preparation method thereof. technical background [0002] Diabetes is a common disease that endangers human health. The number of diabetics worldwide is increasing at an alarming rate. According to an epidemiological survey in 2003, there are nearly 200 million diabetics in the world, and it is estimated that this number will exceed 300 million by 2025. . With the rapid development of my country's economy, the number of people with diabetes is also increasing rapidly. In the past 20 years, the prevalence of diabetes in my country has increased from less than 1% to 3.21%. Judging from the current growth trend, it is estimated that by 2025, the number of diabetic patients in China will exceed 50 million. At present, China has become the second most diabetic country in the world after India. Diabetic complications are s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/445A61K47/42A61P3/10A61K47/10A61K47/32A61K47/36A61K47/38
Inventor 赵志全王玉广
Owner LUNAN PHARMA GROUP CORPORATION
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