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Mecobalamin sustained-release tablet and preparation method thereof

A sustained-release tablet, methylcobalamin technology, applied in the field of medicine, can solve the problems of no reports on methylcobalamin sustained-release preparations, difficulty in achieving effective release, inability to absorb methylcobalamin, etc., and achieve prescription reproducibility Good, good industrial production value, tablet smooth and beautiful effect

Active Publication Date: 2013-01-30
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The common solid preparations of methylcobalamin currently on the market are released quickly in the body, and methylcobalamin cannot be fully absorbed; in addition, as a small-dose drug (daily dosage is 1.5mg), it is difficult to achieve Effective release; and because methylcobalamin is an actively absorbed drug, it is very difficult to prepare a preparation for simultaneous release in vivo and in vitro
[0008] There are no related reports on methylcobalamin sustained-release preparations

Method used

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  • Mecobalamin sustained-release tablet and preparation method thereof
  • Mecobalamin sustained-release tablet and preparation method thereof
  • Mecobalamin sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Preparation of Methylcobalamin Sustained Release Tablets

[0055] The prescription is (per 1000 tablets):

[0056] A: Methylcobalamin 1.5g

[0057] B: Micropowder silica gel 1.5g

[0058] C: Hypromellose (k4m) 20g

[0059] D: Carbomer (71G) 10g

[0060] E: microcrystalline cellulose (PH101) 65g

[0061] F: Magnesium stearate 1g

[0062] The materials A to F are crushed, passed through a 100-mesh sieve, and mixed uniformly to obtain a mixture; they are compressed into sustained-release tablets on a high-speed tablet machine. The above tablet was then coated with Opadry (OY-26528) opaque coating solution until the weight gain was 3%.

[0063] The results of tablet quality study showed that the average tablet weight was 102 mg, and the difference in tablet weight was less than 4.0%. Using 500 mL of phosphate buffer solution with pH 6.8 as the dissolution medium, the cumulative release rates of the three batches of methylcobalamin sustained-release tablets were all a...

Embodiment 2

[0065] Preparation of Methylcobalamin Sustained Release Tablets

[0066] The prescription is (per 1000 tablets):

[0067] A: Methylcobalamin 0.75g

[0068] B: Micropowder silica gel 1.5g

[0069] C: Hypromellose (k4m) 20g

[0070] D: Polyvinylpyrrolidone (K90) 20g

[0071] E: microcrystalline cellulose (PH101) 40g

[0072] F: Magnesium stearate (additional) 0.6g

[0073] G: Polyvinylpyrrolidone (K30) 5g

[0074] H: 95% ethanol 100g

[0075] Crush materials A to E, pass through a 100-mesh sieve, and mix uniformly to obtain a mixture; completely dissolve G: polyvinylpyrrolidone (K30) in H: 95% ethanol to prepare an adhesive; use this adhesive to prepare the mixture Granules, the drying temperature is controlled at 50°C; after the obtained granules are evenly mixed with material F, they are compressed into sustained-release tablets on a high-speed tablet press. The above tablet was then coated with Opadry (OY-26528) opaque coating solution until the weight gain was 3%.

...

Embodiment 3

[0078] Preparation of Methylcobalamin Sustained Release Tablets

[0079] The prescription is (per 1000 tablets):

[0080] A: Methylcobalamin 1.5g

[0081] B: Micropowder silica gel 1.5g

[0082] C: Hypromellose (k4m) 25g

[0083] D: Hypromellose (k100m) 10g

[0084] E: microcrystalline cellulose (PH101) 20g

[0085] F: Mannitol 20g

[0086] G: Magnesium stearate (additional) 1g

[0087] H: Polyvinylpyrrolidone (K30) 5g

[0088] I: 95% ethanol 100g

[0089] Crush materials A to F, pass through a 100-mesh sieve, and mix uniformly to obtain a mixture; completely dissolve H: polyvinylpyrrolidone (K30) in I: 95% alcohol to prepare an adhesive; use this adhesive to prepare the mixture Granules, the drying temperature is controlled at 50°C; after the obtained granules are evenly mixed with material G, they are compressed into sustained-release tablets on a high-speed tablet press. The above tablet was then coated with Opadry (OY-26528) opaque coating solution until the weigh...

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Abstract

The invention discloses a mecobalamin sustained-release tablet and a preparation method thereof. The preparation is a sustained-release tablet containing mecobalamin. The preparation method is to mix mecobalamin, the corresponding slow-releasing material and other accessories and tabletting to obtain the finished product. In the method, mecobalamin is used to prepare the sustained-release tablet, thus solving the problem that the common mecobalamin preparation is poor to absorb, improving drug absorption and increasing bioavailability; and the method is simple, quality control is easy to perform, and the method is suitable for industrial production. Mecobalamin in the preparation is released slowly in 12h or 24h and the tablet is taken once or twice every day, thus the dosing frequency can be reduced, the patient compliance can be improved and the blood concentration can be better balanced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to methylcobalamin sustained-release tablets and a preparation method thereof. Background technique [0002] Diabetes mellitus (DM) is a common and frequently-occurring disease in many countries around the world. According to the statistics of the World Health Organization, the number of people with diabetes in the world is currently 220 million. At present, the number of diabetic patients in China has reached 50 million, accounting for 1 / 5 of the total number of diabetics in the world, and the prevalence rate ranks second in the world after India! And it is increasing at a rate of at least 3,000 people per day, and increasing at a rate of 1.5 million to 2 million people every year. Nearly 80% of diabetic patients have complications, and the complications of diabetes are the main cause of disability and death of patients. At present, the mortality rate of diabetes complications ha...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/714A61K9/22A61K9/28A61K9/36A61K47/38A61K47/32A61K47/34A61K47/36A61K47/44A61P25/02A61K47/10
Inventor 张玉斌孙田江范文源魏春燕沈利罗永慧王延松陆宏国
Owner YANGTZE RIVER PHARM GRP CO LTD
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