Preparation method of mecobalamin dispersible tablets
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A technology of methylcobalamin and dispersible tablets, applied in the field of medicinal chemistry, can solve problems such as instability, and achieve the effects of high production efficiency, high purity and risk reduction
Pending Publication Date: 2020-10-09
ZHUOHE PHARM GRP CO LTD
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The existing preparation process adopts the method of adding equal amounts for mixing, which needs to be weighed many times, mixed for no less than 6 times, and then wet granulated. It takes about 2 hours to pre
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[0030] Example one :
[0031] This embodiment discloses a method for preparing a mecobalamin dispersible tablet, which includes the following steps:
[0032] Step 1: Prepare the following materials for use: methylcobalamin raw material, microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate. Among them, 0.5g of methylcobalamin raw material, 88.9g of microcrystalline cellulose, 28.8g of lactose, 1.2g of croscarmellose sodium, 0.6g of magnesium stearate, weighed under the condition of an ambient humidity of 40% The above materials.
[0033] Step 2: Pass the methylcobalamin raw material through a standard sieve, which is a 60-mesh sieve; divide the microcrystalline cellulose into two parts, the first microcrystalline cellulose is 13.3 g, and the second microcrystalline cellulose is 75.6 g.
[0034] Step 3: Add the first portion of microcrystalline cellulose to the three-dimensional mixer under the condition of avoiding light in the whole process, and then add th...
Example Embodiment
[0038] Example two :
[0039] This embodiment discloses a method for preparing a mecobalamin dispersible tablet, which includes the following steps:
[0040] Step 1: Prepare the following materials for use: methylcobalamin raw material, microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate. Among them, 0.5 g of methylcobalamin raw materials, 88 g of microcrystalline cellulose, 28 g of lactose, 2.5 g of croscarmellose sodium, and 1 g of magnesium stearate were weighed out under the condition of an ambient humidity of 35%.
[0041] Step 2: Pass the methylcobalamin raw material through a standard sieve, which is a 40-mesh sieve; divide the microcrystalline cellulose into two parts, the first part of the microcrystalline cellulose is 15 g, and the second part of the microcrystalline cellulose is 73 g.
[0042] Step 3: Add the first portion of microcrystalline cellulose to the three-dimensional mixer under the condition of avoiding light in the whole process, and ...
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Abstract
The invention provides a preparation method of mecobalamin dispersible tablets, which comprises the following steps: adding a part of microcrystalline cellulose into a three-dimensional mixer, addinga mecobalamin raw material, and mixing to obtain a mixture I; rinsing the tank body of the three-dimensional mixer with lactose, adding the rinsed lactose and the mixture I into the multi-dimensionalmixer, adding croscarmellose sodium and the other part of microcrystalline cellulose into the multi-dimensional mixer, and mixing to obtain a mixture II. The invention provides a preparation method ofmecobalamin dispersible tablets. A direct tabletting method is adopted; links such as granulation, size stabilization and drying are omitted; the method has the characteristics of short process route, high production efficiency, low energy consumption and few degradation impurities; the materials are fully and uniformly mixed by three steps, the mecobalamin raw material can be uniformly distributed in the dispersible tablet, and the obtained mecobalamin dispersible tablet has much lower impurity content and higher purity than the mecobalamin dispersible tablet prepared by the existing wet granulation process.
Description
technical field [0001] The invention relates to the technical field of medicinal chemistry, in particular to a method for preparing methylcobalamin dispersible tablets. Background technique [0002] Methylcobalamin drugs are used for the treatment of peripheral nerve diseases and megaloblastic anemia caused by vitamin B12 deficiency. Compared with other vitamin B12 drugs, methylcobalamin has better transmission in the nervous system and can promote the metabolism of nucleic acid, protein and fat. Pharmacologically, it repairs damaged peripheral nerves by promoting the synthesis of nucleic acid, protein and nerve myelin sheath in nerve cells. Clinically, methylcobalamin drugs have obvious effects on peripheral nerve diseases such as diabetic neuropathy and multiple neuritis, especially on numbness, pain and paralysis. They are currently effective drugs for clinical treatment of such diseases with minimal side effects. In addition, studies have shown that methylcobalamin is ...
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