Composition containing linezolid as well as preparation method thereof
A technology of linezolid and a composition is applied in the field of linezolid tablets and preparation thereof, and can solve the problems of linezolid being easy to change crystal form, poor solubility, immiscibility and the like, and achieves simple production process operation and low cost. Effect
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Examples
example 1-7
[0043] Example 1-7: Preparation prescription dosage
[0044]
[0045] Process:
[0046](1) Pulverize linezolid, with an average particle size of ≤107 μm, d90 ≤ 243 μm, and d50 ≤ 56 μm;
[0047] (2) Mix linezolid, sodium lauryl sulfate, crospovidone internally added, copovidone S-630, anhydrous citric acid internally added, and sodium bicarbonate internally, and dry granulator granulation;
[0048] (3) Add starch lactose, crospovidone extra part, anhydrous citric acid extra part, sodium bicarbonate extra part, magnesium stearate, silicon dioxide, and mix well;
[0049] (4) Conventional method tabletting;
[0050] (5) Pack 2 layers of coatings. For the first time, 80% copovidone S-630 and 20% ethylcellulose are prepared to a concentration of 10% with ethanol, and the weight gain of the coating is 0.8-1.2%; Generation (295F680001WHITE) was prepared with 80% ethanol solution to a concentration of 8%, and the coating weight increased by 1%-2%.
[0051] For the above example...
Embodiment 8-12
[0055] Embodiment 8-12: the comparative test of anhydrous citric acid, sodium bicarbonate adding total amount and adding method
[0056]
Example 8
Example 9
Example 10
Example 11
Example 12
600
600
600
600
600
10
10
10
10
10
Copovidone
40
40
40
40
40
80
80
80
80
80
Added crospovidone
40
40
40
40
40
Crospovidone Plus
10
10
10
10
10
Added anhydrous citric acid
30
0
7
5
4
Anhydrous citric acid plus
0
30
3.5
2.5
2
Added sodium bicarbonate
30
0
7
5
4
Sodium bicarbonate plus
0
30
3.5
2.5
2
5
5
5
5
5
silica
25
25
25
25
25
production
1000 pieces
1000 piece...
Embodiment 13-18
[0061] Embodiment 13-18: Determination of sodium bicarbonate, anhydrous citric acid internal / external addition ratio
[0062] prescription:
[0063]
[0064] Technology: with embodiment 1.
[0065] According to Chinese Pharmacopoeia 2010 edition two appendix V D high performance liquid chromatography in 0.1NHCl, pH4.5 acetate buffer solution, purified water, the 15-minute dissolution rate (%) of prescription 13-18 is detected in phosphate buffer solution.
[0066]
[0067] The results show that when sodium bicarbonate and anhydrous citric acid are added / externally added to be greater than 4 or less than 0.5, the dissolution rate in 15 minutes is unqualified.
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Abstract
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