CN109730969B - Lactic acid levofloxacin dispersible tablet and preparation method thereof - Google Patents
Lactic acid levofloxacin dispersible tablet and preparation method thereof Download PDFInfo
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- CN109730969B CN109730969B CN201910098288.3A CN201910098288A CN109730969B CN 109730969 B CN109730969 B CN 109730969B CN 201910098288 A CN201910098288 A CN 201910098288A CN 109730969 B CN109730969 B CN 109730969B
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- 239000007919 dispersible tablet Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims description 12
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 title description 4
- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 title description 3
- 229960003376 levofloxacin Drugs 0.000 title description 3
- 235000014655 lactic acid Nutrition 0.000 title description 2
- 239000004310 lactic acid Substances 0.000 title description 2
- ONDRRTIAGBDDKP-PPHPATTJSA-N 294662-18-3 Chemical compound CC(O)C(O)=O.C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 ONDRRTIAGBDDKP-PPHPATTJSA-N 0.000 claims abstract description 47
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 47
- 229920002472 Starch Polymers 0.000 claims abstract description 47
- 235000019698 starch Nutrition 0.000 claims abstract description 47
- 239000008107 starch Substances 0.000 claims abstract description 47
- 239000000463 material Substances 0.000 claims abstract description 36
- 239000000741 silica gel Substances 0.000 claims abstract description 33
- IJOOHPMOJXWVHK-UHFFFAOYSA-N chlorotrimethylsilane Chemical compound C[Si](C)(C)Cl IJOOHPMOJXWVHK-UHFFFAOYSA-N 0.000 claims abstract description 32
- 229910002027 silica gel Inorganic materials 0.000 claims abstract description 32
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims abstract description 22
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 22
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 20
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 20
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 20
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 20
- 239000011734 sodium Substances 0.000 claims abstract description 20
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 20
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims abstract description 16
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract description 16
- 239000005051 trimethylchlorosilane Substances 0.000 claims abstract description 16
- 239000000843 powder Substances 0.000 claims abstract description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 11
- 239000001341 hydroxy propyl starch Substances 0.000 claims abstract description 7
- 235000013828 hydroxypropyl starch Nutrition 0.000 claims abstract description 7
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims description 38
- 238000007873 sieving Methods 0.000 claims description 24
- 238000001035 drying Methods 0.000 claims description 17
- CTQNGGLPUBDAKN-UHFFFAOYSA-N O-Xylene Chemical compound CC1=CC=CC=C1C CTQNGGLPUBDAKN-UHFFFAOYSA-N 0.000 claims description 15
- 238000003756 stirring Methods 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 8
- 239000008096 xylene Substances 0.000 claims description 7
- 238000004140 cleaning Methods 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 6
- 238000000227 grinding Methods 0.000 claims description 6
- 238000010438 heat treatment Methods 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 6
- 229910002012 Aerosil® Inorganic materials 0.000 claims 2
- 239000000126 substance Substances 0.000 abstract description 7
- 239000006185 dispersion Substances 0.000 abstract description 5
- 238000004090 dissolution Methods 0.000 abstract description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 9
- 239000002994 raw material Substances 0.000 description 5
- 238000005286 illumination Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 239000003814 drug Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 239000004368 Modified starch Substances 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000009795 derivation Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 235000019426 modified starch Nutrition 0.000 description 1
- 239000003607 modifier Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000007670 refining Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 229910021487 silica fume Inorganic materials 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
Abstract
The invention discloses a levofloxacin lactate dispersible tablet which comprises the following components in parts by weight: 100 parts of levofloxacin lactate, 40-45 parts of microcrystalline cellulose, 20-27 parts of carboxymethyl starch sodium, 38-42 parts of starch, 1-2 parts of superfine silica powder, 2-3 parts of magnesium stearate and 10-20 parts of ethanol water with the mass fraction of 60-70%; the starch is hydroxypropyl starch; the micropowder silica gel is micropowder silica gel modified by trimethylchlorosilane. The invention mainly optimizes partial auxiliary materials, not only can the dosage of each auxiliary material be greatly reduced, but also the related substances, content, dissolution, dispersion uniformity and stability of the product are improved, thereby simultaneously realizing the purposes of reducing the production cost and improving the product quality.
Description
Technical Field
The invention relates to a levofloxacin lactate dispersible tablet and a preparation method thereof, belonging to the technical field of medicine processing.
Background
Levofloxacin lactate is the lactate of levofloxacin and is mainly suitable for treating urinary system infection and respiratory system infection. The levofloxacin lactate dispersible tablet has the advantages of fast disintegration, high bioavailability, convenient taking, convenient storage and transportation and the like, can be swallowed, chewed, sucked or dispersed with water into uniform suspension with good mouthfeel, is particularly suitable for patients to take, and can increase the compliance of the patients. The auxiliary materials in the prescription of the levofloxacin lactate dispersible tablet account for most parts, so the properties and the dosage of the auxiliary materials determine the quality of the product to a great extent. In view of cost saving, producers often need to reduce the dosage of auxiliary materials as much as possible on the premise of ensuring the product properties, but the levofloxacin lactate dispersible tablets have high requirements on the auxiliary materials, and at present, a prescription with small dosage of the auxiliary materials, low cost and stable product is difficult to find.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a levofloxacin lactate dispersible tablet and a preparation method thereof.
The technical scheme adopted by the invention is as follows:
the levofloxacin lactate dispersible tablet comprises the following components in parts by weight: 100 parts of levofloxacin lactate, 40-45 parts of microcrystalline cellulose, 20-27 parts of carboxymethyl starch sodium, 38-42 parts of starch, 1-2 parts of superfine silica powder, 2-3 parts of magnesium stearate and 10-20 parts of ethanol water with the mass fraction of 60-70%;
the starch is hydroxypropyl starch;
the micropowder silica gel is treated by the following method: mixing the micropowder silica gel with xylene, stirring for 1-1.5 h, heating to 80-90 ℃, adding trimethylchlorosilane, continuing stirring for 1-1.5 h, filtering, cleaning and drying.
Preferably, the mass ratio of the micropowder silica gel to the dimethylbenzene is 1 (90-100).
Preferably, the addition amount of the trimethylchlorosilane is 2-3% of the mass of the superfine silica powder.
The invention further provides a preparation method of the levofloxacin lactate dispersible tablet, which comprises the following steps:
(1) sieving starch, microcrystalline cellulose and carboxymethyl starch sodium with a sieve of 80-90 meshes respectively; taking 20-30% of starch, 50-60% of microcrystalline cellulose and 70-75% of carboxymethyl starch sodium in parts by weight, and uniformly mixing to obtain an auxiliary material A for later use;
(2) taking magnesium stearate, and the balance of microcrystalline cellulose and sodium carboxymethyl starch according to the weight parts, and uniformly mixing to obtain an auxiliary material B for later use;
(3) sieving the crushed levofloxacin lactate with a 50-60-mesh sieve; taking levofloxacin lactate according to the weight part, taking micro-powder silica gel 30-40% of the weight part, taking ethanol water with the mass fraction of 60-65% of the weight part of 5-10%, grinding, uniformly mixing, drying, sieving by a 50-60 mesh sieve, adding the balance of starch, and uniformly mixing to obtain a material; wherein the temperature of ethanol water with the mass fraction of 60% is 35-40 ℃;
(4) mixing the material obtained in the step (3) with an auxiliary material A, then adding the rest ethanol water solution with the mass fraction of 65-70%, uniformly mixing, sieving and granulating, drying, sieving and grading to obtain a mixture;
(5) and (5) mixing the mixture obtained in the step (4) with an auxiliary material B, and tabletting to obtain the product.
Preferably, in the step (3), the temperature of the ethanol water with the mass fraction of 60-65% is 35 ℃.
Preferably, in the step (4), the drying condition is 50-55 ℃ for 1-2 hours.
Compared with the prior art, the invention has the beneficial effects that:
the auxiliary materials in the prescription of the levofloxacin lactate dispersible tablet account for most parts, so the properties and the dosage of the auxiliary materials determine the quality of the product to a great extent. However, in view of cost saving, manufacturers often need to reduce the amount of auxiliary materials as much as possible while ensuring the properties of the product. According to the invention, auxiliary materials are optimized, and researches show that when ordinary starch is replaced by hydroxypropyl starch and ordinary micropowder silica gel is replaced by micropowder silica gel subjected to surface modification by trimethylchlorosilane, the using amount of each auxiliary material can be greatly reduced, and related substances, content, dissolution rate, dispersion uniformity and stability of the product are improved, so that the aims of reducing the production cost and improving the product quality are fulfilled.
The preparation method of the levofloxacin lactate dispersible tablet also has certain influence on the quality of the levofloxacin lactate dispersible tablet. The invention optimizes the preparation method of the dispersible tablet on the basis of adopting modified starch and modified micropowder silica gel. Earlier experiments show that the micro silica gel powder modified by trimethylchlorosilane is used as a grinding aid to be mixed and ground with raw materials under the assistance of 35-40 ℃ ethanol water, so that the grinding and refining of the raw materials can be promoted, the particle size of the raw materials is reduced, the water absorption is enhanced, and the disintegration of a dispersing agent is promoted. Meanwhile, the superfine silica powder modified by the trimethylchlorosilane is also used as a modifier for modifying the raw materials, so that the obstruction between the surface of the raw materials and the outside is formed, the illumination influence is reduced, and the product stability is improved.
Detailed Description
The present invention will be described in further detail with reference to the following embodiments.
The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.
Example 1
The levofloxacin lactate dispersible tablet comprises the following components in parts by weight: 100 parts of levofloxacin lactate, 40 parts of microcrystalline cellulose, 20 parts of carboxymethyl starch sodium, 38 parts of starch, 1 part of superfine silica gel powder, 2 parts of magnesium stearate and 10 parts of ethanol water with the mass fraction of 65%;
the starch is hydroxypropyl starch;
the micropowder silica gel is treated by the following method: mixing silica gel micropowder with xylene, stirring for 1h, heating to 80 ℃, adding trimethylchlorosilane, continuously stirring for 1h, filtering, cleaning and drying.
The mass ratio of the micropowder silica gel to the dimethylbenzene is 1: 90.
The addition amount of the trimethylchlorosilane is 2 percent of the mass of the micropowder silica gel.
The preparation method of the levofloxacin lactate dispersible tablet comprises the following steps:
(1) sieving levofloxacin lactate with a 50-mesh sieve; sieving starch, microcrystalline cellulose and carboxymethyl starch sodium with 80 mesh sieve respectively;
(2) uniformly mixing levofloxacin lactate, starch, microcrystalline cellulose and carboxymethyl starch sodium in parts by weight; then adding 65% of ethanol water solution by mass fraction, mixing uniformly, sieving with a 20-mesh sieve for granulation, drying at 50 ℃ for 1 hour, and sieving with a 16-mesh sieve for granule stabilization; adding the micropowder silica gel and magnesium stearate in parts by weight into the granules, fully and uniformly mixing, and tabletting to obtain the product.
Example 2
The levofloxacin lactate dispersible tablet comprises the following components in parts by weight: 100 parts of levofloxacin lactate, 45 parts of microcrystalline cellulose, 27 parts of carboxymethyl starch sodium, 42 parts of starch, 2 parts of superfine silica gel powder, 3 parts of magnesium stearate and 20 parts of ethanol water with the mass fraction of 70%;
the starch is hydroxypropyl starch;
the micropowder silica gel is treated by the following method: mixing silica gel micropowder with xylene, stirring for 1.5h, heating to 90 deg.C, adding trimethylchlorosilane, stirring for 1.5h, filtering, cleaning, and drying.
The mass ratio of the micropowder silica gel to the dimethylbenzene is 1: 100.
The addition amount of the trimethylchlorosilane is 3 percent of the mass of the micropowder silica gel.
The preparation method of levofloxacin lactate dispersible tablets is the same as that of example 1.
Example 3
The levofloxacin lactate dispersible tablet comprises the following components in parts by weight: 100 parts of levofloxacin lactate, 45 parts of microcrystalline cellulose, 27 parts of carboxymethyl starch sodium, 42 parts of starch, 2 parts of superfine silica powder, 3 parts of magnesium stearate and 20 parts of ethanol water with the mass fraction of 60-70%;
the starch is hydroxypropyl starch;
the micropowder silica gel is treated by the following method: mixing silica gel micropowder with xylene, stirring for 1.5h, heating to 90 deg.C, adding trimethylchlorosilane, stirring for 1.5h, filtering, cleaning, and drying.
The mass ratio of the micropowder silica gel to the dimethylbenzene is 1: 90.
The addition amount of the trimethylchlorosilane is 3 percent of the mass of the micropowder silica gel.
The preparation method of the levofloxacin lactate dispersible tablet comprises the following steps:
(1) sieving starch, microcrystalline cellulose and carboxymethyl starch sodium with 80 mesh sieve respectively; taking 20% of starch, 50% of microcrystalline cellulose and 70% of carboxymethyl starch sodium in parts by weight, and uniformly mixing to obtain an auxiliary material A for later use;
(2) taking magnesium stearate, and the balance of microcrystalline cellulose and sodium carboxymethyl starch according to the weight parts, and uniformly mixing to obtain an auxiliary material B for later use;
(3) sieving the crushed levofloxacin lactate with a 50-mesh sieve; taking levofloxacin lactate according to the weight part, taking micro-powder silica gel according to 30% of the weight part and ethanol water with the mass fraction of 60% according to 5% of the weight part, grinding, uniformly mixing, drying, sieving by a 50-mesh sieve, adding the rest starch, and uniformly mixing to obtain a material; wherein the temperature of ethanol water with the mass fraction of 60% is 35 ℃;
(4) mixing the material in the step (3) with the auxiliary material A, then adding the rest ethanol water solution with the mass fraction of 65%, uniformly mixing, sieving and granulating, drying at 50 ℃ for 1 hour, sieving and granulating to obtain a mixture;
(5) and (5) mixing the mixture obtained in the step (4) with an auxiliary material B, and tabletting to obtain the product.
Example 4
Example 4 differs from example 3 in that,
the preparation method of the levofloxacin lactate dispersible tablet comprises the following steps:
(1) sieving starch, microcrystalline cellulose and carboxymethyl starch sodium with 90 mesh sieve respectively; taking 30% of starch, 60% of microcrystalline cellulose and 75% of carboxymethyl starch sodium in parts by weight, and uniformly mixing to obtain an auxiliary material A for later use;
(2) taking magnesium stearate, and the balance of microcrystalline cellulose and sodium carboxymethyl starch according to the weight parts, and uniformly mixing to obtain an auxiliary material B for later use;
(3) sieving the crushed levofloxacin lactate with a 60-mesh sieve; taking levofloxacin lactate according to the weight part, taking micro-powder silica gel according to 40% of the weight part and ethanol water with the mass fraction of 65% according to 10% of the weight part, grinding, uniformly mixing, drying, sieving by a 60-mesh sieve, adding the rest starch, and uniformly mixing to obtain a material; wherein the temperature of ethanol water with the mass fraction of 65% is 40 ℃;
(4) and (3) granulating: mixing the material in the step (3) with the auxiliary material A, then adding the balance of ethanol water solution with the mass fraction of 70%, uniformly mixing, sieving and granulating, drying for 2 hours at 55 ℃, sieving and granulating to obtain a mixture;
(5) total mixing and tabletting: and (5) mixing the mixture obtained in the step (4) with an auxiliary material B, and tabletting to obtain the product.
Comparative example 1
Comparative example 1 is different from example 1 in that,
the micropowder silica gel is not treated with trimethylchlorosilane.
Comparative example 2
Comparative example 2 differs from example 1 in that,
the micropowder silica gel is treated by the following method: mixing silica gel micropowder with xylene, stirring for 1h, heating to 100 ℃, adding trimethylchlorosilane, continuously stirring for 1h, filtering, cleaning and drying.
Test example 1:
taking the levofloxacin lactate dispersible tablets prepared in the examples and the comparative examples, and detecting related substances, content, dissolution rate and dispersion uniformity according to the national food and drug administration standard YBH 08792008. The results are shown in Table 1.
TABLE 1
The results show that by adopting the technical scheme of the embodiment, the related substances, content, dissolution rate and dispersion uniformity of the product all meet the standard regulation and the effect is obviously better than that of the comparative example.
Test example 2
The levofloxacin lactate dispersible tablets prepared in the examples and the comparative examples are taken and placed under the condition of 4500 +/-500 lx illumination for 10 days, and samples are taken on the 5 th and 10 th days to detect related substances. The results are shown in Table 2.
TABLE 2
| 5 days | 10 days | |
| Example 1 | 0.02％ | 0.05％ |
| Example 2 | 0.02％ | 0.06％ |
| Example 3 | 0.01％ | 0.02％ |
| Example 4 | 0.01％ | 0.03％ |
| Comparative example 1 | 0.25％ | 0.32％ |
| Comparative example 2 | 0.19％ | 0.25％ |
The results show that the levofloxacin lactate dispersible tablets prepared by the invention are placed under the condition of 4500 +/-500 lx illumination for 5 days and 10 days, and related substances do not exceed the standard and have no obvious change.
Test example 3
Taking the levofloxacin lactate dispersible tablets prepared in the examples, carrying out aluminum-plastic internal packaging after the levofloxacin lactate dispersible tablets pass the detection, placing the levofloxacin lactate dispersible tablets for 24 months under the conditions of 25 +/-2 ℃ and 60 +/-5% of relative humidity, and sampling at 0, 3, 6, 12, 18 and 24 months, wherein the results show that the related substances, the content, the dissolution rate and the dispersion uniformity of the samples in the examples do not exceed the standard and have no obvious change, thereby indicating that the product has stable quality.
The foregoing is a more detailed description of the present invention that is presented in conjunction with specific embodiments, and the practice of the invention is not to be considered limited to those descriptions. It will be apparent to those skilled in the art that a number of simple derivations or substitutions can be made without departing from the inventive concept.
Claims (5)
1. The levofloxacin lactate dispersible tablet is characterized by comprising the following components in parts by weight: 100 parts of levofloxacin lactate, 40-45 parts of microcrystalline cellulose, 20-27 parts of carboxymethyl starch sodium, 38-42 parts of starch, 1-2 parts of superfine silica powder, 2-3 parts of magnesium stearate and 10-20 parts of ethanol water with the mass fraction of 60-70%;
the starch is hydroxypropyl starch;
the micropowder silica gel is treated by the following method: mixing silica gel micropowder with xylene, stirring for 1-1.5 h, heating to 80-90 ℃, adding trimethylchlorosilane, continuing stirring for 1-1.5 h, filtering, cleaning and drying;
the preparation method of the levofloxacin lactate dispersible tablet comprises the following steps:
(1) sieving starch, microcrystalline cellulose and carboxymethyl starch sodium with a sieve of 80-90 meshes respectively; taking 20-30% of starch, 50-60% of microcrystalline cellulose and 70-75% of carboxymethyl starch sodium in parts by weight, and uniformly mixing to obtain an auxiliary material A for later use;
(2) taking magnesium stearate, and the balance of microcrystalline cellulose and sodium carboxymethyl starch according to the weight parts, and uniformly mixing to obtain an auxiliary material B for later use;
(3) sieving the crushed levofloxacin lactate with a 50-60-mesh sieve; taking levofloxacin lactate according to the weight part, taking micro-powder silica gel 30-40% of the weight part, taking ethanol water with the mass fraction of 60-65% of the weight part of 5-10%, grinding, uniformly mixing, drying, sieving by a 50-60 mesh sieve, adding the balance of starch, and uniformly mixing to obtain a material; wherein the temperature of 60-65% by mass of ethanol water is 35-40 ℃;
(4) mixing the material obtained in the step (3) with an auxiliary material A, then adding the rest ethanol water solution with the mass fraction of 65-70%, uniformly mixing, sieving and granulating, drying, sieving and grading to obtain a mixture;
(5) and (5) mixing the mixture obtained in the step (4) with an auxiliary material B, and tabletting to obtain the product.
2. The levofloxacin lactate dispersible tablet according to claim 1, wherein the mass ratio of the aerosil to the xylene is 1 (90-100).
3. The levofloxacin lactate dispersible tablet according to claim 1, wherein the amount of the trimethylchlorosilane added is 2-3% by mass of the aerosil.
4. The levofloxacin lactate dispersible tablet according to claim 1, wherein in the step (3), the temperature of 60-65% by mass of ethanol water is 35 ℃.
5. The levofloxacin lactate dispersible tablet according to claim 1, wherein the drying in step (4) is performed at 50-55 ℃ for 1-2 hours.
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Denomination of invention: A lactate levofloxacin dispersible tablet and its preparation method Granted publication date: 20200811 Pledgee: Agricultural Bank of China Limited Haikou Nanhang Branch Pledgor: HAINAN QUANXING PHARMACEUTICAL CO.,LTD. Registration number: Y2024980008742 |