CN101664392A - Gentamycin sulfate tablets and preparation method thereof - Google Patents
Gentamycin sulfate tablets and preparation method thereof Download PDFInfo
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Abstract
The invention provides gentamycin sulfate tablets and a preparation method thereof. The stability of the gentamycin sulfate tablets is effectively increased by altering the auxiliary formula of the original production process and the quality problem that the gentamycin sulfate tablets are easy to crack during storage is solved. The auxiliary formula of production technology comprises the followingcomponents by weight percent: 40-70% of starch, 1-10% of microcrystalline cellulose, 10-30% of calcium sulfate and 1-10% of PEG6000. In the product, the water content of particles is reduced and controlled to 1.0-6.0%, and the drying temperature of the original process is reduced and controlled to 55-80 DEG C. The prepared gentamycin sulfate tablets of the invention have smooth surface of tabletsand stable performance, the product is applicable to mass production, and the product quality meets the requirements of the China Pharmacopeia.
Description
Technical field
The present invention relates to a kind of preparation technology of medicine, specifically a kind of gentamycin sulfate tablets and preparation method.
Background technology
Gentamycin sulfate (Gentamycin Sulfate) is the aminoglycoside broad ectrum antibiotic, various gram-negative bacterias and gram-positive bacteria all there are good antibacterial action, various enterobacteriaceae lactobacteriaceaes such as escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Enterobacter, Serratia and Pseudomonas aeruginosa etc. are had good antibacterial action.Neisseria and hemophilus influenza are to its medium sensitivity.Brucella, bacillus pestis, acinetobacter, campylobacter fetus also there is certain effect.And about 80% of methicillin-sensitivity bacterial strain in the staphylococcus (comprising golden Portugal bacterium and coagulase negative staphylococcus) there is good antibacterial action, the mechanism of action of gentamycin sulfate is to combine with bacterial ribosome 30S subunit, suppresses the synthetic of bacterioprotein.Gentamycin sulfate tablets is applicable to treatment bacillary dysentery or other bacillary intestinal infections, also can be used for preparing before the colonic operation.Record be always or usually as specified two kinds of sheet and coated tablets at Chinese Pharmacopoeia, remove whitening color or off-white color behind the coating.
Gentamycin sulfate tablets has and draws moistly by force, and condition of storage is had higher requirement, needs sealing, preserves at the drying place.Former explained hereafter gentamycin sulfate tablets uses starch slurry to make binding agent, in process of production, usually granulate again after the soft material that makes need being put a few minutes during granulation, it is difficult to granulate, the chieftain is many, granular size is inhomogeneous, and the slice, thin piece of extrusion is unilateral piebaldism, takes the method for sugar coating to cover the defective of slice, thin piece mostly.In storage process, often appear at gentamycin sulfate tablets and storing instability in effect duration, unilateral can the be full of cracks.Find that in observation the gentamycin sulfate tablets be full of cracks of glass bottle packaging can be lighter than the be full of cracks degree of plastic bottle packing, illustrates that the sealing of vial is higher than plastic bottle to the sample that keeps sample of gentamycin sulfate tablets.Tablet should be complete bright and clean in production and duration of storage outward appearance, and color and luster is even; Suitable hardness should be arranged, in order to avoid in packing, transporting procedures, fragment takes place.Along with the raising of mechanization degree, vial is eliminated gradually now, and the use of plastic bottle is more and more general.Make diluent with starch separately in the former technology preparation, poor compressibility.
Summary of the invention
The objective of the invention is to solve the quality problems that gentamycin sulfate tablets easily chaps in storage process, a kind of preparation method of gentamycin sulfate tablets is provided for improving the stability of gentamycin sulfate tablets.
This process using wet granulation technology, with the flowability and the compression molding situation of material before the tabletting, be evaluation index the disintegration of measuring after the outward appearance of slice, thin piece, tablet weight variation, friability detection case and the accelerated test.Optimize the big process for producing of gentamycin sulfate tablets by orthogonal test and accelerated test.Select for use 5～15% polyethylene glycol 6000 alcoholic solution as binding agent, the amount ratio of polyethylene glycol 6000 is 1～10%, and the microcrystalline Cellulose amount ratio is 1～10%, and the calcium sulfate amount ratio is 10～30%, and the starch amount ratio is 40～70%.
The concrete technical scheme that the present invention optimizes is as follows:
Pharmaceutical formulation consists of: gentamycin sulfate (according to two requirements of Chinese Pharmacopoeia version in 2005), ratio of adjuvant is a mass percent: starch 40～70%, microcrystalline Cellulose 1～10%, calcium sulfate 10～30%, PEG6000 1～10%, surplus are lubricant.
Described lubricant be magnesium stearate, silicon dioxide and talcous one or more.
Preparation method:
(1) takes by weighing starch, microcrystalline Cellulose, calcium sulfate, PEG6000 by formula ratio, cross 80 mesh sieves respectively;
(2) with starch, microcrystalline Cellulose, calcium sulfate and gentamycin sulfate raw material mix homogeneously;
(3) PEG6000 is dissolved in 75～95% the alcoholic solution preparation working concentration 5～15% and makes binding agent, the system soft material is granulated;
(4) wet granular is dry under 55～80 ℃ of temperature conditions, and granulate adds lubricant, and mixing is measured dried granule moisture content with KETT, control dried granule moisture content 1.0～6.0% with interior tabletting.
The present invention to the prescription adjuvant the selection foundation: tablet is made up of medicine and adjuvant two parts.Selecting for use generally of adjuvant decides according to principal agent character and medication purpose.The be full of cracks moist at drawing of gentamycin sulfate and gentamycin sulfate tablets occurs in storage process, by increasing some new filleies, seek beyond the starch slurry more suitably or some other have hydrophobic material, macromolecular material that humidity resistance is good (is commonly used for coating material, film property is strong, form thin film, humidity resistance is good) make binding agent, improve the compressibility of material, reduce the stability that particulate water content improves gentamycin sulfate tablets.
One, improves the compressibility and the moisture resistance of material.(1) increases compressibility pregelatinized Starch preferably as filler.Pregelatinized Starch is a multi-functional auxiliary material, can make filler, has good flowability, compressibility, self-lubricity and dry adhesive, and disintegration is preferably arranged.(2) cellulose family, microcrystalline Cellulose (MC) has good compressibility, and stronger adhesion is arranged, and the tablet that is pressed into has bigger hardness, and imbibition has disintegration preferably.(3) add inorganic salts calcium sulfate as filler.Calcium sulfate is comparatively commonly used, and its stable in properties does not have and to smell tastelessly, is slightly soluble in water, but with the equal compatibility of multiple medicine, the tablet appearance of making is bright and clean, hardness, disintegrate are all good, and medicine is not had adsorption yet, humidity resistance than other adjuvant commonly used for well.
Two, use new binding agent instead and replace employed binding agent in the original production process, to solve sticking sieve, the caking phenomenon in the pelletization.(1) ethanol can be used for meeting the material that water is easy to decompose, and also can be used for meeting the too big material of water viscosity.(2) Polyethylene Glycol (PEG) class, Polyethylene Glycol (PEG) is a kind of common medicinal supplementary material, countries in the world all recorded the PEG clauses and subclauses.Poly-alcoholic acid preparation is very simple.Oxirane and monoethylene glycol (or two ethylene glycol) are formed Polyethylene Glycol through polymerization under base catalyst catalysis.The molecular weight of the PEG that produces is usually between 200～35000 at present.PEG has good aqueous solubility, and in the solid pharmaceutical preparation prescriptions such as tablet as add the flowability that an amount of macromole PEG can increase medicine when beating sheet, and the gastric dissolubility that improves principal agent finally helps to increase bioavailability.The ability that tablet discharges medicine can be improved in the plasticity of PEG and it, and high-molecular weight PEG (PEG6000) also can make the surperficial glossy and level and smooth and not fragile of tablet.
Effect of the present invention is, solves gentamycin sulfate tablets and is prone to the problem of be full of cracks in the storage life, makes coated tablet not occur cracking in the phase 3 years effects; A kind of energy of both having saved baking usefulness is provided, and the technology that can reduce cost, and this technology again is fit to big production, and product quality is guaranteed, preserves constant product quality under the condition of storage of regulation.
1, will solve gentamycin sulfate tablets and be prone to the problem of be full of cracks in the storage life, key is to reduce the water content that solves the gentamycin sulfate tablets label.This test is owing to used microcrystalline Cellulose with good compressibility, calcium sulfate as filler, adopt the polyethylene glycol 6000 alcoholic solution as binding agent, obviously improved particulate compressibility, make granule under low moisture content condition, just can satisfy tablet molding requirement, the molding of tablet is played an important role.
2, reduce the water content of gentamycin sulfate tablets label, thereby solved gentamycin sulfate tablets is prone to be full of cracks in the storage life problem.This test is adjusted the usage ratio of filler by revising prescription, uses the calcium sulfate of 2 molecular crystalline water to replace part starch in the former prescription, has reduced the deformation of expanding after the label moisture absorption, causes coated tablet not occur cracking in the phase 3 years effects.In prescription, increased microcrystalline Cellulose, improved the compressibility and the hardness of gentamycin sulfate tablets with strong adhesion; Added calcium sulfate as filler, made that tablet character is more stable, moisture resistance is better.Adopt the polyethylene glycol 6000 alcoholic solution to prepare soft material as binding agent, the granule degree of tightness of preparation is suitable, good and the easily granulation and obviously improved particulate compressibility of grain type makes granule just can satisfy tablet molding requirement under low moisture content condition, and the molding of tablet is played an important role.Easily dry under 55～80 ℃ low-temperature bake condition.The tablet appearance that utilizes this formulation and technology to make is bright and clean, and hardness, disintegrate are all good, and the surface is glossy and level and smooth, need not sugar coating and also can guarantee the gentamycin sulfate tablets quality, has improved the stability of gentamycin sulfate tablets.
3, use the calcium sulfate of 2 molecular crystalline water to replace part starch in the former prescription, reduced the deformation of expanding after the label moisture absorption, make coated tablet not occur cracking in the phase 3 years effects.
4, gentamycin sulfate tablets is after researchs such as technology preparation screening, pilot scale amplification, examine stability, and final optimization pass has been determined new production technology, is fit to big production, and product quality is guaranteed, preserves constant product quality under the condition of storage of regulation.
Below the present invention is described in detail with the experimental data in the developmental research process.
Orthogonal test screening prescription:
1, prescription is formed: gentamycin sulfate raw material, starch, microcrystalline Cellulose and calcium sulfate.Starch is inexpensive, and use amount is big, keeps in prescription, and consumption will be determined according to the usage ratio of other adjuvant in the following test.According to preliminary adjuvant The selection result, for further investigating polyethylene glycol 6000 alcoholic solution concentration, the microcrystalline Cellulose consumption, the calcium sulfate consumption is to the influence of gentamycin sulfate tablets quality stability, select more proper supplementary material proportional quantity, this paper is by the method for designing of orthogonal test, selected for use L9 (34) design table to determine three factors, three levels (table 1), and press the relevant use of orthogonal design and show the arrangement scheme, according to design prescription tabletting, and the test products of each prescription carried out accelerated test respectively, flowability and compression molding situation with material before the tabletting, the outward appearance of slice, thin piece, tablet weight variation, the friability detection case is an index for examining or check the disintegration of measuring after index and the accelerated test, the quality of overall merit gentamycin sulfate tablets production prescription.The results are shown in Table 2, table 3.
Table 1 factor level table
Table 2 orthogonal experiments
Annotate: K
iThree index sums of=horizontal i; k
i=K
i/ 3; Extreme difference R=max{K
1, K
2, K
3}～min{K
1, K
2, K
3}
Table 3 analysis of variance table
The R value from table 2 and the variance analysis of table 3 as can be seen, A, B, three factors of C are A＞C＞B to the influence size of gentamycin sulfate tablets comprehensive quality, F＞F of factor A
0.05, factor affecting is remarkable especially, and the quality influence maximum of the concentration of binding agent polyethylene glycol 6000 alcoholic solution to gentamycin sulfate tablets is described, and the F value of microcrystalline Cellulose and calcium sulfate is between F
0.05And F
0.10Between, so the consumption of microcrystalline Cellulose and calcium sulfate is remarkable to the influence of gentamycin sulfate tablets comprehensive quality, calculates according to intuitive analysis and extreme difference, thinks that good condition is: A
3B
1C
3Promptly use 5～15% polyethylene glycol 6000 alcoholic solution to make binding agent, the microcrystalline Cellulose amount ratio is 1～10%, and the calcium sulfate amount ratio is 10～30%.
2, preparation process
Each recipe quantity by Orthogonal Experiment and Design takes by weighing supplementary material, adjuvant is crossed behind 80 mesh sieves and gentamycin sulfate raw material mix homogeneously, PEG6000 is dissolved in 75～95% the alcoholic solution and makes binding agent, the system soft material is granulated, and wet granular is dry under 55～80 ℃ of temperature conditions, granulate, measure dried granule moisture content in the test determination scope with KETT,, determine sheet weight sheet according to drug content in the dried granule.Observe slice, thin piece molding situation, and carry out the tablet friability and detect, the results are shown in Table 2.The friability inspection technique detects down according to two appendix XG of Chinese Pharmacopoeia version in 2005 item.Subtract weight loss and must not cross 1%, and the sheet that must not detect fracture, be full of cracks and pulverize.Outward appearance: should be complete bright and clean, color and luster is even.Tablet weight variation: should be up to specification according to detection under two appendix IA of Chinese Pharmacopoeia version in 2005 item.
The specific embodiment by the following examples is described in further detail foregoing of the present invention.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Description of drawings
Fig. 1 is a moisture equilibrium at dry side curve chart of the present invention.
The specific embodiment
Embodiment 1:
Pharmaceutical formulation consists of: gentamycin sulfate 750g, adjuvant 2000g, the adjuvant mass percent is: starch 40%, microcrystalline Cellulose 10%, calcium sulfate 30%, PEG6000 10%, magnesium stearate 10%.
Preparation method:
(1) takes by weighing starch, microcrystalline Cellulose, calcium sulfate, PEG6000, magnesium stearate by formula ratio, cross 80 mesh sieves respectively;
(2) with starch, microcrystalline Cellulose, calcium sulfate and gentamycin sulfate raw material mix homogeneously;
(3) PEG6000 is dissolved in 95% the alcoholic solution preparation working concentration 5% and makes binding agent, the system soft material is granulated;
(4) wet granular is dry under 55 ℃ of temperature conditions, and granulate adds the magnesium stearate mix homogeneously, measures dried granule moisture content with KETT, controls dried granule moisture content at 1.0% tabletting.
Embodiment 2:
Pharmaceutical formulation consists of: gentamycin sulfate 750g, adjuvant 2000g, the adjuvant mass percent is: starch 55%, microcrystalline Cellulose 7%, calcium sulfate 20%, PEG6000 are 5%, silicon dioxide 8%, magnesium stearate 5%.
Preparation method:
(1) takes by weighing starch, microcrystalline Cellulose, calcium sulfate, PEG6000, silicon dioxide by formula ratio, cross 80 mesh sieves respectively;
(2) with starch, microcrystalline Cellulose, calcium sulfate and gentamycin sulfate raw material mix homogeneously;
(3) PEG6000 is dissolved in 85% the alcoholic solution preparation working concentration 10% and makes binding agent, the system soft material is granulated;
(4) wet granular is dry under 65 ℃ of temperature conditions, and granulate adds silicon dioxide, magnesium stearate mix homogeneously, measures dried granule moisture content with KETT, controls dried granule moisture content at 3.0% tabletting.
Embodiment 3:
Pharmaceutical formulation consists of: gentamycin sulfate 750g, adjuvant 2000g, the adjuvant mass percent is: starch 70%, microcrystalline Cellulose 1%, calcium sulfate 10%, PEG6000 are 1%, Pulvis Talci 18%.
Preparation method:
(1) takes by weighing starch, microcrystalline Cellulose, calcium sulfate, PEG6000, Pulvis Talci by formula ratio, cross 80 mesh sieves respectively;
(2) with starch, microcrystalline Cellulose, calcium sulfate and gentamycin sulfate raw material mix homogeneously;
(3) PEG6000 is dissolved in 75% the alcoholic solution preparation working concentration 15% and makes binding agent, the system soft material is granulated;
(4) wet granular is dry under 80 ℃ of temperature conditions, and granulate adds the Pulvis Talci mix homogeneously, measures dried granule moisture content with KETT, controls dried granule moisture content at 6.0% tabletting.
The technology stability test:
By above-mentioned orthogonal test screening gained prescription, earlier with former, the adjuvant mix homogeneously of recipe quantity, with the alcoholic solution of the PEG6000 of 75～95% dissolve with ethanols as binding agent, add in the mixed powder, the system soft material is granulated, drying, granulate adds lubricant and always mixes back tabletting, coating.Carry out continuous three pilot scales by this prescription and amplify the feasibility of producing checking pilot scale amplification production.Control granule moisture content tabletting in 1.0～6.0% scopes is checked tablet molding, outward appearance situation and is measured disintegration.The results are shown in Table 4, table 5, on the basis that does not change original packing, the gentamycin sulfate tablets (plain sheet and coated tablet) of three pilot scales is carried out accelerated test and long term test respectively, to examine or check its quality stability.
Table 4 pilot-scale experiment (plain sheet)
Table 5 pilot-scale experiment (coated tablet)
Accelerated test:
The gentamycin sulfate tablets of getting trial production in three times is by our company's packing instructions, plain sheet and coated tablet are bottled respectively, the aluminium foil electromagnetic induction seals, put into SH-010 steady-state damp heat test case, in temperature (40 ± 2) ℃, placed 6 months under the condition of relative humidity (75 ± 5) %, sampling in every month once, detect its disintegration (detection method is seen 2.4.3.1), hygroscopicity (detection method: accurately weigh before putting into, weighed in every month once and calculate the moisture absorption percentage rate, moisture absorption percentage rate=(every month weigh～put into before weigh)/weigh before putting into * 100% the results are shown in Table 6, table 7.Moisture equilibrium at dry side curve (seeing accompanying drawing 1).
Table 6 accelerated test result (plain sheet)
Table 7 accelerated test result (coated tablet)
Long term test:
The part of sulfuric acid gentamycin sheet of getting embodiment 1, embodiment 2 and embodiment 3 productions is by our factory's packing instructions, plain sheet and coated tablet are bottled respectively, in temperature (25 ± 2) ℃, placed 36 months under the condition of relative humidity (60 ± 10) %, sampling during respectively at 0,3,6,9,12,18,24 month, detect its disintegration and slice, thin piece outward appearance, the results are shown in Table 8, table 9.
The long-term result of the test of the plain sheet of table 8
| Sample | Test item | 0 month | March | June | JIUYUE | December | 18 months | 24 months | 36 months |
| Embodiment 1 embodiment 2 embodiment 3 | (min) outward appearance disintegration (min) outward appearance disintegration disintegration (min) outward appearance | 7 do not have the no variable color 7 of be full of cracks does not have the no variable color of the no variable color 8 nothing be full of cracks of be full of cracks | 7 do not have the no variable color 8 of be full of cracks does not have the no variable color of the no variable color 7 nothing be full of cracks of be full of cracks | 8 do not have the no variable color 7 of be full of cracks does not have the no variable color of the no variable color 7 nothing be full of cracks of be full of cracks | 7 do not have the no variable color 8 of be full of cracks does not have the no variable color of the no variable color 8 nothing be full of cracks of be full of cracks | 8 do not have the no variable color 8 of be full of cracks does not have the no variable color of the no variable color 7 nothing be full of cracks of be full of cracks | 8 do not have the no variable color 7 of be full of cracks does not have the no variable color of the no variable color 8 nothing be full of cracks of be full of cracks | 9 do not have the no variable color 8 of be full of cracks does not have the no variable color of the no variable color 7 nothing be full of cracks of be full of cracks | 8 do not have the no variable color 8 of be full of cracks does not have the no variable color of the no variable color 7 nothing be full of cracks of be full of cracks |
Table 9 coated tablet long-term test results
| Sample | Test item | 0 month | March | June | JIUYUE | December | 18 months | 24 months | 36 months |
| Embodiment 1 embodiment 2 | (min) outward appearance disintegration disintegration (min) outward appearance | 17 do not have the no variable color 15 of be full of cracks does not have the be full of cracks nothing | 16 do not have the no variable color 17 of be full of cracks does not have the be full of cracks nothing | 18 do not have the no variable color 16 of be full of cracks does not have the be full of cracks nothing | 16 do not have the no variable color 16 of be full of cracks does not have the be full of cracks nothing | 17 do not have the no variable color 17 of be full of cracks does not have the be full of cracks nothing | 17 do not have the no variable color 16 of be full of cracks does not have the be full of cracks nothing | 18 do not have the no variable color 17 of be full of cracks does not have the be full of cracks nothing | 18 do not have the no variable color 17 of be full of cracks does not have the be full of cracks nothing |
| Embodiment 3 | Disintegration (min) outward appearance | Variable color 17 does not have the no variable color of be full of cracks | Variable color 17 does not have the no variable color of be full of cracks | Variable color 16 does not have the no variable color of be full of cracks | Variable color 18 does not have the no variable color of be full of cracks | Variable color 18 does not have the no variable color of be full of cracks | Variable color 17 does not have the no variable color of be full of cracks | Variable color 17 does not have the no variable color of be full of cracks | Variable color 17 does not have the no variable color of be full of cracks |
Result: by above test, the result show with the gentamycin sulfate tablets of this prepared no matter plain sheet still be coated tablet stability better, product quality indicator meets the standards of pharmacopoeia requirement, illustrate this technology amplify produce feasible, constant product quality, controlled.
Claims (3)
1, a kind of gentamycin sulfate tablets and preparation method, it is characterized in that principal agent is the gentamycin sulfate of standard measure, ratio of adjuvant is a mass percent: starch 40～70%, microcrystalline Cellulose 1～10%, calcium sulfate 10～30%, PEG6000 1～10%, surplus are lubricant.
2, a kind of gentamycin sulfate tablets according to claim 1 and preparation method, it is characterized in that being described lubricant be magnesium stearate, silicon dioxide and talcous one or more.
3, gentamycin sulfate tablets according to claim 1 and preparation method is characterized in that carrying out according to the following steps:
(1) takes by weighing starch, microcrystalline Cellulose, calcium sulfate, PEG6000 by formula ratio, cross 80 mesh sieves respectively;
(2) with starch, microcrystalline Cellulose, calcium sulfate and gentamycin sulfate raw material mix homogeneously;
(3) PEG6000 is dissolved in 75～95% the alcoholic solution preparation working concentration 5～15% and makes binding agent, the system soft material is granulated;
(4) wet granular is dry under 55～80 ℃ of temperature conditions, and granulate adds lubricant, and mixing is measured dried granule moisture content with KETT, control dried granule moisture content 1.0～6.0% with interior tabletting.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048709A (en) * | 2010-12-17 | 2011-05-11 | 蚌埠丰原涂山制药有限公司 | Gentamycin sulfate capsule and preparation method thereof |
| CN104017844A (en) * | 2014-06-26 | 2014-09-03 | 烟台只楚药业有限公司 | Preparation method of gentamicin sulphate C1a |
| CN108309947A (en) * | 2018-04-04 | 2018-07-24 | 南京海纳医药科技股份有限公司 | A kind of tablet and preparation method thereof of benzene sulphur bepotastine |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939260A (en) * | 2005-09-26 | 2007-04-04 | 刘凤鸣 | Oral preparation containing gentamicin and its making method |
| CN101269001A (en) * | 2007-03-21 | 2008-09-24 | 北京亿利高科生物工程技术研究所有限公司 | Oral preparation containing gentamicin, preparation method and application thereof |
-
2009
- 2009-09-28 CN CN2009100950145A patent/CN101664392B/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048709A (en) * | 2010-12-17 | 2011-05-11 | 蚌埠丰原涂山制药有限公司 | Gentamycin sulfate capsule and preparation method thereof |
| CN102048709B (en) * | 2010-12-17 | 2013-02-20 | 蚌埠丰原涂山制药有限公司 | Gentamycin sulfate capsule and preparation method thereof |
| CN104017844A (en) * | 2014-06-26 | 2014-09-03 | 烟台只楚药业有限公司 | Preparation method of gentamicin sulphate C1a |
| CN108309947A (en) * | 2018-04-04 | 2018-07-24 | 南京海纳医药科技股份有限公司 | A kind of tablet and preparation method thereof of benzene sulphur bepotastine |
| CN108309947B (en) * | 2018-04-04 | 2020-07-17 | 南京海纳医药科技股份有限公司 | Bepotastine besilate tablet and preparation method thereof |
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