CN105106162A - Compound tablet for treating ulcer caused by helicobacter pylori and preparation method thereof - Google Patents
Compound tablet for treating ulcer caused by helicobacter pylori and preparation method thereof Download PDFInfo
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- CN105106162A CN105106162A CN201510517371.1A CN201510517371A CN105106162A CN 105106162 A CN105106162 A CN 105106162A CN 201510517371 A CN201510517371 A CN 201510517371A CN 105106162 A CN105106162 A CN 105106162A
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Abstract
The invention discloses a compound tablet for treating ulcer caused by helicobacter pylori and a preparation method thereof. The compound tablet comprises. The preparation method is ingenious in concept and rigorous in process; the compound tablet is prepared, so that production cost is low, compliance is improved, and the compound tablet is convenient for patients to carry for administration; due to core covering process, mutual influence among active ingredients can be isolated effectively; the compound bismuth potassium citrate tablet prepared by the method is high in stability, and bioavailability and clinical treating effect of the compound tablet are improved.
Description
Technical field
The invention belongs to medical art, relate to treatment helicobacter pylori (HP) and infect the gastric and duodenal ulcers etc. caused, with compound tablet of eradicate helicobacter pylori and preparation method thereof.
Background technology
Helicobacter pylori (HP) is from the history being found to existing 20 years now, and along with large quantifier elimination finds, HP infection is the Important cause of disease of Type B chronic gastritis, and has substantial connection with the morbidity of peptic ulcer.Existing ulcer treatment scheme result in high relapse rate, if patient accepts short-term acid suppression treatment and do not have eradicate helicobacter pylori, 1 year relapse rate of gastric and duodenal ulcers is about 40% and 80% respectively.And eradicate helicobacter pylori can reduce the relapse rate of ulcer, research shows in the patient eradicating helicobacter pylori, and 1 year relapse rate of peptic ulcer is only 2%.
Bismuth potassium citrate+metronidazole+quadracycline+omeprazole has the potentiality being used as eradicate helicobacter pylori first-line treatment, by testing program analysis display in the III clinical trial phase of North America, the eradication rate of this scheme of combination drug therapy is 92%, and analyzing eradication rate by treatment intention is 88%.But in order to carry out this quadruple chemotherapy, patient must take the Tablet and Capsula agent in 4 bottles, the 1 day 4 times clothes had, 1 day 2 times that have or 1 day 1 time clothes, the non-constant of compliance.If be prepared as compound preparation, acceptability and the compliance of patient can be increased to a certain extent, decrease phenomenons such as wrongly taking, miss, and greatly reduce production cost, Shorten the Treatment Process, treat easy.
Clinical practices a large amount of both at home and abroad proves, bismuth and two kinds of antibacterials conbined usage effectively can eradicate the helicobacter pylori of resistance to metronidazole, also can be used for the patient of the helicobacter pylori infections of resistance to clarithromycin.Wherein, bismuth potassium citrate/metronidazole/quadracycline conbined usage not only can reach 80%-90% to HP eradication rate, but also can reduce drug resistance incidence rate when HP is used alone each component.Bismuth potassium citrate rapid disintegrate the protein forming small colloidal materials and ulcer surface under the effect of gastric acid are combined closely; form fine and close, uniform protecting film; prevent gastric acid and pepsin from the erosion of ulcer surface also can be promoted to the generation of endogenous prostaglandin; promote epithelial regeneration; thus accelerate self repairing of chronic ulcer tissue, also have the stronger effect killing HP simultaneously.Metronidazole and quadracycline have killing action to anaerobe and HP, and the effect of elimination HP is strengthened.
Summary of the invention
The object of the invention is to, for domestic undesirable about HP eradication therapy scheme, provide a kind of and treat compound tablet of ulcer caused by helicobacter pylori and preparation method thereof.
In raw material of the present invention, quadracycline is yellow crystalline powder, have draw moist; Meet photochromic gradual change dark; Containing the antacid of aluminum, calcium or magnesium, the preparation of iron content, zinc or sodium bicarbonate, milk or milk product all can destroy the absorption of tetracycline; And interact with bismuth, estimate that the systemic absorption of tetracycline reduces.Therefore, three kinds of raw materials are directly fed intake simultaneously compacting its related substance of tablet increase and availability is low, adopt compacting clad sheet, and between interior chip and outer-skin sheet bag contagion gown, effectively can cut off the interaction between principal agent, improve the bioavailability of medicine, reach better clinical efficacy.
Prescription comprises: three kinds of principal agents, filler, disintegrating agent, binding agent, fluidizer, lubricant and coating materials.
Described filler is selected from: microcrystalline Cellulose, mannitol, lactose, starch, dextrin etc., choose wherein one or more.
Disintegrating agent is selected from: low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross linked polyvinyl pyrrolidone (polyvinylpolypyrrolidone), cross-linking sodium carboxymethyl cellulose etc., choose wherein one or more, and contrast its Adding Way.
Binding agent is selected from: the hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, acrylic resin etc. of methylcellulose, high substituted degree, chooses wherein a kind of.
The preparation method of compound bismuth potassium citrate sheet, comprises the following steps:
1, the preparation of interior chip
A, quadracycline crossed 100 mesh sieves, that 60 mesh sieves crossed by all the other adjuvants is for subsequent use;
B, by the quadracycline in steps A, add 5% hypromellose cellulose solution soft material, 30 mesh sieves are granulated, and dried particles, to moisture content≤2.0%, is crossed 20 mesh sieve granulate by 55 DEG C of forced air dryings;
C, the dry granule in step B added in mixer with microcrystalline Cellulose, lactose, polyvinylpolypyrrolidone, silicon dioxide, magnesium stearate and mixs homogeneously, tabletting obtained required in chip;
D, chip in step C is put into coating pan, with the stomach dissolution type film coating liquid coating of 10%, during weightening finish about 9.0%, stop coating.
2, the preparation of skin granulate
A, metronidazole, bismuth potassium citrate and poloxamer crossed 100 mesh sieves, that 60 mesh sieves crossed by all the other adjuvants is for subsequent use;
B, the metronidazole by steps A, bismuth potassium citrate, microcrystalline Cellulose, lactose, polyvinylpolypyrrolidone add mix homogeneously in mixer, add 5% hypromellose cellulose solution soft material, 20 mesh sieves are granulated, and dried particles, to moisture content≤2.0%, is crossed 18 mesh sieve granulate by 60 DEG C of forced air dryings;
C, the dry granule in step B added in mixer with poloxamer, silicon dioxide, magnesium stearate and mixs homogeneously;
3, the preparation of clad sheet
A, according to intermediates content, conversion outer-skin sheet standard film weight, with the theoretical sheet weight of the heavy addition calculation clad sheet of the average sheet of above-mentioned coated inner cores sheet, tabletting.
B, the clad sheet in steps A is put into coating pan, with the stomach dissolution type film coating liquid coating of 10%, during weightening finish about 3.0%, stop coating.
Wherein:
Beneficial effect of the present invention is: the present invention is skillfully constructed, and flow process is rigorous, is prepared as compound recipe and not only makes production cost lower, and improves compliance, facilitates patients and carries; Its cored technique more effectively can be isolated between principal agent and influenced each other, and make prepared compound bismuth potassium citrate tablet stability good, bioavailability and the clinical efficacy of medicine increase.
Detailed description of the invention
All features disclosed in this description, or the step in disclosed all methods or process, except mutually exclusive feature and/or step, all can combine by any way.
Comparative example 1: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: crude drug is crossed 100 mesh sieves, 60 mesh sieves crossed by adjuvant, for subsequent use.Accurately take raw material and all adjuvants by recipe quantity, mix homogeneously, with 5% hydroxypropyl cellulose soft material, cross 20 mesh sieves and granulate, 60 DEG C are dried to pellet moisture≤2%, cross 18 mesh sieve granulate, add silicon dioxide and the rear tabletting of magnesium stearate mixing.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 1: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with comparative example 1 preparation method, wherein the Adding Way of disintegrating agent is add in granule and additional each 50%.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 2: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with comparative example 1 preparation method, wherein the Adding Way of disintegrating agent is additional.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 3: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with embodiment 1 preparation method.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 4: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with embodiment 2 preparation method.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 5: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with comparative example 1 preparation method.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 6: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with embodiment 2 preparation method.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 7: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with comparative example 1 preparation method.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Embodiment 8: the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with embodiment 1 preparation method.In compound bismuth potassium citrate, chip disintegration time measurement result is in table 1.
Above-mentioned be divided into " Three factors, three levels " contrast:
Chip disintegration time result in table 1 compound bismuth potassium citrate
Can be found out by the measurement result of table 1, embodiment 2,5,8 is obviously better than comparative example 1, B factor (amount of disintegrating agent) has the greatest impact to disintegration rate, and be secondly C factor (disintegrating agent feed postition), A factor (ratio of lactose and microcrystalline Cellulose) affects minimum on disintegration rate.
Comparative example 2: the supplementary material of following recipe quantity is made 100 tablets of compound bismuth potassium citrate tablets
Preparation method: crude drug is crossed 100 mesh sieves respectively, and 60 mesh sieves crossed by adjuvant, for subsequent use.Accurately take raw material and all adjuvants by recipe quantity, mix homogeneously, with 5% hydroxypropyl cellulose soft material, cross 20 mesh sieves and granulate, 60 DEG C are dried to pellet moisture≤2%, cross 18 mesh sieve granulate, add the rear tabletting of poloxamer, silicon dioxide and magnesium stearate mixing.Place 10 days under putting 60 DEG C of hot conditionss, investigate its stability, quadracycline related substance and dissolution determination the results are shown in Table 2.
Embodiment 9:1, the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method:
A, quadracycline crossed 100 mesh sieves, that 60 mesh sieves crossed by all the other adjuvants is for subsequent use;
B, by the quadracycline in steps A, add 5% hypromellose cellulose solution soft material, 30 mesh sieves are granulated, and dried particles, to moisture content≤2.0%, is crossed 20 mesh sieve granulate by 55 DEG C of forced air dryings;
C, the dry granule in step B added in mixer with microcrystalline Cellulose, lactose, polyvinylpolypyrrolidone, silicon dioxide, magnesium stearate and mixs homogeneously, tabletting obtained required in chip;
2, the supplementary material of following recipe quantity is made 100 compound bismuth potassium citrate clad sheets
Preparation method:
A, metronidazole, bismuth potassium citrate and poloxamer crossed 100 mesh sieves, that 60 mesh sieves crossed by all the other adjuvants is for subsequent use;
B, the metronidazole by steps A, bismuth potassium citrate, microcrystalline Cellulose, lactose, polyvinylpolypyrrolidone add mix homogeneously in mixer, add 5% hypromellose cellulose solution soft material, 20 mesh sieves are granulated, and dried particles, to moisture content≤2.0%, is crossed 18 mesh sieve granulate by 60 DEG C of forced air dryings;
C, the dry granule in step B added in mixer with poloxamer, silicon dioxide, magnesium stearate and mixs homogeneously, add interior chip tabletting.Place 10 days under putting 60 DEG C of hot conditionss, investigate its stability, quadracycline related substance and dissolution determination the results are shown in Table 2.
Embodiment 10:1, the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
Preparation method: with chip preparation method in compound bismuth potassium citrate in embodiment 9, interior chip is put into coating pan, with the stomach dissolution type film coating liquid coating of 10%, stops coating during weightening finish about 9.0%.
2, the supplementary material of following recipe quantity is made 100 compound bismuth potassium citrate clad sheets
Preparation method: with compound bismuth potassium citrate clad sheet preparation method in embodiment 9, then clad sheet is put into coating pan, with the stomach dissolution type film coating liquid coating of 10%, stops coating during weightening finish about 3.0%.Place 10 days under putting 60 DEG C of hot conditionss, investigate its stability, quadracycline related substance and dissolution determination the results are shown in Table 2.
Table 2 quadracycline related substance and dissolution determination result
Can be found out by the measurement result of table 2, place embodiment 9 and 10 after 10 days to significantly improve compared with the stability of comparative example 2, by preparing clad sheet, quadracycline is separated with other principal agents, influencing each other between principal agent can be reduced significantly, the generation of effective control related substance, and this process on the dissolution of quadracycline without impact; Internal chip and clad sheet carry out coating isolation, equally on its normal stripping without impact, and the interaction between principal agent can be cut off further, improve the bioavailability of medicine, reach better clinical efficacy.
Comparative example 3:1, the supplementary material of following recipe quantity is made chip in 100 compound bismuth potassium citrates
| Supplementary material title | Consumption |
| Quadracycline | 12.5 g |
| Microcrystalline Cellulose | 1.5 g |
| Lactose | 1.5 g |
| Polyvinylpolypyrrolidone | 1.5 g |
| 5% hypromellose | In right amount |
| Silicon dioxide | 0.5 g |
| Magnesium stearate | 0.25 g |
| Film coating pre-mix dose (gastric solubility Opadry) | In right amount |
Preparation method: quadracycline is crossed 100 mesh sieves, all the other are with chip preparation method in compound bismuth potassium citrate in embodiment 10.
2, the supplementary material of following recipe quantity is made 100 compound bismuth potassium citrate clad sheets
| Supplementary material title | Consumption |
| Interior chip | 100 |
| Metronidazole | 12.5 g |
| Bismuth potassium citrate | 10.0 g |
| Microcrystalline Cellulose | 12.0 g |
| Lactose | 8.0 g |
| Polyvinylpolypyrrolidone | 4.0 g |
| 5% hypromellose | In right amount |
| Poloxamer | 0.5 g |
| Silicon dioxide | 1.0 g |
| Magnesium stearate | 0.5 g |
| Film coating pre-mix dose (gastric solubility Opadry) | In right amount |
Preparation method: with compound bismuth potassium citrate clad sheet preparation method in embodiment 10. quadracycline in 0.1mol/L hydrochloric acid solution stripping curve measurement result in table 3.
Embodiment 11: except quadracycline was pulverized 200 mesh sieves, all the other were with described in comparative example 3;
Embodiment 12: remove ground for quadracycline 200 mesh sieves, all the other are with described in comparative example 3;
Table 3 quadracycline stripping curve measurement result
Can be found out by the measurement result of table 3, the 15min stripping in 0.1mol/L hydrochloric acid solution of embodiment 11,12 and comparative example 3 all reaches more than 85%, illustrate when quadracycline crude drug size controlling D507.75 μm, D9029.27 μm to D5038.24 μm, between D90196.81 μm time, on the dissolution rate of quadracycline in tablet without impact.
The present invention is not limited to aforesaid detailed description of the invention.The present invention expands to any new feature of disclosing in this manual or any combination newly, and the step of the arbitrary new method disclosed or process or any combination newly.
Claims (10)
1. treat a compound tablet for ulcer caused by helicobacter pylori, it is characterized in that, comprise interior chip, skin granulate, be made up of the component of following weight parts respectively:
Interior chip:
Quadracycline 11.0-13.0 parts
Filler 2.0-4.0 parts
Disintegrating agent 1.0-2.0 parts
Binding agent 1.7-2.0 parts
Fluidizer 0.4-0.6 part
Lubricant 0.2-0.3 part
Coating material 15.5-17.5 parts;
Skin granulate:
Metronidazole 11.0-13.0 parts
Bismuth potassium citrate 3.5-4.4 parts
Filler 18.0-21.0 parts
Disintegrating agent 3.5-4.4 parts
Binding agent 8.0-9.0 parts
Fluidizer 1.35-1.65 parts
Lubricant 0.4-0.6 part
Coating material 18.0-21.0 parts.
2. a kind of compound tablet for the treatment of ulcer caused by helicobacter pylori as claimed in claim 1, is characterized in that: described filler is selected from: one or more in microcrystalline Cellulose, mannitol, lactose, starch or dextrin.
3. a kind of compound tablet for the treatment of ulcer caused by helicobacter pylori as claimed in claim 1, is characterized in that: described disintegrating agent is selected from: one or more in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross linked polyvinyl pyrrolidone or cross-linking sodium carboxymethyl cellulose.
4. a kind of compound tablet for the treatment of ulcer caused by helicobacter pylori as claimed in claim 1, is characterized in that: described binding agent is selected from: one or more in the hydroxypropyl cellulose of methylcellulose, high substituted degree, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose or acrylic resin.
5. a kind of preparation method for the treatment of the compound tablet of ulcer caused by helicobacter pylori according to claim 1, is characterized in that comprising the steps:
The preparation of A, interior chip
Quadracycline and all the other adjuvants are crossed 60-200 mesh sieve for subsequent use; Quadracycline is added suitable amount of adhesive soft material, 30 mesh sieves are granulated, and dried particles, to moisture content≤2.0%, is crossed 20 mesh sieve granulate by 53-57 DEG C of forced air drying; Dry granule is added in mixer with microcrystalline Cellulose, lactose, polyvinylpolypyrrolidone, silicon dioxide, magnesium stearate and mixs homogeneously, the obtained required interior chip of tabletting; Interior chip is put into coating pan, coating solution coating, during weightening finish about 9.0%, stop coating;
The preparation of B, skin granulate
Metronidazole, bismuth potassium citrate and poloxamer are crossed 100 mesh sieves, that 60 mesh sieves crossed by all the other adjuvants is for subsequent use; Metronidazole, bismuth potassium citrate, microcrystalline Cellulose, lactose, polyvinylpolypyrrolidone are added mix homogeneously in mixer, add 5% hypromellose cellulose solution soft material, 20 mesh sieves are granulated, and dried particles, to moisture content≤2.0%, is crossed 18 mesh sieve granulate by 58-62 DEG C of forced air drying; Dry for preparation granule is added in mixer with poloxamer, silicon dioxide, magnesium stearate and mixs homogeneously;
The preparation of C, clad sheet
According to intermediates content, conversion outer-skin sheet standard film weight, with the theoretical sheet weight of the heavy addition calculation clad sheet of the average sheet of above-mentioned coated inner cores sheet, tabletting; Clad sheet is put into coating pan, with coating solution coating.
6. a kind of preparation method for the treatment of the compound tablet of ulcer caused by helicobacter pylori as claimed in claim 5, is characterized in that: described coating solution is the stomach dissolution type film coating liquid of 10%.
7. a kind of preparation method for the treatment of the compound tablet of ulcer caused by helicobacter pylori as claimed in claim 5, is characterized in that: in described steps A, and the dry wet mixing time of granulating is 15-30min; Total mixed incorporation time is 15-30min.
8. a kind of preparation method for the treatment of the compound tablet of ulcer caused by helicobacter pylori as claimed in claim 5, is characterized in that: in described step B, and the dry time that is dry mixed of granulating is 15-25min, and the wet mixing time is 15-30min; Total mixed incorporation time is 15-30min.
9. a kind of preparation method for the treatment of the compound tablet of ulcer caused by helicobacter pylori as claimed in claim 5, it is characterized in that: in described steps A, the tabletting speed of tabletting is 4-6 ten thousand slices/hour.
10. a kind of preparation method for the treatment of the compound tablet of ulcer caused by helicobacter pylori as claimed in claim 5, it is characterized in that: in described steps A, C, the inlet temperature of coating is 65 ± 2 DEG C, and pot rotating speed is 4-7rpm/min, and atomisation pressure is 0.4-0.6Mpa.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510517371.1A CN105106162A (en) | 2015-08-21 | 2015-08-21 | Compound tablet for treating ulcer caused by helicobacter pylori and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510517371.1A CN105106162A (en) | 2015-08-21 | 2015-08-21 | Compound tablet for treating ulcer caused by helicobacter pylori and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1285741A (en) * | 1997-12-17 | 2001-02-28 | 阿克斯肯制药公司 | Double capsule for the administration of active principles in multiple therepies |
| CN1785162A (en) * | 2005-11-09 | 2006-06-14 | 济南百诺医药科技开发有限公司 | Double-layered medicine tablets for eliminating Helicobacter pylori and its prepn. method |
| CN201299812Y (en) * | 2008-05-23 | 2009-09-02 | 黑龙江福和华星制药集团股份有限公司 | Tablet capsule used for treating helicobacter pylori (HP) infection |
| CN202637533U (en) * | 2012-04-19 | 2013-01-02 | 海南海灵化学制药有限公司 | Compound bismuth potassium citrate capsule |
-
2015
- 2015-08-21 CN CN201510517371.1A patent/CN105106162A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1285741A (en) * | 1997-12-17 | 2001-02-28 | 阿克斯肯制药公司 | Double capsule for the administration of active principles in multiple therepies |
| CN1785162A (en) * | 2005-11-09 | 2006-06-14 | 济南百诺医药科技开发有限公司 | Double-layered medicine tablets for eliminating Helicobacter pylori and its prepn. method |
| CN201299812Y (en) * | 2008-05-23 | 2009-09-02 | 黑龙江福和华星制药集团股份有限公司 | Tablet capsule used for treating helicobacter pylori (HP) infection |
| CN202637533U (en) * | 2012-04-19 | 2013-01-02 | 海南海灵化学制药有限公司 | Compound bismuth potassium citrate capsule |
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