CN102451171A - Tindazole vaginal effervescent tablet and preparation method thereof - Google Patents
Tindazole vaginal effervescent tablet and preparation method thereof Download PDFInfo
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- CN102451171A CN102451171A CN2010105209405A CN201010520940A CN102451171A CN 102451171 A CN102451171 A CN 102451171A CN 2010105209405 A CN2010105209405 A CN 2010105209405A CN 201010520940 A CN201010520940 A CN 201010520940A CN 102451171 A CN102451171 A CN 102451171A
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- tinidazole
- effervescent tablet
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Abstract
The invention discloses a tindazole vaginal effervescent tablet and a preparation method thereof. The tindazole vaginal effervescent tablet comprises the following components by weight: 0.2g of tindazole, 0.08-0.15g of tartaric acid, 0.10-0.15g of sodium bicarbonate, 0.15-0.25g of lactose, 0.08-0.16g of hydroxypropylcellulose, 0.05-0.1g of carboxyrnethyl starch sodium, 0.008-0.024g of polyvidone K30, 0.10-0.20g of purified water, 0.003-0.008g of polysorbate-80, talc powder of which the amount accounts for 1.0-3.0 percent of the total weight of particles and 0.5-2.0 percent of superfine silica gel powder of which the amount accounts for 0.5-2.0 percent of the total weight of the particles. The preparation method comprises the following steps of: pelletizing the tartaric acid and sodium bicarbonate respectively; pelletizing prepared acid source particles and gas source particles with 50 percent of main medicaments and auxiliary materials respectively; and uniformly mixing the obtained particles with additional auxiliary materials, and tableting. Compared with the prior art, the tindazole vaginal effervescent tablet has the advantages of easiness for operating, freeness from adhesion and avoidance of a splitting phenomenon in a tableting process, reasonable mixture ratio of an acid source and a gas source, unique preparation method, complete assurance that the foaming amount and external properties of a product are consistent with standard requirements, and avoidance of a package bulging phenomenon after package and within an effective period.
Description
Technical field:
The present invention relates to a kind of infusorian and most of anaerobe are had suppress or Tinidazole vaginal effervescent tablet of killing action and preparation method thereof, belong to technical field of medicine.
Background technology:
Protozoan infection and anaerobic infection are common gynecological disease and frequently-occurring disease, and trichomonal vaginitis is a kind of common sexually transmitted disease, and women's sickness rate is 10%～25%, and etiology is a trichomonal vaginitis.The sickness rate of sexually transmitted disease (STD) increases year by year in recent years; Simple in the past whole body administration can not reach promising result to the vaginitis of anaerobe and protozoan infection; And oral administration and drug administration by injection, still have nauseating, vomiting, mouthful in gastrointestinal reactions such as metallic taste, anorexia, abdomen disease.For better performance drug effect, the untoward reaction of avoiding the whole body administration to cause, in recent years, domestic external preparation research to this medicine was extensive rapidly.Especially Tinidazole vaginal effervescent tablet; Because design principle includes acid source and source of the gas for prescription; Behind the vagina administration, moistening through the physiological vaginal secretions, slowly the effervescent disintegrate produces trickle and persistent bubble and forms foam; Increased contacting of medicine and vagina and cervical mucosa, made the medicine can infiltrate mucosa gauffer deep.Compare effective in cure height with suppository, medicine is difficult for running off, and does not pollute advantages such as clothing.
In the prior art, because of prescription is formed or also there is following shortcoming in technological problems: in the tabletting process sticking is arranged, sliver, phenomenon such as mobility of particle is bad; In gas release low or packing back and the put procedure bag of an expanding phenomenon is arranged; Unilateral have phenomenons such as mottle and friability be defective.
Summary of the invention:
The object of the invention is intended to overcome above-mentioned defective; A kind of Tinidazole vaginal effervescent tablet and preparation method thereof is provided; Have tabletting process sticking easy to operate, no, no sliver phenomenon; Reasonable recipe, technology advanced person under the prerequisite that the gas release that fully guarantees product, appearance character conformance with standard require, have guaranteed not have after the packing and in effect duration the generation of the bag phenomenon that expands.
Technical scheme of the present invention is following:
The Tinidazole vaginal effervescent tablet comprises principal agent and adjuvant, it is characterized in that every contains following component and parts by weight: tinidazole 0.2g; Tartaric acid 0.08g～0.15g; Sodium bicarbonate 0.10g～0.15g, lactose 0.15g～0.25g, hyprolose 0.08～0.16g; Carboxymethylstach sodium 0.05g～0.1g, 30 POVIDONE K 30 BP/USP
300.008～0.024g, purified water 0.10～0.20g, Tween-80 0.003g～0.008g, Pulvis Talci account for 1.0～3.0% of particle weight, and micropowder silica gel accounts for 0.5～2.0% of particle weight.
Wherein tinidazole is an active component, and tartaric acid, sodium bicarbonate are effervescent, and lactose is a diluent, and hyprolose has multiple actions such as diluent, binding agent, disintegrating agent concurrently, and carboxymethylstach sodium is a disintegrating agent, 30 POVIDONE K 30 BP/USP
30Aqueous solution is a binding agent, and Tween-80 is a surfactant, and Pulvis Talci is a lubricant, and differential silica gel is fluidizer.
The method for preparing of Tinidazole vaginal effervescent tablet of the present invention may further comprise the steps:
1) supplementary material pulverize separately is all crossed 80～120 mesh sieves, and is subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, Tween-80 dissolving back is subsequent use as binding agent.
3) accurately take by weighing tartaric acid, sodium bicarbonate respectively with the wet grain of an amount of system of the binding agent of above-mentioned preparation by recipe quantity, respectively at oven dry below 55 ℃, subsequent use with 16 mesh sieve granulate.
4) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the tartaric acid granulate mix homogeneously that makes, with the wet grain of an amount of system of the binding agent of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
5) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the sodium bicarbonate particle mix homogeneously that makes, with the wet grain of an amount of system of the binding agent of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
6) with 4) with 5) granule of preparation and Pulvis Talci, the differential silica gel mix homogeneously of recipe quantity, detect granule content, it is heavy to calculate sheet, tabletting, packing promptly gets.
The invention has the advantages that:
1) reasonable recipe of the present invention, technology uniqueness; Overcome sticking in the prior art tabletting process, sliver, shortcoming such as mobility of particle is bad; Under the prerequisite that the gas release that fully guarantees product, appearance character conformance with standard require, guaranteed not have after the packing and in effect duration the generation of the bag phenomenon that expands.
2) design principle of the present invention includes acid source and source of the gas for prescription; Behind the vagina administration, moistening through the physiological vaginal secretions, slowly the effervescent disintegrate produces trickle and persistent bubble and forms foam; Increased contacting of medicine and vagina and cervical mucosa, made the medicine can infiltrate mucosa gauffer deep.Compare effective in cure height with suppository, medicine is difficult for running off, and does not pollute advantages such as clothing.
3) the present invention has therapeutical effect preferably to the vaginitis of protozoan infection and anaerobic infection.
The specific embodiment:
Embodiment 1
The Tinidazole vaginal effervescent tablet, 1000 prescription and method for preparing are following:
Prescription:
Tinidazole 200g
Tartaric acid 100g
Sodium bicarbonate 106g
Lactose 180g
Hyprolose 120g
Carboxymethylstach sodium 80g
PVP
K30 22g
Tween-80 5g
Purified water 160g
Pulvis Talci 1.0%
Silicon dioxide 0.6%
Process 1000
Method for preparing:
1) supplementary material pulverize separately is all crossed 100 mesh sieves, and is subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, Tween-80 dissolving back is subsequent use as binding agent.
3) accurately take by weighing tartaric acid, sodium bicarbonate respectively with the wet grain of binding agent 18g, 24g system of above-mentioned preparation by recipe quantity, respectively at oven dry below 55 ℃, subsequent use with 16 mesh sieve granulate.
4) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the tartaric acid granulate mix homogeneously that makes, with the wet grain of the binding agent 73g system of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
5) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the sodium bicarbonate particle mix homogeneously that makes, with the wet grain of the binding agent 72g system of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
6) with 4) with 5) granule of preparation and Pulvis Talci, the differential silica gel mix homogeneously of recipe quantity, detect granule content, it is heavy to calculate sheet, special-shaped stamping, packing promptly gets.
Embodiment 2
The Tinidazole vaginal effervescent tablet, 1000 prescription and method for preparing are following:
Prescription:
Tinidazole 200g
Tartaric acid 90g
Sodium bicarbonate 95g
Lactose 150g
Hyprolose 100g
Carboxymethylstach sodium 70g
PVP
K30 17g
Tween-80 4.5g
Purified water 153g
Pulvis Talci 1.0%
Silicon dioxide 0.6%
Process 1000
Method for preparing:
1) supplementary material pulverize separately is all crossed 100 mesh sieves, and is subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, Tween-80 dissolving back is subsequent use as binding agent.
3) accurately take by weighing tartaric acid, sodium bicarbonate respectively with the wet grain of binding agent 16g, 21g system of above-mentioned preparation by recipe quantity, respectively at oven dry below 55 ℃, subsequent use with 16 mesh sieve granulate.
4) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the tartaric acid granulate mix homogeneously that makes, with the wet grain of the binding agent 69g system of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
5) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the sodium bicarbonate particle mix homogeneously that makes, with the wet grain of the binding agent 68g system of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
6) with 4) with 5) granule of preparation and Pulvis Talci, the differential silica gel mix homogeneously of recipe quantity, detect granule content, it is heavy to calculate sheet, special-shaped stamping, packing promptly gets.
Embodiment 3
The Tinidazole vaginal effervescent tablet, 1000 prescription and method for preparing are following:
Prescription:
Tinidazole 200g
Tartaric acid 120g
Sodium bicarbonate 127g
Lactose 230g
Hyprolose 150g
Carboxymethylstach sodium 95g
PVP
K30 24g
Tween-80 6g
Purified water 176g
Pulvis Talci 1.0%
Silicon dioxide 0.6%
Process 1000
Method for preparing:
1) supplementary material pulverize separately is all crossed 100 mesh sieves, and is subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, Tween-80 dissolving back is subsequent use as binding agent.
3) accurately take by weighing tartaric acid, sodium bicarbonate respectively with the wet grain of binding agent 21g, 28g system of above-mentioned preparation by recipe quantity, respectively at oven dry below 55 ℃, subsequent use with 16 mesh sieve granulate.
4) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the tartaric acid granulate mix homogeneously that makes, with the wet grain of the binding agent 79g system of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
5) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the sodium bicarbonate particle mix homogeneously that makes, with the wet grain of the binding agent 78g system of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
6) with 4) with 5) granule of preparation and Pulvis Talci, the differential silica gel mix homogeneously of recipe quantity, detect granule content, it is heavy to calculate sheet, special-shaped stamping, packing promptly gets.
Claims (4)
1. Tinidazole vaginal effervescent tablet; It is characterized in that: every contains following component and parts by weight: tinidazole 0.2g, tartaric acid 0.08g～0.15g, sodium bicarbonate 0.10g～0.15g; Lactose 0.15g～0.25g; Hyprolose 0.08～0.16g, carboxymethylstach sodium 0.05g～0.1g, 30 POVIDONE K 30 BP/USP
300.008～0.024g, purified water 0.10～0.20g, Tween-80 0.003g～0.008g, Pulvis Talci account for 1.0～3.0% of particle weight, and micropowder silica gel accounts for 0.5～2.0% of particle weight.
2. the method for preparing of Tinidazole vaginal effervescent tablet according to claim 1 may further comprise the steps:
1) supplementary material pulverize separately is all crossed 80～120 mesh sieves, and is subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, Tween-80 dissolving back is subsequent use as binding agent.
3) accurately take by weighing tartaric acid, sodium bicarbonate respectively with the wet grain of an amount of system of the binding agent of above-mentioned preparation by recipe quantity, respectively at oven dry below 55 ℃, subsequent use with 16 mesh sieve granulate.
4) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the tartaric acid granulate mix homogeneously that makes, with the wet grain of an amount of system of the binding agent of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
5) take by weighing tinidazole, lactose, hyprolose, the carboxymethylstach sodium of 1/2 recipe quantity and the sodium bicarbonate particle mix homogeneously that makes, with the wet grain of an amount of system of the binding agent of above-mentioned preparation, in oven dry below 55 ℃, with 12 mesh sieve granulate.
6) with 4) with 5) granule of preparation and Pulvis Talci, the micropowder silica gel mix homogeneously of recipe quantity, detect granule content, it is heavy to calculate sheet, tabletting, packing promptly gets.
3. the method for preparing of Tinidazole vaginal effervescent tablet according to claim 1 and 2 is characterized in that: the supplementary material pulverize separately, all cross 80～120 mesh sieves.
4. the method for preparing of Tinidazole vaginal effervescent tablet according to claim 1 and 2; It is characterized in that: tartaric acid, sodium bicarbonate are granulated respectively; Granulate with part tinidazole, lactose, hyprolose, carboxymethylstach sodium respectively, adding adds adjuvant and always mixes tabletting then again.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010520940 CN102451171B (en) | 2010-10-14 | 2010-10-14 | Tindazole vaginal effervescent tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010520940 CN102451171B (en) | 2010-10-14 | 2010-10-14 | Tindazole vaginal effervescent tablet and preparation method thereof |
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| Publication Number | Publication Date |
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| CN102451171A true CN102451171A (en) | 2012-05-16 |
| CN102451171B CN102451171B (en) | 2013-10-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 201010520940 Active CN102451171B (en) | 2010-10-14 | 2010-10-14 | Tindazole vaginal effervescent tablet and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109330983A (en) * | 2018-07-27 | 2019-02-15 | 江苏中天药业有限公司 | A kind of vagina effervescence and preparation method thereof |
| CN112220763A (en) * | 2020-10-21 | 2021-01-15 | 上海桓华制药有限公司 | Terbinafine hydrochloride effervescent tablet and use method thereof |
| CN113230226A (en) * | 2021-05-28 | 2021-08-10 | 丽珠集团丽珠制药厂 | Tinidazole tablet and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1726910A (en) * | 2005-07-22 | 2006-02-01 | 福寿堂制药有限公司 | Effervescence tablet of miconazole nitrate for vagina and preparation technique |
-
2010
- 2010-10-14 CN CN 201010520940 patent/CN102451171B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1726910A (en) * | 2005-07-22 | 2006-02-01 | 福寿堂制药有限公司 | Effervescence tablet of miconazole nitrate for vagina and preparation technique |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109330983A (en) * | 2018-07-27 | 2019-02-15 | 江苏中天药业有限公司 | A kind of vagina effervescence and preparation method thereof |
| CN112220763A (en) * | 2020-10-21 | 2021-01-15 | 上海桓华制药有限公司 | Terbinafine hydrochloride effervescent tablet and use method thereof |
| CN113230226A (en) * | 2021-05-28 | 2021-08-10 | 丽珠集团丽珠制药厂 | Tinidazole tablet and preparation method thereof |
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| Publication number | Publication date |
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| CN102451171B (en) | 2013-10-30 |
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Address after: 274500 the Yellow River Road, Shandong County, Dongming Applicant after: Shandong Fangming Pharmaceutical Group Co., Ltd. Address before: 274500 the Yellow River Road, Shandong County, Dongming Applicant before: Shandong Fangming Pharmaceutical Co., Ltd. |
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Free format text: CORRECT: APPLICANT; FROM: SHANDONG FANGMING PHARMACEUTICAL CO., LTD. TO: SHANDONG FANGMING PHARMACEUTICAL GROUP CO., LTD. |
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