CN102451171B - Tindazole vaginal effervescent tablet and preparation method thereof - Google Patents
Tindazole vaginal effervescent tablet and preparation method thereof Download PDFInfo
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- CN102451171B CN102451171B CN 201010520940 CN201010520940A CN102451171B CN 102451171 B CN102451171 B CN 102451171B CN 201010520940 CN201010520940 CN 201010520940 CN 201010520940 A CN201010520940 A CN 201010520940A CN 102451171 B CN102451171 B CN 102451171B
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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 Tindazole vaginal effervescent tablet agent 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 trichomonal vaginitis.The sickness rate of sexually transmitted disease (STD) increases year by year in recent years, in the past simple 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 the 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 Tindazole vaginal effervescent tablet agent, 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 lasting 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 the advantages such as clothing.
In the prior art, because prescription forms or also there is following shortcoming in technological problems: in the tabletting process sticking is arranged, sliver, the phenomenon such as mobility of particle is bad; After the low or packing of gas release and a swollen bag phenomenon arranged in the put procedure; Unilateral have phenomenons such as mottle and friability be defective.
Summary of the invention:
Purpose of the present invention is intended to overcome defects, a kind of Tindazole vaginal effervescent tablet and preparation method thereof is provided, have the tabletting process easy to operate, without sticking, without the sliver phenomenon, reasonable recipe, technique advanced person, under the prerequisite that the gas release that fully guarantees product, appearance character conformance with standard require, guaranteed after the packing and in effect duration without the generation of swollen bag phenomenon.
Technical scheme of the present invention is as follows:
Tindazole vaginal effervescent tablet, comprise 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 active component, and tartaric acid, sodium bicarbonate are effervescent, and lactose is diluent, and hyprolose has the multiple actions such as diluent, binding agent, disintegrating agent concurrently, and carboxymethylstach sodium is disintegrating agent, 30 POVIDONE K 30 BP/USP
30Aqueous solution is binding agent, and Tween-80 is surfactant, and Pulvis Talci is lubricant, and differential silica gel is fluidizer.
The preparation method of Tindazole vaginal effervescent tablet of the present invention may further comprise the steps:
1) supplementary material is pulverized respectively, all crosses 80～120 mesh sieves, and is for subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, for subsequent use as binding agent after the Tween-80 dissolving.
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 ℃, for 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 and get final product.
The invention has the advantages that:
1) reasonable recipe of the present invention, technique uniqueness, overcome sticking in the prior art tabletting process, sliver, the 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 after the packing and in effect duration without the generation of swollen bag phenomenon.
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 lasting 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 the advantages such as clothing.
3) the present invention has preferably therapeutical effect to the vaginitis of protozoan infection and anaerobic infection.
The specific embodiment:
Embodiment 1
Tindazole vaginal effervescent tablet, 1000 prescription and preparation method are as follows:
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%
Make 1000
Preparation method:
1) supplementary material is pulverized respectively, all crosses 100 mesh sieves, and is for subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, for subsequent use as binding agent after the Tween-80 dissolving.
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 ℃, for 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 and get final product.
Embodiment 2
Tindazole vaginal effervescent tablet, 1000 prescription and preparation method are as follows:
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%
Make 1000
Preparation method:
1) supplementary material is pulverized respectively, all crosses 100 mesh sieves, and is for subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, for subsequent use as binding agent after the Tween-80 dissolving.
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 ℃, for 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 and get final product.
Embodiment 3
Tindazole vaginal effervescent tablet, 1000 prescription and preparation method are as follows:
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%
Make 1000
Preparation method:
1) supplementary material is pulverized respectively, all crosses 100 mesh sieves, and is for subsequent use.
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, for subsequent use as binding agent after the Tween-80 dissolving.
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 ℃, for 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 and get final product.
Claims (2)
1. Tindazole vaginal effervescent tablet is characterized in that its prescription counts by every: tinidazole 0.2g, tartaric acid 0.08g～0.15g, sodium bicarbonate 0.10g～0.15g, lactose 0.15g～0.25g, hyprolose 0.08g～0.16g, carboxymethyl starch sodium 0.05g～0.1g, 30 POVIDONE K 30 BP/USP
300.008g～0.024g, purified water 0.10g～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 preparation method of Tindazole vaginal effervescent tablet according to claim 1 is characterized in that may further comprise the steps:
1) supplementary material is pulverized respectively, all crosses 80～120 mesh sieves, and is for subsequent use;
2) accurately take by weighing purified water, 30 POVIDONE K 30 BP/USP by recipe quantity
30, for subsequent use as binding agent after the Tween-80 dissolving;
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 ℃, for subsequent use with 16 mesh sieve granulate;
4) take by weighing tinidazole, lactose, hyprolose, the carboxymethyl starch 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 carboxymethyl starch 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 and get final product.
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 |
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| 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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| CN102451171A CN102451171A (en) | 2012-05-16 |
| CN102451171B true CN102451171B (en) | 2013-10-30 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Families Citing this family (2)
| 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 |
| 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 (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| CN102451171A (en) | 2012-05-16 |
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| C53 | Correction of patent for invention or patent application | ||
| CB02 | Change of applicant information |
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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