CN1724034A - Vagina effervescent tablets contg. callicarpa nudiflora, and its prepn. method - Google Patents

Vagina effervescent tablets contg. callicarpa nudiflora, and its prepn. method Download PDF

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Publication number
CN1724034A
CN1724034A CN 200510012679 CN200510012679A CN1724034A CN 1724034 A CN1724034 A CN 1724034A CN 200510012679 CN200510012679 CN 200510012679 CN 200510012679 A CN200510012679 A CN 200510012679A CN 1724034 A CN1724034 A CN 1724034A
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China
Prior art keywords
callicarpa nudiflora
sodium bicarbonate
vagina effervescence
citric acid
drying
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CN 200510012679
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Chinese (zh)
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CN100463671C (en
Inventor
梁纪军
李勇
郭惠娟
康丽霞
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Shijiazhuang Pharma Group Zhongnuo Pharmaceutical Shijiazhuang Co Ltd
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Shijiazhuang Pharma Group Zhongnuo Pharmaceutical Shijiazhuang Co Ltd
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Priority to CNB2005100126797A priority Critical patent/CN100463671C/en
Publication of CN1724034A publication Critical patent/CN1724034A/en
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Abstract

A vaginal effervescent tablet with high release speed and no irritation is prepared from achamydeous beautyberry leaf, effervescent agent and auxiliary. Its preparing process is also disclosed.

Description

Callicarpa nudiflora vagina effervescence and preparation method
Technical field
The present invention relates to a kind of Callicarpa nudiflora vagina effervescence and preparation method, belong to drug formulation process
Technical field.
Background technology
Vagina effervescence is a kind of new form of Chinese drug, according to the relevant drug act of China, change dosage form as a kind of new drug research, the extract of Callicarpa nudiflora has multiple dosage form, and the exterior-applied formulation LUOHUAZIZHU SHUAN has been listed in country of the national Bureau of Drugs Supervision standard for traditional Chinese medicines compilation.There is the shortcoming of easy deformation in suppository as the gynecological external use medicine, and easily is bonded on hand when using.
Summary of the invention
Technical problem to be solved by this invention is that we use the modern pharmaceutical technology this production technology and dosage form are improved, and is made into easy to usely, and stay-in-grade vagina effervescence to enrich clinical dosage form, is conveniently gone into civilian medicine.
Technical scheme of the present invention is achieved in that the Callicarpa nudiflora vagina effervescence, it is characterized in that: it is the Callicarpa nudiflora extract powder 432 by following percentage by weight, effervescent 200-225, and tabletting adjuvant surplus is made 1000.
Described Callicarpa nudiflora vagina effervescence, its acid source of described effervescent are one or more in citric acid, tartaric acid, fumaric acid, the malic acid; Described carbon dioxide source is sodium carbonate, sodium bicarbonate, potassium carbonate, one or more in the magnesium carbonate.
Described Callicarpa nudiflora vagina effervescence, described effervescent are citric acid and sodium bicarbonate, and its ratio is a sodium bicarbonate: citric acid is 0.8~1.2: 1.0~1.5.
Described Callicarpa nudiflora vagina effervescence, described effervescent are citric acid and sodium bicarbonate, and consumption is that sodium bicarbonate is 5~15%, and citric acid is 7~18%.
Described Callicarpa nudiflora vagina effervescence, described tabletting adjuvant comprises 30 POVIDONE K 30 BP/USP 30, microcrystalline Cellulose, Icing Sugar, lactose, mannitol, dextrin, magnesium stearate, micropowder silica gel, polyethylene glycol 6000, Macrogol 4000 wherein one or more.
Described Callicarpa nudiflora vagina effervescence, described tabletting adjuvant comprises that also the alcoholic solution of 5% polyvinylpyrrolidone is as binding agent.
Described Callicarpa nudiflora vagina effervescence, it is the Callicarpa nudiflora extract powder 432 by following percentage by weight, citric acid 103, sodium bicarbonate 70, sodium carbonate 30, lactose 350, the alcoholic solution binding agent of polyethylene glycol 6000 15,5% polyvinylpyrrolidones is made 1000.
The preparation method of described Callicarpa nudiflora vagina effervescence may further comprise the steps:
A, preparation Callicarpa nudiflora extract: get Callicarpa nudiflora crude drug 2000g, decoct with water 3 times, amount of water is 6~18 times of amounts of dose for the first time, and second and third time is 4~14 times of amounts of dose, and first and second time of time is 1~4 hour, is 1~3 hour for the third time;
B, concentrate drying: it is 1.02~1.2 clear paste that decocting liquid is condensed into relative density, is 100~200 ℃ in inlet temperature, and leaving air temp is 50~100 ℃, is spray dried to dried cream powder;
C, dried cream powder is divided into two parts according to percentage by weight, a sodium bicarbonate 70 that adds, sodium carbonate 30, lactose 175, mixing is a binding agent with the alcoholic solution of 5% polyvinylpyrrolidone, makes granule, drying, 40 order granulate; Another part adds citric acid 103, lactose 175, and mixing is a binding agent with the alcoholic solution of 5% polyvinylpyrrolidone, makes granule, drying, 40 order granulate; Two kinds of granules mix and add dry polyethylene glycol 6000 15, and mixing is pressed into every heavy 1.0g rhombus sheet, promptly.
The preparation method of described Callicarpa nudiflora vagina effervescence among the step B is concentrated into decocting liquid the clear paste of relative density 1.28~1.32, is that 50~90 ℃ of drying under reduced pressure become dried cream powder in temperature.
The preparation method of described Callicarpa nudiflora vagina effervescence is characterized in that the temperature of particle drying among the step C is controlled at 60~80 ℃.
The technological progress effect of Callicarpa nudiflora vagina effervescence of the present invention and preparation method is that technology is simple, and is easy to use, nonirritant, medicine follows foam to discharge, and increases the medication area, and drug release is fast, steady quality, the patient is easy to accept, and can better meet the clinical application demand.
The specific embodiment
Embodiment 1
A, preparation Callicarpa nudiflora extract powder: Callicarpa nudiflora 2000g medical material is cleaned, remove impurity, after the assay was approved, decoct with water three times, first and second time each 2 hours, 1 hour for the third time, adding water for the first time was 14 times of doses, and second and third time is 10 times of amounts of dose, collecting decoction, filter, filtrate is concentrated into the clear paste of relative density 1.28~1.32 (60~65 ℃), and 50~90 ℃ of drying under reduced pressure become dried cream; Preferably be controlled at 80 ℃; Dried cream powder is broken into fine powder, gets the Callicarpa nudiflora extract powder.
Also decocting filtrate can be condensed into the concentrated solution that relative density is 1.08~1.10 (60~65 ℃) in the preparation method of above-mentioned Callicarpa nudiflora extract powder, be spray dried to dried cream powder, the spray drying inlet temperature is 100~200 ℃, leaving air temp is 50~100 ℃, optimum temperature is 160 ℃, and leaving air temp is 90 ℃.
B, preparation Callicarpa nudiflora effervescent tablet
(1) prescription:
Callicarpa nudiflora extract powder 432g
Citric acid 103g
Sodium bicarbonate 70g
Sodium carbonate 30g
Lactose 350g
Polyethylene Glycol (PEG) 6000 15g
Make 1000
(2) preparation method: by the said components proportioning that citric acid, sodium bicarbonate, sodium carbonate, lactose, PEG6000 is dry respectively, pulverized 100 mesh sieves; The Callicarpa nudiflora extract powder is divided into two parts, a sodium bicarbonate 70g that adds, and sodium carbonate 30g, lactose 175g, mixing is a binding agent with the alcoholic solution of 5% polyvinylpyrrolidone (PVP), makes granule, drying, 40 order granulate; Another part adds citric acid 103g, lactose 175g, and mixing is a binding agent with the alcoholic solution of 5% polyvinylpyrrolidone (PVP), makes granule, drying, 40 order granulate; Two kinds of granules mix, and add dry Polyethylene Glycol (PEG) 600015g, mixing; Be pressed into the rhombus tablet with tablet machine, every heavy 1.0g.
The temperature of particle drying is controlled at 60~80 ℃ in the above-mentioned preparation method, is preferably 60 ℃.
Embodiment 2
(1) prescription:
Callicarpa nudiflora extract powder 432g
Tartaric acid 110g
Sodium bicarbonate 65g
Sodium carbonate 40g
Microcrystalline Cellulose 100g
Mannitol 236g
PEG4000 17g
Make 1000
(2) preparation method: by the said components proportioning that tartaric acid, sodium bicarbonate, sodium carbonate, Celluloasun Microcrystallisatum, mannitol, PEG4000 is dry respectively, pulverized 100 mesh sieves; The Callicarpa nudiflora extract powder is divided into two parts, a sodium bicarbonate 65g that adds, and sodium carbonate 40g, microcrystalline Cellulose 100g, mixing is a binding agent with the alcoholic solution of 5%PVP, makes granule, drying, 40 order granulate; Another part adds tartaric acid 110g, mannitol 236g, and mixing is a binding agent with the alcoholic solution of 5%PVP, makes granule, drying, 40 order granulate; Two kinds of granules mix, and add dry PEG400017g, mixing; Be pressed into the rhombus tablet with tablet machine, every heavy 1.0g.
Embodiment 3
(1) prescription:
Callicarpa nudiflora extract powder 432g
Fumaric acid 115g
Sodium bicarbonate 55g
Potassium carbonate 35g
Icing Sugar 338g
PEG4000 20g
Magnesium stearate 5g
Make 1000
(2) preparation method: by the said components proportioning that fumaric acid, sodium bicarbonate, potassium carbonate, Icing Sugar, PEG4000, magnesium stearate is dry respectively, pulverized 100 mesh sieves; The Callicarpa nudiflora extract powder is divided into two parts, a sodium bicarbonate 55g, the potassium carbonate 35g of adding, and Icing Sugar 169g, mixing is a binding agent with the alcoholic solution of 5%PVP, makes granule, drying, 40 order granulate; Another part adds fumaric acid 115g, Icing Sugar 169g, and mixing is a binding agent with the alcoholic solution of 5%PVP, makes granule, drying, 40 order granulate; Two kinds of granules mix, and add dry PEG4000 20g, magnesium stearate 5g, mixing; Be pressed into the rhombus tablet with tablet machine, every heavy 1.0g.
Embodiment 4
(1) prescription:
Callicarpa nudiflora extract powder 432g
Citric acid 60g
Malic acid 60g
Sodium bicarbonate 55g
Magnesium carbonate 50g
Dextrin 80g
Mannitol 244g
Micropowder silica gel 6g
PEG6000 13g
Make 1000
(2) preparation method: by the said components proportioning that citric acid, malic acid, sodium bicarbonate, magnesium carbonate, dextrin, mannitol, PEG6000, micropowder silica gel is dry respectively, pulverized 100 mesh sieves; The Callicarpa nudiflora extract powder is divided into two parts, a sodium bicarbonate 55g that adds, and magnesium carbonate 50g, dextrin 80g, mixing is a binding agent with the alcoholic solution of 5%PVP, makes granule, drying, 40 order granulate; Another part adds citric acid 60g, malic acid 60g, dextrin 80g, mannitol 244g, and mixing is a binding agent with the alcoholic solution of 5%PVP, makes granule, drying, 40 order granulate; Two kinds of granules mix, and add dry micropowder silica gel 6g, PEG6000 13g, mixing; Be pressed into the rhombus tablet with tablet machine, every heavy 1.0g.
Listed examples of the present invention is intended to further illustrate this Callicarpa nudiflora vagina effervescence and preparation method, and scope of the present invention is not constituted any restriction, the product that obtains with the embodiment of the invention and all can obtain the Callicarpa nudiflora vagina effervescence via claims of the present invention are described.

Claims (10)

1, Callicarpa nudiflora vagina effervescence is characterized in that: it is the Callicarpa nudiflora extract powder 432 by following percentage by weight, effervescent 200-225, and tabletting adjuvant surplus is made 1000.
2, Callicarpa nudiflora vagina effervescence according to claim 1 is characterized in that: its acid source of described effervescent is one or more in citric acid, tartaric acid, fumaric acid, the malic acid; Described carbon dioxide source is sodium carbonate, sodium bicarbonate, potassium carbonate, one or more in the magnesium carbonate.
3, Callicarpa nudiflora vagina effervescence according to claim 2 is characterized in that: described effervescent is citric acid and sodium bicarbonate, and its ratio is a sodium bicarbonate: citric acid is 0.8~1.2: 1.0~1.5.
4, Callicarpa nudiflora vagina effervescence according to claim 3 is characterized in that: described effervescent is citric acid and sodium bicarbonate, and consumption is that sodium bicarbonate is 5~15%, and citric acid is 7~18%.
5, Callicarpa nudiflora vagina effervescence according to claim 1 is characterized in that: described tabletting adjuvant comprises 30 POVIDONE K 30 BP/USP 30, microcrystalline Cellulose, Icing Sugar, lactose, mannitol, dextrin, magnesium stearate, micropowder silica gel, polyethylene glycol 6000, Macrogol 4000 wherein one or more.
6, Callicarpa nudiflora vagina effervescence according to claim 1 is characterized in that: described tabletting adjuvant comprises that also the alcoholic solution of 5% polyvinylpyrrolidone is as binding agent.
7, Callicarpa nudiflora vagina effervescence according to claim 1, it is characterized in that: it is the Callicarpa nudiflora extract powder 432 by following percentage by weight, citric acid 103, sodium bicarbonate 70, sodium carbonate 30, lactose 350, the alcoholic solution binding agent of polyethylene glycol 6000 15,5% polyvinylpyrrolidones is made 1000.
8,, it is characterized in that may further comprise the steps according to the preparation method of the described Callicarpa nudiflora vagina effervescence of claim 1:
A, preparation Callicarpa nudiflora extract: decoct with water 3 times, amount of water is 6~18 times of amounts of dose for the first time, and second and third time is 4~14 times of amounts of dose, and first and second time of time is 1~4 hour, is 1~3 hour for the third time;
B, concentrate drying: it is 1.02~1.2 clear paste that decocting liquid is condensed into relative density, is 100~200 ℃ in inlet temperature, and leaving air temp is 50~100 ℃, is spray dried to dried cream powder;
C, dried cream powder is divided into two parts according to percentage by weight, a sodium bicarbonate 70 that adds, sodium carbonate 30, lactose 175, mixing is a binding agent with the alcoholic solution of 5% polyvinylpyrrolidone, makes granule, drying, 40 order granulate; Another part adds citric acid 103, lactose 175, and mixing is a binding agent with the alcoholic solution of 5% polyvinylpyrrolidone, makes granule, drying, 40 order granulate; Two kinds of granules mix, and add dry polyethylene glycol 6000 15, and mixing is pressed into every heavy 1.0g rhombus sheet, promptly.
9, the preparation method of described according to Claim 8 Callicarpa nudiflora vagina effervescence is characterized in that among the step B decocting liquid being concentrated into the clear paste of relative density 1.28~1.32, is that 50~90 ℃ of drying under reduced pressure become dried cream powder in temperature.
10, the preparation method of described according to Claim 8 Callicarpa nudiflora vagina effervescence is characterized in that the temperature of particle drying among the step C is controlled at 60~80 ℃.
CNB2005100126797A 2005-07-20 2005-07-20 Vagina effervescent tablets contg. callicarpa nudiflora, and its prepn. method Expired - Fee Related CN100463671C (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101791319A (en) * 2010-04-07 2010-08-04 北京欧凯纳斯科技有限公司 Female pudendum nursing product
CN101890143A (en) * 2010-07-15 2010-11-24 戴好富 Callicarpa nudiflora galangal composite washing liquid, preparation method and application thereof
CN102198149A (en) * 2011-05-11 2011-09-28 新乡医学院 New formulation (vaginal effervescent tablets) of Bingpeng powder and preparation method thereof
CN103520380A (en) * 2013-10-11 2014-01-22 哈尔滨欧替药业有限公司 Callicarpa nudiflora expandable vaginal suppository, and preparation method and detection method thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1562246A (en) * 2004-03-31 2005-01-12 一笑堂(湖南)制药有限公司 Preparation of beautyberry and preparation method

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101791319A (en) * 2010-04-07 2010-08-04 北京欧凯纳斯科技有限公司 Female pudendum nursing product
CN101791319B (en) * 2010-04-07 2012-11-14 北京欧凯纳斯科技有限公司 Female pudendum nursing product
CN101890143A (en) * 2010-07-15 2010-11-24 戴好富 Callicarpa nudiflora galangal composite washing liquid, preparation method and application thereof
CN101890143B (en) * 2010-07-15 2011-09-07 戴好富 Callicarpa nudiflora galangal composite washing liquid, preparation method and application thereof
CN102198149A (en) * 2011-05-11 2011-09-28 新乡医学院 New formulation (vaginal effervescent tablets) of Bingpeng powder and preparation method thereof
CN103520380A (en) * 2013-10-11 2014-01-22 哈尔滨欧替药业有限公司 Callicarpa nudiflora expandable vaginal suppository, and preparation method and detection method thereof
CN103520380B (en) * 2013-10-11 2015-10-28 哈尔滨欧替药业有限公司 Callicarpa nudiflora expandable vaginal expansible plug and preparation method thereof and detection method

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