CN1456238A - Sedative tablet preparing method - Google Patents

Sedative tablet preparing method Download PDF

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Publication number
CN1456238A
CN1456238A CN 03118623 CN03118623A CN1456238A CN 1456238 A CN1456238 A CN 1456238A CN 03118623 CN03118623 CN 03118623 CN 03118623 A CN03118623 A CN 03118623A CN 1456238 A CN1456238 A CN 1456238A
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time
radix
powder
technology
standby
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Chinese (zh)
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毛友昌
毛晓敏
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Individual
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Abstract

A process for preparing Chinese medicine "Calming tablet" includes such steps as pulverizing wild jujube kernel and schisandra fruit, decocting 6 Chinese-medicinal materials including Chuan-xiong rhizome to extract xolatile oil, concentrating decoction, spray drying, adding additive, mixing all together, tabletting and coating. Its advantages are high curative effect and quality.

Description

The preparation method of mind tranquilizing tablet
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine tablet, relates in particular to the preparation method of mind tranquilizing tablet.
Background technology
Tablet is a kind of pharmaceutical formulation commonly used, according to the relevant drug act of China, changing dosage form needs as a kind of new drug research, the original dosage form of mind tranquilizing tablet is: ANSHEN JIAONANG, and listed in the Drug Standard of Ministry of Public Health of the Peoples Republic of China (" Chinese traditional patent formulation preparation " the 20th), prescription is made up of eight flavor medicines.The technology features of former dosage form is that Semen Ziziphi Spinosae and Fructus Schisandrae Chinensis powder are broken into fine powder in the prescription, and Six-element decocting liquids such as all the other Rhizoma Chuanxiongs are condensed into thick paste, incapsulate with the fine powder mixing after drying.The loss of volatile ingredient during its defective is to write out a prescription in its quality standard, has only thin layer discriminating simply, and no quantitative target etc. influence the significant drawbacks of quality.Have significant drawback influence quality based on capsule, we use modern pharmaceutical technology and mirror survey means this product technology are done the improvement of necessity, thereby and the quality of product is carried out overall monitor guarantee that product quality benefits the common people.
Summary of the invention
The purpose of this invention is to provide a kind of preparation method of mind tranquilizing tablet, improve the quality of products, satisfy needs of medical treatment better.
The objective of the invention is such realization:
The preparation method of mind tranquilizing tablet comprises the steps:
One, the prescription of mind tranquilizing tablet is formed:
Semen Ziziphi Spinosae 40-80g Rhizoma Chuanxiong 47-94g Rhizoma Anemarrhenae 112-224g
Radix Ophiopogonis 92-184g Radix Polygoni Multiflori Preparata 32-64g Fructus Schisandrae Chinensis 97-194g
Radix Salviae Miltiorrhizae 130-260g Poria 97-194g
Right amount of auxiliary materials is made 1000 altogether.
Its optimum formula is:
Semen Ziziphi Spinosae 60g Rhizoma Chuanxiong 70.5g Rhizoma Anemarrhenae 168g 138g Radix Ophiopogonis
Radix Polygoni Multiflori Preparata 48g Fructus Schisandrae Chinensis 194g Radix Salviae Miltiorrhizae 195g Poria 145.5g
Right amount of auxiliary materials is made 1000 altogether.
Two, mind tranquilizing tablet preparation technology
Technology one, with eight the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis powder is broken into fine powder; Six-elements such as remaining Rhizoma Chuanxiong are ground into coarse powder and decoct with water secondary, and collecting decoction filters, and filtrate is condensed into the thick paste that relative density is 1.10~1.25 (80 ℃), with above-mentioned fine powder mixing, makes granule, drying, and tabletting, coating, quality inspection, packing is promptly.
Technology two, with eight the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, that Fructus Schisandrae Chinensis powder is broken into fine powder is standby; Six-element medicated powder such as all the other Rhizoma Chuanxiongs are broken into coarse powder and add water steaming and decocting secondary, collect volatile oil, become the cyclodextrin of volatile oil clathrate or become the volatile oil alcoholic solution standby with an amount of dissolve with ethanol with cyclodextrin inclusion compound; Merge water and steam liquid, filter, filtrate is condensed into the thick paste that relative density is 1.10~1.25 (80 ℃), adds above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulate, drying adds cyclodextrin of volatile oil clathrate or volatile oil alcoholic solution and appropriate amount of auxiliary materials, mixing, tabletting, coating, quality inspection.
Technology three, with eight the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, that Fructus Schisandrae Chinensis powder is broken into fine powder is standby; Six-element medicine mixed powders such as all the other Rhizoma Chuanxiongs are broken into coarse powder and decoct with water secondary, and collecting decoction filters, and filtrate is concentrated into the concentrated solution that relative density is 1.05~1.15 (60 ℃), be spray dried to dried cream powder, add above-mentioned fine powder and appropriate amount of auxiliary materials, mixing is granulated, drying, tabletting, coating, quality inspection.
Three, by technology one, two, three prepared coated tablet, be Film coated tablets, its film-coat material all adopts stomach dissolution type film-coat pre-mixing agent (Opadry).
Added adjuvant can be any or multiple mixing use in microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, low-substituted hydroxypropyl cellulose, starch, dextrin, the magnesium stearate in the prescription.
The technology Chinese crude drug is ground into coarse powder and was generally 5~20 order coarse powder, is preferably 10 order coarse powder.
The technology Chinese crude drug is ground into fine powder and was generally 80~160 order fine powders, and being preferably superfine powder, to be broken into 200~300 order fine powders standby.
The technology Chinese crude drug adds the secondary decocting and boils/and the condition of water steaming and decocting is: and amount of water is that 6-12 doubly measures for the first time, doubly measures for 4-8 for the second time, and decocting time is 1-4 hour at every turn, being preferably for the first time, amount of water is 10 times of amounts, be 6 times of amounts for the second time, the time is 2 hours for the first time, is 1 hour for the second time.
In the technology, the relative density that secondary water decoction/secondary water boiling liquid is condensed into thick paste is 1.10~1.25 (80 ℃), and best relative density is 1.21 (80 ℃).
In the technology, the relative density of water steaming and decocting concentrated solution is 1.05~1.15 (60 ℃), and best relative density is 1.10 (60 ℃).
In the technology, the spray drying inlet temperature is 100~200 ℃, and leaving air temp is 50~150 ℃, and best inlet temperature is 150 ℃, and leaving air temp is 100 ℃.
The cyclodextrin clathrate of volatile oil preparation in the technology, cyclodextrin can be adopted any in beta-schardinger dextrin-or the hydroxyl beta-schardinger dextrin-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 6-15ml/g, optimal proportion are 1: 10 (ml/g); The ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 3-12ml/g, optimal proportion are 1: 5.5 (ml/g).
Volatile ingredient can obtain keeping preferably after process modification, and its quality standard is improved comprehensively, increases Radix Salviae Miltiorrhizae, the lotus Radix Polygoni Multiflori, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Semen Ziziphi Spinosae in discriminatings and carry out the thin layer discriminating on former only Rhizoma Chuanxiong basis simply; Increase heavy metal limit in the inspection and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths, and Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis are carried out the content regulation.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, keep better that stability improves greatly under the volatility active substance prerequisite, effect duration can reach more than 2 years, quality standard improves greatly, make product that the qualitative, quantitative control method of science be arranged, make the quality of product and curative effect that guarantee arranged.
The specific embodiment
The optimum implementation of this invention is that eight flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; Get Semen Ziziphi Spinosae, that Fructus Schisandrae Chinensis powder is broken into fine powder is standby; Six-element medicated powder such as all the other Rhizoma Chuanxiongs are broken into coarse powder and add water steaming and decocting secondary, collect volatile oil, become the cyclodextrin of volatile oil clathrate or become the volatile oil alcoholic solution standby with an amount of dissolve with ethanol with cyclodextrin inclusion compound; Merge water and steam liquid, filter, filtrate is condensed into the thick paste that relative density is 1.10~1.25 (80 ℃), adds above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulate, drying adds cyclodextrin of volatile oil clathrate or volatile oil alcoholic solution and appropriate amount of auxiliary materials, mixing, tabletting, coating, quality inspection.

Claims (1)

1, the preparation method of mind tranquilizing tablet is characterized in that it may further comprise the steps:
(1) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis powder were broken into 80-160 purpose fine powder in the technology, and it is standby that the best is that superfine powder is broken into 200~300 purpose fine powders.
(2) in the technology Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Poria Six-element to be ground into coarse powder be 5~20 order coarse powder, the best is that to be ground into 10 purpose coarse powder standby.
(3) in the technology Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Poria Six-element medicine secondary decocting boil/condition of secondary water steaming and decocting is that 6-12 doubly measures for amount of water for the first time, doubly measure for 4-8 for the second time, each decocting time is 1-4 hour, best is that amount of water is 10 times of amounts for the first time, be 6 times of amounts for the second time, time is 2 hours for the first time, is 1 hour for the second time.
(4) Rhizoma Chuanxiong in the technology, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Poria Six-element medicine mix to steam and carry volatile oil, form cyclodextrin of volatile oil clathrate/make the volatile oil alcoholic solution with an amount of ethanol with cyclodextrin inclusion compound then.
(5) above-mentioned Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Poria Six-element medicine secondary water decoction/secondary water boiling liquid are condensed into the concentrated solution that relative density is 1.05~1.15 (60 ℃); The thick paste that is spray dried to dried cream powder/be condensed into relative density and is 1.10-1.25 (80 ℃) is standby.
(6) the added adjuvant of prescription can be beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30, any/multiple mixing in the micropowder silica gel, low-substituted hydroxypropyl cellulose, starch, dextrin uses.
(7) coating material of tablet adopts stomach dissolution type film-coat pre-mixing agent (Opadry).
(8) (1), (2), (3), (4), (5), (6), (7) standby composition are fed intake by national standard prescription consumption, mixing, tabletting, coating are made mind tranquilizing tablet.
CN 03118623 2003-02-12 2003-02-12 Sedative tablet preparing method Pending CN1456238A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 03118623 CN1456238A (en) 2003-02-12 2003-02-12 Sedative tablet preparing method

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Application Number Priority Date Filing Date Title
CN 03118623 CN1456238A (en) 2003-02-12 2003-02-12 Sedative tablet preparing method

Publications (1)

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CN1456238A true CN1456238A (en) 2003-11-19

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101073351B (en) * 2007-06-28 2011-03-30 刘统新 Memory-enhancing tea with brain-invigorating and vision-improving functions
CN102895345A (en) * 2012-10-22 2013-01-30 重庆希尔安药业有限公司 Pharmaceutical composition for treating insomnia
CN103566168A (en) * 2013-10-31 2014-02-12 姚晔 Preparation method and application of tranquilizing tablets
CN104306684A (en) * 2014-10-18 2015-01-28 通化斯威药业股份有限公司 Medicine for external use capable of improving sleep, improving intelligence, soothing the nerves and invigorating kidney and preparation method

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101073351B (en) * 2007-06-28 2011-03-30 刘统新 Memory-enhancing tea with brain-invigorating and vision-improving functions
CN102895345A (en) * 2012-10-22 2013-01-30 重庆希尔安药业有限公司 Pharmaceutical composition for treating insomnia
CN103566168A (en) * 2013-10-31 2014-02-12 姚晔 Preparation method and application of tranquilizing tablets
CN104306684A (en) * 2014-10-18 2015-01-28 通化斯威药业股份有限公司 Medicine for external use capable of improving sleep, improving intelligence, soothing the nerves and invigorating kidney and preparation method
CN104306684B (en) * 2014-10-18 2017-07-18 通化斯威药业股份有限公司 It is a kind of to improve sleep, intelligence promoting and tranquilization, the external used medicine of kidney tonifying nourishing heart and preparation method

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