CN1872217B - A medication for treating headache, and preparation method - Google Patents
A medication for treating headache, and preparation method Download PDFInfo
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- CN1872217B CN1872217B CN2005100732903A CN200510073290A CN1872217B CN 1872217 B CN1872217 B CN 1872217B CN 2005100732903 A CN2005100732903 A CN 2005100732903A CN 200510073290 A CN200510073290 A CN 200510073290A CN 1872217 B CN1872217 B CN 1872217B
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Abstract
A Chinese medicine in the form of dispersing tablet for treating headache is prepared from 11 Chinese-medicinal materials including Chinese angelica root, Chuan-xiong rhizome, white peony root, prunella spike, etc and proper auxiliaries including disintegrant, filler and lubricant. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to field of medicaments, particularly, relate to a kind of medicine for the treatment of headache and preparation method thereof.
Background technology
Headache is a kind of commonly encountered diseases, though there is the part Chinese and western drugs to use, effect is all not satisfactory, and especially to the medicine of the headache due to hyperactivity of liver-YANG of treatment blood deficiency, blood stasis type, the curative effect of medicine and drug effect speed influence the key factor of patients ' life quality especially.The Western medicine of treatment headache now commonly used has cafergot, and it is a kind of vasodilation, only is suitable for cerebral artery ischemia expectorant disease.Its mechanism of action of flunarizine capsule of producing in 1988 is optionally to suppress calcium to enter cell, shrinks to reduce venous.The Chinese patent medicine of the treatment of report headache at present has ZHENGTIAN WAN, it is the Chinese medicine and western medicine side of closing, and its mechanism is blood circulation promoting and blood stasis dispelling, and is furnished with the analgesic of Western medicine, this medicine only is suitable for headache due to invasion of exogenous pathogens and so on, to the headache of the internal injury type of traditional Chinese medical science appellation, blood deficiency and blood stasis headache due to hyperactivity of liver-YANG poor effect then.
The Chinese medicine of treatment headache at present is a lot, and dosage form mostly is electuary, granule, and granule exists dissolution velocity slower, and it is big to take dose, and mouthfeel for oral administration is not good, takes and carry shortcomings such as inconvenience.As the applying date be 1993.1.9, application number is 93100050.5, Granted publication number is CN1047938C, denomination of invention is a kind of patent application for the treatment of the Chinese medicine of headache, this invention provides a kind of Chinese medicine granules for the treatment of headache, though this granule curative effect determines and than the decoction taking convenience, dissolution velocity more still makes its use be restricted.Dispersible tablet means the rapid homodisperse a kind of tablet of disintegrate of energy in water, is a kind of quick-effective preparation that development in recent years is got up, because its distinctive advantage more and more is subjected to people's attention.
(1) compares with conventional tablet
Dispersible tablet has the following advantages:
1. good dispersing state, disintegration time are short, the medicine stripping is rapid;
2. absorption is fast, bioavailability is high
3. taking convenience can be swallowed, chew to contain and suck or with taking onset, disease controlling effectively after the aqueous dispersion.
(2) compare with effervescent tablet, freeze-dried instant sheet,
The production technology of dispersible tablet is identical with conventional tablet, does not need gas-producing disintegrant, does not need the gentle relative humidity in control room, does not need vacuum lyophilization and extra package, need not specific (special) requirements, and production cost is low.
(3) compare with drop pill
Dispersible tablet and drop pill are all quick-effective preparation, and dispersible tablet takes that mode is various, and disintegrate is faster, the bioavailability height, and production equipment is identical with conventional tablet, need not to add again equipment.
(4) compare with oral liquid
Dispersible tablet is in external disintegrate, has oral liquid and absorbs fast advantage, has productions simultaneously, carries, convenient transportation and advantage such as stablize.
Summary of the invention
The purpose of this invention is to provide a kind of dispersible tablet for the treatment of headache.
Another object of the present invention provides the preparation method of this medicine.
The present invention is in order to overcome the shortcoming of existing treatment headache pharmaceutical dosage form, has the easy to carry of tablet and liquid preparation onset advantage rapidly concurrently by making dispersible tablet or disintegrating tablet, and overcomes both deficiencies.Compare with conventional tablet, dispersible tablet of the present invention has good dispersing state, and disintegration time is short, the medicine stripping is rapid, absorbs soon advantages such as taking convenience, can swallow, chew, contain and suck or with taking after the aqueous dispersion, especially be fit to the old man and the patient of the difficulty of swallowing takes, be the active remedy of treatment headache; Compare with liquid preparation, dispersible tablet of the present invention has advantage easy to carry.
The raw material of medicine of the present invention comprises: extract, the appropriate amount of auxiliary materials of Radix Angelicae Sinensis 4～9 weight portions, Rhizoma Chuanxiong 4～9 weight portions, the Radix Paeoniae Alba 2～8 weight portions, Radix Rehmanniae Preparata 2～8 weight portions, Ramulus Uncariae Cum Uncis 10～15 weight portions, Caulis Spatholobi 10～15 weight portions, 10～15 parts of Spica Prunellaes, 10～15 parts of Semen Cassiaes, 10～15 parts of Concha Margaritiferas, 4～9 parts of Rhizoma Corydalis, 0.5～2 part of Herba Asari, and wherein adjuvant comprises disintegrating agent, filler, lubricant; Described disintegrating agent comprises one or more in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, the carboxymethylcellulose calcium; Described filler comprises in lactose, microcrystalline Cellulose, pregelatinized Starch, starch, erythritol, sorbitol, fructose, D-ribonic acid-gamma lactone, trehalose, D-ribose, low melting-point agarose, Lac, arabic gum, xylitol, Raffinose, glucose, malic acid, citric acid, isomalt, lactose, dextrin, the maltose one or more; Described lubricant comprises one or more in magnesium stearate, Pulvis Talci, Polyethylene Glycol, the micropowder silica gel.
The raw material of preferred medicine of the present invention comprises: extract, the appropriate amount of auxiliary materials of Radix Angelicae Sinensis 5～7 weight portions, Rhizoma Chuanxiong 5～7 weight portions, the Radix Paeoniae Alba 4～6 weight portions, Radix Rehmanniae Preparata 4～6 weight portions, Ramulus Uncariae Cum Uncis 12～14 weight portions, Caulis Spatholobi 12～14 weight portions, Spica Prunellae 12～14 weight portions, Semen Cassiae 12～14 weight portions, Concha Margaritifera 12～14 weight portions, Rhizoma Corydalis 5～7 weight portions, Herba Asari 1～1.5 weight portion are made, and wherein adjuvant comprises disintegrating agent, filler, lubricant; Described disintegrating agent comprises one or more in crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, the cross-linking sodium carboxymethyl cellulose; Described filler comprises in lactose, microcrystalline Cellulose, pregelatinized Starch, starch, sorbitol, trehalose, Lac, arabic gum, xylitol, the lactose one or more; Described lubricant comprises one or more in magnesium stearate, Pulvis Talci, the micropowder silica gel.
The raw material of best medicine of the present invention comprises: extract, the appropriate amount of auxiliary materials of Radix Angelicae Sinensis 6.75 weight portions, Rhizoma Chuanxiong 6.75 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Radix Rehmanniae Preparata 5.4 weight portions, Ramulus Uncariae Cum Uncis 13.5 weight portions, Caulis Spatholobi 13.5 weight portions, Spica Prunellae 13.5 weight portions, Semen Cassiae 13.5 weight portions, Concha Margaritifera 13.5 weight portions, Rhizoma Corydalis 6.75 weight portions, Herba Asari 1.34 weight portions are made, and wherein adjuvant comprises disintegrating agent, filler, lubricant; Described disintegrating agent is a low-substituted hydroxypropyl cellulose; Described filler comprises in starch, xylitol, arabic gum, the lactose one or more; Described lubricant is a magnesium stearate.
Medicine of the present invention can also comprise wetting agent and adhesive in forming in adjuvant; Described wetting agent is selected from water, dehydrated alcohol, ethanol or certain density ethanol water; Described adhesive is selected from one or more of PVP alcoholic solution, starch slurry, cyclodextrin, agar.
During medicine of the present invention was formed, disintegrating agent was 0.05: 1～0.25: 1 with the ratio of total formulation weight.
During medicine of the present invention was formed, filler was 0.395: 1～0.845: 1 with the ratio of total formulation weight.
During medicine of the present invention was formed, lubricant was 0.005: 1～0.05: 1 with the ratio of total formulation weight.
Medicine of the present invention adds adhesive in forming if desired, and then adhesive is 0.005: 1～0.05: 1 with the ratio of total formulation weight.
In forming in the medicine of the present invention, adjuvant is 1: 0.08～1: 0.6 with the ratio of the weight of extract drugs extractum.
In forming in the preferred medicine of the present invention, adjuvant is 1: 0.1～1: 0.5 with the ratio of the weight of extract drugs extractum.
During best medicine of the present invention was formed, adjuvant was 1: 0.12～1: 0.28 with the ratio of the weight of extract drugs extractum.
During medicine of the present invention was formed, filler was xylitol and starch, and xylitol is 1: 0.2～1: 0.3 with the ratio of the weight of starch.
During medicine of the present invention was formed, filler was lactose and starch, and lactose is 1: 0.2～1: 0.3 with the ratio of the weight of starch.
During medicine of the present invention was formed, filler was xylitol and arabic gum, and the ratio of the weight of xylitol and arabic gum is 1: 0.2～1: 0.4.
Medicine of the present invention can adopt the preparation of Chinese medicine preparation conventional method.Effective ingredient of the present invention can adopt following method: water extraction, decoction and alcohol sedimentation technique, extraction, infusion process, percolation, reflux extraction, continuous backflow extraction method, macroreticular resin absorbing method preparation.Also these crude drug can be ground into powder mixes evenly makes powder and takes after mixing it with water; Also can be with these medicines decocting together, the condensed water decocting liquid is made oral liquid then; Also can the raw materials used medicated powder of medicine of the present invention is broken, with crude drug ground ingredients and adjuvant mix homogeneously, direct compression.The present invention can adopt the said extracted method, make said dosage form on any pharmaceutics; As tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck dosage forms such as agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, ointment, plaster, spray, drop pill, disintegrating tablet, dispersible tablet, but preferably adopt following method to extract crude drug, and be prepared into dispersion sheet, disintegrating tablet, but this is not construed as limiting the invention.
The preparation method that the present invention treats the dispersible tablet of headache comprises the steps:
(a): the preparation of extract: it is standby to get Radix Angelicae Sinensis 4～9 weight portions, Rhizoma Chuanxiong 4～9 weight portions, the Radix Paeoniae Alba 2～8 weight portions, Radix Rehmanniae Preparata 2～8 weight portions, Ramulus Uncariae Cum Uncis 10～15 weight portions, Caulis Spatholobi 10～15 weight portions, Spica Prunellae 10～15 weight portions, Semen Cassiae 10～15 weight portions, Concha Margaritifera 10～15 weight portions, Rhizoma Corydalis 4～9 weight portions, Herba Asari 0.5～2 weight portion; More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add ethanol, reflux, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, add Ramulus Uncariae Cum Uncis, collecting decoction, concentrating under reduced pressure when decocting for the third time, add the ethanol precipitate with ethanol, leave standstill, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and concentrated filtrate are dried to dry extract, and be standby;
(b): adopt wet granule compression tablet, promptly above-mentioned dry extract and filler do not add or add part or all of disintegrating agent and mix, and add wetting agent and make soft material, granulate, and drying, granulate adds in addition partly or entirely disintegrating agent and lubricant, tabletting behind the mix homogeneously.
The preparation method that preferred the present invention treats the dispersible tablet of headache comprises the steps:
(a): the preparation of extract: it is standby to get Radix Angelicae Sinensis 6.75 weight portions, Rhizoma Chuanxiong 6.75 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Radix Rehmanniae Preparata 5.4 weight portions, Ramulus Uncariae Cum Uncis 13.5 weight portions, Caulis Spatholobi 13.5 weight portions, Spica Prunellae 13.5 weight portions, Semen Cassiae 13.5 weight portions, Concha Margaritifera 13.5 weight portions, Rhizoma Corydalis 6.75 weight portions, Herba Asari 1.34 weight portions; More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 70% ethanol, reflux 2 hours, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, being evaporated to relative density is 1.09～1.13 (55 ℃), add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and to be concentrated into relative density be 1.10～1.20 (55 ℃) is dried to dry extract, and is standby;
(b): adopt wet granule compression tablet, promptly above-mentioned dry extract and filler do not add or add part or all of disintegrating agent and mix, and add wetting agent and make soft material, granulate, and drying, granulate adds in addition partly or entirely disintegrating agent and lubricant, tabletting behind the mix homogeneously.
The dosage form of the best of the present invention is dispersible tablet and disintegrating tablet.
Medicine of the present invention is formed when producing and can be increased or reduce according to corresponding ratio, as large-scale production can be unit with kilogram or with the ton, small-scale production can be unit with the gram also, and weight can increase or reduce, but the crude drug material weight proportion constant rate between each composition.
More than each single medicinal material, especially adjuvant drug, messenger drug or adjuvant drug and messenger drug in forming, can be replaced by suitable Chinese medicine individually or simultaneously with the identical property of medicine, effect, it is constant to replace back Chinese medicine preparation and drug effect thereof.
Medicine of the present invention can be determined usage and dosage according to patient's situation in use, but every day 1-3 time, and every day, each crude drug consumption was as the criterion with the state-promulgated pharmacopoeia dosage, was no more than the pharmacopeia ormal weight.
The dispersible tablet that the present invention makes adopts the requirement check of Chinese Pharmacopoeia 2000 editions.
According to Chinese Pharmacopoeia 2000 editions, the parameter of definition dispersible tablet is as follows:
Dispersing uniformity: get two of dispersible tablets, place the jolting of 100ml water, in 20 ℃ ± 1 ℃ water, three minutes all disintegrate and by No. 2 the sieve.
Dissolution test: measure dissolution according to 2000 editions two appendix XC second methods of Chinese Pharmacopoeia.
The specific embodiment
Embodiment 1: the preparation of crude drug extract
Get Radix Angelicae Sinensis 4～9g, Rhizoma Chuanxiong 4～9g, the Radix Paeoniae Alba 2～8g, Radix Rehmanniae Preparata 2～8g, Ramulus Uncariae Cum Uncis 10～15g, Caulis Spatholobi 10～15g, Spica Prunellae 10～15g, Semen Cassiae 10～15g, Concha Margaritifera 10～15g, Rhizoma Corydalis 4～9g, Herba Asari 0.5～2g is standby;
More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add ethanol, reflux, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, add Ramulus Uncariae Cum Uncis, collecting decoction, concentrating under reduced pressure when decocting for the third time, add the ethanol precipitate with ethanol, leave standstill, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and concentrated filtrate are dried to dry extract, and be standby.
Embodiment 2: the preparation of crude drug extract
Get Radix Angelicae Sinensis 6.75g, Rhizoma Chuanxiong 6.75g, Radix Paeoniae Alba 5.4g, Radix Rehmanniae Preparata 5.4g, Ramulus Uncariae Cum Uncis 13.5g, Caulis Spatholobi 13.5g, Spica Prunellae 13.5g, Semen Cassiae 13.5g, Concha Margaritifera 13.5g, Rhizoma Corydalis 6.75g, Herba Asari 1.34g is standby;
More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 70% ethanol, reflux 2 hours, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, being evaporated to relative density is 1.09～1.13 (55 ℃), add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and to be concentrated into relative density be 1.10～1.20 (55 ℃) is dried to dry extract, and is standby.
Embodiment 3: the preparation of crude drug extract
Get Radix Angelicae Sinensis 405.6g, Rhizoma Chuanxiong 405.6g, Radix Paeoniae Alba 324.3g, Radix Rehmanniae Preparata 324.3g, Ramulus Uncariae Cum Uncis 810.8g, Caulis Spatholobi 810.8g, Spica Prunellae 810.8g, Semen Cassiae 810.8g, Concha Margaritifera 810.8g, Rhizoma Corydalis 405.6g, Herba Asari 80.8g is standby;
More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 70% ethanol, reflux 2 hours, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, being evaporated to relative density is 1.09～1.13 (55 ℃), add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and to be concentrated into relative density be 1.10～1.20 (55 ℃) is dried to dry extract, and is standby.
Embodiment 4
Get that to obtain crude drug extract dry extract 120g, xylitol 330g, starch 127g, microcrystalline Cellulose 350g, low-substituted hydroxypropyl cellulose 65g, magnesium stearate 8g, 75% ethanol according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, xylitol, starch, microcrystalline Cellulose, the abundant mixing of low-substituted hydroxypropyl cellulose, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: the results are shown in following table
Table 1 dispersible tablet of the present invention and general granule dissolution are relatively
From table the result as seen, the dispersible tablet release promptly reached more than 90% rapidly, fully in 5 minutes, was about 3 times of plain particles, illustrated that drug effect of the present invention is faster than plain particles.
Embodiment 5
Get that to obtain crude drug extract dry extract 130g, lactose 370g, starch 117g, microcrystalline Cellulose 300g, crospolyvinylpyrrolidone 75g, magnesium stearate 8g, 75% ethanol according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, lactose, starch, microcrystalline Cellulose, the abundant mixing of crospolyvinylpyrrolidone, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 6
Get according to embodiment 1 method and obtain crude drug extract dry extract 140g, xylitol 280g, arabic gum 57g, microcrystalline Cellulose 400g, an amount of for hydroxypropyl cellulose 85g, magnesium stearate 6g, dehydrated alcohol;
Method for making: with crude drug extract dry extract, xylitol, arabic gum, microcrystalline Cellulose, for the abundant mixing of hydroxypropyl cellulose, add an amount of dehydrated alcohol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate add the magnesium stearate mixing, tabletting promptly gets disintegrating tablet of the present invention.
Embodiment 7
Get that to obtain crude drug extract dry extract 50g, erythritol 280g, pregelatinized Starch 70g, dextrin 400g, cross-linking sodium carboxymethyl cellulose 185g, magnesium stearate 15g, 75% ethanol according to embodiment 1 method an amount of;
Method for making: with crude drug extract dry extract, erythritol, pregelatinized Starch, dextrin, the abundant mixing of cross-linking sodium carboxymethyl cellulose, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification
Embodiment 8
Get that to obtain crude drug extract dry extract 150g, lactose 310g, pregelatinized Starch 85g, Lac 40g, agar 28g, microcrystalline Cellulose 310g, crospolyvinylpyrrolidone 75g, Pulvis Talci 12g, 75% ethanol according to embodiment 2 methods an amount of;
Method for making: with crude drug extract dry extract, lactose, pregelatinized Starch, Lac, agar, microcrystalline Cellulose, the abundant mixing of crospolyvinylpyrrolidone, add an amount of 60% ethanol and make soft material, 60 mesh sieves are granulated, 50 ℃ of oven dry, 60 mesh sieve granulate, add the Pulvis Talci mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 9
Get that to obtain crude drug extract dry extract 180g, xylitol 540g, starch 180g, carboxymethylcellulose calcium 90g, magnesium stearate 10g, ethanol according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, xylitol, starch, the abundant mixing of carboxymethylcellulose calcium, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, and 20 mesh sieve granulate add the magnesium stearate mixing, and tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 10
Get that to obtain crude drug extract dry extract 280g, lactose 180g, microcrystalline Cellulose 410g, carboxymethyl starch sodium 55g, crospolyvinylpyrrolidone 65g, magnesium stearate 10g, ethanol according to embodiment 1 method an amount of;
Method for making: with crude drug extract dry extract, lactose, microcrystalline Cellulose, carboxymethyl starch sodium, the abundant mixing of crospolyvinylpyrrolidone, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 11
Get that to obtain crude drug extract dry extract 135g, lactose 370g, starch 52g, microcrystalline Cellulose 300g, carboxymethyl starch sodium 50g, low-substituted hydroxypropyl cellulose 75g, micropowder silica gel 10g, magnesium stearate 8g, 75% ethanol according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, lactose, starch, microcrystalline Cellulose, carboxymethyl starch sodium, the abundant mixing of low-substituted hydroxypropyl cellulose, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add magnesium stearate, micropowder silica gel mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 12
Get that to obtain crude drug extract dry extract 130g, trehalose 370g, starch 67g, microcrystalline Cellulose 300g, crospolyvinylpyrrolidone 75g, cross-linking sodium carboxymethyl cellulose 50g, magnesium stearate 8g, dehydrated alcohol according to embodiment 2 methods an amount of;
Method for making: with crude drug extract dry extract, trehalose, starch, microcrystalline Cellulose, crospolyvinylpyrrolidone, the abundant mixing of cross-linking sodium carboxymethyl cellulose, add an amount of dehydrated alcohol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 13
Get that to obtain crude drug extract dry extract 160g, low melting-point agarose 150g, pregelatinized Starch 90g, sorbitol 45g, microcrystalline Cellulose 400g, Lac 35g, crospolyvinylpyrrolidone 85g, magnesium stearate 15g, PVP alcoholic solution 20g, water according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, low melting-point agarose, pregelatinized Starch, sorbitol, microcrystalline Cellulose, Lac, crospolyvinylpyrrolidone, an amount of abundant mixing of PVP alcoholic solution, add water and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 14
Get that to obtain crude drug extract dry extract 135g, lactose 65g, microcrystalline Cellulose 200g, pregelatinized Starch 200g, sorbitol 85g, arabic gum 45g, xylitol 70g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 85g, magnesium stearate 9g, micropowder silica gel 6g, starch slurry 50g, 75% ethanol according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, lactose, microcrystalline Cellulose, pregelatinized Starch, sorbitol, arabic gum, xylitol, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, the abundant mixing of starch slurry, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add magnesium stearate, micropowder silica gel mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Embodiment 15
Get that to obtain crude drug extract dry extract 80g, microcrystalline Cellulose 350g, pregelatinized Starch 88g, starch 40g, arabic gum 35g, xylitol 170g, lactose 50g, low-substituted hydroxypropyl cellulose 75g, cross-linking sodium carboxymethyl cellulose 35g, Pulvis Talci 15g, micropowder silica gel 12g, cyclodextrin 40g, 75% ethanol according to embodiment 3 methods an amount of;
Method for making: with crude drug extract dry extract, microcrystalline Cellulose, pregelatinized Starch, starch, arabic gum, xylitol, lactose, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, Pulvis Talci, micropowder silica gel, the abundant mixing of cyclodextrin, add an amount of 75% ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add the magnesium stearate mixing, tabletting promptly gets dispersible tablet of the present invention.
The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Dissolution test: up to specification.
Claims (6)
1. medicine for the treatment of headache, it is characterized in that: this medicine is to be made by extracts of bulk drugs and suitable adjuvant, and wherein the crude drug extract prepares by following method: it is standby to get Radix Angelicae Sinensis 4～9 weight portions, Rhizoma Chuanxiong 4～9 weight portions, the Radix Paeoniae Alba 2～8 weight portions, Radix Rehmanniae Preparata 2～8 weight portions, Ramulus Uncariae Cum Uncis 10～15 weight portions, Caulis Spatholobi 10～15 weight portions, Spica Prunellae 10～15 weight portions, Semen Cassiae 10～15 weight portions, Concha Margaritifera 10～15 weight portions, Rhizoma Corydalis 4～9 weight portions, Herba Asari 0.5～2 weight portion; More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add ethanol, reflux, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, add Ramulus Uncariae Cum Uncis, collecting decoction, concentrating under reduced pressure when decocting for the third time, add the ethanol precipitate with ethanol, leave standstill, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and concentrated filtrate, dry as for extractum, standby; Wherein adjuvant is made up of disintegrating agent, filler, lubricant, wetting agent and adhesive; Described disintegrating agent is one or more in crospolyvinylpyrrolidone, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose; Described filler is starch and xylitol, and xylitol is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Perhaps be lactose and starch, lactose is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Perhaps be xylitol and arabic gum, the ratio of the weight of xylitol and arabic gum is 1: 0.2～1: 0.4; Described lubricant is one or both in Polyethylene Glycol, the micropowder silica gel; Described wetting agent is water, dehydrated alcohol or ethanol water; Described adhesive is one or both of PVP alcoholic solution, agar; Described adjuvant is 1: 0.12～1: 0.28 with the ratio of the weight of extract drugs extractum, and used disintegrating agent is 0.05: 1～0.25: 1 with the ratio of total formulation weight; Used filler is 0.395: 1～0.845: 1 with the ratio of total formulation weight; Used lubricant is 0.005: 1～0.05: 1 with the ratio of total formulation weight; Described adhesive is 0.005: 1～0.05: 1 with the ratio of total formulation weight.
2. the medicine of treatment headache as claimed in claim 1, it is characterized in that: this medicine is to be made by extracts of bulk drugs and suitable adjuvant, and wherein crude drug is made up of Radix Angelicae Sinensis 5～7 weight portions, Rhizoma Chuanxiong 5～7 weight portions, the Radix Paeoniae Alba 4～6 weight portions, Radix Rehmanniae Preparata 4～6 weight portions, Ramulus Uncariae Cum Uncis 12～14 weight portions, Caulis Spatholobi 12～14 weight portions, Spica Prunellae 12～14 weight portions, Semen Cassiae 12～14 weight portions, Concha Margaritifera 12～14 weight portions, Rhizoma Corydalis 5～7 weight portions, Herba Asari 1～1.5 weight portion.
3. the medicine of treatment headache as claimed in claim 1, it is characterized in that: this medicine is to be made by extracts of bulk drugs and an amount of adjuvant, wherein crude drug is made up of Radix Angelicae Sinensis 6.75 weight portions, Rhizoma Chuanxiong 6.75 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Radix Rehmanniae Preparata 5.4 weight portions, Ramulus Uncariae Cum Uncis 13.5 weight portions, Caulis Spatholobi 13.5 weight portions, Spica Prunellae 13.5 weight portions, Semen Cassiae 13.5 weight portions, Concha Margaritifera 13.5 weight portions, Rhizoma Corydalis 6.75 weight portions, Herba Asari 1.34 weight portions, wherein, described disintegrating agent is a low-substituted hydroxypropyl cellulose; Described lubricant is a Polyethylene Glycol; Described binding agent is the PVP alcoholic solution.
4. as claim 1,2 or 3 arbitrary described medicines, it is characterized in that this medicine is dispersible tablet, disintegrating tablet.
5. a preparation method for the treatment of the medicine of headache comprises the steps:
(a): the preparation of extract: it is standby to get Radix Angelicae Sinensis 4～9 weight portions, Rhizoma Chuanxiong 4～9 weight portions, the Radix Paeoniae Alba 2～8 weight portions, Radix Rehmanniae Preparata 2～8 weight portions, Ramulus Uncariae Cum Uncis 10～15 weight portions, Caulis Spatholobi 10～15 weight portions, Spica Prunellae 10～15 weight portions, Semen Cassiae 10～15 weight portions, Concha Margaritifera 10～15 weight portions, Rhizoma Corydalis 4～9 weight portions, Herba Asari 0.5～2 weight portion; More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add ethanol, reflux, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, add Ramulus Uncariae Cum Uncis, collecting decoction, concentrating under reduced pressure when decocting for the third time, add the ethanol precipitate with ethanol, leave standstill, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and concentrated filtrate are dried to dry extract, and be standby;
(b): adopt wet granule compression tablet, be above-mentioned dry extract and filler, not adding or add part or all of disintegrating agent mixes, add wetting agent and make soft material, granulate drying, granulate, add in addition part or all of disintegrating agent and lubricant, tabletting behind the mix homogeneously, described disintegrating agent are one or more in crospolyvinylpyrrolidone, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose; Described filler is starch and xylitol, and xylitol is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Perhaps be lactose and starch, lactose is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Perhaps be xylitol and arabic gum, the ratio of the weight of xylitol and arabic gum is 1: 0.2～1: 0.4; Described lubricant is one or both in Polyethylene Glycol, the micropowder silica gel; Described wetting agent is water, dehydrated alcohol or ethanol water; Described adjuvant is 1: 0.12～1: 0.28 with the ratio of the weight of extract drugs extractum, and used disintegrating agent is 0.05: 1～0.25: 1 with the ratio of total formulation weight; Used filler is 0.395: 1～0.845: 1 with the ratio of total formulation weight; Used lubricant is 0.005: 1～0.05: 1 with the ratio of total formulation weight.
6. as the preparation method of the medicine of treatment headache as described in the claim 5, it is characterized in that comprising the steps:
(a): the preparation of extract: it is standby to get Radix Angelicae Sinensis 6.75 weight portions, Rhizoma Chuanxiong 6.75 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Radix Rehmanniae Preparata 5.4 weight portions, Ramulus Uncariae Cum Uncis 13.5 weight portions, Caulis Spatholobi 13.5 weight portions, Spica Prunellae 13.5 weight portions, Semen Cassiae 13.5 weight portions, Concha Margaritifera 13.5 weight portions, Rhizoma Corydalis 6.75 weight portions, Herba Asari 1.34 weight portions; More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 70% ethanol, reflux 2 hours, backflow device in addition stores; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, relative density is 1.09～1.13 when being evaporated to 55 ℃, add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter, filtrate and above-mentioned backflow merge, decompression recycling ethanol and when being concentrated into 55 ℃ relative density be 1.10～1.20, be dried to dry extract, standby;
(b): adopt wet granule compression tablet, promptly above-mentioned dry extract and filler do not add or add part or all of disintegrating agent and mix, and add wetting agent and make soft material, granulate, and drying, granulate adds in addition partly or entirely disintegrating agent and lubricant, tabletting behind the mix homogeneously.
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| CN2005100732903A CN1872217B (en) | 2005-06-03 | 2005-06-03 | A medication for treating headache, and preparation method |
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| CN2005100732903A CN1872217B (en) | 2005-06-03 | 2005-06-03 | A medication for treating headache, and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101194963B (en) * | 2006-12-08 | 2013-06-05 | 天士力制药集团股份有限公司 | Process for preparing medicine for treating headache |
| CN101194962B (en) * | 2006-12-08 | 2013-04-17 | 天士力制药集团股份有限公司 | Pill for treating headache and method for preparing the same |
| CN101194967B (en) * | 2006-12-08 | 2012-06-06 | 天津天士力制药股份有限公司 | Hypoglossis buccal tablets for treating headache and method for preparing the same |
| CN101194966B (en) * | 2006-12-08 | 2012-06-06 | 天津天士力制药股份有限公司 | Buccal tablets for treating headache and method for preparing the same |
| CN103877241A (en) * | 2012-12-21 | 2014-06-25 | 天士力制药集团股份有限公司 | Medicine for treating headache |
| MY172207A (en) | 2012-12-21 | 2019-11-15 | Tasly Pharmaceutical Group Co | Pharmaceutical composition for treating headache, and preparation method thereof |
| CN103877243A (en) * | 2012-12-21 | 2014-06-25 | 天士力制药集团股份有限公司 | Pharmaceutical preparation for treating headache |
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| CN1593634A (en) * | 2004-06-25 | 2005-03-16 | 张晴龙 | Blood nourishing, brain refreshing orally disintegrating tablet and its preparation process |
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