CN103386103A - Xuangui sustain release tablet and preparation method thereof - Google Patents
Xuangui sustain release tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Xuangui sustain release tablet and a preparation method thereof. The preparation method comprises following steps: weighing Chinese angelica, corydalis tuber and dried gingers, adding ethanol water solution in the Chinese angelica and dried gingers, reflux extracting, filtering, recycling ethanol, cooling, extracting with an organic solvent, recycling the extract liquor, condensing the solvent to obtain the extract 1; adding corydalis tuber in ethanol water solution, reflux extracting, filtering, recycling the ethanol, adjusting the pH value, extracting with an organic solvent, recycling the extract liquor, condensing the solvent to obtain the extract 2; drying and grinding the extract 1 and the extract 2, then mixing the extract 1 and the extract 2 to obtain a mixture, screening and blending the mixture with a stuffing agent, hydroxypropyl methylcellulose and a release-speed conditioning agent, adding an adhesive agent to prepare the soft material, then sieving to prepare particles, drying, granulating, and pressing into tablets. The Xuangui sustain release tablet has the functions of promoting blood circulation to remove blood stasis and warming the channels to relieve pain, is used for curing primary dysmenorrhea (PD) of congealing cold and blood stasis, has the advantages of rapid effect, convenient use, prominent curative effect, and treatment on both symptoms and root causes, and thus needs of patients are fully satisfied. Furthermore, the preparation method has the advantages of short preparation time and high transfer rate of effective components.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, relate to a kind of Chinese medicine preparation for the treatment of dysmenorrhea and preparation method thereof.
Background technology
Dysmenorrhea is that a kind of women occurs that in menstrual period or its front and back periodically hypogastralgia is the commonly encountered diseases of primary symptom.Primary dysmenorrhea refers to gynecologial examination, and the genitals is without significant organic pathological changes person, be mainly in menarche after adolescent girls or the young woman of fertility not of 2-3 years.And all there is the disease of dysmenorrhea in the young woman of most of maiden or not fertility.The visible lower abdomen pain of its severe one, waist are ached, face white, dripping cold sweat, extreme cold of the limbs, vomiting and diarrhoea or rectal tenesmus all of a sudden, have had a strong impact on work, study and daily life, have brought misery for numerous women.The incidence rate of dysmenorrhea is higher, is commonly encountered diseases clinically.Show according to the national sampling survey result of China 1980, dysmenorrhea incidence rate 33.19%, wherein primary dysmenorrhea 36.06%, and is slight 45.73%, and moderate 38.81%, the severe that has a strong impact on work are 13.55%(whole nation woman in menstrual period physical constants cooperative groups, 1980).Nineteen eighty-two shows the young woman's random sampling of city, Sweden Goteborg, and dysmenorrhea incidence rate 72%, 15% limits daily routines because of serious dysmenorrhea, and invalid to analgesic.Because the cause of disease that causes primary disease is complicated, its treatment is rather thorny.Many patients suffer from and do not heal for a long time, trouble for it month in and month out, fear menstrual onset, cause serious stress and psychic trauma, but are difficult to obtain the medicine of satisfactory effect.Modern medicine is the fenamic acids Drug therapys that adopt steroids at present more, think the generation of dysmenorrhea, may with the excessive release prostaglandin F of endometrium
2a(lower letter: PGF
2a) relevant, thereby use flufenamic acid, mefenamic acid class medicine, with antagonism PGF
2aSynthetic, reach the purpose for the treatment of dysmenorrhea.But this class PGF
2aThe antagonist side effect is larger, and patient is difficult to accept; Also have and use the hormonotherapy therapist, but this is to the adolescence women and be not suitable for.The Chinese patent medicine for the treatment of dysmenorrhea mainly contains at present: TONGJINGBAO KELI, Tiaojing Zhitong capsule, FUKE ZAIZAO WAN, WUJI BAIFENG WAN etc.Although these Chinese patent medicine side effect are little, often onset is slower, mainly play the effect of blood circulation promoting and blood stasis dispelling, regulating menstruation, and analgesic effect is unsatisfactory.
Summary of the invention
The object of the invention just is to provide that a kind of determined curative effect, side effect are little, rapid-action, the profound slow releasing tablet of returning of taking convenience.
Second purpose of the present invention is to provide a kind of profound preparation method of returning slow releasing tablet.
Technical scheme of the present invention is summarized as follows:
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 10～80%, Rhizoma Corydalis 10%～80%, Rhizoma Zingiberis 10%～50%;
(2) be equivalent to Radix Angelicae Sinensis and Rhizoma Zingiberis quality 2-8 volumetric concentration doubly is the ethanol water of 30%-99% to adding in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 1-3 hour, filter, relative density is 1.05～1.30 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, use organic solvent extraction, extract reclaims organic solvent and concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis being added the volumetric concentration that is equivalent to Rhizoma Corydalis quality 2-8 times is the ethanol water of 30%-99%, reflux, extract, 1-3 hour, filter, relative density is 1.05～1.30 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to alkalescence, use organic solvent extraction, extract reclaims organic solvent and concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion the appropriate and filler 15-25 mass parts of described mixture 300 mass parts, hypromellose 70-90 mass parts, rate of release regulator 3-8 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 40-50 ℃ of drying, dried granule is crossed 20 mesh sieve granulate, tabletting.
Step (1) is preferably: take by weight percentage Radix Angelicae Sinensis 30%～50%, Rhizoma Corydalis 30%～50%, Rhizoma Zingiberis 15%～30%.
Step (1) is preferably: take by weight percentage Radix Angelicae Sinensis 40%, Rhizoma Corydalis 40%, Rhizoma Zingiberis 20%.
The preferred n-butyl alcohol of organic solvent, ethyl acetate, butanone, chloroform or petroleum ether.
Hypromellose is selected from HPMC K4M, hypromellose K15M or hypromellose K100M.
The rate of release regulator is selected from carboxymethyl starch sodium or polyvinylpolypyrrolidone.
It is that 3% polyvidone alcoholic solution or mass concentration are 3% ethyl cellulose alcoholic solution that binding agent is selected from mass concentration.
Filler preferably microcrystalline cellulose, calcium sulfate, lactose, polyvidone or amylum pregelatinisatum.
A kind of profound slow releasing tablet of returning of said method preparation.
The profound slow releasing tablet of returning of the present invention has blood circulation promoting and blood stasis dispelling, and the effect of antalgic is used for cold blood stasis type essential dysmenorrhea.The profound slow releasing tablet of returning of method of the present invention preparation, rapid-action, taking convenience, evident in efficacy, treating both the principal and secondary aspects of a disease, thus can meet the demand of extensive patients.The man-hour of preparation method is few, and the effective ingredient rate of transform is high.
The specific embodiment
Medicament selection Radix Angelicae Sinensis of the present invention, Rhizoma Corydalis and Rhizoma Zingiberis make up, and make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat dysmenorrhea.Wherein the Radix Angelicae Sinensis nature and flavor are sweet, hot, warm, and having enriches blood invigorates blood circulation, menstruction regulating and pain relieving, and the effects such as cold expelling can blood-supplementing blood-nourishing, blood circulation promoting competent silt, can stimulate the menstrual flow by cold expelling again, pain relieving, be warm and not dry, tonify without causing stagnation, enrich blood and do not stay the stasis of blood, Removing Blood Stasis and just not hindering, for controlling the key medicine of gynecological, therefore be we's monarch; Rhizoma Corydalis have invigorate blood circulation, the effect of circulation of qi promoting, pain relieving, and the Rhizoma Corydalis analgesic effect is remarkable, site of action is more extensive, and tool toxicity, be product on pain relieving lastingly and not, but not only promoting the circulation of QI and blood pain relieving of this product, simultaneously more help the performance of Radix Angelicae Sinensis regulating menstruation by adjusting the flow of blood, blood-activating analgetic curative effect, therefore be ministerial drug; The hot warm dispersing cold for relieving pain of Rhizoma Zingiberis and keep and do not walk, be warming middle-JIAO to relieve pain, the medicine of warming uterus for dispelling cold first-selection, it can help Radix Angelicae Sinensis temperature Tonghua stasis of blood, dispersing cold for relieving pain can help again Rhizoma Corydalis promoting flow of QI and blood, pain relieving, and again priming return through, therefore make it product for Fang Zhongzuo.The party's medicine is brief and power is grand, plays altogether the effect of blood circulation promoting and blood stasis dispelling, antalgic.
The present invention is further illustrated below in conjunction with the specific embodiment.
Embodiment 1
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 40%, Rhizoma Corydalis 40%, Rhizoma Zingiberis 20%.
(2) be 75% ethanol water to adding the volumetric concentration that is equivalent to 5 times of Radix Angelicae Sinensis and Rhizoma Zingiberis quality in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 2 hours, filter, relative density is 1.20 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, use n-butanol extraction, extract reclaims n-butyl alcohol and concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis being added the volumetric concentration that is equivalent to 5 times of Rhizoma Corydalis quality is 75% ethanol water, reflux, extract, 2 hours, filter, relative density is 1.20 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to 7.5, use n-butanol extraction, extract reclaims n-butyl alcohol and concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion appropriate and microcrystalline Cellulose 20 mass parts of described mixture 300 mass parts, HPMC K4M 80 mass parts, carboxymethyl starch sodium 5 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 45 ℃ of dryings, dried granule is crossed 20 mesh sieve granulate, tabletting.Binding agent is that mass concentration is 3% polyvidone alcoholic solution.
Embodiment 2
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 30%, Rhizoma Corydalis 40%, Rhizoma Zingiberis 30%.
(2) be 99% ethanol water to adding the volumetric concentration that is equivalent to 2 times of Radix Angelicae Sinensis and Rhizoma Zingiberis quality in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 1 hour, filter, relative density is 1.05 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, use ethyl acetate extraction, extract recovery of acetic acid ethyl ester also concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis being added the volumetric concentration that is equivalent to 2 times of Rhizoma Corydalis quality is 99% ethanol water, reflux, extract, 1 hour, filter, relative density is 1.05 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to 8, use ethyl acetate extraction, extract recovery of acetic acid ethyl ester also concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion appropriate and calcium sulfate 15 mass parts of described mixture 300 mass parts, hypromellose K15M70 mass parts, carboxymethyl starch sodium 8 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 40 ℃ of dryings, dried granule is crossed 20 mesh sieve granulate, tabletting.Binding agent is that mass concentration is 3% polyvidone alcoholic solution.
Embodiment 3
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 50%, Rhizoma Corydalis 30%, Rhizoma Zingiberis 20%.
(2) be 30% ethanol water to adding the volumetric concentration that is equivalent to 8 times of Radix Angelicae Sinensis and Rhizoma Zingiberis quality in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 3 hours, filter, relative density is 1.30 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, with the butanone extraction, extract reclaims butanone and concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis is added to be equivalent to Rhizoma Corydalis quality 2-8 volumetric concentration doubly be 30% ethanol water, reflux, extract, 3 hours, filter, relative density is 1.30 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to 8.5, with the butanone extraction, extract reclaims butanone and concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion appropriate and lactose 25 mass parts of described mixture 300 mass parts, hypromellose K100M90 mass parts, carboxymethyl starch sodium 3 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 50 ℃ of dryings, dried granule is crossed 20 mesh sieve granulate, tabletting.Binding agent is that mass concentration is 3% ethyl cellulose alcoholic solution.
Embodiment 4
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 10%, Rhizoma Corydalis 80%, Rhizoma Zingiberis 10%;
(2) be 75% ethanol water to adding the volumetric concentration that is equivalent to 5 times of Radix Angelicae Sinensis and Rhizoma Zingiberis quality in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 2 hours, filter, relative density is 1.20 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, use chloroform extraction, extract reclaims chloroform and concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis being added the volumetric concentration that is equivalent to 5 times of Rhizoma Corydalis quality is 75% ethanol water, reflux, extract, 2 hours, filter, relative density is 1.20 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to 7.5, use chloroform extraction, extract reclaims chloroform and concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion appropriate and polyvidone 20 mass parts of described mixture 300 mass parts, hypromellose K100M80 mass parts, polyvinylpolypyrrolidone 5 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 45 ℃ of dryings, dried granule is crossed 20 mesh sieve granulate, tabletting.Binding agent is that mass concentration is 3% ethyl cellulose alcoholic solution.
Embodiment 5
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 80%, Rhizoma Corydalis 10%, Rhizoma Zingiberis 10%;
(2) be 99% ethanol water to adding the volumetric concentration that is equivalent to 2 times of Radix Angelicae Sinensis and Rhizoma Zingiberis quality in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 1 hour, filter, relative density is 1.05 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, use petroleum ether extraction, extract reclaims petroleum ether and concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis being added the volumetric concentration that is equivalent to 2 times of Rhizoma Corydalis quality is 99% ethanol water, reflux, extract, 1 hour, filter, relative density is 1.05 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to 8, use petroleum ether extraction, extract reclaims petroleum ether and concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion appropriate and amylum pregelatinisatum 20 mass parts of described mixture 300 mass parts, hypromellose K100M80 mass parts, polyvinylpolypyrrolidone 5 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 45 ℃ of dryings, dried granule is crossed 20 mesh sieve granulate, tabletting.Binding agent is that mass concentration is 3% ethyl cellulose alcoholic solution.
Embodiment 6
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 35%, Rhizoma Corydalis 50%, Rhizoma Zingiberis 15%;
(2) with embodiment 1;
(3) with embodiment 1;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) with embodiment 1.
Embodiment 7
A kind of profound preparation method of returning slow releasing tablet, comprise the steps:
(1) take by weight percentage Radix Angelicae Sinensis 30%, Rhizoma Corydalis 20%, Rhizoma Zingiberis 50%;
(2) with embodiment 1;
(3) with embodiment 1;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) with embodiment 1.
Embodiment 8 effect experiments:
1 experiment material
1.1 laboratory animal
Healthy Kunming kind white mice, female, unpregnancy, body weight 18～22g, be purchased from Beijing Vital River Experimental Animals Technology Co., Ltd..The healthy SD rat, female, unpregnancy, body weight 180～200g, be purchased from Beijing Vital River Experimental Animals Technology Co., Ltd..Raise under Tianjin University Of Traditional Chinese Medicine's Experimental Animal Center secondary Animal Lab. condition.
1.2 Experimental agents and reagent
The profound slow releasing tablet of returning, embodiment 1 preparation.
Diethylstilbestrol injection (lot number 0806021): Tianjin gold credit aminoacid company limited; Aspirin Enteric-coated Tablets (lot number BT06357): Bayer Bitterfeld GmbH; PGF
2 α(018H37987): Sigma company; Acecoline (lot number 060517): Beijing chemical reagents corporation; Oxytocin inj (lot number 040912): Shanghai No.1 Bio-Chemical Pharmacetical Industry Co., Ltd; Sodium chloride injection (lot number 2020010): Otsuka Pharmaceutical (China) Co., Ltd.; Dimethylbenzene, analytical pure: the north, Tianjin day medical chemistry chemical reagent work; Tyrode (NaCl8.0g, 10%KCl2.0mL (0.2g), 10%MgSO
47H
2O2.6mL (0.26g), 5%NaH
2PO
42H
2O1.3mL (0.065g), NaHCO
31.0g, 1M CaCl
21.8mL(0.2g), glucose 1.0g, distilled water adds to 1000mL).1.3 key instrument
RM6240B/C Biological Signal Collecting System 2.0j version, and the muscle tone transducing (the JZ101 type, 0-5g), temperature chamber (WC/09-05), Magnus' bath, photo-thermal dolorimeter, card punch.
2 experimental techniques
The experiment of Isolated Rat Uterus smooth muscle
Get female sd inbred rats body weight 180-220g, be divided at random profound slow releasing tablet high dose group, profound dosage group in slow releasing tablet, profound slow releasing tablet low dose group, aspirin group, the Normal group (tyrode matched group) of returning of returning of returning, every group 8, subcutaneous injection diethylstilbestrol 2mg/kg, to increase the sensitivity of uterine smooth muscle bar to medicine.After 24h, the dislocation of rat neck is put to death, cut open rapidly and get uterus, two cornua uteris are respectively got the uterus section of 2cm, and it is hung on and is full of tyrode's solution (Nacl8.0g, 10%Kcl2.0mL (0.2g), 10%MgSO
47H
2O2.6mL (0.26g), 5%NaH
2PO
42H
2O1.3ml (0.065g), NaHCO
31.0g, 1M CaCl
21.8mL(0.2g), glucose 1.0g, distilled water adds to 1000ml) Magnus' bath in, one end is fixed on bathes on interior T shape hook, one end is connected with the muscle tone transducer, 37 ℃ of constant temperature, saturated oxygen are hatched, muscle is opened transducer by computer software RM6240C biological signal collecting reason system 2.0j version, records the contraction situation of flesh bar.
After uterine contraction is stable, first record 5～10min normal contraction curve, add subsequently in tyrode's solution administration respectively, oxytocin (final concentration 10IU/L), Ach (final concentration 10 μ mol/L), PGF
2 α(final concentration 1mg/L), KCL(final concentration 60mmol/L) stimulate uterine contraction 10min after, add respectively more tested medicine, add profound slow releasing tablet high dose group (final concentration 48mg/L), profound dosage group in slow releasing tablet (final concentration 24mg/L), profound slow releasing tablet low dose group (final concentration 12mg/L), the aspirin (final concentration 16mg/L) of returning of returning of returning, record frequency of uterine contraction after administration, amplitude, observe the antagonism of medicine to the spastic contraction in uterus, record 20min, after rinsing 3 times with nutritional solution, carry out laboratory observation next time.With RM6240C type multi-path physiology signal acquiring processing system acquisition process data, and obtain uterine contraction area under curve (AUC).
3 date processing
Count results with
Expression.Adopt one factor analysis of variance group difference significance, application SPSS11.5 statistical software processes.
4 experimental results
Impact on the Isolated Rat Uterus smooth muscle contraction
4.1 uterine contraction promoter (oxytocin, dinoprost, acetylcholine) is brought out the impact of hysterospasm contraction
Results suggest, before administration, profound isolated uterine specimen zero difference of returning in slow releasing tablet high dose group, middle dosage group, low dose group, aspirin group and tyrode's solution contrast.Add uterus agonist OT, PGF
2 α, after Ach, profound high, the middle dosage group of slow releasing tablet, aspirin group of returning compared before the spastic contraction in uterus and dosing, obvious inhibition effect (P＜0.01) is all arranged, and the profound slow releasing tablet low dose group of returning has to a certain degree inhibitory action (P＜0.05) to OT, to PGF
2 α, Ach inhibitory action more remarkable (P＜0.01).
The impact of table 1 on uterus agonist stimulation in rats isolated uterine smooth muscle contraction
*Compare P＜0.05 with the tyrode's solution matched group;
*Compare P＜0.01 with the tyrode's solution matched group.
The profound slow releasing tablet of returning that experiment showed, embodiment 2-7 preparation is similar to the profound slow releasing tablet effect of returning of embodiment 1 preparation.
Claims (9)
1. a profound preparation method of returning slow releasing tablet, is characterized in that comprising the steps:
(1) take by weight percentage Radix Angelicae Sinensis 10～80%, Rhizoma Corydalis 10%～80%, Rhizoma Zingiberis 10%～50%;
(2) be equivalent to Radix Angelicae Sinensis and Rhizoma Zingiberis quality 2-8 volumetric concentration doubly is the ethanol water of 30%-99% to adding in described Radix Angelicae Sinensis and Rhizoma Zingiberis, reflux, extract, 1-3 hour, filter, relative density is 1.05～1.30 with filtrate recycling ethanol and while being concentrated into 80 ℃, let cool, use organic solvent extraction, extract reclaims organic solvent and concentrates to obtain extractum 1;
(3) described Rhizoma Corydalis being added the volumetric concentration that is equivalent to Rhizoma Corydalis quality 2-8 times is the ethanol water of 30%-99%, reflux, extract, 1-3 hour, filter, relative density is 1.05～1.30 concentrated solution with filtrate recycling ethanol and while being concentrated into 80 ℃, regulate pH value and be adjusted to alkalescence, use organic solvent extraction, extract reclaims organic solvent and concentrates to obtain extractum 2;
(4) extractum 1 and extractum 2 drying and crushing are mixed to get mixture;
(5) take in proportion the appropriate and filler 15-25 mass parts of described mixture 300 mass parts, hypromellose 70-90 mass parts, rate of release regulator 3-8 mass parts, binding agent; Described mixture, filler, hypromellose and rate of release regulator are crossed 60 mesh sieves mix, add binding agent soft material processed in right amount, cross 20 mesh sieves and granulate, 40-50 ℃ of drying, dried granule is crossed 20 mesh sieve granulate, tabletting.
2. a kind of profound preparation method of returning slow releasing tablet according to claim 1, is characterized in that described step (1) for taking by weight percentage Radix Angelicae Sinensis 30%～50%, Rhizoma Corydalis 30%～50%, Rhizoma Zingiberis 15%～30%.
3. a kind of profound preparation method of returning slow releasing tablet according to claim 2, is characterized in that described step (1) for taking by weight percentage Radix Angelicae Sinensis 40%, Rhizoma Corydalis 40%, Rhizoma Zingiberis 20%.
4. a kind of profound preparation method of returning slow releasing tablet according to claim 1, is characterized in that described organic solvent is n-butyl alcohol, ethyl acetate, butanone, chloroform or petroleum ether.
5. one of according to claim 1-3 described a kind of profound preparation methoies of returning slow releasing tablet, is characterized in that described hypromellose is selected from HPMC K4M, hypromellose K15M or hypromellose K100M.
6. one of according to claim 1-3 described a kind of profound preparation methoies of returning slow releasing tablet, is characterized in that described rate of release regulator is selected from carboxymethyl starch sodium or polyvinylpolypyrrolidone.
7. one of according to claim 1-3 described a kind of profound preparation methoies of returning slow releasing tablet, is characterized in that it is that 3% polyvidone alcoholic solution or mass concentration are 3% ethyl cellulose alcoholic solution that described binding agent is selected from mass concentration.
8. one of according to claim 1-3 described a kind of profound preparation methoies of returning slow releasing tablet, is characterized in that described filler is microcrystalline Cellulose, calcium sulfate, lactose, polyvidone or amylum pregelatinisatum.
9. a kind of profound slow releasing tablet of returning of the method for one of claim 1-8 preparation.
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| CN103920134A (en) * | 2014-05-08 | 2014-07-16 | 崔韡 | Sustained release tablet for treating child vertigo and preparation method thereof |
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| CN102872439A (en) * | 2012-10-23 | 2013-01-16 | 天津中新药业集团股份有限公司第六中药厂 | Application of Xuangui dropping pill to preparing medicine for relieving spasm of uterine smooth muscles |
| CN102872441A (en) * | 2012-10-23 | 2013-01-16 | 天津中新药业集团股份有限公司第六中药厂 | Application of Xuangui dropping pill to preparing anti-inflammatory drug |
| CN102973669A (en) * | 2012-12-29 | 2013-03-20 | 天津中新药业集团股份有限公司第六中药厂 | Throat clearing sustained release tablet and preparation method thereof |
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| CN103920134A (en) * | 2014-05-08 | 2014-07-16 | 崔韡 | Sustained release tablet for treating child vertigo and preparation method thereof |
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Application publication date: 20131113 |