CN103877245A - Pharmaceutical composition for treating headache - Google Patents
Pharmaceutical composition for treating headache Download PDFInfo
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- CN103877245A CN103877245A CN201310733337.9A CN201310733337A CN103877245A CN 103877245 A CN103877245 A CN 103877245A CN 201310733337 A CN201310733337 A CN 201310733337A CN 103877245 A CN103877245 A CN 103877245A
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Abstract
The invention discloses a pharmaceutical composition for treating headache, which is prepared from angelica, hemlock parsley, white peony root, radix rehmanniae preparata, uncaria, spatholobus stem, self-heal, cassia seed, mother-of-pearl, corydalis tuber, asarum and proper amounts of auxiliary materials. The pharmaceutical composition for treating headache is prepared by the following steps: decocting the medicinal materials with water, filtering, concentrating, adding ethanol, standing, filtering, recycling the ethanol, concentrating to obtain an extract, and adding the auxiliary materials to prepare the preparation. The invention also discloses a preparation method of the pharmaceutical composition and application of the pharmaceutical composition in preparing medicines for treating headache, traumatic cerebral nerve syndrome, vertigo, distractedness, insomnia and dreamful sleep.
Description
Technical field
The present invention relates to the field of Chinese medicines, especially relate to a kind of pharmaceutical composition for the treatment of headache and preparation method thereof.
Background technology
Headache is a kind of common symptom in daily life, and almost everyone all has the generation of headache in life.The reason that causes headache is diversified.At present, the medicine for the treatment of headache is both at home and abroad a lot, and all can only symptomatic treatment, pain relieving is main, seldom adopts operative treatment, but effect is all undesirable, it is cured the symptoms, not the disease, patient's headache outbreak repeatedly, and its long-term taking pain relieving class medicine can produce drug resistance and addiction, therefore the unsuitable long-term taking of such medicine, can not fundamentally solve the puzzlement of headache.In addition, also use antianxiety drug, resist melancholy agent, sympathetic inhibitor, calcium channel blocker, antiepileptic etc. according to the different causes of disease clinically, these side effects of pharmaceutical drugs are larger, long-term taking can make curative effect reduce gradually, so that patient's dosage of having to increase gradually, result is taken medicine more, has a headache but serious all the more.The medicine for the treatment of headache at present, Chinese patent medicine has ZHENGTIAN WAN, and 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 Western medicine analgesic, and uncertain therapeutic efficacy is cut, and is difficult to reach the object of radical cure.At present, the Chinese medicine preparation for the treatment of headache is more, but onset is its major defect more slowly, and this has affected patient's quality of life.
Chinese patent 93100050.5 discloses a kind of pharmaceutical composition being made up of ten Herba indigoferae Pseudotinctoriae such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asaris, it be motherland's theory of medicine guidance under, and sum up and form through clinical practice for many years, there is the headache effect that treatment internal injury causes, be applicable to clinically the symptom such as dizziness, headache that angioneurotic headache, migraine and hypertension cause.In this prescription ratio, the granule dosage form of making is produced by Tasly Pharmaceutical Group Co., Ltd., and name is called " blood-nourishing and brain-refreshing granules "." function with cure mainly " got permission is the suppressing the hyperactive liver that nourishes blood, promoting blood circulation to remove obstruction in the collateral.For various headaches, traumatic cranial nerve syndrome due to blood deficiency and excessive liver-YANG, stagger, susceptible to lose temper due to restlessness, insomnia and dreamful sleep etc.Be mainly used in clinically treating the headache due to blood deficiency, blood stasis, hyperactivity of YANG due to deficiency of YIN.Due to its definite curative effect, since listing, win the trust of extensive patients.
In the party Rhizoma Chuanxiong, Chinese Angelica blood replonishing invigorate blood circulation, promoting the circulation of QI to relieve pain, be monarch drug; Radix Rehmanniae Preparata, Radix Paeoniae Alba yin and blood nourishing, nourishing the liver and kidney and pain relieving, Concha Margaritifera suppressing the hyperactive liver and subsiding YANG, Ramulus Uncariae Cum Uncis heat clearing away suppressing the hyperactive liver, to control headache dizzy for ministerial drug; Semen Cassiae, Spica Prunellae clearing away liver-fire and press down yang hyperactivity, the pain relieving of Rhizoma Corydalis blood-activating and qi-promoting, Caulis Spatholobi promoting blood circulation and stopping pain is adjuvant drug; Other all medicines are played altogether and are nourished blood, effect of suppressing the hyperactive liver, activating collaterals to relieve pain.
But the extraction process of said preparation and the preparation method of preparation also need to be optimized.For the problems referred to above, the present invention, through experimentation repeatedly, draws a kind of new preparation method and the pharmaceutical composition being made by this preparation method.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition for the treatment of headache.
Another object of the present invention is to provide a kind of preparation method of pharmaceutical composition for the treatment of headache.
Pharmaceutical composition of the present invention, contain 4～9 parts of 10～15 parts of 10～15 parts of 10～15 parts of 10～15 parts of 10～15 parts of 2～8 parts of 2～8 parts of 4～9 parts of 4～9 parts of Radix Angelicae Sinensis, Rhizoma Chuanxiongs, the Radix Paeoniae Albas, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobis, Spica Prunellaes, Semen Cassiaes, Concha Margaritiferas, Rhizoma Corydalis, 0.5～2 part of Herba Asari by weight, this pharmaceutical composition is prepared by the following method:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, decoct with water, filter, concentrated, add ethanol, leave standstill, filter, reclaim ethanol, concentrated, to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
One of according to the embodiment of the present invention, described pharmaceutical composition is prepared by the following method:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, add 4～10 times of water gagings to decoct 2～3 times, 0.5～3 hour for the first time, second and third time 1～3 hour, filter, be concentrated into relative density 1.06～1.10(75～85 ℃), add ethanol make containing alcohol amount be 60～85%, leave standstill 12～24 hours, filter, reclaim ethanol, be concentrated into relative density 1.270～1.350(75～85 ℃), to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
Preferably, described pharmaceutical composition is prepared by the following method:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, add 5 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 65～70%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.320～1.325(79～81 ℃), to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
Wherein, the described adjuvant of step (2) comprises one or more of filler, correctives etc.
Described filler can be selected from one or more of cellulose, starch, soluble starch, Icing Sugar, dextrin, mannitol, lactose, sucrose, microcrystalline Cellulose etc.
Correctives can be selected from one or more of steviosin, aspartame, glycerol, saccharin sodium, sorbitol, mannitol, xylitol, high fructose and cyclamate etc.
Preferably, filler is selected from dextrin, starch, soluble starch, sucrose, lactose, microcrystalline Cellulose; Correctives is selected from steviosin, Aspartane.
Most preferred, filler is selected from dextrin; Correctives is selected from steviosin.
One of according to the embodiment of the present invention, the extract of described step (2) and the ratio of adjuvant are 40:60～65:35(percentage by weight).
According to another embodiment of the present invention, the extract of described step (2) and the ratio of adjuvant are 55:45～65:35(percentage by weight).
The ratio of wherein said extract and adjuvant is that extract is amounted to into after dry extract and the ratio of adjuvant.
Pharmaceutical composition of the present invention can be made into any pharmaceutically acceptable oral formulations, includes but not limited to granule, tablet, capsule etc., preferred particulates agent.
Pharmaceutical composition of the present invention, the preparation method of preparation can be selected from any pharmaceutically acceptable method, such as spray-drying process method, fluidized-bed spray granulation method, wet granulation, dry-pressing granulation, rolling granulation etc.
Method of granulating 1: recipe quantity dextrin is melted with the rare described pharmaceutical composition of appropriate water extraction and suitable quantity of water, and heating makes slurry temperature remain on 55 ℃ ± 5 ℃, continues to stir 20 minutes, add water and regulate slurry proportion 1.22～1.23, cross colloid mill, 60 orders filter, and spraying is drying to obtain.
Method of granulating 2: get dextrin, melt by purified water, add steviosin, fully stir and make to dissolve; Described pharmaceutical composition is added in above-mentioned slurry, stir; Adjust slurry proportion between 1.12～1.23; 60 order～100 order on-line filtrations; Spray granulation; Dry; Granulate sieves and get final product.
Method of granulating 3: get described pharmaceutical composition and adjuvant mix homogeneously adds binding agent or wetting agent, become soft material after mix homogeneously, by swing or rotating type granulating machine, be squeezed into granule, then be drying to obtain.
Method of granulating 4: get the adjuvant mix homogeneously such as described pharmaceutical composition and filler, correctives, be compressed into large lamellar or tabular after, be ground into required size particles.
Method of granulating 5: by described pharmaceutical composition and suitable auxiliary materials and mixing, put in coating pan or suitable container and rotate, in rolling, wetting agent ethanol or water are to vaporific and spray into, make wet adhesive granulating, continue rolling to particle drying.
Pharmaceutical composition of the present invention, can, according to the different dosage form of making, make the packing of suitable specification, for example granule, and specification can be selected from 3 grams/bag or 4 grams/bag.
The preparation method of pharmaceutical composition of the present invention, comprises the following steps:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, decoct with water, filter, concentrated, add ethanol, leave standstill, filter, reclaim ethanol, concentrated, to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
Preferably, the preparation method of described extract is: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, add 4～10 times of water gagings to decoct 2～3 times, 0.5～3 hour for the first time, second and third time 1～3 hour, filter, be concentrated into relative density 1.06～1.10(75～85 ℃), add ethanol make containing alcohol amount be 60～85%, leave standstill 12～24 hours, filter, reclaim ethanol, be concentrated into relative density 1.270～1.350(75～85 ℃), to obtain final product;
Most preferred, the preparation method of described extract is: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, add 5 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol make containing alcohol amount be 65～70%, leave standstill 12～24 hours, filter, reclaim ethanol, be concentrated into relative density 1.320～1.325(79～81 ℃), to obtain final product;
Preparation in accordance with the present invention, the described adjuvant of step (2) comprises one or more of filler, correctives etc.
Described filler can be selected from one or more of cellulose, starch, soluble starch, Icing Sugar, dextrin, mannitol, lactose, sucrose, microcrystalline Cellulose etc.
Correctives can be selected from one or more of steviosin, aspartame, glycerol, saccharin sodium, sorbitol, mannitol, xylitol, high fructose and cyclamate etc.
Preferably, filler is selected from dextrin, starch, soluble starch, sucrose, lactose, microcrystalline Cellulose; Correctives is selected from steviosin, Aspartane.
Most preferred, filler is selected from dextrin; Correctives is selected from steviosin.
One of according to the embodiment of the present invention, the extract of described step (2) and the ratio of adjuvant are 40:60～65:35(percentage by weight).
According to another embodiment of the present invention, the extract of described step (2) and the ratio of adjuvant are 55:45～65:35(percentage by weight).
The ratio of wherein said extract and adjuvant is that extract is amounted to into after dry extract and the ratio of adjuvant.
Pharmaceutical composition of the present invention can be made into any pharmaceutically acceptable oral formulations, includes but not limited to granule, tablet, capsule etc., preferred particulates agent.
Pharmaceutical composition of the present invention, the preparation method of preparation can be selected from any pharmaceutically acceptable method, such as spray-drying process method, fluidized-bed spray granulation method, wet granulation, dry-pressing granulation, rolling granulation etc.
Pharmaceutical composition of the present invention at preparation treatment headache, traumatic cranial nerve syndrome, stagger, application in the medicine of susceptible to lose temper due to restlessness, insomnia and dreamful sleep.
Pharmacological evaluation proves, pharmaceutical composition of the present invention can improve animal pia mater encephali microcirculation, increases cerebral blood flow, alleviating vascular spasm, pain relieving.Prove by pharmacodynamic experiment, with respect to the preparation technology of prior art, pharmaceutical composition of the present invention has quite or more excellent effect aspect treatment headache.
The aspect that the present invention is additional and advantage in the following description part provide, and part will become obviously from the following description, or recognize by practice of the present invention.
Experiment one, the improvement effect of blood-nourishing and brain-refreshing preparation to rat Nerve in Migraine Model due to nitroglycerin
One, experiment purpose
Observe the blood-nourishing and brain-refreshing formula extraction that under same dose, Different Extraction Method obtains and treat migrainous effectiveness and diversity.
Two, experiment material
1, laboratory animal: SD rat, male, body weight 180-200g, is provided by dimension tonneau China's zoopery center.Single cage is raised, natural lighting, well-ventilated, ad lib water.Animal feed: granule rat feed, by Jinan, greatly healthy feed corporation,Ltd produces, credit number: accurate word is raised in Shandong: No. 364; Experimental animal feeding environment meets " Tianjin management of laboratory animal standard ".
2, Experimental agents: tested medicine: medicine of the present invention (Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Rehmanniae Preparata etc., prepare and obtain according to embodiment 1), drugs compared (Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Rehmanniae Preparata etc., extract and make according to the method in Chinese patent 200510073290.3), Tasly Pharmaceutical Group Co., Ltd. provides; Positive drug: Qiyeshen an sheet (lot number: the accurate word Z45022054 of traditional Chinese medicines), Guangxi Beisheng Pharmaceutical Co., Ltd. produces (lot number: 20130123); Day dose, 20mg/ day.
3, experiment reagent: nitricoxide synthase (NOS) mensuration test kit, Coomassie brilliant blue protein determination kit, nitric oxide (NO) are measured test kit and all built up Science and Technology Ltd. (LOT:20120726) purchased from Nanjing; Rat 5-HT test kit is purchased from Jiang Lai bio tech ltd, Shanghai (LOT:12-05); 5-HIAA(5 hydroxyindoleacetic acid) enzyme-linked immunosorbent assay kit is purchased from Mei Lian bio tech ltd, Shanghai; Rat dopamine (DA) Elisa test kit is purchased from Shanghai Kai Bo biochemical reagents company limited; Normal saline, 10% chloral hydrate.
4, experimental apparatus: Shimadzu UV2100 ultraviolet spectrophotometer, FLUKO F6/10 high-shearing dispersion emulsifying machine, Hettich ROTANTA460R High speed refrigerated centrifuge, electronic balance, ultrasonic doppler blood flow survey meter.
Three, experimental technique
1 grouping and administration
Laboratory animal case body weight is divided into model control group, positive drug group, blank group, the high, medium and low dosage group of medicine of the present invention and the high, medium and low dosage group of drugs compared, every group of 10 animals at random.Positive drug group, medicine group of the present invention and the preventative successive administration 10d of drugs compared group.Medicine high dose group 1.562g extractum/kg of the present invention, middle dosage group 0.781g extractum/kg, low dose group 0.391g extractum/kg; Drugs compared high dose group 1.562g extractum/kg, middle dosage group 0.781g extractum/kg, low dose group 0.391g extractum/kg; Positive drug group 20mg/ day; Model control group and the isometric normal saline of blank group gavage.
Modelling is observed by 2 behavioristicss
Except blank group does not process, all the other each treated animals give rat skin lower injection nitroglycerin (10ml/kg), copy experimental migraine model, and gastric infusion is rubescent there are ears, and forelimb frequently increased frequency difficult to tackle is the successful index of modeling.(1) ear is red: the time of the red appearing and subsiding of ear after the modeling of observation rat; (2) difficult to tackle: from modeling, using every 30min as one observing time section, adopt the method for persistent period fragmentation count to observe after rat modeling at each time period number of times difficult to tackle.The time occurring difficult to tackle, occurs that take rat number of times continuously difficult to tackle reaches 5 times above as mark, and extinction time is less than 5 times and occurs asthenia, the tired mark that shows as with the number of times difficult to tackle of rat in the time period.
3 Biochemical Indexes
After the modeling according to the method described above of each treated animal, administration, within 4 hours after modeling, get blood, get brain, prepare serum and brain tissue homogenate frozen stand-by.Chemical colorimetry, operates according to test kit explanation, measures the content of serum NO level and the activity of NOS; Measure cerebral tissue 5-HT, 5-HIAA, NA and DA content.
4 statistical method:
Total data adopts SPSS20.0 software to analyze, and experimental result is all used
represent relatively t check between statistical test employing group.
Four, experimental result
1. ear is red
There is not the situation that ear is red in blank group, medicine group of the present invention, drugs compared group and model control group rat occur the red phenomenon of ear in approximately 3 minutes after modeling, and the red time of occurrence of ear is compared not statistically significant with model control group.After drug treatment, in medicine of the present invention, the red extinction time of low dose group rat ears has statistical significance (P < 0.05 compared with model control group, P < 0.01), and the each dosage of drugs compared does not all make significant difference, high, the middle dosage group of the present invention has significant difference (P < 0.05) compared with drugs compared same dose group.The results are shown in Table 1.
Table 1 medicine of the present invention and drugs compared for rat occur red time of ear and the red extinction time of ear impact (min,
)
With model control group ratio,
*p<0.05,
*p<0.01; With drugs compared ratio, #P<0.05
2. number of times difficult to tackle
Blank group only has within a few time period accidental 1 twice, and medicine group of the present invention, drugs compared group and model control group rat occur phenomenon difficult to tackle in approximately 3 minutes after modeling, compare not statistically significant with model control group.0～30min after drug treatment, 30～60min period indegree are more, the high, medium and low dosage group of medicine of the present invention rat number of times difficult to tackle has statistical significance (P < 0.05 compared with model control group, P < 0.01), and the each dosage of drugs compared does not all make significant difference, in the present invention, low dose group has significant difference (P < 0.05) compared with drugs compared same dose group.The results are shown in Table 2.
The impact on the number of times difficult to tackle of rat in day part of table 2 medicine of the present invention and drugs compared
With model control group ratio,
*p<0.05,
*p<0.01; With drugs compared ratio, #P<0.05
3. serum NO, NOS content
In the high, medium and low dosage group of medicine of the present invention rat blood serum, NO has statistical significance (P < 0.05 with NOS content compared with model control group, P < 0.01), and the each dosage of drugs compared does not all make significant difference, in the present invention, low dose group has significant difference (P < 0.05) compared with drugs compared same dose group.The results are shown in Table 3.
The impact on rat blood serum NO and NOS content of table 3 medicine of the present invention and drugs compared
With model control group ratio,
*p<0.05,
*p<0.01; With drugs compared ratio, #P<0.05
4.5-HT, 5-HIAA and DA content
The high, medium and low dosage group of medicine of the present invention rat 5-HT, 5-HIAA have statistical significance (P < 0.05 with DA content compared with model control group, P < 0.01), and the each dosage of drugs compared does not all make significant difference, for 5-HT and 5-HIAA, in the present invention, low dose group has significant difference (P < 0.05) compared with drugs compared same dose group; For DA, the middle and high dosage group of the present invention has significant difference (P < 0.05) compared with drugs compared same dose group.The results are shown in Table 4.
Table 4 medicine of the present invention and drugs compared are on rat 5-HT(ng/g), the impact of 5-HIAA and DA content
Five, conclusion
Medicine of the present invention can improve the Migraine Rats behavioristics index that nitroglycerin causes, improves the migrainous biochemical indicator level that nitroglycerin causes.The demonstration of this experimentation, medicine of the present invention can subtract and improve the Migraine Rats behavioristics index that nitroglycerin causes, and effect is better than drugs compared.
The specific embodiment
Describe embodiments of the invention below in detail, the embodiment describing by reference to accompanying drawing is exemplary, only for explaining the present invention, and can not be interpreted as limitation of the present invention.
Embodiment 1
Get Radix Angelicae Sinensis 253.5g, Rhizoma Chuanxiong 253.5g, Radix Paeoniae Alba 202.7g, Radix Rehmanniae Preparata 202.7g, Ramulus Uncariae Cum Uncis 506.8g, Caulis Spatholobi 506.8, Spica Prunellae 506.8g, Semen Cassiae 506.8g, Concha Margaritifera 506.8g, Rhizoma Corydalis 253.5g, Herba Asari 50.5g.
The preparation of extract: get above-mentioned medical material, add 5 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 65～70%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.320～1.325(79～81 ℃), to obtain final product.
Get dextrin 300g, melt by purified water, add steviosin 3.0g, fully stir and make to dissolve, by the above-mentioned extractum of getting ready altogether 600g substep add in above-mentioned slurry, stir.Adjust slurry proportion in 1.12～1.23(42～50 ℃) between.60 order～100 order on-line filtrations.
Remaining dextrin 250.0g is dropped into granulator, regulate the grain made parameters such as blower fan frequency, inlet temperature, transfusion frequency and atomizing pressure, make an interior material in good fluidized state.Spray granulation, pelletization control temperature of charge is between 30～60 ℃.Dry, make temperature of charge rise to 80～90 ℃ and be fully dried.
Granulate sieves, always mixed, granulation agent, aluminum-plastic composite membrane pillow pouch packing, 3 grams/bag of specifications.
Embodiment 2
Get Radix Angelicae Sinensis 338g, Rhizoma Chuanxiong 338g, Radix Paeoniae Alba 270.3g, Radix Rehmanniae Preparata 270.3g, Ramulus Uncariae Cum Uncis 675.7g, Caulis Spatholobi 675.7g, Spica Prunellae 675.7g, Semen Cassiae 675.7g, Concha Margaritifera 675.7g, Rhizoma Corydalis 338g, Herba Asari 67.3g.
The preparation of extract: get above-mentioned medical material, add 4 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 65～72%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.320～1.325(79～81 ℃), to obtain final product.
Recipe quantity sucrose is melted with appropriate extract and suitable quantity of water, opens heating and make slurry temperature remain on 55 ℃ ± 5 ℃, continue to stir 20 minutes, add water and regulate slurry proportion at 1.22～1.23(55 ℃), cross colloid mill, before spraying, online 60 orders filter.Setting spray dryer inlet temperature is 185 ℃ ± 5 ℃, and shower nozzle rotary speed is set as 45 ± 5Hz, and leaving air temp is controlled at 95 ℃ ± 5 ℃, and spraying is dry.
Granulate sieves, always mixed, granulation agent, aluminum-plastic composite membrane pillow pouch packing, 3 grams/bag of specifications.
Embodiment 3
Get Radix Angelicae Sinensis 150g, Rhizoma Chuanxiong 150g, Radix Paeoniae Alba 225g, Radix Rehmanniae Preparata 225g, Ramulus Uncariae Cum Uncis 551g, Caulis Spatholobi 551g, Spica Prunellae 551g, Semen Cassiae 551g, Concha Margaritifera 551g, Rhizoma Corydalis 225g, Herba Asari 19g.
The preparation of extract: get above-mentioned medical material, add 10 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 60～65%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.27～1.320(75～80 ℃), to obtain final product.
Get the adjuvant such as extract and microcrystalline Cellulose, aspartame mix homogeneously and add water, after mix homogeneously, become soft material, by oscillating granulator, be squeezed into granule, drier.
Granulate sieves, always mixed, granulation agent, aluminum-plastic composite membrane pillow pouch packing, 4 grams/bag of specifications.
Embodiment 4
Get Radix Angelicae Sinensis 250g, Rhizoma Chuanxiong 250g, Radix Paeoniae Alba 250g, Radix Rehmanniae Preparata 250g, Ramulus Uncariae Cum Uncis 740g, Caulis Spatholobi 740g, Spica Prunellae 740g, Semen Cassiae 740g, Concha Margaritifera 740g, Rhizoma Corydalis 250g, Herba Asari 50g.
The preparation of extract: get above-mentioned medical material, add 8 times of water gagings to decoct 2 times, 3 hours for the first time, 2 hours for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 80～85%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.30～1.350(80～85 ℃), to obtain final product.
Get the adjuvant mix homogeneously such as said extracted thing and starch, steviosin, be compressed into large lamellar or tabular after, be ground into required size particles.
Granulate sieves, always mixed, granulation agent, aluminum-plastic composite membrane pillow pouch packing, 3 grams/bag of specifications.
Embodiment 5
Get Radix Angelicae Sinensis 338g, Rhizoma Chuanxiong 338g, Radix Paeoniae Alba 75g, Radix Rehmanniae Preparata 75g, Ramulus Uncariae Cum Uncis 510g, Caulis Spatholobi 510g, Spica Prunellae 510g, Semen Cassiae 510g, Concha Margaritifera 510g, Rhizoma Corydalis 337g, Herba Asari 37g.
The preparation of extract: get above-mentioned medical material, add 10 times of water gagings to decoct 2 times, 2 hours for the first time, 2 hours for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 63～70%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.290～1.330(78～83 ℃), to obtain final product.
Extract fine powder and lactose, steviosin are mixed, put in coating pan and rotate, in rolling, wetting agent ethanol is to vaporific and sprays into, make wet adhesive granulating, continue rolling to particle drying.
Granulate sieves, always mixed, granulation agent, aluminum-plastic composite membrane pillow pouch packing, 3 grams/bag of specifications.
Embodiment 6
Get Radix Angelicae Sinensis 300g, Rhizoma Chuanxiong 300g, Radix Paeoniae Alba 400g, Radix Rehmanniae Preparata 400g, Ramulus Uncariae Cum Uncis 650g, Caulis Spatholobi 650g, Spica Prunellae 650g, Semen Cassiae 650g, Concha Margaritifera 650g, Rhizoma Corydalis 300g, Herba Asari 50g.
The preparation of extract: get above-mentioned medical material, add 7 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 70～75%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.310～1.330(77～82 ℃), to obtain final product.
Get dextrin 84g, melt by purified water, add steviosin 3g, fully stir and make to dissolve, by the above-mentioned extractum of getting ready altogether 780g substep add in above-mentioned slurry, stir.Adjust slurry proportion in 1.12～1.23(42～50 ℃) between.60 order～100 order on-line filtrations.
Remaining dextrin 336g is dropped into granulator, regulate the grain made parameters such as blower fan frequency, inlet temperature, transfusion frequency and atomizing pressure, make an interior material in good fluidized state.Spray granulation, pelletization control temperature of charge is between 30～60 ℃.Dry, make temperature of charge rise to 70～90 ℃ and be fully dried.
Granulate sieves, always mixed, granulation agent, aluminum-plastic composite membrane pillow pouch packing, 3 grams/bag of specifications.
Claims (10)
1. treat the pharmaceutical composition of headache for one kind, contain 4～9 parts of 10～15 parts of 10～15 parts of 10～15 parts of 10～15 parts of 10～15 parts of 2～8 parts of 2～8 parts of 4～9 parts of 4～9 parts of Radix Angelicae Sinensis, Rhizoma Chuanxiongs, the Radix Paeoniae Albas, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobis, Spica Prunellaes, Semen Cassiaes, Concha Margaritiferas, Rhizoma Corydalis, 0.5～2 part of Herba Asari by weight, it is characterized in that, described pharmaceutical composition is prepared by the following method:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, decoct with water, filter, concentrated, add ethanol, leave standstill, filter, reclaim ethanol, concentrated, to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
2. pharmaceutical composition as claimed in claim 1, is characterized in that, described pharmaceutical composition is prepared by the following method:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, add 4～10 times of water gagings to decoct 2～3 times, 0.5～3 hour for the first time, second and third time 1～3 hour, filter, be concentrated into relative density 1.06～1.10(75～85 ℃), add ethanol make containing alcohol amount be 60～85%, leave standstill 12～24 hours, filter, reclaim ethanol, be concentrated into relative density 1.270～1.350(75～85 ℃), to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
3. pharmaceutical composition as claimed in claim 2, is characterized in that, described pharmaceutical composition is prepared by the following method:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, add 5 times of water gagings to decoct 2 times, 2 hours for the first time, 1 hour for the second time, filter, be concentrated into relative density 1.06～1.10(80 ℃), add ethanol and make to be 65～70%, to leave standstill 12～24 hours containing alcohol amount, filter, reclaim ethanol, be concentrated into relative density 1.320～1.325(79～81 ℃), to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
4. the pharmaceutical composition as described in as arbitrary in claim 1～3, is characterized in that, the described adjuvant of step (2) comprises one or more filleies and correctives.
5. pharmaceutical composition as claimed in claim 4, is characterized in that, described filler is selected from dextrin, starch, soluble starch, sucrose, lactose, microcrystalline Cellulose, and described correctives is selected from steviosin, aspartame.
6. pharmaceutical composition as claimed in claim 5, is characterized in that, filler is dextrin, and correctives is steviosin.
7. pharmaceutical composition as claimed in claim 1, is characterized in that, the extract of described step (2) and the ratio of adjuvant are 40:60～65:35(percentage by weight).
8. pharmaceutical composition as claimed in claim 1, is characterized in that, the extract of described step (2) and the ratio of adjuvant are 55:45～65:35(percentage by weight).
9. the preparation method of pharmaceutical composition as claimed in claim 1, is characterized in that, comprises the following steps:
(1) preparation of extract: get in proportion Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Ramulus Uncariae Cum Uncis, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Rhizoma Corydalis, Herba Asari, decoct with water, filter, concentrated, add ethanol, leave standstill, filter, reclaim ethanol, concentrated, to obtain final product;
(2) preparation of preparation: get the extract of described step (1), add appropriate amount of auxiliary materials, dry, granulate, to obtain final product.
As described in claim 1-8 any one pharmaceutical composition at preparation treatment headache, traumatic cranial nerve syndrome, stagger, application in the medicine of susceptible to lose temper due to restlessness, insomnia and dreamful sleep.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310733337.9A CN103877245A (en) | 2012-12-21 | 2013-12-19 | Pharmaceutical composition for treating headache |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210568260 | 2012-12-21 | ||
| CN201210568260.X | 2012-12-21 | ||
| CN201310733337.9A CN103877245A (en) | 2012-12-21 | 2013-12-19 | Pharmaceutical composition for treating headache |
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| Application Number | Title | Priority Date | Filing Date |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1552416A (en) * | 2003-06-03 | 2004-12-08 | 天津天士力制药股份有限公司 | Medicine composition application for preparing hypertension medicine |
| CN101194945A (en) * | 2006-12-08 | 2008-06-11 | 天津天士力制药股份有限公司 | Tablet for treating headache and method for preparing the same |
-
2013
- 2013-12-19 CN CN201310733337.9A patent/CN103877245A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1552416A (en) * | 2003-06-03 | 2004-12-08 | 天津天士力制药股份有限公司 | Medicine composition application for preparing hypertension medicine |
| CN101194945A (en) * | 2006-12-08 | 2008-06-11 | 天津天士力制药股份有限公司 | Tablet for treating headache and method for preparing the same |
Non-Patent Citations (1)
| Title |
|---|
| 吴清: "《230中中药颗粒剂和胶囊剂制备关键技术》", 31 January 2009, 化学工业出版社 * |
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Address after: 300410 Tianjin city Beichen District Huaihe road and road intersection Dingjiang tianzhijiao Park forensic Center for Intellectual Property Department Applicant after: Tasly Pharmaceutical Group Limited by Share Ltd Address before: 300410 Tianjin city Beichen District Huaihe road and road intersection Dingjiang tianzhijiao Park forensic Center for Intellectual Property Department Applicant before: Tasly Pharmaceutical Group Co., Ltd. |
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