Summary of the invention
The purpose of this invention is to provide a kind of sublingual tablet of treating headache and preparation method thereof.
Medicine of the present invention is formed and is comprised: 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; Appropriate amount of auxiliary materials is formed.
Medicine preferred of the present invention is formed and is comprised: 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; Appropriate amount of auxiliary materials is formed.
Best medicine of the present invention is formed and is comprised: 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; Appropriate amount of auxiliary materials is formed.
The used adjuvant of medicine of the present invention comprises: filler, disintegrating agent, binding agent, lubricant; Filler is one or more in xylitol, sorbitol, the mannitol; Said disintegrating agent is a carboxymethyl starch sodium; Described binding agent is a polyvinylpyrrolidone (PVP), starch slurry is a kind of or combination; Described lubricant is a kind of or combination in magnesium stearate, the silicon dioxide.
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 can these crude drug be ground into powder mixes evenly processes powder and takes after mixing it with water; Also can be with these medicines decocting together, the condensed water decocting liquid is processed 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, process said dosage form on any pharmaceutics; Like 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, soft capsule; But preferably adopt following method to extract crude drug; And be prepared into sublingual lozenge, but this is not construed as limiting the invention.
The present invention treats the method for preparing of the sublingual lozenge of headache, comprises the steps:
(a): the preparation of extract: it is subsequent use 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-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis 2~4 times add Ramulus Uncariae Cum Uncis, collecting decoction when decocting the last time; Concentrating under reduced pressure adds the ethanol precipitate with ethanol, leaves standstill; Filter, filtrating merges decompression recycling ethanol and concentrated filtrate with above-mentioned backflow; Be dried to dry extract, it is subsequent use to be ground into fine powder;
(b): get above-mentioned medicated powder and mix, granulate, process Hypoglossis buccal tablets according to conventional method with adjuvant.
Preferred the present invention treats the method for preparing of the sublingual lozenge of headache, comprises the steps:
(a): the preparation of extract: it is subsequent use to get 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; More than ten simply, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 60~80% ethanol, reflux 1~3 hour, backflow device in addition stores; Medicinal residues and the Six-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis 2~4 times each 0.5~2 hour, add Ramulus Uncariae Cum Uncis when decocting the last time; Collecting decoction, being evaporated to relative density is 1.05~1.15 (45~60 ℃), adds ethanol and makes and contain alcohol amount and reach 60~70%; Left standstill 18~30 hours, and filtered, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and to be concentrated into relative density be 1.05~1.25 (45~60 ℃) is dried to dry extract, and it is subsequent use to be ground into fine powder;
(b): get above-mentioned medicated powder and mix, granulate, process Hypoglossis buccal tablets according to conventional method with adjuvant.
Best the present invention treats the method for preparing of the sublingual lozenge of headache, comprises the steps:
(a): the preparation of extract: it is subsequent use 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 flavors, Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 70% ethanol, reflux 2 hours, backflow in addition device stores; Medicinal residues and the Six-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis three times each 1 hour, add Ramulus Uncariae Cum Uncis when decocting for the third time; Collecting decoction, being evaporated to relative density is 1.09~1.13 (55 ℃), adds ethanol and makes and contain alcohol amount and reach 65%; Left standstill 24 hours, and filtered, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and to be concentrated into relative density be 1.10~1.20 (55 ℃) is dried to dry extract, and it is subsequent use to be ground into fine powder;
(b): get above-mentioned medicated powder and mix, granulate, process Hypoglossis buccal tablets according to conventional method with adjuvant.
Medicine of the present invention is formed when producing and can increased or reduce according to corresponding ratio; Like 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 individually or simultaneously by suitable Chinese medicine replacement with the identical property of medicine, effect, replacement back Chinese medicine preparation and drug effect thereof are constant.
Medicine of the present invention can be confirmed 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 NF dosage, was no more than the pharmacopeia ormal weight.
The tablet convenient drug administration that the present invention is prepared is suitable for old patient and takes.Medicine of the present invention confirms to have the medicine of treatment headache through a large amount of tests.
Get according to embodiment 5 and obtain medicine of the present invention, through the outpatient service clinical trial: use 300 examples, wherein male's 100 examples. women's 200 examples; Age 14-70 year; The course of disease 2 months~30 years is headache or migraine, all case impassivity system exception sign; Wherein the part patient all once obeyed cafergot, its clinical observation result of medicines such as gastrodine, somedon:
Clinical practice proves that medicine of the present invention has the effect of good curing headache, and its total effective rate is 90.2%.
The specific embodiment
Embodiment 1:
It is subsequent use to get Radix Angelicae Sinensis 40g, Rhizoma Chuanxiong 40g, Radix Paeoniae Alba 20g, Radix Rehmanniae Preparata 20g, Ramulus Uncariae Cum Uncis 100g, Caulis Spatholobi 100g, Spica Prunellae 100g, Semen Cassiae 100g, Concha Margaritifera 100g, Rhizoma Corydalis 40g, Herba Asari 5g; 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-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis 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, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and concentrated filtrate are dried to dry extract, are ground into fine powder;
Get above-mentioned fine powder 100g and add carboxymethyl acid sodium 4.5g, PVP30g, xylitol 215g, magnesium stearate 5g, mix homogeneously sieves, and processes every 100mg by the conventional method tabletting, promptly gets.
Embodiment 2:
It is subsequent use to get Radix Angelicae Sinensis 7g, Rhizoma Chuanxiong 5g, Radix Paeoniae Alba 6g, Radix Rehmanniae Preparata 4g, Ramulus Uncariae Cum Uncis 14g, Caulis Spatholobi 12g, Spica Prunellae 14g, Semen Cassiae 12g, Concha Margaritifera 14g, Rhizoma Corydalis 5g, Herba Asari 1g; 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-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis three times each 1 hour, add Ramulus Uncariae Cum Uncis when decocting for the third time; Collecting decoction, being evaporated to 55 ℃, relative density is 1.09~1.13, adds ethanol and makes and contain the alcohol amount and reach 65%; Left standstill 24 hours, and filtered, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and to be concentrated into 55 ℃, relative density be 1.10~1.20 is dried to dry extract, is ground into fine powder;
Get above-mentioned fine powder 10g and add carboxymethyl acid sodium 2.2g, starch slurry 6g, mannitol 25g, silicon dioxide 0.8g, mix homogeneously sieves, and processes every 100mg by the conventional method tabletting, promptly gets.
Embodiment 3:
It is subsequent use to 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; 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-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis three times each 1 hour, add Ramulus Uncariae Cum Uncis when decocting for the third time; Collecting decoction, being evaporated to relative density is 1.09~1.13 (55 ℃), adds ethanol and makes and contain alcohol amount and reach 65%; Left standstill 24 hours, and filtered, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and to be concentrated into relative density be 1.10~1.20 (55 ℃) is dried to dry extract, is ground into fine powder;
Get above-mentioned fine powder 8g and add carboxymethyl acid sodium 3.2g, starch slurry 8g, xylitol 15g, sorbitol 5g, magnesium stearate (0.5g), mix homogeneously sieves, and processes every 100mg by the conventional method tabletting, promptly gets.
Embodiment 4:
It is subsequent use to 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; 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-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis three times each 1 hour, add Ramulus Uncariae Cum Uncis when decocting for the third time; Collecting decoction, being evaporated to relative density is 1.09~1.13 (55 ℃), adds ethanol and makes and contain alcohol amount and reach 65%; Left standstill 24 hours, and filtered, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and to be concentrated into relative density be 1.10~1.20 (55 ℃) is dried to dry extract, is ground into fine powder;
Get above-mentioned fine powder 250g and add carboxymethyl acid sodium 55g, polyvinylpyrrolidone 45g, xylitol 450g, mannitol 150g, silica 1 5g, mix homogeneously sieves, and processes every 100mg by the conventional method tabletting, promptly gets.
Embodiment 5:
Get Radix Angelicae Sinensis 338g, Rhizoma Chuanxiong 338g, Radix Paeoniae Alba 170.3g, 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 in proportion; 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 store; Medicinal residues and the Six-element decocte with water such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis three times each 1 hour, add Ramulus Uncariae Cum Uncis when decocting for the third time; Collecting decoction, being evaporated to 55 ℃, relative density is 1.09~1.13, adds ethanol and makes and contain the alcohol amount and reach 65%; Left standstill 24 hours, and filtered, filtrating merges with above-mentioned backflow; Decompression recycling ethanol and to be concentrated into 55 ℃, relative density be 1.10~1.20, spray drying is pulverized and is obtained medicated powder;
Get above-mentioned fine powder 100g and add carboxymethyl acid sodium 55g, polyvinylpyrrolidone 55g, xylitol 200g, mannitol 350g, silicon dioxide 8g, mix homogeneously sieves, and processes every 100mg by the conventional method tabletting, promptly gets.