CN1739612A - Wind dispelling and pain relieving Chinese medicine prepn and its prepn process and quality control method - Google Patents

Wind dispelling and pain relieving Chinese medicine prepn and its prepn process and quality control method Download PDF

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CN1739612A
CN1739612A CN 200510032127 CN200510032127A CN1739612A CN 1739612 A CN1739612 A CN 1739612A CN 200510032127 CN200510032127 CN 200510032127 CN 200510032127 A CN200510032127 A CN 200510032127A CN 1739612 A CN1739612 A CN 1739612A
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王衡新
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Abstract

The wind dispelling and pain relieving Chinese medicine preparation is prepared with Chuanxiong rhizome, dahurian angelica root, notopterygium, asarum herb, ledebouriella root and other three kinds of Chinese medicinal materials, and may be prepared into dripping pill, micro pill, soft capsule or capsule. The preparation process includes decocting six of the Chinese medicinal materials, filtering, extracting volatile oil and water solution from two of the Chinese medicinal materials, filtering, merging, concentrating to obtain ropy paste, drying mixing, adding supplementary material, spraying the volatile oil and other steps to prepare dripping pill, micro pill, soft capsule or capsule. The quality control method includes identification and content measurement. The preparation has less irritation to gastrointestinal tract, stable product quality, high curative effect, etc.

Description

Chinese medicine preparation of dispelling wind and relieving and preparation method thereof and method of quality control
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and method of quality control, relate in particular to a kind of Chinese medicine preparation and preparation method thereof and method of quality control of dispelling wind and relieving.
Background technology:
By the patent retrieval of Chuan Xiong Tea, Chinese patent discloses CN1363335 nano medicine ' Chuan Xiong Tea ' and preparation method thereof, does not see other relevant patent and bibliographical informations.Drop pill in the Chinese medicine preparation or micropill or pellet capsule or capsule or soft capsule, change dosage form and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.The existing dosage form of this product is granule, sheet, ball etc., has all listed the national drug standards in.
The existing particulate technology features of Chuan Xiong Tea is to get Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Radix Glycyrrhizae to decoct with water, and decocting liquid filters; Its aqueous solution filtered after Herba Menthae, Herba Schizonepetae were extracted volatile oil, and filtrate and above-mentioned medicinal liquid merge, and was concentrated into, and clear paste is granulated, and drying sprays into Herba Menthae, Herba Schizonepetae volatile oil, mixing, promptly.
Existing Chuan Xiong Tea granule exists and carries, stores, takes inconvenience, needs boiled water shortcoming such as take after mixing it with water.
The technology features of existing Chuan Xiong Tea sheet is that the Radix Angelicae Dahuricae and Radix Glycyrrhizae powder are broken into fine powder, sieves, and gets the part fine powder, and standby, residual powder is deposited in addition; Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Herba Menthae, Herba Schizonepetae are extracted volatile oil, and the aqueous solution behind distillation device is in addition collected; Medicinal residues and residual powder decoct with water filtration, merging filtrate, and the aqueous solution behind the adding distillation is condensed into thick paste, adds standby Radix Angelicae Dahuricae Radix Glycyrrhizae fine powder, is ground into fine powder, sieves, and granulates, and drying adds volatile oil such as Rhizoma Chuanxiong, mixing, compacting is in blocks, promptly.
Existing Chuan Xiong Tea sheet has bioavailability low, child and old people shortcoming such as be difficult for swallowing.
The technology features of existing Chuan Xiong Tea ball is to get eight flavor medical materials, is ground into fine powder, sieves, and mixing is used water pill, cold drying, promptly.
Existing Chuan Xiong Tea ball has bioavailability low, and the medicine produce effects is slow, shortcoming such as is difficult for taking.
Summary of the invention:
The Chinese medicine preparation and preparation method thereof and the method for quality control that the purpose of this invention is to provide a kind of dispelling wind and relieving overcome the above-mentioned drawback of prior art, improve quality, curative effect, the bioavailability of product, satisfy the needs of medical treatment better.
The objective of the invention is to be achieved through the following technical solutions.
A kind of Chinese medicine preparation of dispelling wind and relieving, it is that main constituent is Expellin extract pill or micropill or pellet capsule or capsule or the soft capsule of Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Herba Menthae, Herba Schizonepetae, Radix Glycyrrhizae.
Its preparation method is:
(1) medicine constituent and percentage by weight thereof are as follows:
Rhizoma Chuanxiong, Herba Schizonepetae each 12~20%, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Radix Glycyrrhizae each 5~12%, Herba Asari 2~6%, Radix Saposhnikoviae 3~8%, Herba Menthae 25~35%;
Medicine constituent optimum weight percentage ratio is:
Rhizoma Chuanxiong, Herba Schizonepetae each 16.33%, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Radix Glycyrrhizae each 8.16%, Herba Asari 4.08%, Radix Saposhnikoviae 6.12%, Herba Menthae 32.66%.
(2) Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Radix Glycyrrhizae decoct with water 1~3 time, and each 1~3 hour, collecting decoction filtered, and medicinal liquid is standby;
(3) Herba Menthae, Herba Schizonepetae are extracted volatile oil, and be standby; Its aqueous solution filters, and filtrate merges with (2) gained medicinal liquid, is concentrated into thick paste, and drying is pulverized, and gets fine drug powder, and is standby;
(4) get (3) gained fine drug powder, spray into (3) gained Herba Menthae, Herba Schizonepetae volatile oil, mixing gets hybrid medicine, and is standby;
(5) with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, be heated to the hybrid medicine that adds (4) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70~100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill;
Its coating material is one or more combinations or other suitable material of following material, uses with by arbitrary proportion: Lac, cellulose acetate-phthalate (CAP), acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose (HPMC), ethyl cellulose (EC), cellulose acetate, cellulose propionate, cellulose-acetate propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, acetic acid succinic acid hydroxypropyl emthylcellulose aqueous dispersion.
(6) get the fine drug powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and sprays into the volatile oil of (3) gained, and coating or coating are not made the micropill of diameter less than 2.5mm, maybe with the micropill that makes, incapsulate, and promptly get pellet capsule;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
(7) get the fine drug powder of (3) gained, add an amount of adjuvant, mix homogeneously; Granulate, dry, as to spray into (3) gained volatile oil divides pack into Capsules or enteric hollow capsule, promptly gets capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: starch, carboxymethyl starch sodium, pregelatinized Starch, sucrose, glucose, mannitol, sorbitol, syrup, microcrystalline Cellulose, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, light magnesium oxide, Pulvis Talci, micropowder silica gel, aluminium hydroxide, boric acid, sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
(8) its preparation of soft capsule method is: get the fine drug powder of (3) gained, add suitable adjuvant, and mix homogeneously, the volatile oil of adding (3) gained is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
A kind of method of quality control of Chinese medicine preparation of dispelling wind and relieving is:
Differentiate, get this medicine 5~15g, porphyrize, 20~the 80ml that adds diethyl ether, reflux 0.5~2 hour filters, filtrate evaporate to dryness, residue add ethyl acetate 1~5ml makes dissolving, as need testing solution, other gets Rhizoma Chuanxiong control medicinal material 2-6g, decocts with water secondary, each 20~40 minutes, get decoction liquor, secondary is extracted in the jolting that adds diethyl ether, each 10-30ml, merge ether solution, volatilize, shine medical material solution in pairs, according to the thin layer chromatography test with legal system, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-petroleum ether (60~90 ℃) (8~9.5: 0.5~2) be developing solvent, launch, take out, dry, put ultra-violet lamp and (inspect under 300~400nm), in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Get glacial acetic acid-methanol-water (0.5~5: 30~50: 50~70) be mobile phase; Detect wavelength 295~355nm; Theoretical cam curve is calculated by the ferulic acid peak should be no less than 2000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 0.03-0.10mg, in contrast product solution;
This medicine 1~10g is got in the preparation of need testing solution, and accurate the title decides, and the accurate methanol 50~100ml that adds claims to decide weight, supersound process 20~40 minutes is put and is chilled to room temperature, claims to decide weight again, supplies the weight that subtracts mistake with methanol, shake up, leave standstill, filter, get subsequent filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 5~10ul of need testing solution of drawing injects chromatograph of liquid, measures.
Specific embodiments:
The present invention further specifies in conjunction with specific embodiments, can be for reference, do not limit the scope of the invention:
A kind of Chinese medicine preparation of dispelling wind and relieving, it is that main constituent is Expellin extract pill or micropill or pellet capsule or capsule or the soft capsule of Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Herba Menthae, Herba Schizonepetae, Radix Glycyrrhizae.
The Chinese medicine preparation of a kind of dispelling wind and relieving of the present invention mainly can dispelling wind and relieving.Be used for the headache due to the diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, or aversion to cold is arranged, heating, nasal obstruction.
The preparation method of Chinese medicine preparation of the present invention is:
(1) medicine constituent and weight consumption are as follows:
Rhizoma Chuanxiong, each 120g of Herba Schizonepetae, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, each 60g of Radix Glycyrrhizae, Herba Asari 30g, Radix Saposhnikoviae 45g, Herba Menthae 240g;
(2) Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Radix Glycyrrhizae decoct with water 2 times, and each 1.5 hours, collecting decoction filtered, and medicinal liquid is standby;
(3) Herba Menthae, Herba Schizonepetae are extracted volatile oil, and be standby; Its aqueous solution filters, and filtrate merges with (2) gained medicinal liquid, is concentrated into thick paste, and drying is pulverized, and gets fine drug powder, and is standby;
(4) get (3) gained fine drug powder, spray into (3) gained Herba Menthae, Herba Schizonepetae volatile oil, mixing gets hybrid medicine, and is standby;
(5) a kind of Chinese medicine preparation drop pill of dispelling wind and relieving is an Expellin extract pill, its preparation method is a hybrid medicine of getting (4) gained, Polyethylene Glycol PEG6000 52g, stearic acid 18g, Poloxamer188 10g, treat to add above-mentioned hybrid medicine after Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying promptly gets drop pill.
(6) a kind of Chinese medicine preparation drop pill of dispelling wind and relieving is the Chuan Xiong Tea enteric coated drop pill, its preparation method is a hybrid medicine of getting (4) gained, Polyethylene Glycol PEG6000 52g, stearic acid 18g, Poloxamer188 10g, treat Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds above-mentioned hybrid medicine after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, acrylic resin is used in cold drying, phthalic acid diethyl ester, the mixed liquor coating that the Semen Ricini wet goods is made makes enteric coated drop pill.
(7) a kind of Chinese medicine preparation micropill of dispelling wind and relieving is the Chuan Xiong Tea micropill, its preparation method is a fine drug powder of getting (3) gained, with 53g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 60 purpose granules and make parent nucleus, is binding agent with 5%PVP alcohol liquid again, sprays into the volatile oil of (3) gained, add the mixed powder amplification and make 40 purpose micropills, promptly make micropill.
(8) a kind of Chinese medicine preparation pellet capsule of dispelling wind and relieving is the Chuan Xiong Tea pellet capsule, its preparation method is a fine drug powder of getting (3) gained, with 53g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 60 purpose granules and makes parent nucleus, and be binding agent with 5%PVP alcohol liquid again, spray into the volatile oil of (3) gained, add the mixed powder amplification and make 40 purpose micropills, the micropill that makes is incapsulated, promptly get pellet capsule.
(9) a kind of Chinese medicine preparation capsule of dispelling wind and relieving is the Chuan Xiong Tea enteric coated capsule, and its preparation method is to get (3) gained fine drug powder, adds micropowder silica gel, starch is an amount of, behind granulation, drying, the granulate, spray into (3) gained volatile oil again, the enteric hollow capsule of packing into promptly gets enteric coated capsule.
(10) a kind of Chinese medicine preparation soft capsule of dispelling wind and relieving is a Chuan Xiong Tea soft capsule, its preparation method is a fine drug powder of getting (3) gained, behind water dissolution, the adding adjuvant is the combination of one or more different proportions in PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, the tween, spray into the volatile oil of (3) gained, suppress or drip and make soft capsule.
A kind of method of quality control of Chinese medicine preparation of dispelling wind and relieving is:
Differentiate, get this medicine 10g, porphyrize, the 50ml that adds diethyl ether, reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Rhizoma Chuanxiong control medicinal material 4g, decocts with water secondary, and each 30 minutes, get decoction liquor, secondary is extracted in the jolting that adds diethyl ether, and each 20ml merges ether solution, volatilizes, and shines medical material solution in pairs with legal system.According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with chloroform-petroleum ether (60~90 ℃) (9: 1), launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Get glacial acetic acid-methanol-water (1: 40: 59) and be mobile phase; Detect wavelength 312nm; Theoretical cam curve is calculated by the ferulic acid peak should be no less than 2000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 0.04mg, in contrast product solution;
This medicine 5g is got in the preparation of need testing solution, and accurate the title decides, and the accurate methanol 50~100ml that adds claims to decide weight, supersound process 20-40 minute, put and be chilled to room temperature, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, leave standstill, filter, get subsequent filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures.
You point of the present invention is:
Take, easy to carry, gastrointestinal irritation is little, constant product quality, You is beneficial to the raising drug effect.

Claims (5)

1, a kind of Chinese medicine preparation of dispelling wind and relieving is characterized in that it is that main constituent is Expellin extract pill or micropill or pellet capsule or capsule or the soft capsule of Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Herba Menthae, Herba Schizonepetae, Radix Glycyrrhizae.
2, a kind of preparation method of Chinese medicine preparation of dispelling wind and relieving, it is Expellin extract pill or micropill or pellet capsule or capsule or preparation of soft capsule method, it is characterized in that:
(1) medicine constituent and percentage by weight thereof are as follows:
Rhizoma Chuanxiong, Herba Schizonepetae each 12~20%, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Radix Glycyrrhizae each 5~12%, Herba Asari 2~6%, Radix Saposhnikoviae 3~8%, Herba Menthae 25~35%;
(2) get Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Herba Asari, Radix Saposhnikoviae, Radix Glycyrrhizae and decoct with water 1~3 time, each 1~3 hour, collecting decoction filtered, and medicinal liquid is standby;
(3) Herba Menthae, Herba Schizonepetae are extracted volatile oil, and be standby; Its aqueous solution filters, and filtrate merges with (2) gained medicinal liquid, is concentrated into thick paste, and drying is pulverized, and gets fine drug powder, and is standby;
(4) get (3) gained fine drug powder, spray into (3) gained Herba Menthae, Herba Schizonepetae volatile oil, mixing gets hybrid medicine, and is standby;
(5) get the hybrid medicine of (4) gained, add suitable adjuvant after, make drop pill or micropill or pellet capsule or capsule or soft capsule;
The preparation method of its drop pill is: with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, be heated to the hybrid medicine that adds (4) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70~100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill;
The preparation method of its micropill or pellet capsule is: get the fine drug powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, spray into the volatile oil of (3) gained, coating or coating are not made the micropill of diameter less than 2.5mm, maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its capsular preparation method is: get (3) prepared fine drug powder, add an amount of adjuvant, mix homogeneously; Granulate, dry, as to spray into (3) gained volatile oil divides pack into Capsules or enteric hollow capsule, promptly gets capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: starch, carboxymethyl starch sodium, pregelatinized Starch, sucrose, glucose, mannitol, sorbitol, syrup, microcrystalline Cellulose, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, light magnesium oxide, Pulvis Talci, micropowder silica gel, aluminium hydroxide, boric acid, sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
Its preparation of soft capsule method is: get the fine drug powder of (3) gained, add suitable adjuvant, mix homogeneously sprays into the volatile oil of (3) gained, compacting or drip and make soft capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
3, the preparation method of the Chinese medicine preparation of a kind of dispelling wind and relieving according to claim 2, it is characterized in that its coating material is one or more combinations or other suitable material of following material, uses with by arbitrary proportion: Lac, cellulose acetate-phthalate (CAP), acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose (HPMC), ethyl cellulose (EC), cellulose acetate, cellulose propionate, cellulose-acetate propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, acetic acid succinic acid hydroxypropyl emthylcellulose aqueous dispersion.
4, a kind of method of quality control of Chinese medicine preparation of dispelling wind and relieving, it is the method for quality control of Expellin extract pill or micropill or pellet capsule or capsule or soft capsule, it is characterized in that:
Differentiate, get this medicine 5~15g, porphyrize, 20~the 80ml that adds diethyl ether, reflux 0.5~2 hour filters, filtrate evaporate to dryness, residue add ethyl acetate 1~5ml makes dissolving, as need testing solution, other gets Rhizoma Chuanxiong control medicinal material 2~6g, decocts with water secondary, each 20~40 minutes, get decoction liquor, secondary, each 10~30ml are extracted in the jolting that adds diethyl ether, merge ether solution, volatilize, shine medical material solution in pairs, according to the thin layer chromatography test with legal system, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-petroleum ether (60~90 ℃) (8~9.5: 0.5~2) be developing solvent, launch, take out, dry, put ultra-violet lamp and (inspect under 300~400nm), in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Get glacial acetic acid-methanol-water (0.5~5: 30~50: 50~70) be mobile phase; Detect wavelength 295~355nm; Theoretical cam curve is calculated by the ferulic acid peak should be no less than 2000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 0.03~0.10mg, in contrast product solution;
This medicine 1~10g is got in the preparation of need testing solution, and accurate the title decides, and the accurate methanol 50~100ml that adds claims to decide weight, supersound process 20~40 minutes is put and is chilled to room temperature, claims to decide weight again, supplies the weight that subtracts mistake with methanol, shake up, leave standstill, filter, get subsequent filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 5~10ul of need testing solution of drawing injects chromatograph of liquid, measures.
5, the preparation method of the Chinese medicine preparation of a kind of dispelling wind and relieving according to claim 2 is characterized in that the optimum weight percentage ratio of its main constituent is:
Rhizoma Chuanxiong, Herba Schizonepetae each 16.33%, the Radix Angelicae Dahuricae, Rhizoma Et Radix Notopterygii, Radix Glycyrrhizae each 8.16%, Herba Asari 4.08%, Radix Saposhnikoviae 6.12%, Herba Menthae 32.66%.
CN 200510032127 2005-09-08 2005-09-08 Wind dispelling and pain relieving Chinese medicine prepn and its prepn process and quality control method Pending CN1739612A (en)

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CN103446236A (en) * 2012-06-05 2013-12-18 北京亚东生物制药有限公司 Dispersible tablet of traditional Chinese medicine composition
CN103655797A (en) * 2013-11-28 2014-03-26 李红冉 Chinese traditional medicine formula for treatment of headache
CN103784505A (en) * 2014-02-24 2014-05-14 福州华凯医药科技有限公司 Ligusticum wallichii tea prepartion
CN103800438A (en) * 2014-02-24 2014-05-21 福州华凯医药科技有限公司 Ligusticum wallichii tea modulator and preparation method thereof
CN103816223A (en) * 2014-02-24 2014-05-28 贵州威门药业股份有限公司 Sugar-free Ligusticum wallichii tea-mixed granules
CN112494540A (en) * 2020-12-26 2021-03-16 贵州健兴药业有限公司 Preparation method of improved ligusticum wallichii tea-blending pharmaceutical composition
CN113237989A (en) * 2021-05-07 2021-08-10 上海凯宝药业股份有限公司 Quality control method of ligusticum wallichii in capsule for dispelling wind and relieving pain
CN113476489A (en) * 2020-12-31 2021-10-08 成都中医药大学 Ligusticum wallichii volatile oil plaster for treating dysmenorrhea as well as preparation method and application thereof
CN113552276A (en) * 2021-07-06 2021-10-26 贵州健兴药业有限公司 Detection method of ligusticum wallichii and tea blending dropping pill

Cited By (13)

* Cited by examiner, † Cited by third party
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CN102590423A (en) * 2012-02-27 2012-07-18 贵州威门药业股份有限公司 Fingerprint spectrum determination method of ligusticum wallichii tea-blending granular preparation
CN103446236A (en) * 2012-06-05 2013-12-18 北京亚东生物制药有限公司 Dispersible tablet of traditional Chinese medicine composition
CN103446236B (en) * 2012-06-05 2017-03-22 北京亚东生物制药有限公司 Dispersible tablet of traditional Chinese medicine composition
CN103655797A (en) * 2013-11-28 2014-03-26 李红冉 Chinese traditional medicine formula for treatment of headache
CN103784505B (en) * 2014-02-24 2016-08-24 北京三泉医药技术有限公司 'Chuan Xiong Tea '
CN103816223A (en) * 2014-02-24 2014-05-28 贵州威门药业股份有限公司 Sugar-free Ligusticum wallichii tea-mixed granules
CN103800438A (en) * 2014-02-24 2014-05-21 福州华凯医药科技有限公司 Ligusticum wallichii tea modulator and preparation method thereof
CN103800438B (en) * 2014-02-24 2017-02-15 北京三泉医药技术有限公司 Ligusticum wallichii tea modulator and preparation method thereof
CN103784505A (en) * 2014-02-24 2014-05-14 福州华凯医药科技有限公司 Ligusticum wallichii tea prepartion
CN112494540A (en) * 2020-12-26 2021-03-16 贵州健兴药业有限公司 Preparation method of improved ligusticum wallichii tea-blending pharmaceutical composition
CN113476489A (en) * 2020-12-31 2021-10-08 成都中医药大学 Ligusticum wallichii volatile oil plaster for treating dysmenorrhea as well as preparation method and application thereof
CN113237989A (en) * 2021-05-07 2021-08-10 上海凯宝药业股份有限公司 Quality control method of ligusticum wallichii in capsule for dispelling wind and relieving pain
CN113552276A (en) * 2021-07-06 2021-10-26 贵州健兴药业有限公司 Detection method of ligusticum wallichii and tea blending dropping pill

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