CN1742869A - Chinese medicine preparation for regulating menstruation and nourishing blood - Google Patents
Chinese medicine preparation for regulating menstruation and nourishing blood Download PDFInfo
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- CN1742869A CN1742869A CN 200510100124 CN200510100124A CN1742869A CN 1742869 A CN1742869 A CN 1742869A CN 200510100124 CN200510100124 CN 200510100124 CN 200510100124 A CN200510100124 A CN 200510100124A CN 1742869 A CN1742869 A CN 1742869A
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Abstract
The present invention relates to a compound Chinese medicine preparation for regulating menstruation and nourishing blood and its preparation method. It is a capsule preparation made up by using four Chinese medicinal materials of ligusticum root, Chinese angelica root, cooked rehmannia and white peony root,
Description
Technical field
The present invention relates to a kind of pure Chinese medicinal preparation and process thereof, be specifically related to the preparation method of four composite capsules of a kind of Radix Angelicae Sinensis, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, Radix Paeoniae Alba composition.
Technical background
The SIWU TANG prescription is the famous Chinese medicinal formulae that records in " peaceful Huimin mixture office side ", and former side is that four Chinese medicine mixes decoction, and dose is big, takes inconvenience.Siwu mixture, four thing cream are the Chinese patent medicine of being made up of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Rehmanniae Preparata, the Radix Paeoniae Alba, record respectively in 2000 editions " gynecological's fascicles of Chinese pharmacopoeia and " national standard for traditional Chinese medicines compilation " Chinese patent medicine provincial standard rising national standard part.This side's harmonizing yingfen and weifen, nourish QI and blood, cure mainly and dash diseases such as appointing deficient, the empty pain of uncomfortable, few abdomen of women's menses, metrorrhagia and metrostaxis.
In recent years, SIWU TANG is used for the treatment of the radioactivity anemia, hematopoietic disorder, and the application of SIWU TANG has been expanded in the treatment of anoxia greatly.Along with the continuous variation and the human adaptive variation for medicine of environment, people have had higher requirement for the bioavailability and the drug effect of Chinese medicine.
Summary of the invention
One of the object of the invention be on the basis of traditional SIWU TANG compound recipe by following technology, preparation SIWU KELI agent, promptly a kind of granule of making by Radix Angelicae Sinensis, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, the Radix Paeoniae Alba.。
The component weight proportion of the present invention's four thing preparations is:
Radix Angelicae Sinensis 625g Rhizoma Chuanxiong 625g Radix Paeoniae Alba 625g Radix Rehmanniae Preparata 625g
The medicinal substances extract of above-mentioned component cooperates the pharmaceutically alleged adjuvant or the substrate of the suitable kind of employing to make 1000 of capsules, and each dose is 2～10.Or best each dose is 4～6.
Its preparation technology may further comprise the steps:
1, inclusion essential oil: Radix Angelicae Sinensis, Rhizoma Chuanxiong adopt steam distillation to extract volatile oil, the volatile oil of gained is made clathrate with cyclodextrin and is used, described inclusion essential oil method is: volatile oil with doubly reach cyclodextrin or hydroxypropyl cyclodextrin or sulfonic group cyclodextrin composition weight ratio is 1: 7～9, cyclodextrin is made saturated solution and is mixed with volatile oil, supersound process, and fully stir, to filter, precipitate with distilled water wash, cold drying is promptly.
Enclose is respectively with consumption, the operating condition of cyclodextrin:
Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts; 40 ℃ were stirred more than 2 hours, cold preservation 24 hours, and sucking filtration, 40 ℃ of drying under reduced pressure get Benexate Hydrochloride; Radix Angelicae Sinensis, Rhizoma Chuanxiong adopt steam distillation to extract volatile oil, preceding usefulness 30%～70% alcohol dipping 0.5 hour, best 50% the ethanol that uses;
2, the extract of four Chinese medicine material is made granule or micropill filled capsules.
The capsular preparation method of filler particles:
Prescription four flavors were got Radix Angelicae Sinensis, Rhizoma Chuanxiong merceration 0.5 hour, and vapor distillation extracts volatile oil, and water liquid is standby.Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride, standby.The medicinal residues and the Radix Paeoniae Alba, Radix Rehmanniae Preparata decoct with water three times, and 1 hour for the first time, second and third time each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned water liquid are concentrated in right amount, add ethanol, make to contain pure measuring and reach 55%, left standstill 24 hours, and filtered, reclaim ethanol, being concentrated into relative density is the thick paste of 1.26～1.30 (55～65 ℃), 70 ℃ of drying under reduced pressure are ground into fine powder, granulate, the bag film-coat is with above-mentioned Benexate Hydrochloride, mixing, incapsulate, make 1000, promptly.
Fill the preparation method of pellet capsule:
Prescription four flavors were got Radix Angelicae Sinensis, Rhizoma Chuanxiong merceration 0.5 hour, and vapor distillation extracts volatile oil, and water liquid is standby.Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride, standby.The medicinal residues and the Radix Paeoniae Alba, Radix Rehmanniae Preparata decoct with water three times, and 1 hour for the first time, second and third time each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned water liquid are concentrated in right amount, add ethanol, make to contain pure measuring and reach 55%, left standstill 24 hours, and filtered, reclaim ethanol, being concentrated into relative density is the thick paste of 1.26～1.30 (55～65 ℃), adds the micropill micropill that adjuvant is made diameter 0.5～2.0mm, drying, the bag film-coat is with above-mentioned Benexate Hydrochloride, mixing, incapsulate, make 1000, promptly.
Coating of the present invention:
With 70 ℃ of drying under reduced pressure of four thing extracts, be ground into fine powder, add to be no more than 5% starch or microcrystalline Cellulose, mix homogeneously, with 95% ethanol or contain the 95% ethanol liquid wet granulation of 3%PVP, granulate is chosen 16～18 order granules;
Preheating coating pan (the rotating speed 32r/min of elder generation, 78 ℃～82 ℃ of hot-blast outlet temperature), then the granule that conforms to quality requirements is put in the coating pan, granule is preheated to 50 ℃ ± 2 ℃, start pulp shooting machine, the about 90mL/min of spouting liquid makes coating solution evenly spray into the particle surface of rotation, with 57 ℃ ± 1 ℃ hot air drying.It is about 2.0%～2.5% that coated granule is increased weight, promptly.
The coating solution prescription is: HPMC (0.6kg), acrylic resin IV number (0.6kg), tween 80 (200mL), PEG6000 (0.25kg), titanium dioxide (0.5kg), Pulvis Talci (0.1kg), ethanol (20.5kg).
A kind of content control method of Chinese medicine preparation of regulating menstruation and nourishing blood is characterized in that may further comprise the steps:
Chromatographic condition and system suitability: filler is for using octadecylsilane chemically bonded silica; Mobile phase is acetonitrile-0.1% phosphoric acid solution of different proportion, and optimal proportion is 15: 85; The detection wavelength is 210-250nm, and the optimum detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1000; Or it is best for being filler with octadecylsilane chemically bonded silica; Acetonitrile-0.1% phosphoric acid solution (15: 85) is a mobile phase; The detection wavelength is 230nm.Number of theoretical plate calculates by the peoniflorin peak should be not less than 2000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds methanol and make the solution that every 1ml contains 0.075mg;
The preparation of need testing solution: it is an amount of to get regulating menstruation and nourishing blood formulation samples content, and porphyrize is got 1 the amount that is equivalent to, the accurate title, decide, and puts in the 25ml measuring bottle, and adding methanol is an amount of, supersound process 10-60 minute, the best was that ultrasonic (power 150W, frequency 40kHz) handled 30 minutes, put cold, add methanol and be diluted to scale, shake up, filter with microporous filter membrane, get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, and every of this product contains the Radix Paeoniae Alba with peoniflorin (C
23H
28O
11) meter, must not be less than 1.0mg.
Good effect of the present invention:
Because the moisture absorption characteristic of Radix Angelicae Sinensis, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, Radix Paeoniae Alba extract, four thing preparations are made comparatively difficulty energy of capsule, the stable requirement of capsule 's content character in the inaccessible shelf-life.According to the Chinese Pharmacopoeia regulation, the capsule 's content water content must not surpass 9%.
The present invention's four composite capsules make capsule 's content stability improve by inclusion essential oil and granule coating, satisfy industrial requirement.
Specific embodiment
Embodiment 1: volatile oil extracts and enclose:
Radix Angelicae Sinensis 625g Rhizoma Chuanxiong 625g Radix Paeoniae Alba 625g Radix Rehmanniae Preparata 625g
Get Radix Angelicae Sinensis, Rhizoma Chuanxiong, with 50% alcohol dipping 0.5 hour, adopt steam distillation to extract volatile oil, the volatile oil of gained is made clathrate with cyclodextrin.
Embodiment 2: volatile oil extracts and enclose:
Get Radix Angelicae Sinensis, Rhizoma Chuanxiong and adopt steam distillation to extract volatile oil, get and be equivalent to doubly reaching cyclodextrin, making saturated solution and mix with volatile oil of 8 times of volatile oil weight ratios, 40 ℃ of stirrings are more than 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure get Benexate Hydrochloride.
The preparation of 3: four composite capsules of embodiment:
Get Radix Angelicae Sinensis, Rhizoma Chuanxiong with 50% ethanol merceration 0.5 hour, vapor distillation extracts volatile oil, and water liquid is standby.Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride, standby.The medicinal residues and the Radix Paeoniae Alba, Radix Rehmanniae Preparata decoct with water three times, and 1 hour for the first time, second and third time each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned water liquid are concentrated in right amount, add ethanol, make to contain pure measuring and reach 55%, left standstill 24 hours, and filtered, reclaim ethanol, being concentrated into relative density is the thick paste of 1.26～1.30 (55～65 ℃), 70 ℃ of drying under reduced pressure are ground into fine powder, granulate, the bag film-coat is with above-mentioned Benexate Hydrochloride, mixing, incapsulate, make 1000, promptly.
The preparation of 4: four thing micropills of embodiment filled capsules:
Prescription four flavors are got Radix Angelicae Sinensis, Rhizoma Chuanxiong with 50% ethanol merceration 0.5 hour, vapor distillation extraction volatile oil, and water liquid is standby.Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride, standby.The medicinal residues and the Radix Paeoniae Alba, Radix Rehmanniae Preparata decoct with water three times, and 1 hour for the first time, second and third time each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned water liquid are concentrated in right amount, add ethanol, make to contain pure measuring and reach 55%, left standstill 24 hours, and filtered, reclaim ethanol, being concentrated into relative density is the thick paste of 1.26～1.30 (55～65 ℃), adds the micropill that adjuvant is made diameter 0.5～2.0mm, drying, the bag film-coat is with above-mentioned Benexate Hydrochloride, mixing, incapsulate, make 1000, promptly.
Embodiment 5: the preparation of coating solution of the present invention:
The coating solution prescription of capsule 's content granule of the present invention or content is:
HPMC (0.6kg), acrylic resin IV number (0.6kg), tween 80 (200mL), PEG6000 (0.25kg), titanium dioxide (0.5kg), Pulvis Talci (0.1kg), ethanol (20.5kg).
Embodiment 6: coating method of the present invention:
With 70 ℃ of drying under reduced pressure of four thing extracts, be ground into fine powder, add being no more than 5% starch, mix homogeneously, with 95% ethanol liquid wet granulation, granulate is chosen 16～18 order granules;
Preheating coating pan (the rotating speed 32r/min of elder generation, 78 ℃～82 ℃ of hot-blast outlet temperature), then the granule that conforms to quality requirements is put in the coating pan, granule is preheated to 50 ℃ ± 2 ℃, start pulp shooting machine, the about 90mL/min of spouting liquid makes coating solution evenly spray into the particle surface of rotation, with 57 ℃ ± 1 ℃ hot air drying.It is about 2.0%～2.5% that coated granule is increased weight, promptly.
The assay of 7: four composite capsules of embodiment:
Chromatographic condition and system suitability: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.1% phosphoric acid solution (15: 85) is a mobile phase; The detection wavelength is 230nm.Number of theoretical plate calculates by the peoniflorin peak should be not less than 2000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds methanol and make the solution that every 1ml contains 0.075mg;
The preparation of need testing solution: it is an amount of to get under the content uniformity item content, and porphyrize is got 1 the amount that is equivalent to, the accurate title, decide, and puts in the 25ml measuring bottle, and adding methanol is an amount of, ultrasonic (power 150W, frequency 40kHz) handles 30 minutes, put coldly, add methanol and be diluted to scale, shake up, filter with microporous filter membrane (0.45 μ m), get subsequent filtrate, promptly;
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, and every of this product contains the Radix Paeoniae Alba with peoniflorin (C
23H
28O
11) meter, must not be less than 1.150mg.
Claims (13)
1, a kind of Chinese medicine preparation of regulating menstruation and nourishing blood is characterized in that, used medical material component weight proportion is: Radix Angelicae Sinensis: Rhizoma Chuanxiong: the Radix Paeoniae Alba: Radix Rehmanniae Preparata=1: 1: 1: 1,
The medicinal substances extract of above-mentioned component cooperates pharmaceutically alleged adjuvant that adopts suitable kind or the capsule that substrate is made.
2, a kind of four composite capsule agent according to claim 1 is characterized in that, used medical material component weight proportion the best is:
Radix Angelicae Sinensis 625g Rhizoma Chuanxiong 625g Radix Paeoniae Alba 625g Radix Rehmanniae Preparata 625g
The medicinal substances extract of above-mentioned component cooperates the pharmaceutically alleged adjuvant or the substrate of the suitable kind of employing to make 1000 of capsules, and each dose is 2～10.
3, according to claim 2 composite capsule agent preparation method, it is characterized in that Radix Angelicae Sinensis, Rhizoma Chuanxiong adopt steam distillation to extract volatile oil, the volatile oil of gained is made clathrate with cyclodextrin and is used, described inclusion essential oil method is: volatile oil with doubly reach cyclodextrin or hydroxypropyl cyclodextrin or sulfonic group cyclodextrin composition weight ratio is 1: 7～9, cyclodextrin is made saturated solution and is mixed with volatile oil, supersound process, and fully stir, filter, precipitate with distilled water wash, cold drying promptly.
4, according to claim 2 composite capsule agent preparation method, it is characterized in that: volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred more than 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride.
5, according to claim 2 composite capsule agent preparation method, it is characterized in that Radix Angelicae Sinensis, Rhizoma Chuanxiong adopt steam distillation to extract volatile oil before, with 30%～70% alcohol dipping 0.5 hour, the ethanol of best use 50%.
6, according to claim 2 composite capsule agent preparation method, it is characterized in that: the capsule 's content state is a coated granules.
7, according to claim 2 composite capsule agent preparation method, it is characterized in that: the capsule 's content state is the micropill of micropill or coating.
8, according to claim 2 composite capsule agent preparation method, it is characterized in that method for making may further comprise the steps: prescription four flavors, got Radix Angelicae Sinensis, Rhizoma Chuanxiong merceration 0.5 hour, vapor distillation extracts volatile oil, and water liquid is standby; Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride, standby; The medicinal residues and the Radix Paeoniae Alba, Radix Rehmanniae Preparata decoct with water three times, and 1 hour for the first time, second and third time each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned water liquid are concentrated in right amount, add ethanol, make to contain pure measuring and reach 55%, left standstill 24 hours, and filtered, reclaim ethanol, being concentrated into relative density is the thick paste of 1.26～1.30 (55～65 ℃), 70 ℃ of drying under reduced pressure are ground into fine powder, granulate, the bag film-coat is with above-mentioned Benexate Hydrochloride, mixing, incapsulate, make 1000, promptly.
9, according to claim 2 composite capsule agent preparation method, it is characterized in that method for making may further comprise the steps: prescription four flavors, got Radix Angelicae Sinensis, Rhizoma Chuanxiong merceration 0.5 hour, vapor distillation extracts volatile oil, and water liquid is standby; Volatile oil is with the beta-schardinger dextrin-of 8 times of amounts, and 40 ℃ were stirred 2 hours, cold preservation 24 hours, sucking filtration, 40 ℃ of drying under reduced pressure, Benexate Hydrochloride, standby; The medicinal residues and the Radix Paeoniae Alba, Radix Rehmanniae Preparata decoct with water three times, and 1 hour for the first time, second and third time each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned water liquid are concentrated in right amount, add ethanol, make to contain pure measuring and reach 55%, left standstill 24 hours, and filtered, reclaim ethanol, being concentrated into relative density is the thick paste of 1.26～1.30 (55～65 ℃), adds the micropill that adjuvant is made diameter 0.5～2.0mm, drying, the bag film-coat is with above-mentioned Benexate Hydrochloride, mixing, incapsulate, make 1000, promptly.
10, the Chinese medicine preparation of a kind of regulating menstruation and nourishing blood according to claim 1 is characterized in that: can adopt the content of paeoniflorin in the contained Radix Paeoniae Alba in high effective liquid chromatography for measuring claim 1, the described regulating menstruation and nourishing blood pharmaceutical formulation of claim 2.
11, the determination of the Chinese medicine preparation of a kind of regulating menstruation and nourishing blood according to claim 10 is characterized in that: adopt the chromatographic condition and the system suitability of its content of high effective liquid chromatography for measuring to be: filler is for using octadecylsilane chemically bonded silica; Mobile phase is acetonitrile-0.1% phosphoric acid solution of different proportion, and optimal proportion is 15: 85; The detection wavelength is 210-250nm, and the optimum detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1000.
12, the determination of the Chinese medicine preparation of a kind of regulating menstruation and nourishing blood according to claim 10, it is characterized in that: being prepared as of need testing solution of adopting its content of high effective liquid chromatography for measuring: it is an amount of to get regulating menstruation and nourishing blood formulation samples content, porphyrize, get 1 the amount that is equivalent to, the accurate title, decide, put in the 25ml measuring bottle, adding methanol is an amount of, supersound process 10-60 minute, the best is ultrasonic (power 150W, frequency 40kHz) handles 30 minutes, put coldly, add methanol and be diluted to scale, shake up, filter with microporous filter membrane, get subsequent filtrate, promptly.
13, the determination of the Chinese medicine preparation of a kind of regulating menstruation and nourishing blood according to claim 10 is characterized in that: every of this product contains the Radix Paeoniae Alba with peoniflorin (C
23H
28O
11) meter, must not be less than 1.0mg.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510100124 CN1742869A (en) | 2005-09-28 | 2005-09-28 | Chinese medicine preparation for regulating menstruation and nourishing blood |
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| CN 200510100124 CN1742869A (en) | 2005-09-28 | 2005-09-28 | Chinese medicine preparation for regulating menstruation and nourishing blood |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102178779A (en) * | 2011-04-25 | 2011-09-14 | 悦康药业集团有限公司 | Method for preparing capsules containing prepared rehmannia root, white paeony root, Chinese angelica and szechuan lovage rhizome and application |
| CN103211907A (en) * | 2013-02-04 | 2013-07-24 | 康美药业股份有限公司 | Siwu decoction formulated particles, and preparation method and detection method thereof |
| CN103316139A (en) * | 2013-05-31 | 2013-09-25 | 安徽源和堂药业股份有限公司 | Preparation method of ligusticum wallichii decoction piece |
| CN109364154A (en) * | 2018-12-12 | 2019-02-22 | 怀化正好制药有限公司 | Chinese medicinal ointment and preparation method thereof for menstruation regulating blood nourishing |
| CN110141656A (en) * | 2019-06-27 | 2019-08-20 | 党永强 | A kind of Fuke Tiaojing blood-nourishing Chinese medicine composition and preparation method thereof |
| CN112603934A (en) * | 2020-12-31 | 2021-04-06 | 北京悦康科创医药科技股份有限公司 | Chinese angelica and ligusticum wallichii composition and preparation method thereof |
-
2005
- 2005-09-28 CN CN 200510100124 patent/CN1742869A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102178779A (en) * | 2011-04-25 | 2011-09-14 | 悦康药业集团有限公司 | Method for preparing capsules containing prepared rehmannia root, white paeony root, Chinese angelica and szechuan lovage rhizome and application |
| CN102178779B (en) * | 2011-04-25 | 2012-07-18 | 悦康药业集团有限公司 | Method for preparing capsules containing prepared rehmannia root, white paeony root, Chinese angelica and szechuan lovage rhizome and application |
| CN103211907A (en) * | 2013-02-04 | 2013-07-24 | 康美药业股份有限公司 | Siwu decoction formulated particles, and preparation method and detection method thereof |
| CN103316139A (en) * | 2013-05-31 | 2013-09-25 | 安徽源和堂药业股份有限公司 | Preparation method of ligusticum wallichii decoction piece |
| CN103316139B (en) * | 2013-05-31 | 2015-11-25 | 安徽源和堂药业股份有限公司 | A kind of preparation method of ligusticum wallichii decoction piece |
| CN109364154A (en) * | 2018-12-12 | 2019-02-22 | 怀化正好制药有限公司 | Chinese medicinal ointment and preparation method thereof for menstruation regulating blood nourishing |
| CN110141656A (en) * | 2019-06-27 | 2019-08-20 | 党永强 | A kind of Fuke Tiaojing blood-nourishing Chinese medicine composition and preparation method thereof |
| CN112603934A (en) * | 2020-12-31 | 2021-04-06 | 北京悦康科创医药科技股份有限公司 | Chinese angelica and ligusticum wallichii composition and preparation method thereof |
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