CN1775263A - Qiju-dihuang preparation and new preparation method - Google Patents
Qiju-dihuang preparation and new preparation method Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine composition and its preparation method. In particular, it relates to a Chinese medicine prescription for curing the diseases of deficiency of liver-yin and kidney-yin, dizziness, tinnitus, photophobia, epiphora induced by wind and poor vision, etc, and its preparation process. Said invention can be made into dripping pills and soft capsule preparation.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of hepatic and renal YIN deficiency that is used for, vertigo and tinnitus, photophobia photophobia, epiphora induced by wind, the prescription of blurring of vision and preparation technology thereof.
Background technology:
Hepatic and renal YIN deficiency, vertigo and tinnitus, the photophobia photophobia, epiphora induced by wind, blurring of vision are clinical common symptons, and the traditional Chinese medical science often takes the means of nourishing the kidney and liver that it is treated, and evident in efficacy, and QIJU DIHUANG WAN is that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, its pill that makes can be used for curing mainly hepatic and renal YIN deficiency, vertigo and tinnitus, the photophobia photophobia, epiphora induced by wind, blurring of vision.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is prepared from by following proportion raw material:
80～1379 parts of 20～345 parts of Radix Rehmanniae Preparata of 20～345 parts of Flos Chrysanthemis of Fructus Lycii
40～690 parts of Rhizoma Dioscoreae 30～517 parts of Fructus Corni of 40～690 parts of Cortex Moutans (system)
30～517 parts of 30～517 portions of Rhizoma Alismatis of Poria
Preferably:
160 parts of 40 parts of Radix Rehmanniae Preparata of 40 parts of Flos Chrysanthemis of Fructus Lycii
80 parts of Rhizoma Dioscoreae 60 parts of Fructus Corni of 80 parts of Cortex Moutans (system)
60 parts of 60 portions of Rhizoma Alismatis of Poria
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, drop pill 1000 balls, granule 1000g etc., also can make big packing as granule, as 100～500 bags, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50～1000 taking doses,, make 125 bags, take 1～2 bag at every turn, can take altogether 62.5～125 times as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, soft capsule, granule, chewable tablet.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) get the prescription medical material, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction filtered, and filtrate is concentrated into certain volume;
(2) get above-mentioned dense decocting liquid, add 60～95% ethanol of 3～10 times of amounts, stir, leave standstill, deepfreeze 12～60h filters, and filtrate is condensed into thick paste;
(3) above active component is the active constituents of medicine of preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get the prescription medical material, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) above active component is the active constituents of medicine of preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5～10, and preferred ratio is 1: 2～4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4～1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8～1.2; The content of active component is 50mg～500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
One, to the influence of chronic ethanol liver damage rat serum, liver lipid peroxide
Rat is divided into 5 groups at random, and grouping sees Table 1 with administration, gastric infusion, and first perfusion thing is given modeling agent (or equivalent distilled water), continuous 22 days after 2 hours.Normal group is given 3% gum arabic solution, distilled water, blank group is given 3% gum arabic solution, 60% ethanol, technology 1. extractum group gives extractum 0.08g/kg, 60% ethanol, technology 2. extractum group gives extractum 0.14g/kg, 60% ethanol, and the vitamin E group gives VitE250mg/kg, 60% ethanol.Rat after administration 22 days is got blood from the eye socket venous plexus, and separation of serum is according to TBA determination of color serum lipid peroxide (LPO).Each significance of organizing mean adopts the t check.
The influence of table 1 pair ethanol liver damage rat serum, liver lipid peroxide (x ± s)
| Group | Number of animals (only) | Dosage (g/kg) | Serum LPO (mnol/L) | LPO (mnol/L) in the liver |
| The blank group of matched group technology is 2. extractum group VitE of extractum group technology 1. | 5 10 10 10 10 | 10ml 10ml 0.08 0.14 0.25 | 6.18±1.11 * 7.92±1.6 6.15±1.55 * 6.03±1.12 * 8.03±0.60 | 510.26±49 * 648.26±120.03 238.36±53.26 ** 325.61±130.02 ** 130.26±25.32 |
Compare with the blank group
*P＜005,
*P＜0.01
Table 1 shows, blank group and normal group relatively, serum and liver endoperoxides lipid all raise (P＜0.05).Illustrate that taking absorption ethanol for a long time all has the rising effect to blood, liver PLO.Extractum group and blank group relatively, LPO all obviously reduces (P＜0.05) in serum and the liver, illustrates that this extractum all has obvious reduction effect to the rising of LPO in serum due to the ethanol and the liver.Compare with normal group, LPO reduces (P＜0.01) in the liver.Point out this extractum the reduction effect also to be arranged to LPO in the normal hepatocytes.
Two, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD
50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment hepatic and renal YIN deficiency, vertigo and tinnitus, the photophobia photophobia, epiphora induced by wind, the medicine of blurring of vision, and change preparation technology, can obviously strengthen clinical efficacies such as its nourishing the kidney and liver, its hypotoxicity in addition, prolonged application safety, therefore, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Fructus Lycii 86g Flos Chrysanthemi 86g Radix Rehmanniae Preparata 346g
Rhizoma Dioscoreae 173g Cortex Moutan 130g Fructus Corni (system) 173g
Poria 130g Rhizoma Alismatis 130g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) get the prescription medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is concentrated into certain volume;
(2) get above-mentioned dense decocting liquid, add 75% ethanol of 5 times of amounts, stir, leave standstill, deepfreeze 48h filters, and filtrate is condensed into thick paste;
(3) with above-mentioned extract obtained, the PEG4000 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Fructus Lycii 345g Flos Chrysanthemi 345g Radix Rehmanniae Preparata 1379g
Rhizoma Dioscoreae 690g Cortex Moutan 517g Fructus Corni (system) 690g
Poria 517g Rhizoma Alismatis 517g
PEG400 400g
Make 1000
Preparation method:
(1) get the prescription medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is concentrated into certain volume;
(2) get above-mentioned dense decocting liquid, add 75% ethanol of 5 times of amounts, stir, leave standstill, deepfreeze 48h filters, and filtrate is condensed into thick paste;
(3) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Fructus Lycii 320g Flos Chrysanthemi 320g Radix Rehmanniae Preparata 1280g
Rhizoma Dioscoreae 640g Cortex Moutan 480g Fructus Corni (system) 640g
480 parts of Poria 480g Rhizoma Alismatis
Make 1000g
Preparation method:
(1) get the prescription medical material, soaked 40 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) above active component is merged, add aspartame 5.0g, dextrin 300.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Fructus Lycii 160g Flos Chrysanthemi 160g Radix Rehmanniae Preparata 640g
Rhizoma Dioscoreae 320g Cortex Moutan 240g Fructus Corni (system) 320g
240 parts of Poria 240g Rhizoma Alismatis
Make 1000
Preparation method:
(1) get the prescription medical material, soaked 40 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) above active component is merged, add aspartame 3.0g, mannitol 150.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.
Claims (10)
1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
80～1379 parts of 20～345 parts of Radix Rehmanniae Preparata of 20～345 parts of Flos Chrysanthemis of Fructus Lycii
40～690 parts of Rhizoma Dioscoreae 30～517 parts of Fructus Corni of 40～690 parts of Cortex Moutans (system)
30～517 parts of 30～517 portions of Rhizoma Alismatis of Poria.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
160 parts of 40 parts of Radix Rehmanniae Preparata of 40 parts of Flos Chrysanthemis of Fructus Lycii
80 parts of Rhizoma Dioscoreae 60 parts of Fructus Corni of 80 parts of Cortex Moutans (system)
60 parts of 60 portions of Rhizoma Alismatis of Poria.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) get the prescription medical material, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction filtered, and filtrate is concentrated into certain volume;
(2) get above-mentioned dense decocting liquid, add 60～95% ethanol of 3～10 times of amounts, stir, leave standstill, deepfreeze 12～60h filters, and filtrate is condensed into thick paste;
(3) above active component is the active constituents of medicine of preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get the prescription medical material, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) above active component is the active constituents of medicine of preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1～9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) get the prescription medical material, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction filtered, and filtrate is concentrated into certain volume;
(2) get above-mentioned dense decocting liquid, add 60～95% ethanol of 3～10 times of amounts, stir, leave standstill, deepfreeze 12～60h filters, and filtrate is condensed into thick paste;
(3) above active component is the active constituents of medicine of preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get the prescription medical material, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) above active component is the active constituents of medicine of preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CNA2005101159995A CN1775263A (en) | 2005-11-18 | 2005-11-18 | Qiju-dihuang preparation and new preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005101159995A CN1775263A (en) | 2005-11-18 | 2005-11-18 | Qiju-dihuang preparation and new preparation method |
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| CN1775263A true CN1775263A (en) | 2006-05-24 |
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ID=36765062
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|---|---|---|---|
| CNA2005101159995A Pending CN1775263A (en) | 2005-11-18 | 2005-11-18 | Qiju-dihuang preparation and new preparation method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101491628B (en) * | 2008-12-19 | 2012-01-11 | 四川美大康药业股份有限公司 | Lycium-rehmannia preparation preparation method |
| WO2012032209A2 (en) | 2010-09-08 | 2012-03-15 | Universidad Miguel Hernández De Elche | Pharmaceutical composition for the treatment of dry eye |
| CN105213789A (en) * | 2015-11-19 | 2016-01-06 | 哈尔滨圣吉药业股份有限公司 | A kind of compound rehmannia chewable tablet and preparation method thereof |
| CN108042700A (en) * | 2017-11-28 | 2018-05-18 | 广州纽得赛生物科技有限公司 | A kind of enriching yin nourishing the liver Chinese mugwort cake |
-
2005
- 2005-11-18 CN CNA2005101159995A patent/CN1775263A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101491628B (en) * | 2008-12-19 | 2012-01-11 | 四川美大康药业股份有限公司 | Lycium-rehmannia preparation preparation method |
| WO2012032209A2 (en) | 2010-09-08 | 2012-03-15 | Universidad Miguel Hernández De Elche | Pharmaceutical composition for the treatment of dry eye |
| EP4268814A2 (en) | 2010-09-08 | 2023-11-01 | Universidad Miguel Hernández De Elche | Pharmaceutical composition for the treatment of dry eye |
| CN105213789A (en) * | 2015-11-19 | 2016-01-06 | 哈尔滨圣吉药业股份有限公司 | A kind of compound rehmannia chewable tablet and preparation method thereof |
| CN108042700A (en) * | 2017-11-28 | 2018-05-18 | 广州纽得赛生物科技有限公司 | A kind of enriching yin nourishing the liver Chinese mugwort cake |
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