CN109999201A - A kind of novel taste masking companion agent and application thereof - Google Patents
A kind of novel taste masking companion agent and application thereof Download PDFInfo
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- CN109999201A CN109999201A CN201910319283.9A CN201910319283A CN109999201A CN 109999201 A CN109999201 A CN 109999201A CN 201910319283 A CN201910319283 A CN 201910319283A CN 109999201 A CN109999201 A CN 109999201A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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Abstract
The present invention provides a kind of novel taste masking companion agent, it is made of amphipathic nature block polymer, cyclodextrin and artificial sweetener.The novel taste masking companion agent of the present invention unexpectedly significantly reduces the original bad mouthfeel of drug while guaranteeing drug safety and validity, improve the Compliance of patient, it avoids and a large amount of corrigents is added, reduce the dosage of sweetener in prescription, reduce production cost；Taste masking effect is obvious, does not increase the dosage of patient, simple and practical.
Description
Technical field
Present invention relates particularly to a kind of novel taste masking companion agent and application thereof.
Background technique
The bad mouthfeel of drug includes sour, bitter, salty, puckery, fishy smell etc., and wherein bitter taste is most difficult to make us receiving.To certain
For pharmaceutical preparation or dosage form, such as the chemicals medicine that solid pharmaceutical preparation, ingredient are single, pharmacy worker can pass through system
Agent learns to do section and is such as coated, is packed into capsule, inclusion, microencapsulation or the purpose for reaching taste masking by chemical means such as chemical modification.
However, often helpless for other large dosage, multicomponent liquid preparation or solid pharmaceutical preparation, these taste masking means.
For traditional Chinese herbal decoction as one of most representative bad mouthfeel medicament forms, bitter taste often makes people " keeping someone at a respectful distance ", causes
The advantage of Chinese traditional treatment is desalinated or is weakened.Therefore, for oral preparation of Chinese traditional medicinal, especially traditional Chinese herbal decoction, for adverse drug
The taste masking of mouthfeel is studied, it has also become important topic of the pendulum in face of pharmacy worker.Common taste masking " trilogy " be " suppression bitter ",
" sweetened " and " flavoring ".The first step " suppression is bitter " is basic and crucial in trilogy, and " sweetened " and " flavoring " is auxiliary and strengthens.
For bitter taste, many drug hardship degree are higher, if not inhibiting bitter taste effectively by bitter inhibitor etc., depend merely on be added sweetener and
Aromatic can not fundamentally achieve the purpose that taste masking, may make the taste more " five tastes are miscellaneous old " of drug instead.Therefore, it studies
Safe and efficient, pervasive, stable taste masking companion's agent is the key that taste masking research.
The combination of bitter substance (ligand) and receptor is the first step that bitter taste is formed.Currently, how to swash about bitter substance
Receptor living, three point contact theory think that bitter molecules and bitterness receptors should all have AH (electrophilic groups), B (nucleophilic group)
And X (hydrophobic grouping), wherein bitter substance AH and receptor A ' is combined, and X and receptor X ' are combined, and the position B ' is hanging, could be formed
Bitter taste.Since amphipathic nature block polymer has hydrophobic grouping, and water-wet side will form barrier between ingredient and receptor, theoretical
On " stealth modification " can be done to bitter principle, and micella can be self-assembly of in water, but its whether to have masking agents bad
The effect of mouthfeel, there are no researchs to report.
Cyclodextrin molecular has the hollow cylinder three-dimensional ring structure tapered slightly, in its empty structure, outer upper end
(larger open end) is by C2And C3Secondary hydroxyl constitute, lower end (smaller opening end) is by C6Primary hydroxyl constitute, have hydrophily,
And since the shielding action by c h bond forms hydrophobic region in cavity.Therefore, it can provide a hydrophobic binding site,
As the various objects appropriate of main body envelope, by the hydrophobic grouping of bitter molecules in cavity, in bitter substance and receptor
Between formed barrier.Cyclodextrin includes alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin and its modified cyclodextrine derivatives.
Artificial sweetener is that one kind is widely used in the artificial synthesized or hemizygous of food, beverage, drug and personal care articles
At the organic compound instead of sucrose, since most of artificial sweetener is hardly converted by human body, be referred to as without heat
The sugar of amount.In addition, artificial sweetener can interfere the maincenter of bitter taste signal to conduct, suppression is realized by competition signal path conductive quantity
It is bitter.The generation of bitter taste perception, mainly bitter substance activate α-gusducin-PDE (effect enzyme)-in conjunction with the T2Rs on taste bud
CNMP access or activation β, γ-gusducin-PLC-IP3/DAG access, cause Ca2+Release, leads to membrane depolarization and neurotransmitter
Release.Though sweet receptor is T1R2+T1R3, the perception access in taste perception cell exists again with bitter taste to partly overlap, people
The sweet taste reaction access of work sweetener stimulation is consistent with bitter taste β, γ-gusducin-PLC-IP3/DAG access, to interfere nerve
Maincenter Taste Signals are integrated to achieve the purpose that taste masking.
Currently, it is not yet reported that amphipathic nature block polymer to be used for the bad mouthfeel of masking agents, more not by amphiphilic
Property block copolymer combines the research for being prepared into novel taste masking companion agent with cyclodextrin and artificial sweetener.
Summary of the invention
It is an object of that present invention to provide a kind of novel taste masking companion agent and purposes.Another object of the present invention is to provide two
Parent's property block copolymer individually use and novel taste masking companion agent in after combination of two in the purposes of the bad mouthfeel of masking agents.
The present invention provides a kind of novel taste masking companion agent, it is by amphipathic nature block polymer, cyclodextrin and artificial sweet tea
Taste agent composition.
Further, 0.01~20 part of the amphipathic nature block polymer weight proportion, cyclodextrin weight proportion 0~20
Part, 0~15 part of artificial sweetener weight proportion.
Further, the amphipathic nature block polymer weight proportion is 0.01~1 part, cyclodextrin weight proportion 0.5
~5 parts, 0.01~1 part of artificial sweetener weight proportion.
Further, the amphipathic nature block polymer weight proportion be 0.16 part, 2 parts of cyclodextrin weight proportion, people
0.125 part of work sweetener weight proportion.
Further, the amphipathic nature block polymer is that the copolymer of amphiphilic diblock or diblock or more is any one
Kind or several, preferred amphiphilic diblock copolymer, more preferable mPEG-PLA.
Further, the cyclodextrin is that alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin or cyclodextrine derivatives are any one
Kind is several, preferably gamma-cyclodextrin.
Further, the artificial sweetener is saccharin, honey element, Aspartame, neotame, acesulfame potassium, NHDC, trichlorine sugarcane
Sugar any one or a few, preferred Aspartame.
The present invention also provides a kind of purposes of novel taste masking companion agent in the drug for preparing good taste.
Further, the good taste is bitter taste, astringent taste, fishy smell, saline taste and/or the tart flavour of masking agents.
Further, the dosage form of the drug is granule, granule, tablet, traditional Chinese herbal decoction, mixture or aqua aromatica
Agent.
The novel taste masking companion agent of the present invention is unexpectedly substantially dropped while guaranteeing drug safety and validity
The low original bad mouthfeel of drug, improves the Compliance of patient, avoids and a large amount of corrigents are added, reduce prescription
The dosage of middle sweetener, reduces production cost；Taste masking effect is obvious, does not increase the dosage of patient, simple and practical.
Tests prove that: amphipathic nature block polymer taste masking effect is good, with cyclodextrin and artificial sweetener any one
Mixing, can play the bad mouthfeel of better masking agents, three kinds of ingredients combine the effect of the bad mouthfeel of masking agents
Fruit is best, can be used for preparing the oral preparation (solving sensory issues) that a variety of traditional handicrafts cannot achieve, in particular for certain
The special form (such as granule, dispersible tablet preparation) of a little specific crowd (such as children and swallow the old man having any problem), operation letter
Just, low in cost, be conducive to be mass produced, have a good application prospect.
Obviously, above content according to the present invention is not being departed from according to the ordinary technical knowledge and customary means of this field
Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification, replacement or change of other diversified forms can also be made.
The specific embodiment of form by the following examples remakes further specifically above content of the invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on above content of the present invention
The technology realized all belongs to the scope of the present invention.
Specific embodiment
Raw material, equipment used in the specific embodiment of the invention are known product, are obtained by purchase commercial product.
Embodiment 1: improvement of the amphipathic nature block polymer to Berberine hydrochloride bitter taste
1, the preparation of Berberine hydrochloride COPOLYMER MICELLE SOLUTION
Using dissolution method: dosage Berberine hydrochloride 4mg is added in 100mL water, and amphiphilic is added to being completely dissolved in ultrasound
Property block copolymer, and ultrasound is completely dissolved to get Berberine hydrochloride COPOLYMER MICELLE SOLUTION to copolymer.
2, bitter taste measures
Mono blind method is taken to carry out taste test 10 volunteers, the specific method is as follows: 10mL being taken to wait for that mouth tastes solution by will
Hope person is contained in mouth, timing 15s, and oral cavity is gargled movement around here so that tongue can sufficiently experience bitter taste of drug, allow volunteer by
Visual analogue scales (VAS) marking, spues, gargles 5 times, until (the every group of examination of another solution without bitter taste, is evaluated after 15min in oral cavity
It tests and is required to taste stoste).
3, (mPEG2000-PLLA2000 is a kind of block copolymer, chemistry for the investigation of mPEG2000-PLLA2000 dosage
Entitled methoxy poly (ethylene glycol)-Poly L-lactide, wherein methoxy poly (ethylene glycol) molecular weight is 2000, Poly L-lactide molecule
2000) amount is
| Dosage | 0.12% | 0.14% | 0.16% | 0.18% | Stoste |
| VAS scoring | 6 | 5 | 4 | 4.2 | 8.6 |
Test result shows that different amounts mPEG2000-PLLA2000 all has the effect of masking bitter taste to Berberine hydrochloride
Fruit, when wherein dosage is 0.16%, taste masking effect is best.
4, the investigation of mPEG2000-PLLA2000 (mP) and drug addition sequence
It is bitter that test result shows that the mPEG2000-PLLA2000 of different addition sequences all has masking to Berberine hydrochloride
The effect of taste, when wherein addition sequence is Berberine hydrochloride+mPEG2000-PLLA2000+ water, taste masking effect is best.
5, influence of the mPEG2000-PLLA2000 and mPEG2000-PCL1140 to the bitter taste of Berberine hydrochloride
(mPEG2000-PCL1140 is a kind of block copolymer, and chemical name is methoxy polyethylene glycol-polycaprolactone, wherein methoxy
Base molecular weight polyethylene glycol is 2000,1140) polycaprolactone molecular weight is
Test result shows mPEG2000-PLLA2000, mPEG2000-PCL1140, mPEG2000-PLLA2000
(1.5%)+mPEG2000-PCL1140 (0.5%) all has the effect of masking bitter taste to Berberine hydrochloride, wherein mPEG2000-
PLLA2000, taste masking effect are best.
Improvement of the embodiment 2:mPEG2000-PLLA2000 to quinine sulfate hydrate bitter taste
1, the preparation of quinine sulfate micellar solution
Using dissolution method: dosage quinine sulfate hydrate 8mg is added in 100mL water, and ultrasound is added to being completely dissolved
MPEG2000-PLLA2000, and ultrasound to amphipathic nature block polymer is completely dissolved to get quinine sulfate micellar solution.
2, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
3, the investigation of mPEG2000-PLLA2000 dosage
| Dosage | 0.12% | 0.14% | 0.16% | 0.18% | Stoste |
| VAS scoring | 7.3 | 6 | 5 | 5.3 | 8 |
Test result shows that different amounts mPEG2000-PLLA2000 all has the effect of masking bitter taste to quinine sulfate,
When wherein dosage is 0.16%, taste masking effect is best.
4, the investigation of mPEG2000-PLLA2000 (mP) and drug addition sequence
Test result shows that the mPEG2000-PLLA2000 of different addition sequences all has masking bitter taste to quinine sulfate
Effect, wherein addition sequence be quinine sulfate+mPEG2000-PLLA2000+ water when, taste masking effect is best.
5, influence of the mPEG2000-PLLA2000 and mPEG2000-PCL1140 to the bitter taste of quinine sulfate
Test result shows mPEG2000-PLLA2000, mPEG2000-PCL1140, mPEG2000-PLLA2000+
MPEG2000-PCL1140 all has the effect of masking bitter taste to quinine sulfate, wherein mPEG2000-PLLA2000, taste masking effect
It is best.
Improvement of the embodiment 3:mPEG2000-PLLA2000 to coptis decocting liquid bitter taste
1, the preparation of coptis decocting liquid
Rhizoma Coptidis 2g is taken, 100mL water is added, refluxing extraction 2 times, each 30min, merging filtrate is to get coptis decocting
Liquid.
2, the preparation of micellar solution
MPEG2000-PLLA2000 is added into coptis decocting liquid, ultrasound is completely dissolved to get micellar solution to it.
3, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
4, the investigation of mPEG2000-PLLA2000 dosage
| Dosage | 0.12% | 0.14% | 0.16% | 0.18% | Stoste |
| VAS scoring | 8 | 7 | 6 | 7 | 10 |
Test result shows that different amounts mPEG2000-PLLA2000 all has the effect of masking bitter taste to coptis decocting liquid
Fruit, when wherein dosage is 0.16%, taste masking effect is best.
5, influence of the mPEG2000-PLLA2000 and mPEG2000-PCL1140 to the bitter taste of coptis decocting liquid
Test result shows mPEG2000-PLLA2000, mPEG2000-PCL1140, mPEG2000-PLLA2000+
MPEG2000-PCL1140 all has the effect of masking bitter taste to coptis decocting liquid, wherein mPEG2000-PLLA2000, taste masking effect
Fruit is best.
The improvement of embodiment 4:mPEG2000-PLLA2000 and gamma-cyclodextrin to coptis decocting liquid bitter taste
1, the preparation of coptis decocting liquid
Sample is prepared according to 3 measurement of embodiment.
2, flavoring method
It is separately added into 0.16%mPEG2000-PLLA2000,2% gamma-cyclodextrin and the two mixture and decocting liquid is added, surpass
Sound is completely dissolved to get flavoring solution to it.
3, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
4, volunteer mouthful attempts to test
Test result shows mPEG2000-PLLA2000 and gamma-cyclodextrin is individually added into be all have taste masking effect, but
The mixed taste masking effect of the two is better than taste masking effect when individually using.
The improvement of embodiment 5:mPEG2000-PLLA2000 and Aspartame to coptis decocting liquid bitter taste
1, the preparation of coptis decocting liquid
Sample is prepared according to 3 measurement of embodiment.
2, flavoring method
It is separately added into 0.16%mPEG2000-PLLA2000,0.125% Aspartame and the two mixture and decocting is added
Liquid, ultrasound are completely dissolved to get flavoring solution to it.
3, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
4, volunteer mouthful attempts to test
It is to all have taste masking effect that test result, which shows mPEG2000-PLLA2000, and Aspartame is individually added into, but two
The mixed taste masking effect of person is better than taste masking effect when individually using.
Embodiment 6: the improvement of gamma-cyclodextrin and Aspartame to coptis decocting liquid bitter taste
1, the preparation of coptis decocting liquid
Sample is prepared according to 3 measurement of embodiment.
2, flavoring method
It is separately added into 2% gamma-cyclodextrin, 0.125% Aspartame and the two mixture and decocting liquid is added, ultrasound is complete to its
Fully dissolved is to get flavoring solution.
3, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
4, volunteer mouthful attempts to test
It is to all have taste masking effect that test result, which shows gamma-cyclodextrin, and Aspartame is individually added into, but after the two mixing
Taste masking effect better than individually use when taste masking effect.
The improvement of embodiment 7:mPEG2000-PLLA2000, gamma-cyclodextrin and Aspartame to coptis decocting liquid bitter taste
1, the preparation of coptis decocting liquid
Sample is prepared according to 3 measurement of embodiment.
2, flavoring method
It is mixed to be separately added into 0.16%mPEG2000-PLLA2000,2% gamma-cyclodextrin, 0.125% Aspartame and three
It closes object and decocting liquid is added, ultrasound is completely dissolved to get flavoring solution to it.
3, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
4, volunteer mouthful attempts to test
It is to all have to cover that test result, which shows that mPEG2000-PLLA2000, gamma-cyclodextrin and Aspartame are individually added into,
Taste effect, but the mixed taste masking effect of three is better than taste masking effect when individually using.
The improvement of embodiment 8:mPEG2000-PLLA2000, gamma-cyclodextrin and Aspartame to glabrous sarcandra herb extract bitter taste
1, glabrous sarcandra herb extract
Glabrous sarcandra herb extract is provided by Jiang Zhong pharmacy Group Co., Ltd, then dilutes 3 times, as model drug.
2, flavoring method
It is mixed to be separately added into 0.16%mPEG2000-PLLA2000,2% gamma-cyclodextrin, 0.125% Aspartame and three
It closes object and decocting liquid is added, ultrasound is completely dissolved to get flavoring solution to it.
3, bitter taste measures
Solution bitter taste is measured according to embodiment 1.
4, volunteer mouthful attempts to test
It is to all have to cover that test result, which shows that mPEG2000-PLLA2000, gamma-cyclodextrin and Aspartame are individually added into,
Taste effect, but the mixed taste masking effect of three is better than taste masking effect when individually using.
The improvement of embodiment 9:mPEG2000-PLLA2000, gamma-cyclodextrin and Aspartame to three fruit soup astringent tastes
1, the preparation of three fruit soup decocting liquids
2 parts of myrobalan, 1 part of terminaliae billericae,fructus, 1 part of emblic are weighed, 10 times of amount water are added, at 100 DEG C, is extracted twice, every time
1h.Extracting solution is merged to get three fruit soup decocting liquids.
2, flavoring method
It is mixed to be separately added into 0.16%mPEG2000-PLLA2000,2% gamma-cyclodextrin, 0.125% Aspartame and three
It closes object and decocting liquid is added, ultrasound is completely dissolved to get flavoring solution to it.
3, astringent taste measures
Mono blind method is taken to carry out taste test 10 volunteers, the specific method is as follows: 10mL being taken to wait for that mouth tastes solution by will
Hope person is contained in mouth, timing 15s, and oral cavity is gargled movement around here so that tongue can sufficiently experience drug astringent taste, allow volunteer by
Visual analogue scales (VAS) marking, spues, gargles 5 times, until (the every group of examination of another solution without bitter taste, is evaluated after 15min in oral cavity
It tests and is required to taste stoste).
4, volunteer mouthful attempts to test
It is to all have to cover that test result, which shows that mPEG2000-PLLA2000, gamma-cyclodextrin and Aspartame are individually added into,
Taste effect, but taste masking effect when the mixed taste masking effect of three is substantially better than independent utilization.
To sum up, amphipathic nature block polymer can be used for the bad mouthfeel of masking agents, and taste masking effect is good, with cyclodextrin and
Any one mixing of artificial sweetener, has better taste masking effect, as amphipathic nature block polymer, cyclodextrin and people in drug
When work sweetener consumption proportion is respectively 0.16%, 2%, 0.125%, taste masking effect is best, and the medication for improving patient is complied with
Property.The taste masking companion's agent being composed of amphipathic nature block polymer, cyclodextrin and artificial sweetener, avoids a large amount of corrigents
Use, reduce the dosage of sweetener in prescription, reduce production cost, it is simple and practical, have practical extending application value.
Claims (10)
1. a kind of novel taste masking companion agent, it is characterised in that: it is by amphipathic nature block polymer, cyclodextrin and artificial sweetener
Composition.
2. novel taste masking companion agent according to claim 1, it is characterised in that: the amphipathic nature block polymer weight is matched
Than 0.01~20 part, 0~20 part of cyclodextrin weight proportion, 0~15 part of artificial sweetener weight proportion.
3. novel taste masking companion agent according to claim 2, it is characterised in that: the amphipathic nature block polymer weight is matched
Than being 0.01~1 part, 0.5~5 part of cyclodextrin weight proportion, 0.01~1 part of artificial sweetener weight proportion.
4. novel taste masking companion agent according to claim 3, it is characterised in that: the amphipathic nature block polymer weight is matched
Than being 0.16 part, 2 parts of cyclodextrin weight proportion, 0.125 part of artificial sweetener weight proportion.
5. novel taste masking companion agent described in any one according to claim 1~4, it is characterised in that: the amphipathic block
Copolymer be amphiphilic diblock or diblock or more copolymer any one or a few, preferred amphiphilic di-block copolymer
Object, more preferable mPEG-PLA.
6. novel taste masking companion agent described in any one according to claim 1~4, it is characterised in that: the cyclodextrin is α-
Cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin or cyclodextrine derivatives any one or a few, preferred gamma-cyclodextrin.
7. novel taste masking companion agent described in any one according to claim 1~4, it is characterised in that: the artificial sweetener
For saccharin, honey element, Aspartame, neotame, acesulfame potassium, NHDC, Sucralose any one or a few, preferred Aspartame.
8. purposes of companion's agent in the drug for preparing good taste described in claim 1.
9. purposes according to claim 8, it is characterised in that: the good taste is bitter taste, astringent taste, the fishy smell of masking agents
And/or tart flavour.
10. purposes according to claim 9, it is characterised in that: the dosage form of the drug be granule, granule, tablet,
Traditional Chinese herbal decoction, mixture, oral solution or aromatic waters.
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| Publication number | Publication date |
|---|---|
| CN109999201B (en) | 2023-02-17 |
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