CN107669635A - It is a kind of to be used to treat aerosol of respiratory disease and preparation method thereof - Google Patents
It is a kind of to be used to treat aerosol of respiratory disease and preparation method thereof Download PDFInfo
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- CN107669635A CN107669635A CN201610876871.9A CN201610876871A CN107669635A CN 107669635 A CN107669635 A CN 107669635A CN 201610876871 A CN201610876871 A CN 201610876871A CN 107669635 A CN107669635 A CN 107669635A
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- aerosol
- ribavirin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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Abstract
The present invention relates to a kind of aerosol for being used to treat respiratory disease and preparation method thereof, belong to field of pharmaceutical preparations.The aerosol of the present invention is prepared from the following components：The 50g of ambroxol hydrochloride 30, the 40g of budesonide 20, the 30g of Ribavirin 20, the 200g of glycerine 100, Sorbitan Trioleate 15 25g, PVP 15 25g, the 1g of sorbic acid 0.5, the 2g of Mint Essence 0.5, appropriate saccharin sodium, dichlorodifluoro ethane are appropriate, Purified Water q. s, steady quality, significant effect, it can effectively treat respiratory disease.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of aerosol and its system for being used to treat respiratory disease
Preparation Method.
Background technology
Respiratory disease is a kind of common disease, and it includes flu, tracheitis, pneumonia etc., throughout the year in can fall ill,
Especially using winter-spring season as very.Why respiratory disease is common disease, this region of anatomy and physiological function with respiratory system
It is relevant.
We are made up of usually said respiratory system nose, pharynx, larynx, tracheae, bronchus at different levels and alveolar.Mucous secretion
Liquid, make the with the humid air of suction, and the foreign matter of suction can be wrapped up, discharged by cough or nasal mucus.Before nasal cavity, pharynx nasalis and nose
The vibrissa in front yard, can blocks dust and external foreign matter pass through.Bottleneck throat amygdala, there is abundant lymphoid tissue, to bacterium
There is defensive barrier effect with virus, but can also form focus.Tracheae has substantial amounts of glandular secretion mucus, ramuscule gas with bronchus
Pipe has ciliated columnar epithelium, and cilium is constantly swung to pharyngeal direction, and to exclude secretion or foreign matter, therefore it is exhaled with holding
Inhale road cleaning, unobstructed, glandular secretion and the physiological function such as immune.
Ambroxol hydrochloride (Ambroxol Hydrochloride) is also known as AMB, is by German Bo Linge Yin
The mucolytic of Ge Han companies research and development, it is the glutinous phlegm lytic agent of a new generation, expectoration can be improved, and with promotion lung surface active
Material and Airway secretion and the effect of ciliary movement.Ambroxol hydrochloride can clinically adjust mucus and be secreted with glutinous slurry, activation
Fibre swing, it is easy to dilute sputum, strengthens mucus and outwards transport, be easy to discharge, it can also promote pulmonary surfactant to close
Into to maintain alveolar tension, guarantee lung functions index；Promoting antibiotic, to improve concentration, enhancing sterilization is made to tissue infiltration
With；It is anti-oxidant, inflammatory mediator release is reduced, with the reaction that reduces inflammation；Cooperateed with bronchus spasmolysis material, to improve spasmolysis medicine
The effect of.Therefore, the medicine clinically can be widely applied to the acute and chronic respiratory tract disease with respiratory tract abnormal secretion, especially
It is the eliminating the phlegm treatment of chronic bronchitis, the auxiliary treatment of transient respiratory distress of the newborn disease and pulmonary surgery has that toxicity is low, treats
Effect is definite and can be with antibiotic and with good synergy be produced the advantages that, for one of the most frequently used expectorant.Existed in recent years
In the emphasis hospital administration ranking of China main cities, it ranks forefront always.Existing formulation has oral liquid, tablet, capsule, micropill
Deng.
Budesonide (Budesonide) is a glucocorticoid with the effect of efficient local anti-inflammatory, and it can strengthen endothelium
The stability of cell, smooth muscle cell and lysosome membrane, suppress immune response and reduce antibody synthesis, so that the allergy such as histamine
The release of active medium is reduced and activity reduces, and can mitigate the enzymatic processes excited when antigen-antibody combines, suppresses bronchus
Shrink material synthesis and release and mitigate the contractile response of smooth muscle.The research discovery of acute, subacute and long term toxicity, this product
General action, it is weaker than other glucocorticoids or suitable such as Body weight loss, lymphoid tissue and Adrenal cortex atrophy.
Ribavirin (Biopolymers) also known as virazole, ribavirin, Nice can wait, and be the disease-resistant of broad spectrum high-effect
Cytotoxic drug, it is now widely used for the preventing and treating of viral disease.Common formulations have injection, tablet, oral liquid, aerosol etc..
Ribavirin is nucleoside transporting, may absorb about 45% from alimentary canal, once in blood plasma, Ribavirin is to pass through cell
The transport of film is also by nucleoside transporting.Ribavirin be distributed widely in a organized way, including cerebrospinal fluid and brain.Ribavirin is synthesis
Ucleosides antiviral agent.Cell culture invitro experiment shows that Ribavirin has selectivity to Respiratory Syncytial Virus(RSV) (RSV)
Inhibitory action.Ribavirin is a kind of pro-drug, when microorganism hereditary carrier is similar to purine RNA nucleotides, its meeting
Viral interference replicates required RNA metabolism.
Although it will be studied in the prior art associated with ambroxol hydrochloride, budesonide and Ribavirin, not
Develop into feasible formulation.
The content of the invention
The purpose of the present invention be to provide it is a kind of safely and effectively, steady quality, being used for of significant effect treats respiratory system
The aerosol of disease.
The present invention solve the technical problem technical scheme be：
A kind of aerosol for being used to treat respiratory disease, is prepared from the following components：Ambroxol hydrochloride 30-50g,
Budesonide 20-40g, Ribavirin 20-30g, glycerine 100-200g, Sorbitan Trioleate 15-25g, PVP 15-25g, sorb
Sour 0.5-1g, Mint Essence 0.5-2g, appropriate saccharin sodium, dichlorodifluoro ethane is appropriate, Purified Water q. s.
Preferably it is prepared from the following components：Ambroxol hydrochloride 40g, budesonide 30g, Ribavirin 25g, glycerine
150g, Sorbitan Trioleate 20g, PVP 20g, sorbic acid 1g, Mint Essence 1g, appropriate saccharin sodium, dichlorodifluoro ethane is appropriate,
Purified Water q. s.
Invention also provides the above-mentioned preparation method for being used to treat the aerosol of respiratory disease, its operating procedure
It is as follows：Ambroxol hydrochloride, budesonide and Ribavirin be crushed into 200 mesh sieves, stirring and dissolving is uniform in addition purified water, adds
Enter glycerine, Sorbitan Trioleate, PVP, sorbic acid and saccharin sodium, homogeneous stirring, preferably carry out homogeneous with high pressure homogenizer, then
Mint Essence is added, continues to stir, filling bundle valve, fills propellant dichlorodifluoro ethane, leak detection is weighed, and installs mobility aid,
Produce.
The aerosol steady quality for being used to treat respiratory disease of the present invention, significant effect, can effectively treat breathing
Systemic disease.
Embodiment
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate the present invention
Rather than limitation the scope of the present invention.The experimental method of unreceipted actual conditions in the following example, generally according to conventional strip
Part or according to the condition proposed by manufacturer.Unless otherwise indicated, otherwise all percentage, ratio, ratio or number is pressed
Weight meter.
Unless otherwise defined, anticipated known to all specialties used in text and scientific words and one skilled in the art
Justice is identical.In addition, any method similar or impartial to described content and material all can be applied in the inventive method.Wen Zhong
Described preferable implementation only presents a demonstration with material to be used.
Embodiment 1
Each component is weighed by following weight proportion：Ambroxol hydrochloride 30g, budesonide 20g, Ribavirin 20g, glycerine
100g, Sorbitan Trioleate 15g, PVP 15g, sorbic acid 0.5g, Mint Essence 0.5g, by ambroxol hydrochloride, budesonide and
Ribavirin crushed 200 mesh sieves, and stirring and dissolving is uniform in addition purified water, adds glycerine, Sorbitan Trioleate, PVP, sorb
Acid and saccharin sodium, stirred with high pressure homogenizer homogeneous, then add Mint Essence, continue to stir, filling bundle valve, fill projectile
Agent dichlorodifluoro ethane, leak detection are weighed, and are installed mobility aid, are produced.
Embodiment 2
Each component is weighed by following weight proportion：Ambroxol hydrochloride 50g, budesonide 40g, Ribavirin 30g, glycerine
200g, Sorbitan Trioleate 25g, PVP 25g, sorbic acid 1g, Mint Essence 2g, by ambroxol hydrochloride, budesonide and Li Ba
Wei Lin crushed 200 mesh sieves, and it is uniform to add stirring and dissolving in purified water, add glycerine, Sorbitan Trioleate, PVP, sorbic acid and
Saccharin sodium, stirred with high pressure homogenizer homogeneous, then add Mint Essence, continue to stir, filling bundle valve, fill propellant two
Chlorine Difluoroethane, leak detection are weighed, and are installed mobility aid, are produced.
Embodiment 3
Each component is weighed by following weight proportion：Ambroxol hydrochloride 40g, budesonide 30g, Ribavirin 25g, glycerine
150g, Sorbitan Trioleate 20g, PVP 20g, sorbic acid 1g, Mint Essence 1g, by ambroxol hydrochloride and salbutamol sulfate powder
The broken mesh sieve of mistake 200, add purified water in stirring and dissolving it is uniform, be subsequently added into ethanol, propane diols, dodecyl sodium sulfate, PVP,
Vitamin C and methyl p-hydroxybenzoate, homogeneous stir about 30min under high-shear homogenizing machine, flavoring apple essence is added, continues to stir
About 20min, filling bundle valve, fills propellant F12, and leak detection is weighed, and installs mobility aid, produces.
Embodiment 4
Stability test
1. influence factor is tested
The aerosol of embodiment 3 is respectively placed in low temperature (4 DEG C), strong light (4500lx), high temperature (60 DEG C) by commercially available back
And 10 days under the conditions of high humidity (RH75%), sampled respectively at the 0th, 5,10 day, drug content, drug content, relevant is often pressed in detection
Every quality index such as material, the results are shown in Table 1.
The aerosol influence factor result of the test of the present invention of table 1
As a result show：The aerosol of the present invention is pressed by commercially available back respectively in high temperature (60 DEG C), low temperature (4 DEG C), Qiang Guang
Placed 10 days under the conditions of (4500lx), high humidity (RH75%), detect every quality index, compared with 0 day, except high temperature (60 DEG C) has
Pass material is increased slightly and the content of active component has declined outside, and other every quality index have no significant change.
2. accelerated test
By the aerosol of embodiment 3 by commercially available back be placed in 40 DEG C, RH20% constant temperature, 6 months in constant humidity cabinet, respectively at
Sample within 0th, 1,2,3,6 month, measure often presses every quality index such as drug content, drug content, relevant material, the results are shown in Table
2。
The aerosol accelerated test result of the present invention of table 2
As a result show：The aerosol of the present invention is placed 6 months by commercially available back under conditions of 40 DEG C, RH20%, with 0
The moon compares, and in addition to relevant material is increased slightly, other every quality index have no significant change, and steady quality is reliable, meet rule
It is fixed.
3. long term test
The aerosol of embodiment 3 is placed in 25 DEG C, in RH60% environment by commercially available back, respectively at the 0th, 3,6,9,
12nd, sample within 18,24 months, every quality index such as drug content, drug content, relevant material are often pressed in inspection, the results are shown in Table 3.
The aerosol long-term test results of the present invention of table 3
As a result show：The aerosol of the present invention is placed 36 months by commercially available back in 25 DEG C, RH60% environment, and items refer to
Mark had no significant change compared with 0 month, and steady quality is reliable, meets regulation.
Embodiment 5
The phenol red secretory volume pharmacological testing of mouse tracheae
70 mouse are taken to be randomly divided into 7 groups, respectively blank control group, ambroxol hydrochloride group, budesonide group, Li Bawei
Woods group, embodiment 3 are not filled by basic, normal, high three dosage groups of aerosol of propellant, weigh, mark, the dosage such as institute of table 4
Show, blank control group gives physiological saline, and administering mode is gavage.After 30min, phenol red solution 0.1mL/ is injected intraperitoneally respectively
After 10g, 30min, animal is put to death, anatomical isolation tracheae, polish No. 7 syringe needles are inserted into tracheae about 0.3cm under larynx, with silk
Knot prick it is fixed after, extract sodium bicarbonate solution 0.5mL with 1mL syringes, by syringe needle lavation respiratory tract 3 times back and forth, last 1
It is secondary extract irrigating solution in injecting tube out, continuous 3 times of aforesaid operations, rinse 9 times altogether, be pumped irrigating solution about 1.2-1.5mL, be placed in
In test tube, centrifugation, with 721 type spectrophotometers, wavelength 546nm, trap OD values are read.Checked on standard curve corresponding
Phenol red concentration, compare the difference of each group tracheae section phenols contents.As a result it is as shown in table 4.
The phenol red secretory volume result of the test of the mouse tracheae of table 4
Due to mouse peritoneal injection indicator it is phenol red after, the latter partly can secrete from tracheae to discharge, and hydrochloric acid ammonia
Bromine rope, budesonide and Ribavirin can strengthen the secreting function of respiratory tract, so as to accordingly increase phenol red excretion amount, through carbon
After sour hydrogen sodium solution lavation tracheae, irrigating solution is developed the color, detect OD values with spectrophotometer, check in phenol red excretion amount, so as to
It can verify that the phlegm-dispelling functions of medicine.As a result showing, each administration group can substantially increase the phenol red secretory volume of Respiratory Tract of Mice, its
Middle basic, normal, high three dosage groups of composition of the invention are made compared with alone ambroxol hydrochloride, budesonide or Ribavirin group
With enhancing, significant difference, and action effect are relevant with the dosage of each composition, and effect of high dosage is best.
Claims (3)
1. a kind of aerosol for being used to treat respiratory disease, it is characterised in that be prepared from the following components：Hydrochloric acid ammonia bromine
Rope 30-50g, budesonide 20-40g, Ribavirin 20-30g, glycerine 100-200g, Sorbitan Trioleate 15-25g, PVP15-
25g, sorbic acid 0.5-1g, Mint Essence 0.5-2g, appropriate saccharin sodium, dichlorodifluoro ethane is appropriate, Purified Water q. s.
2. the aerosol according to claim 1 for being used to treat respiratory disease, it is characterised in that preferably by following
Component is prepared：Ambroxol hydrochloride 40g, budesonide 30g, Ribavirin 25g, glycerine 150g, Sorbitan Trioleate 20g,
PVP 20g, sorbic acid 1g, Mint Essence 1g, appropriate saccharin sodium, dichlorodifluoro ethane is appropriate, Purified Water q. s.
3. the preparation method according to claim 1 or 2 for being used to treat the aerosol of respiratory disease, its feature exist
In its operating procedure is as follows：Ambroxol hydrochloride, budesonide and Ribavirin be crushed into 200 mesh sieves, add in purified water and stir
Mix and be uniformly dissolved, add glycerine, Sorbitan Trioleate, PVP, sorbic acid and saccharin sodium, homogeneous stirring, preferably use high pressure homogenizer
Homogeneous is carried out, Mint Essence is then added, continues to stir, filling bundle valve fills propellant dichlorodifluoro ethane, and leak detection claims
Weight, mobility aid is installed, produced.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610876871.9A CN107669635A (en) | 2016-09-30 | 2016-09-30 | It is a kind of to be used to treat aerosol of respiratory disease and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610876871.9A CN107669635A (en) | 2016-09-30 | 2016-09-30 | It is a kind of to be used to treat aerosol of respiratory disease and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110575446A (en) * | 2019-09-09 | 2019-12-17 | 上海臣邦医药科技股份有限公司 | compound inhalation composition and preparation method thereof |
| CN111228244A (en) * | 2020-03-27 | 2020-06-05 | 杭州汉库医药科技有限公司 | Ribavirin inhalation preparation and application thereof in preparation of medicine for treating neocoronary pneumonia |
| CN112717107A (en) * | 2020-12-30 | 2021-04-30 | 茂名市人民医院 | Chinese herbal medicine cold compress gel |
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| CN1695601A (en) * | 2005-05-18 | 2005-11-16 | 湖北南洋药业有限公司 | Aerosol of ambroxol hydrochloride and preparation method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110575446A (en) * | 2019-09-09 | 2019-12-17 | 上海臣邦医药科技股份有限公司 | compound inhalation composition and preparation method thereof |
| CN111228244A (en) * | 2020-03-27 | 2020-06-05 | 杭州汉库医药科技有限公司 | Ribavirin inhalation preparation and application thereof in preparation of medicine for treating neocoronary pneumonia |
| CN112717107A (en) * | 2020-12-30 | 2021-04-30 | 茂名市人民医院 | Chinese herbal medicine cold compress gel |
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