CN106176805A - A kind of gynecilogical operation anti-sticking flush fluid and preparation method thereof - Google Patents
A kind of gynecilogical operation anti-sticking flush fluid and preparation method thereof Download PDFInfo
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- CN106176805A CN106176805A CN201610713248.1A CN201610713248A CN106176805A CN 106176805 A CN106176805 A CN 106176805A CN 201610713248 A CN201610713248 A CN 201610713248A CN 106176805 A CN106176805 A CN 106176805A
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- flush fluid
- icodextrin
- flushing liquor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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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
- A61K9/08—Solutions
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Abstract
The invention discloses a kind of gynecilogical operation anti-sticking flush fluid and preparation method thereof, belong to the technical field of surgical flush fluid.The flushing liquor of every 1L present invention is prepared from by the raw material of following weight portion: icodextrin 30 50g, sodium chloride 4.5 6.5g, calcium chloride 0.1 0.5g, magnesium chloride 0.01 0.1g, sodium lactate 4.0 5.0g, injection water are appropriate, present invention also offers the preparation method of above-mentioned flushing liquor.The present invention takes full advantage of the anti effect of icodextrin, and with the addition of calcium ion, magnesium ion and sodium lactate, the interpolation of calcium ion and magnesium ion enhances its antibacterial and bacteriostasis, be conducive to the healing of wound surface, sodium lactate is as pH buffer agent, ensure that the normal osmotic pressure of intraperitoneal and pH value, decrease the generation of side reaction；Further, the flushing liquor good stability of the present invention, the most degradable and degeneration, developing result and preventing adhesiving effect are good, non-stimulated to skin, easy to use.
Description
Technical field
The invention belongs to the technical field of surgical flush fluid, particularly relate to a kind of gynecilogical operation anti-sticking flush fluid and
Preparation method.
Background technology
Adhesion refers to the attachment that tissue is abnormal with tissue surface, is the peritoneum excessive physiological reaction to damage；Adhesion conduct
A part for wound healing process is typically useful, but, adhesion is also to cause gynecologic surgery small intestinal obstruction, infertile, slow
The major reason of property pelvic pain；Meanwhile, the difficulty that patient performs the operation again is too increased.Research shows, gynecologic surgery visceral layer
Peritoneum (uterus, ovary, fallopian tube) is easier to stick together than parietal peritoneum (pelvic cavity and abdominal cavity), and the infertility of 20% is by gluing
Even cause；But, the patient's adhesion incidence rate living through open gynecilogical operation is up to 97%, after initial surgery in 10 years, because of
Pelvic adhesion relevant disease and the risk be again admitted to hospital accounts for 5%, the postoperative patient of nearly 35% is admitted to hospital again up to more than 2 times.
In recent years, anti-abdominal adhesions medicine only has physical barriers class material, and such as solid and liquid formulation, these materials can
Obtaining food and drug administration (FDA) accreditation in American-European or even the whole world and extensively apply, they are mainly by physical barriers mode
Commitment at Adhesion formation make the region be wound and peripheral tissues's isolation thus the formation of barrier fibers albumen bridge in case
Only abdominal adhesions is formed.Therefore, these physical barriers class materials'uses are inconvenient, unstable properties big to skin irritation, and
And, it is easy to cause surgical adhesions and traumatic infection, induce secondary disease.
Summary of the invention
The present invention provides a kind of gynecilogical operation anti-sticking flush fluid and preparation method thereof, solves of the prior art anti-
The problem that abdominal adhesions medicine preventing adhesiving effect difference is easily caused secondary disease.
A kind of gynecilogical operation anti-sticking flush fluid of the present invention, it is mainly realized by the following technical programs
: flushing liquor described in every 1000mL is prepared from by the raw material of following weight portion: icodextrin 30-50g, sodium chloride 4.5-
6.5g, calcium chloride 0.1-0.5g, magnesium chloride 0.01-0.1g, sodium lactate 4.0-5.0g, injection water are appropriate.
The present invention takes full advantage of the anti effect of icodextrin, and with the addition of calcium ion, magnesium ion and sodium lactate,
Under the effect of sodium ion, the interpolation of calcium ion and magnesium ion further enhancing its antibacterial and bacteriostasis, advantageously in wound
The healing in face；Sodium lactate is as pH buffer agent, it is ensured that the normal osmotic pressure of intraperitoneal and pH value, decreases sending out of side reaction
Raw, reduce the stimulation to skin；Further, the flushing liquor good stability of the present invention, the most degradable and degeneration, storage side
Just, the holding time is long；Its surgery washing is effective, and preventing adhesiving effect is good, easy to use.
As a kind of preferred embodiment, flushing liquor described in every 1000mL is prepared from by the raw material of following weight portion:
Icodextrin 35-45g, sodium chloride 5.0-6.0g, calcium chloride 0.2-0.4g, magnesium chloride 0.04-0.08g, sodium lactate 4.2-4.8g,
Injection water is appropriate.By optimizing the adding proportion of each raw material, improve sterilization and the bacteriostasis of flushing liquor further, shorten wound surface
Healing time；Adjust the pH value of flushing liquor so that it is gentleer, non-stimulated to skin, reach more preferable surgery washing and prevent
Adhesion effect.
As a kind of preferred embodiment, the molecular weight of described icodextrin is 13000-19000 dalton.This point
Son amount icodextrin preventing adhesiving effect more preferably, and, it is easier to disperse with other raw material, thus form homogeneous flushing
Liquid.
As a kind of preferred embodiment, the osmotic pressure of described flushing liquor is 270-280mOsm/L, described flushing liquor
PH value is 6.5-7.5, and the dynamic viscosity at 20 DEG C of described flushing liquor is 0.9-1.5mPa s.This pH value of the present invention with
Body fluid is more nearly, and is a kind of isotonic flushing liquor, has fully ensured that the normal osmotic pressure of intraperitoneal and pH value, has decreased side reaction
Generation, reduce the stimulation to skin.
The preparation method of a kind of gynecilogical operation anti-sticking flush fluid of the present invention, it is the most by the following technical programs
Realized: comprise the following steps: 1) by the icodextrin of recipe quantity, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, add
In the injection water of recipe quantity, stirring so that it is dissolve, obtain solution；2) step 1) gained solution is carried out moist heat sterilization, sterilising temp
Being 121 DEG C, sterilization time is 15-30min, obtains product.
The preparation method of the present invention is carried out at normal temperatures and pressures, it is not necessary to special equipment, temperature and pressure requirement, operation side
Just, energy consumption is low, cost-effective, convenient and swift, it is easy to accomplish industrialization；Gained property of flush fluid of the present invention is stable, surgery washing
Good with preventing adhesiving effect, easy to use.
As a kind of preferred embodiment, described step 2) before, by step 1) gained solution respectively through 5 μm, 0.45 μ
M filter element and reflux line, circulating reflux 20-30min, finally, through 0.22 μm filter element filtering.Increase filtration step to remove flushing
Impurity in liquid, improves the bio-safety performance of flushing liquor.
As a kind of preferred embodiment, the molecular weight of described icodextrin is 13000-19000 dalton.This point
The icodextrin of son amount is easy to use, and dissolution velocity is fast, improves conventional efficient.
As a kind of preferred embodiment, described step 2) osmotic pressure of products obtained therefrom is 270-280mOsm/L, pH value
For 6.5-7.5, the dynamic viscosity at 20 DEG C is 0.9-1.5mPa s.The present invention is mutually matched by each raw material, is prepared for one
Plant isotonic flushing liquor, fully ensured that the normal osmotic pressure of intraperitoneal and pH value, decreased the generation of side reaction, reduce skin
The stimulation of skin.
Beneficial effects of the present invention: the present invention takes full advantage of the anti effect of icodextrin, and with the addition of calcium ion,
Magnesium ion and sodium lactate, under the effect of sodium ion, the interpolation of calcium ion and magnesium ion enhances its antibacterial and bacteriostasis, has
It is beneficial to the healing of wound surface；Sodium lactate is as pH buffer agent, it is ensured that the normal osmotic pressure of intraperitoneal and pH value, decreases side reaction
Generation, reduce the stimulation to skin；Further, the gynecilogical operation of present invention anti-sticking flush fluid good stability, no
Degradable and degeneration, the holding time is long；Developing result and preventing adhesiving effect are good, easy to use.
Detailed description of the invention
Technical scheme is clearly and completely described by the specific embodiment below in conjunction with the present invention, aobvious
So, described embodiment is only a part of embodiment of the present invention rather than whole embodiments.Based in the present invention
Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under not making creative work premise, all
Belong to the scope of protection of the invention.
A kind of gynecilogical operation anti-sticking flush fluid of the present invention, former by following weight portion of flushing liquor described in every 1000mL
Material is prepared from: icodextrin 30-50g, sodium chloride 4.5-6.5g, calcium chloride 0.1-0.5g, magnesium chloride 0.01-0.1g, lactic acid
Sodium 4.0-5.0g, injection water are appropriate.
Preferably, flushing liquor described in every 1000mL is prepared from by the raw material of following weight portion: icodextrin 35-45g, chlorine
Change sodium 5.0-6.0g, calcium chloride 0.2-0.4g, magnesium chloride 0.04-0.08g, sodium lactate 4.2-4.8g, injection water are appropriate.
Specifically, the molecular weight of described icodextrin is 13000-19000 dalton.
Further, the osmotic pressure of described flushing liquor is 270-280mOsm/L, and the pH value of described flushing liquor is 6.5-7.5,
Dynamic viscosity at 20 DEG C of described flushing liquor is 0.9-1.5mPa s.
The preparation method of a kind of gynecilogical operation anti-sticking flush fluid of the present invention, comprises the following steps: 1) by recipe quantity
Icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, add recipe quantity injection water in, stirring so that it is dissolve,
Solution；2) step 1) gained solution being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 15-30min, obtains product
Product.
Preferably, described step 2) before, by step 1) gained solution respectively through 5 μm, 0.45 μm filter element and reflux line,
Circulating reflux 20-30min, finally, through 0.22 μm filter element filtering.
Specifically, the molecular weight of described icodextrin is 13000-19000 dalton.
Further, described step 2) osmotic pressure of products obtained therefrom is 270-280mOsm/L, pH value is 6.5-7.5,20 DEG C
Under dynamic viscosity be 0.9-1.5mPa s.
Embodiment one
The preparation method of a kind of gynecilogical operation anti-sticking flush fluid of the present invention comprises the following steps:
1) raw material is weighed: icodextrin 40g, sodium chloride 5.4g, sodium lactate 4.5g, calcium chloride 0.257g, magnesium chloride 0.051g, note
Penetrate and use water 1000mL, water for injection i.e. injection water in the present invention；
2) above-mentioned icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride are sequentially added in above-mentioned injection water, stirring, make
It dissolves, and obtains solution；
3) above-mentioned solution being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 30min, obtains product.
Embodiment two
The preparation method of a kind of gynecilogical operation anti-sticking flush fluid of the present invention comprises the following steps:
1) raw material is weighed: icodextrin 50g, sodium chloride 6.5g, sodium lactate 4.0g, calcium chloride 0.1g, magnesium chloride 0.01g, injection
Use water 1000mL；
2) above-mentioned icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride are sequentially added in above-mentioned injection water, stirring, make
It dissolves, and obtains solution；
3) above-mentioned solution being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 15min, obtains product.
Embodiment three
The preparation method of a kind of gynecilogical operation anti-sticking flush fluid of the present invention comprises the following steps:
1) raw material is weighed: icodextrin 30g, sodium chloride 4.5g, sodium lactate 5.0g, calcium chloride 0.5g, magnesium chloride 0.1g, injection
Water 1000mL；
2) above-mentioned icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride are sequentially added in above-mentioned injection water, stirring, make
It dissolves, and obtains solution；
3) by above-mentioned solution respectively through 5 μm, 0.45 μm filter element and reflux line, circulating reflux 20min, finally, filter through 0.22 μm
Core filters, and obtains filtrate；
4) above-mentioned filtrate being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 20min, obtains product.
Embodiment four
1) raw material is weighed: icodextrin 35g, sodium chloride 5.0g, sodium lactate 4.2g, calcium chloride 0.2g, magnesium chloride 0.04g, injection
Using water 1000mL, wherein, the molecular weight of icodextrin is 13000-19000 dalton；
2) above-mentioned icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride are sequentially added in above-mentioned injection water, stirring, make
It dissolves, and obtains solution；
3) by above-mentioned solution respectively through 5 μm, 0.45 μm filter element and reflux line, circulating reflux 30min, finally, filter through 0.22 μm
Core filters, and obtains filtrate；
4) above-mentioned filtrate being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 20min, obtains product.
Embodiment five
1) raw material is weighed: icodextrin 45g, sodium chloride 6.0g, sodium lactate 4.8g, calcium chloride 0.4g, magnesium chloride 0.08g, injection
Using water 1000mL, wherein, the molecular weight of icodextrin is 13000-19000 dalton；
2) above-mentioned icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride are sequentially added in above-mentioned injection water, stirring, make
It dissolves, and obtains solution；
3) by above-mentioned solution respectively through 5 μm, 0.45 μm filter element and reflux line, circulating reflux 25min, finally, filter through 0.22 μm
Core filters, and obtains filtrate；
4) above-mentioned filtrate being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 20min, obtains product.
Experiment 1
Five kinds of gynecilogical operation anti-sticking flush fluids of embodiments of the invention one to embodiment five gained are carried out quality inspection respectively
Surveying, wherein, chloride content uses titration measuring, and sodium gluconate uses high effective liquid chromatography for measuring, the mensuration of heavy metal
Method carries out detecting that (limitation is ten million point according to four general rule 0821 heavy metal inspection technique the first methods of " Chinese Pharmacopoeia " version in 2015
Three), the assay method of bacterial endotoxin is carried out according to " Chinese Pharmacopoeia " version four general rules 1,143 first method in 2015, experiment knot
Fruit lists table 1 in.
As can be seen from Table 1, the pH value of gynecilogical operation anti-sticking flush fluid of the present invention between 6.5-7.5, osmotic pressure
Between 270-280mOsmol/kg, the dynamic viscosity at 20 DEG C is between 0.9-1.5mPa s；Therefore, the gynecological of the present invention
The pH value of operation anti-sticking flush fluid and osmotic pressure, all close to physiological level, are more suitable for human body needs；The present invention rinses
The content of beary metal of liquid all meets regulation, and its bacterial endotoxin is also respectively less than 0.5EU/mL, therefore, the production technology mistake of the present invention
Cheng Zhong, less to primary attachment, quality control is strict, and product biological safety is good.
The quality measurements of table 1 flushing liquor of the present invention
Experiment 2
By embodiments of the invention one to embodiment five gained five kinds of gynecilogical operation anti-sticking flush fluids, existing Clinical practice
Physical barriers class material (liquid reagent) of anti-abdominal adhesions and normal saline flushing liquid carry out animal surgery respectively and rinse real
Test.
Experimental technique: take female rats 70, is randomly divided into 7 groups by rat, often group 10, respectively normal saline group,
The flushing liquor group of existing Clinical practice and five experimental grouies of the embodiment of the present invention one to embodiment five；After rat anesthesia, enter
Row ovarian resection, uses above-mentioned different flushing liquor to be rinsed, sews up a wound, with rat postoperative survival rate, survival rats
The convalescence after Miles operation and peritoneal adhesion situation are investigated as index, and experimental result lists table 2 in.
As can be seen from Table 2, compared with normal saline group, gained gynecilogical operation anti-sticking flush fluid of the present invention, operation
During adhesion phenomenon does not the most occur, its developing result and preventing adhesiving effect are more preferable, and animal dis motility rate is higher, during surgery recovery
Between be greatly shortened；Compared with the flushing liquor of existing Clinical practice, gained gynecilogical operation anti-sticking flush fluid of the present invention, operation
During adhesion phenomenon does not the most occur, its developing result and preventing adhesiving effect are more preferable, and animal dis motility rate improves further, hands
Art shortens recovery time further；Therefore, gained gynecilogical operation anti-sticking flush fluid of the present invention has more preferable surgical effect.
The different flushing liquor zoopery comparing result of table 2
Beneficial effects of the present invention: the present invention takes full advantage of the anti effect of icodextrin, and with the addition of calcium ion, magnesium from
Son and sodium lactate, under the effect of sodium ion, the interpolation of calcium ion and magnesium ion enhances its antibacterial and bacteriostasis, is conducive to
The healing of wound surface；Sodium lactate is as pH buffer agent, it is ensured that the normal osmotic pressure of intraperitoneal and pH value, decreases sending out of side reaction
Raw, reduce the stimulation to skin；Further, the gynecilogical operation of present invention anti-sticking flush fluid good stability, it is difficult to fall
Solving and degeneration, the holding time is long；Developing result and preventing adhesiving effect are good, easy to use.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all essences in the present invention
Within god and principle, any modification, equivalent substitution and improvement etc. made, should be included within the scope of the present invention.
Claims (8)
1. a gynecilogical operation anti-sticking flush fluid, it is characterised in that described in every 1000mL, flushing liquor is by following weight portion
Raw material is prepared from:
Icodextrin 30-50g, sodium chloride 4.5-6.5g, calcium chloride 0.1-0.5g, magnesium chloride 0.01-0.1g, sodium lactate 4.0-
5.0g, injection water are appropriate.
Gynecilogical operation anti-sticking flush fluid the most according to claim 1, it is characterised in that flushing liquor described in every 1000mL
It is prepared from by the raw material of following weight portion:
Icodextrin 35-45g, sodium chloride 5.0-6.0g, calcium chloride 0.2-0.4g, magnesium chloride 0.04-0.08g, sodium lactate 4.2-
4.8g, injection water are appropriate.
Gynecilogical operation anti-sticking flush fluid the most according to claim 1 and 2, it is characterised in that:
The molecular weight of described icodextrin is 13000-19000 dalton.
Gynecilogical operation anti-sticking flush fluid the most according to claim 1 and 2, it is characterised in that:
The osmotic pressure of described flushing liquor is 270-280mOsm/L, and the pH value of described flushing liquor is 6.5-7.5, described flushing liquor
Dynamic viscosity at 20 DEG C is 0.9-1.5mPa s.
The preparation method of gynecilogical operation anti-sticking flush fluid the most according to claim 1 and 2, it is characterised in that include
Following steps:
1) by the icodextrin of recipe quantity, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, add in the injection water of recipe quantity, stir
Mix so that it is dissolve, obtain solution；
2) step 1) gained solution being carried out moist heat sterilization, sterilising temp is 121 DEG C, and sterilization time is 15-30min, obtains product.
The preparation method of gynecilogical operation anti-sticking flush fluid the most according to claim 5, it is characterised in that:
Described step 2) before, by step 1) gained solution respectively through 5 μm, 0.45 μm filter element and reflux line, circulating reflux 20-
30min, finally, through 0.22 μm filter element filtering.
The preparation method of gynecilogical operation anti-sticking flush fluid the most according to claim 5, it is characterised in that:
The molecular weight of described icodextrin is 13000-19000 dalton.
The preparation method of gynecilogical operation anti-sticking flush fluid the most according to claim 5, it is characterised in that:
Described step 2) osmotic pressure of products obtained therefrom is 270-280mOsm/L, pH value is 6.5-7.5, the dynamic viscosity at 20 DEG C
For 0.9-1.5mPa s.
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| CN201610713248.1A CN106176805A (en) | 2016-08-24 | 2016-08-24 | A kind of gynecilogical operation anti-sticking flush fluid and preparation method thereof |
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Cited By (3)
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| CN107308184A (en) * | 2017-07-18 | 2017-11-03 | 江苏海尔滋生物科技有限公司 | Icodextrin biomaterial and preparation method thereof |
| CN111617307A (en) * | 2020-06-29 | 2020-09-04 | 华仁药业股份有限公司 | Novel cold compress paste |
| CN111643395A (en) * | 2020-06-29 | 2020-09-11 | 华仁药业股份有限公司 | Toothpaste for protecting oral mucosa and preparation method thereof |
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| CN104619348A (en) * | 2012-11-27 | 2015-05-13 | 泰尔茂株式会社 | Peritoneal dialysis fluid |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107308184A (en) * | 2017-07-18 | 2017-11-03 | 江苏海尔滋生物科技有限公司 | Icodextrin biomaterial and preparation method thereof |
| CN111617307A (en) * | 2020-06-29 | 2020-09-04 | 华仁药业股份有限公司 | Novel cold compress paste |
| CN111643395A (en) * | 2020-06-29 | 2020-09-11 | 华仁药业股份有限公司 | Toothpaste for protecting oral mucosa and preparation method thereof |
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Application publication date: 20161207 |