CN107080732B - Preparation method of simethicone emulsifiable paste - Google Patents
Preparation method of simethicone emulsifiable paste Download PDFInfo
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- CN107080732B CN107080732B CN201710219565.2A CN201710219565A CN107080732B CN 107080732 B CN107080732 B CN 107080732B CN 201710219565 A CN201710219565 A CN 201710219565A CN 107080732 B CN107080732 B CN 107080732B
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- simethicone
- heating
- cream
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- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 title claims abstract description 25
- 229940083037 simethicone Drugs 0.000 title claims abstract description 25
- 238000002360 preparation method Methods 0.000 title abstract description 18
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 39
- 239000006071 cream Substances 0.000 claims abstract description 28
- 238000000034 method Methods 0.000 claims abstract description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- 238000002156 mixing Methods 0.000 claims abstract description 22
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims abstract description 16
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 14
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims abstract description 14
- 229940008099 dimethicone Drugs 0.000 claims abstract description 14
- 239000004205 dimethyl polysiloxane Substances 0.000 claims abstract description 14
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims abstract description 14
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 14
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000008117 stearic acid Substances 0.000 claims abstract description 14
- 239000004166 Lanolin Substances 0.000 claims abstract description 13
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims abstract description 13
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims abstract description 13
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims abstract description 13
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229940039717 lanolin Drugs 0.000 claims abstract description 13
- 235000019388 lanolin Nutrition 0.000 claims abstract description 13
- 239000003871 white petrolatum Substances 0.000 claims abstract description 10
- 238000003756 stirring Methods 0.000 claims description 31
- 238000010438 heat treatment Methods 0.000 claims description 27
- 238000005345 coagulation Methods 0.000 claims description 6
- 230000015271 coagulation Effects 0.000 claims description 6
- 238000013019 agitation Methods 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 abstract description 6
- 229960004274 stearic acid Drugs 0.000 abstract description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 229960005150 glycerol Drugs 0.000 abstract description 3
- 229960004418 trolamine Drugs 0.000 abstract description 3
- 235000011187 glycerol Nutrition 0.000 abstract description 2
- 230000002349 favourable effect Effects 0.000 abstract 1
- 238000003860 storage Methods 0.000 abstract 1
- 239000002245 particle Substances 0.000 description 15
- 239000000203 mixture Substances 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 6
- 238000001816 cooling Methods 0.000 description 5
- 230000009286 beneficial effect Effects 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 229940099259 vaseline Drugs 0.000 description 3
- 230000007547 defect Effects 0.000 description 2
- 229960001275 dimeticone Drugs 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000005265 energy consumption Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- CXQXSVUQTKDNFP-UHFFFAOYSA-N octamethyltrisiloxane Chemical compound C[Si](C)(C)O[Si](C)(C)O[Si](C)(C)C CXQXSVUQTKDNFP-UHFFFAOYSA-N 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 238000001514 detection method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 239000000344 soap Substances 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
Classifications
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/80—Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Cosmetics (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a novel method for preparing simethicone cream, which is prepared from simethicone, ethylparaben, triethanolamine, glycerol, stearic acid, lanolin, white vaseline and water. The present invention has surprisingly found that, on the basis of the existing preparation method of the dimethicone cream, the dimethicone cream prepared by the specific addition or mixing sequence of the components in the method of the present invention has the advantages of easy control of the production process, white product property, fine texture, good storage stability and favorable transdermal absorption compared with the dimethicone cream prepared by the prior art method.
Description
Technical Field
The invention relates to a preparation method of simethicone cream. Belongs to the field of pharmaceutical preparation.
Background
The simethicone cream is a hospital preparation product collected in the formulation code of medical institutions in Beijing, and the formula of the product comprises the following components: the liquid soap comprises simethicone, stearic acid, lanolin, white vaseline, glycerol, triethanolamine, ethylparaben and water, and comprises the following components:
the preparation method of the product comprises the following steps:
1. mixing simethicone, stearic acid, lanolin and white vaseline together, heating to melt, and cooling to about 70 deg.C;
2. mixing ethylparaben, triethanolamine, glycerol and water, heating to dissolve, and cooling to about 70 deg.C;
3. slowly adding the oil phase component at about 70 deg.C into the water phase component at similar temperature, and stirring in the same direction until coagulation.
The existing preparation method still has more defects, such as:
1. the prepared product has rough shape, the product has poor ductility during smearing, is not easy to smear uniformly, and has greasy skin, so that the absorption and the penetration of the product are poor, the curative effect of the product is influenced, and the product is not favored by patients;
2. the paste body is dark in color, is yellow-white or white-like cream, and is non-white cream;
3. the product is placed at a high temperature of about 30 ℃ for 2 months in summer, the character is rough, water seeps out of the surface layer of the paste body, and the product is in a demulsification state with separated water phase components and oil phase components.
Disclosure of Invention
In order to solve the technical defects of the simethicone cream prepared by the existing preparation method, the invention aims to provide a novel preparation method of the simethicone cream, thereby solving the problems that the prepared simethicone cream in the prior art has rough properties and poor stability, is not beneficial to transdermal absorption and the like, and providing a novel preparation method which ensures that the simethicone cream product has good properties and stable quality and is beneficial to transdermal absorption.
The technical scheme of the invention is as follows:
the invention provides a method for preparing simethicone cream, which is prepared from simethicone, ethylparaben, triethanolamine, glycerol, stearic acid, lanolin, white vaseline and water, and is characterized by comprising the following steps of:
(1) mixing triethanolamine and stearic acid;
(2) mixing dimethicone, white vaseline and lanolin;
(3) mixing glycerol, ethylparaben and water;
(4) adding the product prepared in the step (1) into the product prepared in the step (3);
(5) adding the product obtained in the step (2) into the product obtained in the step (4).
The method is characterized in that the mixing and heating temperature of the triethanolamine and the stearic acid in the step (1) is 55-70 ℃, and preferably 58-65 ℃.
The method of the present invention is characterized in that the temperature of the mixing and heating in the step (2) or the step (3) is 65 to 85 ℃, preferably 67 to 80 ℃.
The method of the present invention is characterized in that heating is performed while stirring in the step (1), the step (2) or the step (3).
The method of the present invention is characterized in that the stirring in the step (4) is performed uniformly.
The method of the present invention as described above, wherein the stirring is performed in one direction until coagulation in the step (5).
The method of the present invention, wherein in the step (4) or the step (5), the temperature is 65 to 85 ℃, preferably 65 to 78 ℃.
As a specific embodiment of the present invention, the method of the present invention is characterized by comprising the steps of:
(1) mixing triethanolamine and stearic acid, stirring and heating to 58-63 ℃, and preserving heat for 5-10 minutes;
(2) mixing dimethicone, white vaseline and lanolin, heating to melt at 67-80 deg.C;
(3) mixing glycerol, ethylparaben and water, heating, stirring and dissolving at 67-80 deg.C;
(4) adding the product prepared in the step (1) into the product prepared in the step (3), and uniformly stirring at the temperature of 65-78 ℃;
(5) adding the product obtained in the step (2) into the product obtained in the step (4), and stirring in one direction until the product is coagulated at the temperature of 65-78 ℃.
The method of the present invention, wherein the dimethicone cream comprises, by weight, 1000 parts of dimethicone cream, 200 parts of dimethicone, 1 part of ethylparaben, 20 parts of triethanolamine, 40 parts of glycerol, 149 parts of stearic acid, 20 parts of lanolin, 70 parts of white vaseline, and the balance of purified water.
It has been unexpectedly found in the present invention that the simethicone cream prepared by the specific addition or mixing sequence of the components of the method of the present invention has at least the following unexpected benefits over simethicone creams prepared by prior art methods:
1. the preparation method breaks through the limitation that the mixed emulsification temperature is about 70 ℃ in the prior art, expands the temperature range, is convenient to control the production process, has white product character and fine texture, reduces cooling and steam heating operation in the processes that the water phase components and the oil phase components are adjusted to be close in temperature, reduces energy consumption and production working hours, and saves the product cost;
2. the dimeticone emulsifiable paste prepared by the preparation method is oily and fine, the particle size can reach 1 mu m, and the particle size is smaller than that of a product prepared by the prior art; and after the constant-temperature and constant-humidity drying oven is placed for 3 months, the phenomenon of demulsification of oil-water separation does not occur, and the particle size is not changed, which shows that the product prepared by the preparation method of the invention has stable quality and good properties, and is beneficial to transdermal absorption;
3. the preparation method of the invention has simple operation, does not need to increase equipment, saves production working hours and energy consumption, and reduces product cost.
Detailed Description
The following describes in detail specific embodiments of the present invention. It should be understood that the detailed description and specific examples, while indicating the present invention, are given by way of illustration and explanation only, not limitation.
Preparation of simethicone cream
Example 1
The product comprises the following components:
the preparation method comprises the following steps:
1.1, putting stearic acid and triethanolamine into the same container, heating to 61 ℃ in a water bath with stirring, and preserving heat for 8 minutes;
1.2, placing the simethicone, the vaseline and the lanolin in a same container, heating and stirring until the temperature is 75 ℃, and completely melting an oil phase;
1.3, putting the glycerol, the ethylparaben and the purified water into the same container, heating and stirring the mixture until the temperature is 75 ℃, and completely dissolving the water phase;
1.4 adding item 1.1 to item 1.3 at 74 deg.C, stirring, adding item 1.2 to item 1.3 at 73 deg.C, and stirring in one direction to coagulate to obtain simethicone cream.
Example 2
The product composition and process flow were as in example 1.
1.1, putting stearic acid and triethanolamine into the same container, heating to 63 ℃ in a water bath with stirring, and preserving heat for 5 minutes;
1.2, placing the simethicone, the vaseline and the lanolin in a same container, heating and stirring the mixture until the temperature is 80 ℃, and completely melting an oil phase;
1.3, putting the glycerol, the ethylparaben and the purified water into the same container, heating and stirring the mixture until the temperature is 80 ℃, and completely dissolving the water phase;
1.4 adding item 1.1 to item 1.3, stirring at 78 deg.C, adding item 1.2 to item 1.3, stirring at 78 deg.C until coagulation, and making into dimethicone cream.
Example 3
The product composition and process flow were the same as in example 1.
1.1, putting stearic acid and triethanolamine into the same container, heating to 58 ℃ while stirring in a water bath, and preserving heat for 10 minutes;
1.2, placing the simethicone, the vaseline and the lanolin in a same container, heating and stirring until the temperature is 67 ℃, and completely melting an oil phase;
1.3, putting the glycerol, the ethylparaben and the purified water into the same container, heating and stirring until the temperature is 67 ℃, and completely dissolving the water phase;
1.4, adding 1.1 item to 1.3 item, stirring at 65 deg.C, adding 1.2 item to 1.3 item, stirring at 65 deg.C in the same direction until coagulation, and making into dimethicone cream.
Comparative example 1:
the product composition was the same as in example 1.
The existing dimeticone cream preparation method is adopted:
1.1, mixing simethicone, stearic acid, lanolin and white vaseline together, heating to melt, and cooling to 70 ℃ for later use;
1.2, mixing ethylparaben, triethanolamine, glycerol and water together, heating to dissolve, and cooling to 70 ℃ for later use;
1.3, slowly adding 1.1 item of 70 ℃ into 1.2 items of 70 ℃, and stirring in the same direction until coagulation to obtain the simethicone cream.
Comparison of detection results of (di) simethicone cream products
1. The dimethicone creams prepared in example 1, example 2, example 3 and comparative example 1 were sampled, smeared and observed under a microscope for the particle size of the formulated product:
(1) example 1 the prepared product has oily and fine properties; the particle size is generally 1 μm and larger is 3-4 μm when observed under a microscope;
(2) example 2 the prepared product has oily and fine properties; the particle size is generally 1 μm and 3-5 μm larger when observed under a microscope;
(3) example 3 the prepared product has oily and fine properties; the particle size is generally 1 μm and 3-5 μm larger when observed under a microscope;
(4) the prepared product has oily and fine properties in a comparative example 1; the particle size is typically 3-4 μm, 2-3 μm smaller and 8-10 μm larger when observed under a microscope.
2. The example 1, example 2, example 3 and comparative example 1 formulations were placed in a constant temperature and humidity cabinet: and (3) observing the product properties and observing the particle size under a microscope after standing for 3 months at the temperature of 40 +/-2 ℃ and the relative humidity of 75% +/-5%:
(1) example 1 formulated product with no change in properties: is oily and fine; the particle size is generally 1 μm and larger is 3-4 μm when observed under a microscope;
(2) example 2 formulated product with no change in properties: is oily and fine; the particle size is generally 1 μm and 3-5 μm larger when observed under a microscope;
(3) example 3 formulated product with no change in properties: is oily and fine; the particle size is generally 1 μm and 3-5 μm larger when observed under a microscope;
(4) comparative example 1 preparation of product properties: the appearance of the paste is slightly oily, slightly rough and slightly changed in fineness; the particle size is typically 5-7 μm, 4-5 μm smaller and 12-14 μm larger when observed under a microscope.
3. And (4) conclusion: the prepared product in the embodiment of the invention is oily and fine, and the particle size is smaller than that of the prepared product in the comparative example; after the cream is placed in a constant temperature and humidity drying oven for 3 months, the demulsification change of the separation of the oil phase component and the water phase component does not occur, and the particle size is not changed, which shows that the dimethicone cream prepared by the method has stable quality and good properties and is beneficial to transdermal absorption.
The present invention has been described in detail with reference to the embodiments, but the present invention is not limited to the details of the above embodiments, and various simple modifications can be made to the technical solution of the present invention within the technical idea of the present invention, and the simple modifications are within the protective scope of the present invention.
Claims (7)
1. The method for preparing the simethicone cream is characterized by comprising the following steps of:
(1) mixing triethanolamine and stearic acid, stirring and heating to 58-65 ℃, and preserving heat for 5-10 minutes;
(2) mixing dimethicone, white vaseline and lanolin;
(3) mixing glycerol, ethylparaben and water;
(4) adding the product prepared in the step (1) into the product prepared in the step (3);
(5) adding the product obtained in the step (2) into the product obtained in the step (4).
2. The method according to claim 1, wherein the temperature of the mixing heating in the step (2) or the step (3) is 65 to 85 ℃.
3. The method according to claim 2, wherein the temperature of the mixing heating in the step (2) or the step (3) is 67-80 ℃.
4. The method according to any one of claims 1 to 3, wherein heating while stirring is performed in step (1), step (2) or step (3).
5. The method according to any one of claims 1 to 3, wherein the stirring is performed uniformly in the step (4).
6. A method according to any one of claims 1 to 3, wherein in step (5) the agitation is in one direction to coagulation.
7. A method according to any of claims 1-3, characterized by the steps of:
(1) mixing triethanolamine and stearic acid, stirring and heating to 58-65 ℃, and preserving heat for 5-10 minutes;
(2) mixing dimethicone, white vaseline and lanolin, heating to melt at 67-80 deg.C;
(3) mixing glycerol, ethylparaben and water, heating, stirring and dissolving at 67-80 deg.C;
(4) adding the product prepared in the step (1) into the product prepared in the step (3), and uniformly stirring;
(5) adding the product prepared in the step (2) into the product prepared in the step (4), and stirring in one direction until the product is coagulated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710219565.2A CN107080732B (en) | 2017-04-06 | 2017-04-06 | Preparation method of simethicone emulsifiable paste |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710219565.2A CN107080732B (en) | 2017-04-06 | 2017-04-06 | Preparation method of simethicone emulsifiable paste |
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| Publication Number | Publication Date |
|---|---|
| CN107080732A CN107080732A (en) | 2017-08-22 |
| CN107080732B true CN107080732B (en) | 2020-08-11 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201710219565.2A Active CN107080732B (en) | 2017-04-06 | 2017-04-06 | Preparation method of simethicone emulsifiable paste |
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| Country | Link |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1282368A (en) * | 1997-12-22 | 2001-01-31 | 道·康宁澳大利亚有限公司 | Stable emulsions |
-
2017
- 2017-04-06 CN CN201710219565.2A patent/CN107080732B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1282368A (en) * | 1997-12-22 | 2001-01-31 | 道·康宁澳大利亚有限公司 | Stable emulsions |
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| CN107080732A (en) | 2017-08-22 |
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Address after: 101304 Beijing city Shunyi District Li Qiao Zhen Li Li Road Bridge No. 5 Patentee after: Beijing Shou'er Pharmaceutical Factory Address before: 101304 Beijing city Shunyi District Li Qiao Zhen Li Li Road Bridge No. 5 Patentee before: BEIJING SHOUER PHARMACEUTICAL FACTORY |
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Effective date of registration: 20231211 Address after: 100020 Beijing city Chaoyang District Yabao Road No. 2 Patentee after: CAPITAL INSTITUTE OF PEDIATRICS Address before: 101304 Beijing city Shunyi District Li Qiao Zhen Li Li Road Bridge No. 5 Patentee before: Beijing Shou'er Pharmaceutical Factory |