CN114748417A - Oral glucosamine preparation and preparation method and application thereof - Google Patents
Oral glucosamine preparation and preparation method and application thereof Download PDFInfo
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- CN114748417A CN114748417A CN202210586935.7A CN202210586935A CN114748417A CN 114748417 A CN114748417 A CN 114748417A CN 202210586935 A CN202210586935 A CN 202210586935A CN 114748417 A CN114748417 A CN 114748417A
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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
- A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
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- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6921—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
- A61K47/6923—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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Abstract
The invention relates to the technical field of glucosamine oral liquid preparation, in particular to a glucosamine preparation suitable for oral administration and a preparation method and application thereof. The preparation comprises the following components in parts by weight: 22-38 parts of glucosamine and/or medically acceptable salt, 12-18 parts of flavoring agent, 0.15-0.3 part of antioxidant, 0.5-3.8 parts of hydrotalcite powder, 1.6-2.95 parts of ferric acetate and 170-220 parts of water; the pH of the preparation is kept between 6 and 7. The glucosamine preparation disclosed by the invention is added with two special components of hydrotalcite powder and ferric acetate, so that the glucosamine preparation for oral administration disclosed by the invention has good light-shielding capability, the stability of the glucosamine preparation can be effectively improved, and the storage time of the glucosamine oral liquid is prolonged.
Description
Technical Field
The invention relates to the technical field of glucosamine oral liquid preparation, in particular to a glucosamine preparation suitable for oral administration and a preparation method and application thereof.
Background
Glucosamine, which participates in the structure of tissues, cell membranes, etc. in the human body, is an intermediate substance for the synthesis of proteoglycan macromolecules, is mainly present in cartilage, collagen and proteins in the human body, is a relatively important nutrient for the formation of chondrocytes, and is a natural component of healthy articular cartilage, and therefore, is mainly used for supplementing cartilage matrix and promoting cartilage repair. Research results show that glucosamine in a human body is gradually reduced along with the increase of the age, so that the elderly easily lack the glucosamine in the human body, and further, the articular cartilage is degenerated and abraded. Therefore, the oral glucosamine can be supplemented to help repair and maintain damaged articular cartilage, and has the functions of stimulating the growth of articular chondrocytes and generating articular cartilage matrix. However, the chemical property of glucosamine is unstable, and the common oral glucosamine solution is not easy to store, and can be decomposed by light irradiation even in a common illumination environment.
Disclosure of Invention
Aiming at the problems, the invention provides an oral glucosamine preparation, and a preparation method and application thereof. The glucosamine preparation prepared by the invention has good light-shielding capability, and the stability and the storage time of the glucosamine preparation can be effectively improved. To achieve the above object, the present invention discloses the following aspects.
On one hand, the invention discloses an oral glucosamine preparation, which comprises the following components in parts by weight: 22-38 parts of glucosamine and/or medically acceptable salt, 12-18 parts of flavoring agent, 0.15-0.3 part of antioxidant, 0.5-3.8 parts of hydrotalcite, 1.6-2.95 parts of ferric acetate and 170-220 parts of water; the pH value of the preparation is kept between 6 and 7.
Further, the pharmaceutically acceptable salt includes any one of glucosamine hydrochloride, glucosamine sulfate, glucosamine double salt, and the like.
Further, the flavoring agent includes at least one of honey, sucrose, xylitol, etc. to increase the taste of the oral preparation for easy administration.
Further, the antioxidant comprises: any one of vitamin C, sodium bisulfite, sodium sulfite, sodium metabisulfite, sodium ascorbate, etc.
Further, the pH of the formulation is achieved by the addition of a pH adjusting agent. Optionally, the pH adjuster comprises: acetic acid, citric acid, lactic acid, malic acid, sodium dihydrogen phosphate, etc.
Furthermore, the fineness of the hydrotalcite powder is 5000-8000 meshes, so that the hydrotalcite powder is fully dispersed in a liquid phase, and agglomeration is reduced.
In another aspect, the present invention discloses a method for preparing the oral glucosamine preparation, which comprises the following steps:
(1) and adding the glucosamine and/or medically acceptable salt, antioxidant and hydrotalcite powder into the water, and uniformly mixing to obtain a mixed solution A.
(2) And adding the iron acetate and the flavoring agent into the mixed solution A, uniformly mixing, and then adjusting the pH value of the system to a set value to obtain the product.
Further, in the step (1), the operation of uniformly mixing is performed by means of ultrasonic stirring, so that the hydrotalcite powder is uniformly dispersed in the liquid phase.
Further, in the step (2), the operation of uniformly mixing is performed by adopting a mechanical stirring mode.
Further, in the step (2), the pH regulator is added to regulate the pH value, and the mixture is stirred again after the pH value is regulated, so that the uniform glucosamine preparation is obtained.
In one aspect, the invention discloses the use of said oral glucosamine formulations in the fields of rehabilitation, medicine and the like.
Compared with the prior art, the invention has the following beneficial effects: the glucosamine preparation disclosed by the invention is added with two special components of hydrotalcite powder and ferric acetate, so that the glucosamine preparation for oral administration disclosed by the invention has good light-shielding capability, the stability of the glucosamine preparation can be effectively improved, and the storage time of the glucosamine oral liquid is prolonged. This is because: the hydrotalcite is a special interlayer structure formed by a metal hydroxide layer with positive charges and interlayer filling exchangeable anions, and the interlayers have a large amount of hydroxyl groups, so that on one hand, the interlayer structure can absorb glucosamine in a large amount, the glucosamine is embedded in the interlayer structure of the hydrotalcite, the contact with illumination is effectively reduced, the decomposition of the glucosamine is reduced, and meanwhile, the hydroxyl groups in the interlayer structure can be combined with glucosamine molecules, so that the glucosamine is stably embedded in the interlayer structure of the hydrotalcite, and the glucosamine molecules are prevented from being removed from the interlayer structure of the hydrotalcite. And the ferric acetate is hydrolyzed to enable the system to be brown, so that the external light is effectively reduced from entering the container of the glucosamine preparation, and the stability of the glucosamine preparation is improved.
Detailed Description
It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise. The invention will now be further illustrated by specific examples.
Example 1
A method of preparing a glucosamine formulation suitable for oral administration comprising the steps of:
(1) weighing the following components: 30 parts of glucosamine hydrochloride (sodium chloride), 14 parts of honey, 0.25 part of vitamin C, 2.0 parts of hydrotalcite, 2.5 parts of ferric acetate, 200 parts of water and a plurality of sodium dihydrogen phosphates. Wherein the pH of the glucosamine preparation consisting of the components is 6.5 +/-0.1. The fineness of the hydrotalcite powder is 6000 meshes.
(2) And adding the glucosamine hydrochloride, the vitamin C and the hydrotalcite powder into the water, and then ultrasonically stirring for 5min to obtain a mixed solution A.
(3) Adding the iron acetate and the honey into the mixed solution A, uniformly mixing, and then adding sodium dihydrogen phosphate to adjust the pH value of the system to 6.5 +/-0.1, thus obtaining the oral glucosamine preparation.
Example 2
A method for preparing a glucosamine preparation suitable for oral administration, comprising the steps of:
(1) weighing the following components: 22 parts of glucosamine sodium sulfate, 12 parts of xylitol, 0.15 part of vitamin C, 0.5 part of hydrotalcite, 1.6 parts of ferric acetate, 170 parts of water and a plurality of citric acids. Wherein the pH value of the glucosamine preparation consisting of the components is 6.0 +/-0.1. The fineness of the hydrotalcite powder is 8000 meshes.
(2) And adding the glucosamine sodium sulfate, the vitamin C and the hydrotalcite powder into the water, and then ultrasonically stirring for 5min to obtain a mixed solution A.
(3) Adding the iron acetate and the xylitol into the mixed solution A, uniformly mixing, and then adding citric acid to adjust the pH value of the system to 6.0 +/-0.1, thus obtaining the oral glucosamine preparation.
Example 3
A method of preparing a glucosamine formulation suitable for oral administration comprising the steps of:
(1) Weighing the following components: 36 parts of glucosamine sodium sulfate, 18 parts of cane sugar, 0.25 part of vitamin C, 3.8 parts of hydrotalcite, 2.7 parts of ferric acetate, 210 parts of water and a plurality of malic acids. Wherein the pH value of the glucosamine preparation consisting of the components is 6.7 +/-0.1. The fineness of the hydrotalcite powder is 5000 meshes.
(2) And adding the glucosamine sodium sulfate, the vitamin C and the hydrotalcite powder into the water, and then ultrasonically stirring for 5min to obtain a mixed solution A.
(3) Adding the iron acetate and the sucrose into the mixed solution A, uniformly mixing, and then adding malic acid to adjust the pH value of the system to 6.7 +/-0.1, thus obtaining the oral glucosamine preparation.
Example 4
A method for preparing a glucosamine preparation suitable for oral administration, comprising the steps of:
(1) weighing the following components: 38 parts of glucosamine hydrochloride (sodium chloride), 16 parts of honey, 0.3 part of vitamin C, 2.0 parts of hydrotalcite, 2.95 parts of ferric acetate, 220 parts of water and a plurality of sodium dihydrogen phosphates. Wherein the pH value of the glucosamine preparation consisting of the components is 6.5 +/-0.1. The fineness of the hydrotalcite powder is 6000 meshes.
(2) And adding the glucosamine hydrochloride, the vitamin C and the hydrotalcite powder into the water, and then ultrasonically stirring for 5min to obtain a mixed solution A.
(3) Adding the iron acetate and the honey into the mixed solution A, uniformly mixing, and then adding sodium dihydrogen phosphate to adjust the pH value of the system to 6.5 +/-0.1, thus obtaining the oral glucosamine preparation.
Example 5
A method for preparing a glucosamine preparation suitable for oral administration, comprising the steps of:
(1) weighing the following components: 30 parts of glucosamine hydrochloride (sodium chloride), 14 parts of honey, 0.25 part of vitamin C, 2.0 parts of hydrotalcite, 200 parts of water and a plurality of sodium dihydrogen phosphates. Wherein the pH value of the glucosamine preparation consisting of the components is 6.5 +/-0.1. The fineness of the hydrotalcite powder is 6000 meshes.
(2) And adding the glucosamine hydrochloride, the vitamin C and the hydrotalcite powder into the water, and then carrying out ultrasonic stirring for 5min to obtain a mixed solution A.
(3) Adding the honey into the mixed solution A, uniformly mixing, and then adding sodium dihydrogen phosphate to adjust the pH value of the system to 6.5 +/-0.1, thus obtaining the glucosamine preparation suitable for oral administration.
Example 6
A method of preparing a glucosamine formulation suitable for oral administration comprising the steps of:
(1) Weighing the following components: 30 parts of glucosamine hydrochloride (sodium chloride), 14 parts of honey, 0.25 part of vitamin C, 2.5 parts of ferric acetate, 200 parts of water and a plurality of sodium dihydrogen phosphates. Wherein the pH value of the glucosamine preparation consisting of the components is 6.5 +/-0.1. The fineness of the hydrotalcite powder is 6000 meshes.
(2) And adding the glucosamine hydrochloride and the vitamin C into the water, and then ultrasonically stirring for 5min to obtain a mixed solution A.
(3) Adding the iron acetate and the honey into the mixed solution A, uniformly mixing, and then adding sodium dihydrogen phosphate to adjust the pH value of the system to 6.5 +/-0.1, thus obtaining the oral glucosamine preparation.
Example 7
A method of preparing a glucosamine formulation suitable for oral administration comprising the steps of:
(1) weighing the following components: 30 parts of glucosamine hydrochloride (sodium chloride), 14 parts of honey, 0.25 part of vitamin C, 200 parts of water and a plurality of sodium dihydrogen phosphates. Wherein the pH of the glucosamine preparation consisting of the components is 6.5 +/-0.1. The fineness of the hydrotalcite powder is 6000 meshes.
(2) And adding the glucosamine hydrochloride and the vitamin C into the water, and then ultrasonically stirring for 5min to obtain a mixed solution A.
(3) Adding the honey into the mixed solution A, uniformly mixing, and then adding sodium dihydrogen phosphate to adjust the pH value of the system to 6.5 +/-0.1, thus obtaining the glucosamine preparation suitable for oral administration.
Performance test
The stability of the glucosamine preparations of the above embodiments is tested by the following specific methods: the glucosamine preparation prepared in each example is placed in a transparent glass test tube, then the test tubes are placed in a transparent sealing box, are sequentially arranged and are vertically fixed on a test tube rack, finally the transparent sealing box is placed in an illumination environment (under indoor natural light in the daytime and under a 40W fluorescent lamp at night), and the content of the basal glucose in each test tube after the test tubes are placed for 3 days is measured by an RP-HPL derivatization method. In the calculation, the content immediately after the preparation was taken as an initial amount (the retention rate is 1), and the retention rate of glucosamine was expressed by the ratio of the content at 3 days of light irradiation to the initial amount, and the results are recorded in the following table.
| Example number | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| Retention ratio% | 98.74 | 99.22 | 99.35 | 98.17 | 86.41 | 90.56 | 71.39 |
As can be seen from the above results, the glucosamine retention in the glucosamine preparations prepared in examples 1 to 4 was significantly higher than that of the other examples. Among these, examples 5 and 6 are significantly higher than example 7, mainly because the glucosamine formulation of example 7 does not contain the two specific components of hydrotalcite and ferric acetate, resulting in significantly poor stability of the glucosamine formulation under light conditions, because: the hydrotalcite is a special interlayer structure formed by a metal hydroxide layer with positive charges and interlayer filling exchangeable anions, and the interlayers have a large amount of hydroxyl groups, so that on one hand, the interlayer structure can adsorb a large amount of glucosamine, the glucosamine is embedded in the interlayer structure of the hydrotalcite, the contact with illumination is effectively reduced, the decomposition of the glucosamine is reduced, and meanwhile, the hydroxyl groups in the interlayer structure can be combined with glucosamine molecules, so that the glucosamine is stably embedded in the interlayer structure of the hydrotalcite, and the glucosamine molecules are prevented from being removed from the interlayer structure of the hydrotalcite. And the ferric acetate is hydrolyzed to enable the system to be brown, so that the external light is effectively reduced from entering the container of the glucosamine preparation, and the stability of the glucosamine preparation is improved.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made to the present invention by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The glucosamine preparation suitable for oral administration is characterized by comprising the following components in parts by weight: 22-38 parts of glucosamine and/or medically acceptable salt, 12-18 parts of flavoring agent, 0.15-0.3 part of antioxidant, 0.5-3.8 parts of hydrotalcite powder, 1.6-2.95 parts of ferric acetate and 170-220 parts of water; the pH value of the preparation is kept between 6 and 7.
2. The glucosamine formulation according to claim 1, wherein said pharmaceutically acceptable salt comprises any one of glucosamine hydrochloride, glucosamine sulfate, and glucosamine double salt.
3. The glucosamine formulation according to claim 1, wherein said flavoring agent comprises at least one of honey, sucrose, and xylitol.
4. The glucosamine formulation according to claim 1, wherein said antioxidant comprises: any one of vitamin C, sodium bisulfite, sodium sulfite, sodium pyrosulfite, and sodium ascorbate.
5. The glucosamine formulation suitable for oral administration according to claim 1, wherein said hydrotalcite is of fineness 5000-8000 mesh so as to be sufficiently dispersed in a liquid phase.
6. The glucosamine formulation suitable for oral administration according to any one of claims 1-5, wherein the pH of said formulation is achieved by addition of a pH adjusting agent; preferably, the pH adjuster includes any one of acetic acid, citric acid, lactic acid, malic acid, and sodium dihydrogen phosphate.
7. A process for preparing a glucosamine formulation suitable for oral administration according to any one of claims 1-6, comprising the steps of:
(1) adding the glucosamine and/or medically acceptable salt, antioxidant and hydrotalcite powder into the water, and uniformly mixing to obtain a mixed solution A;
(2) and adding the iron acetate and the flavoring agent into the mixed solution A, uniformly mixing, and then adjusting the pH value of the system to a set value to obtain the product.
8. The method for preparing a glucosamine preparation suitable for oral administration according to claim 7, wherein the step (1) comprises the step of mixing uniformly by means of ultrasonic agitation.
9. The method for preparing a glucosamine preparation suitable for oral administration according to claim 7 or 8, wherein the step (2) comprises performing the step of mixing uniformly by means of mechanical stirring; preferably, in the step (2), the pH regulator is added to regulate the pH value, and the mixture is stirred again after the pH value is regulated, so that the uniform glucosamine preparation is obtained.
10. Use of a glucosamine formulation suitable for oral administration according to any one of claims 1-7 or a glucosamine formulation obtained by the method of manufacture according to claim 8 or 9 in the rehabilitation and medical fields.
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| CN202210586935.7A CN114748417A (en) | 2022-05-26 | 2022-05-26 | Oral glucosamine preparation and preparation method and application thereof |
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| CN202210586935.7A CN114748417A (en) | 2022-05-26 | 2022-05-26 | Oral glucosamine preparation and preparation method and application thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101947234A (en) * | 2010-09-02 | 2011-01-19 | 南京威尔曼药物研究所 | Preparation method for preparation containing glucosamine and application thereof |
| CN105395478A (en) * | 2015-12-02 | 2016-03-16 | 北京康力基生物科技有限公司 | Stable glucosamine oral liquid and preparation process thereof |
| CN110755375A (en) * | 2019-12-02 | 2020-02-07 | 山东润德生物科技有限公司 | Glucosamine oral liquid and preparation method thereof |
-
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- 2022-05-26 CN CN202210586935.7A patent/CN114748417A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101947234A (en) * | 2010-09-02 | 2011-01-19 | 南京威尔曼药物研究所 | Preparation method for preparation containing glucosamine and application thereof |
| CN105395478A (en) * | 2015-12-02 | 2016-03-16 | 北京康力基生物科技有限公司 | Stable glucosamine oral liquid and preparation process thereof |
| CN110755375A (en) * | 2019-12-02 | 2020-02-07 | 山东润德生物科技有限公司 | Glucosamine oral liquid and preparation method thereof |
Non-Patent Citations (1)
| Title |
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| 杨浩等: "《Zn-Al 类水滑石功能材料的应用》", 《广东化工》 * |
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