CN113769100A - High-water-solubility pharmaceutical adjuvant and preparation method thereof - Google Patents
High-water-solubility pharmaceutical adjuvant and preparation method thereof Download PDFInfo
- Publication number
- CN113769100A CN113769100A CN202110823403.6A CN202110823403A CN113769100A CN 113769100 A CN113769100 A CN 113769100A CN 202110823403 A CN202110823403 A CN 202110823403A CN 113769100 A CN113769100 A CN 113769100A
- Authority
- CN
- China
- Prior art keywords
- parts
- pharmaceutical excipient
- highly water
- soluble pharmaceutical
- excipient according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000546 pharmaceutical excipient Substances 0.000 title claims abstract description 23
- 238000002360 preparation method Methods 0.000 title abstract description 15
- 150000001720 carbohydrates Chemical class 0.000 claims abstract description 17
- 238000002156 mixing Methods 0.000 claims abstract description 17
- 238000001035 drying Methods 0.000 claims abstract description 13
- 238000007873 sieving Methods 0.000 claims abstract description 8
- 239000008247 solid mixture Substances 0.000 claims abstract description 8
- 238000001816 cooling Methods 0.000 claims abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 6
- 229910017053 inorganic salt Inorganic materials 0.000 claims abstract description 5
- 230000001007 puffing effect Effects 0.000 claims abstract description 3
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 claims description 32
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 32
- 229910052943 magnesium sulfate Inorganic materials 0.000 claims description 16
- 235000019341 magnesium sulphate Nutrition 0.000 claims description 16
- 239000011780 sodium chloride Substances 0.000 claims description 16
- 229940124531 pharmaceutical excipient Drugs 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 6
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 4
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 4
- 239000011265 semifinished product Substances 0.000 claims description 4
- 239000002671 adjuvant Substances 0.000 claims description 3
- 239000000047 product Substances 0.000 claims description 3
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 2
- 229910001629 magnesium chloride Inorganic materials 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 claims 6
- 239000000843 powder Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 22
- 239000000463 material Substances 0.000 abstract description 19
- 235000019629 palatability Nutrition 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 description 7
- 238000010521 absorption reaction Methods 0.000 description 4
- 239000012467 final product Substances 0.000 description 3
- 238000000643 oven drying Methods 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 230000008859 change Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000007792 addition Methods 0.000 description 1
- 239000000443 aerosol Substances 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
Classifications
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
Abstract
The invention belongs to the technical field of animal medicine, and particularly relates to a high-water-solubility pharmaceutical adjuvant and a preparation method thereof, wherein the preparation method comprises the following steps: uniformly mixing 10-30 parts of saccharides and 70-90 parts of inorganic salt; uniformly mixing to obtain a solid mixture, then performing puffing crushing under a low-temperature condition, and sieving; and drying the sieved medicinal auxiliary materials, cooling and bagging to obtain the medicinal auxiliary materials with the water content of less than 3 percent, good fluidity and the solubility of 45-50 percent. The medicinal auxiliary material is not easy to absorb moisture and agglomerate, changes color, has good fluidity and stability, high water solubility and good palatability.
Description
Technical Field
The invention belongs to the technical field of animal medicine, and particularly relates to a high-water-solubility pharmaceutical adjuvant and a preparation method thereof.
Background
The pharmaceutical excipients are general terms for all other materials added to prepare a pharmaceutical preparation into a suitable dosage form, and are substances added to maintain stability, safety or homogeneity of the pharmaceutical preparation during molding, or to promote dissolution, sustained release, or the like in accordance with the characteristics of the preparation. The medicinal auxiliary materials have no physiological activity, and the properties of the medicinal auxiliary materials are stable and do not react with the medicament, so that the content determination of the medicament is not influenced.
The pharmaceutical excipients have the following functions: (1) the processing of the finished product is facilitated in the preparation process of the pharmaceutical preparation; (2) the forming function: the medicine must be prepared into dosage forms through auxiliary materials to exert curative effect, and the medicinal preparations can be divided into liquid preparations (such as solution, injection and the like), solid preparations (such as tablets, capsules and the like), semi-solid preparations (such as ointments, gels and the like) and gas preparations (such as aerosol, sprays and the like) according to the difference of the added auxiliary materials; (3) influence on the efficacy of the drug: the same medicine can be prepared into different preparations by using different auxiliary materials, so that the effect of the medicine can be changed; (4) influence on drug absorption: the auxiliary materials are closely related to the absorption rate and the absorption amount of the medicine; (5) the solubility of the drug is improved: the auxiliary material has the function of improving the solubility of the insoluble drug; (6) improving the stability of the medicine.
Part of the medicinal auxiliary materials have the problems of moisture absorption, agglomeration, color change, low solubility and the like. Adjuvant problems can directly affect the efficacy, stability, etc. of the drug.
Disclosure of Invention
In order to overcome the defects and shortcomings of the prior art, the invention provides the high-water-solubility medicinal auxiliary material which has good fluidity, good stability, good palatability and is not easy to absorb moisture, agglomerate and discolor and the preparation method thereof.
In order to achieve the purpose, the invention provides the following technical scheme: a high water-solubility pharmaceutical adjuvant comprises the following components in parts by weight: 10-30 parts of saccharides and 70-90 parts of inorganic salt; the medicinal adjuvant has water content less than 3%, good fluidity, and solubility of 45-50%.
Preferably, the high water-solubility pharmaceutical excipient is characterized in that: the inorganic salt is one or more of sodium chloride, calcium carbonate, magnesium sulfate and magnesium chloride.
Preferably, the high water-solubility pharmaceutical adjuvant comprises the following components in parts by weight: 10-30 parts of saccharides, 50-60 parts of magnesium sulfate and 10-30 parts of sodium chloride
Preferably, the high water-solubility pharmaceutical adjuvant comprises the following components in parts by weight: 10-30 parts of saccharides, 30-50 parts of magnesium sulfate and 40-50 parts of sodium chloride.
Preferably, the high water-solubility pharmaceutical adjuvant comprises the following components in parts by weight: 10-30 parts of saccharides, 20-40 parts of magnesium sulfate and 30-50 parts of sodium chloride.
A preparation method of a high water-solubility pharmaceutical adjuvant comprises the following steps:
1) uniformly mixing saccharide, magnesium sulfate and sodium chloride;
2) uniformly mixing to obtain a solid mixture, and puffing and crushing the solid mixture at a low temperature;
3) sieving the crushed particles to obtain a semi-finished product;
4) and drying the screened semi-finished product to obtain a finished product, cooling and bagging.
Preferably, the mixing time in step 1) is 8 to 15 minutes.
Preferably, the mixture obtained in the step 2) is uniformly mixed and then is crushed to 80 meshes.
Preferably, the sieving in the step 2) adopts 100% sieving through a No. 5 standard pharmacopoeia sieve.
Preferably, the drying temperature in the step 3) is 70-100 ℃, and the drying time is 0.5-2 h.
The medicinal auxiliary materials of the invention can not change color at high temperature; the dried and cooled bag is bundled and stored, and is not easy to agglomerate; the raw materials are easy to be mixed uniformly and are not easy to be layered; has high water solubility, is easy to dissolve in water, is favorable for promoting the dissolution of the medicine, and has good palatability.
Detailed Description
The present invention is further described in detail with reference to the following examples, but the scope of the present invention is not limited thereto.
Example 1
Uniformly mixing saccharide, magnesium sulfate and sodium chloride, and then crushing to 80 meshes; the mixing time is 8-15 minutes, and a solid mixture is obtained after uniform mixing;
sieving with 100% sieve of No. 5 standard pharmacopeia, oven drying to obtain the final product, cooling, and packaging; the drying temperature is 70-100 ℃, and the drying time is 0.5-2 h.
The medicine auxiliary material comprises the following components in parts by weight: 10-30 parts of saccharides, 50-60 parts of magnesium sulfate and 10-30 parts of sodium chloride.
The medicine auxiliary material of the embodiment has good fluidity, and is not easy to be layered with the bulk drugs after being mixed and stored with the bulk drugs; the solubility is 45%, and the caking is not easy to occur during storage.
Example 2
Uniformly mixing saccharide, magnesium sulfate and sodium chloride, and then crushing to 80 meshes; the mixing time is 8-15 minutes, and a solid mixture is obtained after uniform mixing;
sieving with 100% sieve of No. 5 standard pharmacopeia, oven drying to obtain the final product, cooling, and packaging; the drying temperature is 70-100 ℃, and the drying time is 0.5-2 h.
The medicine auxiliary material comprises the following components in parts by weight: : 10-30 parts of saccharides, 30-50 parts of magnesium sulfate and 40-50 parts of sodium chloride.
The medicine auxiliary material of the embodiment has good fluidity and 50% solubility, and is easy to agglomerate when stored.
Example 3
Uniformly mixing saccharide, magnesium sulfate and sodium chloride, and then crushing to 80 meshes; the mixing time is 8-15 minutes, and a solid mixture is obtained after uniform mixing;
sieving with 100% sieve of No. 5 standard pharmacopeia, oven drying to obtain the final product, cooling, and packaging; the drying temperature is 70-100 ℃, and the drying time is 0.5-2 h.
The medicine auxiliary material comprises the following components in parts by weight: 10-30 parts of saccharides, 20-40 parts of magnesium sulfate and 30-50 parts of sodium chloride.
The pharmaceutical excipients of this example are relatively fluid and 50% soluble, but may form lumps when stored for extended periods of time.
It is to be understood that the above description is not intended to limit the present invention, and the present invention is not limited to the above examples, and those skilled in the art may make modifications, alterations, additions or substitutions within the spirit and scope of the present invention.
Claims (10)
1. A high water-solubility pharmaceutical excipient is characterized in that: the composition comprises the following components in parts by weight: 10-30 parts of saccharides and 70-90 parts of inorganic salt; the medicinal adjuvant has water content less than 3%, good fluidity, and solubility of 45-50%.
2. The highly water-soluble pharmaceutical excipient according to claim 1, characterized in that: the inorganic salt is one or more of sodium chloride, calcium carbonate, magnesium sulfate and magnesium chloride.
3. The highly water-soluble pharmaceutical excipient according to claim 1, characterized in that: the composition comprises the following components in parts by weight: 10-30 parts of saccharides, 50-60 parts of magnesium sulfate and 10-30 parts of sodium chloride.
4. The highly water-soluble pharmaceutical excipient according to claim 1, characterized in that: the composition comprises the following components in parts by weight: 10-30 parts of saccharides, 30-50 parts of magnesium sulfate and 40-50 parts of sodium chloride.
5. The highly water-soluble pharmaceutical excipient according to claim 1, characterized in that: the composition comprises the following components in parts by weight: 10-30 parts of saccharides, 20-40 parts of magnesium sulfate and 30-50 parts of sodium chloride.
6. A method for preparing the highly water-soluble pharmaceutical excipient according to claim 1, wherein the method comprises the steps of: which comprises the following steps:
1) uniformly mixing saccharide, magnesium sulfate and sodium chloride;
2) uniformly mixing to obtain a solid mixture, and puffing and crushing the solid mixture at a low temperature;
3) sieving the crushed particles to obtain a semi-finished product;
4) and drying the screened semi-finished product to obtain a finished product, cooling and bagging.
7. The method for preparing a highly water-soluble pharmaceutical excipient according to claim 5, wherein: the mixing time in the step 1) is 8-15 minutes.
8. The method for preparing a highly water-soluble pharmaceutical excipient according to claim 5, wherein: the mixture obtained in the step 2) is uniformly mixed and then is crushed into 80 meshes.
9. The method for preparing a highly water-soluble pharmaceutical excipient according to claim 5, wherein: and in the step 3), 100% of the powder is sieved by a No. 5 standard pharmacopoeia sieve.
10. The method for preparing a highly water-soluble pharmaceutical excipient according to claim 5, wherein: the drying temperature in the step 4) is 70-100 ℃, and the drying time is 0.5-2 h.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110823403.6A CN113769100A (en) | 2021-07-21 | 2021-07-21 | High-water-solubility pharmaceutical adjuvant and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110823403.6A CN113769100A (en) | 2021-07-21 | 2021-07-21 | High-water-solubility pharmaceutical adjuvant and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113769100A true CN113769100A (en) | 2021-12-10 |
Family
ID=78836225
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110823403.6A Pending CN113769100A (en) | 2021-07-21 | 2021-07-21 | High-water-solubility pharmaceutical adjuvant and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113769100A (en) |
-
2021
- 2021-07-21 CN CN202110823403.6A patent/CN113769100A/en active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20211210 |