CN111714513A - Preparation process of magnesium aluminocarbonate raw material medicine - Google Patents
Preparation process of magnesium aluminocarbonate raw material medicine Download PDFInfo
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- CN111714513A CN111714513A CN202010515111.1A CN202010515111A CN111714513A CN 111714513 A CN111714513 A CN 111714513A CN 202010515111 A CN202010515111 A CN 202010515111A CN 111714513 A CN111714513 A CN 111714513A
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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
- A61K33/10—Carbonates; Bicarbonates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01F—COMPOUNDS OF THE METALS BERYLLIUM, MAGNESIUM, ALUMINIUM, CALCIUM, STRONTIUM, BARIUM, RADIUM, THORIUM, OR OF THE RARE-EARTH METALS
- C01F7/00—Compounds of aluminium
- C01F7/78—Compounds containing aluminium and two or more other elements, with the exception of oxygen and hydrogen
- C01F7/782—Compounds containing aluminium and two or more other elements, with the exception of oxygen and hydrogen containing carbonate ions, e.g. dawsonite
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01P—INDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS
- C01P2002/00—Crystal-structural characteristics
- C01P2002/70—Crystal-structural characteristics defined by measured X-ray, neutron or electron diffraction data
- C01P2002/72—Crystal-structural characteristics defined by measured X-ray, neutron or electron diffraction data by d-values or two theta-values, e.g. as X-ray diagram
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Compounds Of Alkaline-Earth Elements, Aluminum Or Rare-Earth Metals (AREA)
Abstract
The invention relates to the technical field of preparation of magnesium aluminate carbonate raw material medicines, and discloses a preparation process of a magnesium aluminate carbonate raw material medicine, which comprises the following processing steps: s1, blending; s2 reaction: carrying out heat preservation reaction; s3 centrifugation: cooling and centrifuging; drying S4, and crushing S5; s1 the ingredients comprise the following raw materials in parts by weight: 10-11 parts of sodium hydroxide, 9-10 parts of aluminum trichloride hexahydrate and 11-12 parts of heavy magnesium carbonate. On the basis of meeting the standard of Chinese pharmacopoeia, the raw material medicine of the magnesium aluminate carbonate produced by the process has the acidity-making time obtained by acidity-making curve detection meeting the requirement of the original medicine research (more than or equal to 80 minutes), and the X-ray diffraction spectrum has no impurity peak in comparison with the original medicine research spectrum, can approach the original medicine research to the maximum extent, better exerts the medicine effect, meets the requirements of different customers, and can reduce the production cost at the same time.
Description
Technical Field
The invention relates to the technical field of preparation of magnesium aluminocarbonate raw material medicines, in particular to a preparation process of a magnesium aluminocarbonate raw material medicine.
Background
The bulk drug of the hydrotalcite belongs to a novel antacid and is used for treating peptic ulcer. First in 1970, the pharmaceutical factory in Japan Sal Yew was successfully developed, and was produced by the manufacturers in Japan, England, West Germany, Italy, etc. in the 70-80 s, and the British pharmacopoeia was listed in 1998.
The hydrotalcite has the characteristics of fast speed of neutralizing gastric acid of artificial gastric acid, mild action, the highest pH value of gastric juice of 4.2, long action time, 98 percent of acid neutralization rate, which is obviously higher than 71 percent of aluminum hydroxide, rapid, mild and long action and high acid reaction rate compared with sodium bicarbonate, completely meets the requirement of 'ideal antacid preparation', and documents report that the medicine can inhibit the activity of protease due to pepsin and can overcome the side effects of constipation, diarrhea and the like caused by pure aluminum, magnesium and salt.
However, the magnesium aluminocarbonate raw material medicine on the market is impure and has impurities, and the antacid curve is different from the original medicine, so that the requirements of different customers cannot be met.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a preparation process of a magnesium aluminate carbonate raw material medicine, improve the quality of magnesium aluminate carbonate, enable the product to approach the standard of the original medicine research as much as possible, and meet the requirements of different customers.
The technical scheme of the invention is realized as follows: a preparation process of a magnesium aluminocarbonate bulk drug comprises the following processing steps:
s1, blending;
s2 reaction: carrying out heat preservation reaction;
s3 centrifugation: cooling and centrifuging;
the drying is carried out in the S4 way,
s5 grinding;
s1 the ingredients comprise the following raw materials in parts by weight:
10-11 parts of sodium hydroxide, 9-10 parts of aluminum trichloride hexahydrate and 11-12 parts of heavy magnesium carbonate.
In a preferred embodiment, the reaction mode of S2 is to sequentially add sodium hydroxide, aluminum trichloride hexahydrate and heavy magnesium carbonate into a 2000L reaction kettle, and to keep the temperature at 85-95 ℃ and stir for 4-6 hours.
As a preferable embodiment, the centrifugation mode of S3 is to cool the temperature to below 60 ℃, dewater and filter, monitor the conductivity of the filtrate, repeatedly soak and filter until the conductivity of the filtrate is less than or equal to 150 mus/cm.
In a preferred embodiment, the drying temperature of the drying in the step S4 is 85-95 ℃, and the moisture content after the drying is controlled to be less than or equal to 5.0%.
In a preferred embodiment, the pulverization in S5 is performed by using a 80 mesh sieve.
As a preferred embodiment, the ingredient of S1 includes the following raw materials by weight: 10.4 parts of sodium hydroxide, 9.6 parts of aluminum trichloride hexahydrate and 11.4 parts of heavy magnesium carbonate.
By adopting the technical scheme, compared with the prior art, the invention has the following beneficial effects:
the produced magnesium aluminum carbonate bulk drug meets the requirement (more than or equal to 80 minutes) of the original research drug on the basis of meeting the standard of Chinese pharmacopoeia, the acid making time obtained by acid making curve detection meets the requirement of the original research drug, and the X-ray diffraction spectrum has no impurity peak compared with the original research drug spectrum, can approach the original research drug to the maximum extent, better exerts the drug effect, meets the requirements of different customers, and can reduce the production cost at the same time.
Detailed Description
The following further describes the embodiments of the present invention. It should be noted that the description of the embodiments is provided to help understanding of the present invention, but the present invention is not limited thereto. In addition, the technical features involved in the embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
The present invention is further described to enable those skilled in the art to better practice the invention.
A preparation process of a magnesium aluminocarbonate bulk drug comprises the following processing steps:
s1, blending; the feed comprises the following raw materials in parts by weight: 10-11 parts of sodium hydroxide, 9-10 parts of aluminum trichloride hexahydrate and 11-12 parts of heavy magnesium carbonate.
S2 reaction: carrying out heat preservation reaction; the reaction mode is that sodium hydroxide, aluminum trichloride hexahydrate and heavy magnesium carbonate are sequentially added into a 2000L reaction kettle, and the reaction is carried out for 4-6 hours under the condition of heat preservation and stirring at 85-95 ℃.
S3 centrifugation: cooling and centrifuging; the centrifugation mode is to cool the solution to below 60 ℃, dewater and pump filter the solution, monitor the conductivity of the filtrate, repeatedly soak the solution and pump filter the solution until the conductivity of the filtrate is less than or equal to 150 mus/cm.
S4, drying, wherein the drying temperature is 85-95 ℃, and the moisture after drying is controlled to be less than or equal to 5.0%.
S5 grinding; the crushing is carried out by adopting the sieve with 80 meshes of spiral pieces.
The preparation process of the hydrotalcite bulk drug can adopt the following raw materials in parts by weight:
(1) 10 parts of sodium hydroxide, 9 parts of aluminum trichloride hexahydrate and 11 parts of heavy magnesium carbonate;
(2) 11 parts of sodium hydroxide, 10 parts of aluminum trichloride hexahydrate and 12 parts of heavy magnesium carbonate;
(3) 10.5 parts of sodium hydroxide, 9.5 parts of aluminum trichloride hexahydrate and 11.5 parts of heavy magnesium carbonate;
(4) in combination with the characteristics of each raw material, it is preferable that 10.4 parts of sodium hydroxide, 9.6 parts of aluminum trichloride hexahydrate, and 11.4 parts of heavy magnesium carbonate be present.
The present invention is further described below with reference to examples.
Example 1
The hydrotalcite bulk drug is prepared from the following raw materials:
sodium hydroxide: 10.40kg
Aluminum trichloride hexahydrate: 9.60kg
Heavy magnesium carbonate: 11.40kg
The preparation steps are as follows:
s1, batching: accurately weighing 10.40kg of sodium hydroxide, 9.60kg of aluminum trichloride hexahydrate and 11.40kg of heavy magnesium carbonate for later use;
s2 reaction: adding 120L of purified water into a reaction tank, adding 10.40kg of sodium hydroxide into the reaction tank, stirring and dissolving for 5 minutes, adding 9.60kg of aluminum trichloride hexahydrate, adding 11.40kg of heavy magnesium carbonate for 5 minutes, starting heating, heating to 95 ℃, and carrying out heat preservation reaction for 4 hours;
s3 centrifugation: cooling to 54 deg.C (below 60 deg.C), dewatering, filtering, monitoring filtrate conductivity, repeatedly soaking, and filtering to obtain wet product with filtrate conductivity of 115 μ s/cm (less than or equal to 150 μ s/cm).
S4 drying: the drying temperature is between 85 ℃ and 87 ℃, and the moisture content reaches 3.99 percent (less than or equal to 5.0 percent) after the drying is finished.
S5 crushing: the mesh number of the snail tablets is 80 meshes, and the granularity (reserved by 60 meshes) is 0.3-0.8%.
The product quality standard and the actual detection result produced according to the preparation process are as follows:
example 2
The hydrotalcite bulk drug is prepared from the following raw materials:
sodium hydroxide: 10.40kg
Aluminum trichloride hexahydrate: 9.60kg
Heavy magnesium carbonate: 11.40kg
The preparation steps are as follows:
s1, batching: accurately weighing 10.40kg of sodium hydroxide, 9.60kg of aluminum trichloride hexahydrate and 11.40kg of heavy magnesium carbonate for later use;
s2 reaction: adding 120L of purified water into a reaction tank, adding 10.40kg of sodium hydroxide into the reaction tank, stirring and dissolving for 5 minutes at intervals, adding 9.60kg of aluminum trichloride hexahydrate, adding 11.40kg of heavy magnesium carbonate at intervals of 5 minutes, starting heating, heating to 85 ℃, and carrying out heat preservation reaction for 5 hours;
s3 centrifugation: cooling to 58 deg.C (below 60 deg.C), dewatering, filtering, monitoring filtrate conductivity, repeatedly soaking, and filtering to obtain wet product with filtrate conductivity of 134 μ s/cm (less than or equal to 150 μ s/cm).
S4 drying: the drying temperature is between 94 ℃ and 95 ℃, and the moisture content reaches 3.68 percent (less than or equal to 5.0 percent) after the drying is finished.
S5 crushing: the mesh number of the snail tablets is 80 meshes, and the granularity (reserved by 60 meshes) is 0.9 percent.
The product quality standard and the actual detection result produced according to the preparation process are as follows:
the hydrotalcite prepared by the process accords with Chinese pharmacopoeia, and the X-ray diffraction pattern shows that the hydrotalcite is completely consistent with the daily original medicine, and has no impurity peak; the acid making time is superior to that of the original medicine, the original medicine requires more than 80 minutes, and the product can reach 100 minutes. Can better exert the drug effect, relieve the pain of patients and benefit human beings.
The embodiments of the present invention have been described in detail, but the present invention is not limited to the described embodiments. It will be apparent to those skilled in the art that various changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, and the scope of protection is still within the scope of the invention.
Claims (6)
1. A preparation process of a magnesium aluminocarbonate bulk drug is characterized by comprising the following processing steps:
s1, blending;
s2 reaction: carrying out heat preservation reaction;
s3 centrifugation: cooling and centrifuging;
the drying is carried out in the S4 way,
s5 grinding;
s1 the ingredients comprise the following raw materials in parts by weight:
10-11 parts of sodium hydroxide, 9-10 parts of aluminum trichloride hexahydrate and 11-12 parts of heavy magnesium carbonate.
2. The process for preparing a magnesium aluminocarbonate bulk drug according to claim 1, which is characterized in that: s2 the reaction mode is that sodium hydroxide, aluminum trichloride hexahydrate and heavy magnesium carbonate are sequentially added into a 2000L reaction kettle, and the mixture is stirred and reacted for 4 to 6 hours at the temperature of 85 to 95 ℃.
3. The process for preparing a magnesium aluminocarbonate bulk drug according to claim 1, which is characterized in that: s3, cooling to below 60 ℃, dehydrating, filtering, monitoring the conductivity of the filtrate, repeatedly soaking and filtering until the conductivity of the filtrate is less than or equal to 150 mus/cm.
4. The process for preparing a magnesium aluminocarbonate bulk drug according to claim 1, which is characterized in that: s4, the drying temperature of the drying is 85-95 ℃, and the moisture after drying is controlled to be less than or equal to 5.0%.
5. The process for preparing a magnesium aluminocarbonate bulk drug according to claim 1, which is characterized in that: s5, crushing by adopting a sieve with 80 meshes.
6. The process for preparing a magnesium aluminocarbonate bulk drug according to claim 1, which is characterized in that: s1 the ingredients comprise the following raw materials in parts by weight: 10.4 parts of sodium hydroxide, 9.6 parts of aluminum trichloride hexahydrate and 11.4 parts of heavy magnesium carbonate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010515111.1A CN111714513A (en) | 2020-06-08 | 2020-06-08 | Preparation process of magnesium aluminocarbonate raw material medicine |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010515111.1A CN111714513A (en) | 2020-06-08 | 2020-06-08 | Preparation process of magnesium aluminocarbonate raw material medicine |
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| CN111714513A true CN111714513A (en) | 2020-09-29 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1996005140A1 (en) * | 1994-08-15 | 1996-02-22 | Aluminum Company Of America | Two powder synthesis of hydrotalcite and hydrotalcite-like compounds |
| JP2010006640A (en) * | 2008-06-27 | 2010-01-14 | Kyowa Chem Ind Co Ltd | New synthetic hydrotalcite particles and method for producing the same |
| JP2010228987A (en) * | 2009-03-27 | 2010-10-14 | Kyowa Chem Ind Co Ltd | Novel synthetic hydrotalcite particle and method of manufacturing the same |
| CN103395808A (en) * | 2013-07-26 | 2013-11-20 | 台山市新宁制药有限公司 | Preparation method of aluminum magnesium carbonate |
-
2020
- 2020-06-08 CN CN202010515111.1A patent/CN111714513A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1996005140A1 (en) * | 1994-08-15 | 1996-02-22 | Aluminum Company Of America | Two powder synthesis of hydrotalcite and hydrotalcite-like compounds |
| JP2010006640A (en) * | 2008-06-27 | 2010-01-14 | Kyowa Chem Ind Co Ltd | New synthetic hydrotalcite particles and method for producing the same |
| JP2010228987A (en) * | 2009-03-27 | 2010-10-14 | Kyowa Chem Ind Co Ltd | Novel synthetic hydrotalcite particle and method of manufacturing the same |
| CN103395808A (en) * | 2013-07-26 | 2013-11-20 | 台山市新宁制药有限公司 | Preparation method of aluminum magnesium carbonate |
Non-Patent Citations (4)
| Title |
|---|
| A. BANKAUSKAITE ET AL.: "The Hydrothermal Synthesis of Hydrotalcite by Using Different Partially Soluble and Insoluble in Water Mangesium and Aluminium Components", 《SCIENCE OF SINTERING》 * |
| SHIN ET AL.: "Optimal synthesis conditions of hydrotalcite (II)", 《YAKHAK HOEJI》 * |
| 孙伯韬: "一步法制备镁铝水滑石晶须的研究", 《中国优秀博硕士学位论文全文数据库(硕士)工程科技Ⅰ辑》 * |
| 孟繁浩: "铝碳酸镁的制备及结构分析", 《化学工业与工程》 * |
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