Technology Transfer of "Magnesium Aluminum Carbonate Chewable Tablets"
[Registration Classification] Chemicals 6, National Medical Insurance B
[Specification] 0.5g
[Indications] Chronic gastritis; gastric discomfort related to gastric acid, such as stomachache, heartburn, acid belching, fullness, etc.
[Project Profile]
Magnesium aluminium carbonate is a compound of aluminium hydroxide, magnesium hydroxide, carbonate and water. It is a new type of long-acting acid-fast drug. Its active ingredients are arranged in layered lattice structure, which is a unique network structure and has dual functions. On the one hand, it can make gastric juice reach the appropriate range of pH3-5 quickly, prevent pepsin activity and promote ulcer healing. At the same time, it combines with bile acid and pepsin reversibly to eliminate the damage of bile acid to gastric mucosa. It can be used for hyperacidity, acute and chronic gastritis, bile reflux gastritis, reflux esophagitis, duodenal bulb ulcer, gastric ulcer, and various reasons (excessive use of coffee, alcohol, strong tea, nicotine, etc.) and non-steroidal use. Non-ulcerative dyspepsia and digestive tract discomfort caused by body anti-inflammatory drugs. Compared with traditional antacid drugs, magnesium aluminium carbonate has the following advantages: 1.0 g magnesium aluminium carbonate within 14* can increase the pH of 150 ml artificial gastric juice to pH 3, which is significantly faster than that of aluminium hydroxide (134*); this medicine can make gastric juice reach the appropriate range of pH 3-5* while the same amount of sodium bicarbonate can make the gastric juice pH reach 6.2, so this product can be used. Mild use can avoid the exacerbation of gastric acid secretion caused by excessive pH. (2) Durable action: under the same conditions, the action duration of this product is 6 times as long as that of sodium bicarbonate. Compared with other anti-acid drugs containing aluminium, magnesium aluminate carbonate can react adequately with gastric acid. The acid reaction rate of magnesium aluminate can reach 98* ** while that of aluminium hydroxide is only 72*. (3) Treatment of both symptoms and signs: Magnesium aluminium carbonate is not only alkaline gastric juice, but also reversibly combined with cholic acid and pepsin. Besides quick and effective pain relief, it can also treat bile reflux gastritis, promote the recovery of ulcer surface and protect gastric mucosa. Studies have shown that it has a good therapeutic effect on non-ulcerative dyspepsia, and *** is significantly higher than that of sucralfate group. (4) Low side effects: This product contains two metal ions, aluminum and magnesium, thus counteracting the side effects of constipation and diarrhea.
Magnesium Aluminium Carbonate Chewable Tablets have been widely used in clinic in recent years in China. They are one of the ideal drugs for treating acute and chronic gastritis, peptic ulcer and gastric discomfort related to gastric acid and cholic acid. Clinical experiments showed that the healing rate of magnesium aluminium carbonate in the treatment of duodenal bulbar ulcer was 78.5*, its *** was *** and the healing rate of gastric ulcer was 87.5*, the total *** was *****. The 6-week healing rate of ranitidine in the treatment of duodenal bulbar ulcer was 76.7 *, and the total *** was 97.6 *. The 8-week healing rate of gastric ulcer was 71.4*, with a total ***71.4*. The 8-week healing rate of peptic ulcer was 72*, and the total healing rate was 94*, which was similar to that of peptic ulcer. During the course of treatment, patients were tested for blood, urine, stool routine, liver and kidney function (GPT, Bill, A/G, Cr, Bun). There was no change in biochemical parameters before and after treatment in the magnesium aluminate group, while in the ranitidine group, the white blood cells of 10 patients fell below 2500, and GPT increased in two patients. All patients monitored the changes of blood pressure and heart rate during the treatment, and no abnormalities were found.
Multicenter clinical observation of 113 cases of non-ulcerative dyspepsia treated with magnesium aluminium carbonate chewable tablets showed that the marked efficiency and total *** were 72.6 *, 91.2 *, respectively, and 44.9 *, 71.4 *, respectively, in the aluminium sulphate group (98 cases). The content of 6-aminohexosaccharide and EGF in gastric mucosa increased significantly after treatment in magnesium aluminate group.
Magnesium aluminium carbonate has been produced and used in China, and has reliable safety and good therapeutic effect. Dashi chewable tablets produced by German Bayer Company have been on the market in China for many years. Chewable tablets are an excellent formulation. Compared with ordinary tablets, chewable tablets have the characteristics of quick action, good taste, easy to take, easy to accept for patients, fast dissolution rate of active ingredients, complete absorption, high bioavailability, no need of water, and taking at any time and anywhere. Therefore, in the sales volume ranking, "Daxi" film sales rank first in Shanghai, also in Beijing in the top three, in Guangzhou in the fourth place. Magnesium Aluminium Carbonate Chewable Tablets have reliable curative effect, little side effects and are easy to accept by patients. They have entered the catalogue of Chinese medical insurance products and become the first OTC products to pass, and have broad market prospects. APIs are sold domestically at a price of about 120 yuan/kg. According to 0.5g/piece, the production cost of 24 pieces/box is estimated to be about 2-3 yuan/box.
Magnesium Aluminium Carbonate Chewable Tablets are anti-acid drugs, which do not absorb in vivo and enter the blood circulation, so they can apply for exemption from bioequivalence test. The development cost is reduced and the development cycle is shortened.
[Technology transfer]
The company has completed the preparation technology, quality research and stability investigation of magnesium aluminate chewable tablets, and can transfer technology to pharmaceutical manufacturers.