A kind of medicine for the treatment of hyperchlorhydria and preparation method thereofTechnical field
The present invention relates to a kind of medicine for the treatment of hyperchlorhydria and preparation method thereof.
Background technology
Adult's hyperchlorhydria can cause the clinical symptoms such as warm acid, epigastric discomfort, upper abdominal pain and/or heartburn sense, and this symptom also had quite high sickness rate in child in the last few years.Development along with medical science technology, the extensive use of gastroscopy in child, hyperchlorhydria child except dyspepsia, still can cause upper gastrointestinal organic disease, as reflux esophagitis, gastritis, duodenitis and peptic ulcer etc., having data to be shown as human peptic ulcer has 2.1%～50% to derive from the Childhood, therefore must treat early.
By retrieval, (1) China Patent Publication No. is a kind of gastrointestinal drug of CN 1135883A and preparation method thereof, its technical scheme is that metronidazole powder comminution is made to fine powder and magnesium trisilicate, press metronidazole 50～90%, magnesium trisilicate 10～50%(is weight ratio) mix after, stir, make tablet or capsule;
(2) formula of a kind of compound recipe aluminum bismuth granule of China Patent Publication No. CN 1150024A, its technical scheme is to include following composition:, often containing bismuth aluminate 200 g, also contain sodium bicarbonate 100～300 g, Heavy Magnesium Carbonate 300～500 g, Radix Glycyrrhizae extractum 200～400 g, bark of polyFrangula alnus Miller 15～30 g, Fructus Foeniculi powder 1～20 g, ethanol or water 100～1500 g;
(3) China Patent Publication No. is a kind of Calcium aluminium suspension of CN 1517098A, and its technical scheme is that percentage by weight composition is: eugenol 0.1%～5%, calcium carbonate 2%～10%, magnesium trisilicate 8%～28%, aluminium oxide 0.2%～7%, suspending agent 0.05%～0.2%, sucrose 50%～70%.
(4) a kind of gastric antiacids of Chinese Patent Application No. 201210001044.7 is exactly specifically a kind of hydrotalcite tablet and preparation method thereof; Hydrotalcite tablet contains by weight percentage: 33.3%～71. 4% micronization hydrotalcite, 0. 5%～5% weak acid class pH adjusting agent, 0. 5%～2% sodium lauryl sulphate, 3%～8% low-substituted hydroxypropyl cellulose or cross-linking sodium carboxymethyl cellulose, 1%～2.2% polyvinylpyrrolidone or hypromellose, 0.5%～1.5% lubricant, 0.2%～0.5 Mentholum, surplus are filler and pharmaceutically acceptable other adjuvants;
(5) pharmaceutical composition that prevents and/or treats diarrhoea that Chinese Patent Application No. is 201210388229.8, it comprises eugenol, calcium carbonate, magnesium trisilicate, aluminium hydroxide and aspartame.
Yet the medicine for the treatment of hyperchlorhydria on the disclosed medicine of above-mentioned patent documentation and market is all not suitable for children taking.In the disclosed technical scheme of China Patent Publication No. CN 1135883A, used antibiotic metronidazole, the toxic and side effects of metronidazole is larger, is not suitable for child's administration, is also not suitable for long-term taking; China Patent Publication No. CN 1150024A, China Patent Publication No. CN 1517098A, application number 201210001044.7, disclosed technical scheme in application number 201210388229.8 patent documentations such as grade, all used the compound containing aluminum, and aluminium element can cause child's brain development slow, be unfavorable for child's normal growth, be therefore also not suitable for children.
For this reason, provide a kind of medicine for the treatment of hyperchlorhydria of applicable children taking to seem particularly important.
The compound hyperchlorhydria that is used for the treatment of of three kinds of principal agent compositions of available technology adopting (calcium carbonate, Heavy Magnesium Carbonate, magnesium trisilicate) there is not yet report.In technical scheme of the present invention, the medicine of employing is without any side effects, does not contain aluminium ion etc. to childhood development harmful composition of growing up; Drug effect is gentleer, can not damage child's comparatively weak gastric mucosa.Meanwhile, the compositions such as calcium carbonate in the technical program also contribute to child to replenish the calcium.Therefore, the drug regimen that technical scheme of the present invention provides is not only applicable to treatment adult's hyperchlorhydria, is applicable to children yet.
Below in conjunction with the specific embodiment, the present invention is described further.
Summary of the invention
The object of the invention is the shortcoming and defect existing in order to overcome prior art, and provide a kind of effect to relax and lasting but to gastric acid secretion without direct repression, can improve gastric acid pH and eliminate the feedback suppression of gastric acid to parietal cell secretion, and applicable to the medicine of the treatment hyperchlorhydria of children taking.
Another object of the present invention is to provide a kind of preparation method of medicine for the treatment of hyperchlorhydria of children taking.
For realizing above-mentioned first object, technical scheme of the present invention is that its formula comprises following component, by percentage to the quality:
Principal agent, 20～80wt%, this principal agent includes calcium carbonate, Heavy Magnesium Carbonate and magnesium trisilicate; Surplus is adjuvant, and this adjuvant includes filler, binding agent, disintegrating agent and lubricant.
Further optimizing setting is principal agent 30～50 wt%.Further arranging is that principal agent is 38wt% again.
Further optimizing setting is that described filler is one or more in conventional water solublity and water-insoluble filler, one or more in the natural and composite adhesives of binding agent, disintegrating agent is one or more in carboxymethyl starch sodium, silicon dioxide, cross-linking sodium carboxymethyl cellulose, and lubricant is one or more in water solublity and water-insoluble lubricant.Further arrange be again described filler be in microcrystalline Cellulose, corn starch, pregelatinized Starch, low-substituted hydroxypropyl cellulose, sucrose one or more, described binding agent is one or more in corn starch liquid, hydroxypropyl methylcellulose, polyvidone, and described lubricant is one or more in stearic acid, magnesium stearate, Pulvis Talci.
Preferably arranging is calcium carbonate 35 wt% in described principal agent, Heavy Magnesium Carbonate 2 wt%, magnesium trisilicate 1 wt%, in described adjuvant: sucrose 52.5 wt%, PVP K30 2 wt%, Pulvis Talci 5 wt%, magnesium stearate 2 wt%, cross-linking sodium carboxymethyl cellulose 0.5 wt%.
For realizing second object of the present invention, technical scheme of the present invention is to comprise the following steps:
(1) each principal agent and adjuvant were ground into respectively to the fine powder of 80 mesh sieves, and by the calcium carbonate of formula ratio, Heavy Magnesium Carbonate, magnesium trisilicate, sucrose mix homogeneously;
(2) polyvidone of getting formula ratio is dissolved in the alcoholic solution that contains Oleum menthae, as binding agent;
(3) binding agent is added in the material of step (1) gained, mix homogeneously, crosses 16 mesh sieves and granulates, 70 ℃ of airpillow-dry 5-45 minute, 10-16 mesh sieve granulate;
(4) pre-composition step (3) being made adds Pulvis Talci, magnesium stearate, the cross-linking sodium carboxymethyl cellulose of formula ratio, and mix homogeneously must be treated the medicine of hyperchlorhydria.
Further arranging is the medicine of above-mentioned treatment hyperchlorhydria can also be made to corresponding dosage form, as granule, tablet, capsule etc.
Pharmacological analysis of the present invention:
Calcium carbonate is a kind of calcic antacid, can neutralize or cushion gastric acid, its pharmacotoxicological effect mechanism be by and gastric acid and reduce pepsin activity to reach the object of pain relieving, relief of symptoms.Effect relaxes and lasting, but to gastric acid secretion without direct repression, can improve gastric acid pH and eliminate the feedback suppression of gastric acid to parietal cell secretion.Calcium carbonate is also a kind of calcium preparation simultaneously, can be supplemented children's torso calcium.Heavy Magnesium Carbonate can neutralize part gastric acid as antacid, thereby prevents gastric acid and the erosion damage of pepsin to gastric mucosa.Magnesium trisilicate is as antacid, and in energy, with gastric acid and protection ulcer surface, effect slowly and lastingly.
The specific embodiment
Below by embodiment, the present invention is specifically described; only be used to further illustrate the present invention; can not be interpreted as limiting the scope of the present invention, the technician in this field can make some nonessential improvement and adjustment to the present invention according to the content of foregoing invention.
embodiment 1
Take the supplementary material of following recipe quantity:
Preparation method:
(1) each component in formula was ground into respectively to the fine powder of 80 mesh sieves; By the calcium carbonate of formula ratio, Heavy Magnesium Carbonate, magnesium trisilicate, sucrose, microcrystalline Cellulose mix homogeneously;
(2) polyvidone of getting formula ratio is dissolved in the alcoholic solution that contains Oleum menthae, as binding agent;
(3) binding agent is added in the material of (1) step gained, mix homogeneously, crosses 16 mesh sieves and granulates, 70 ℃ of airpillow-dry 5-45 minute, 10-16 mesh sieve granulate;
(4) pre-composition (3) step being made adds Pulvis Talci, magnesium stearate, the cross-linking sodium carboxymethyl cellulose of formula ratio, and mix homogeneously must be treated the drug particles of hyperchlorhydria.
Target level of product quality and the actual testing result of to pressing above-mentioned preparation technology, producing:
embodiment 2
Take the supplementary material of following recipe quantity:
Preparation method:
(1) each component in formula was ground into respectively to the fine powder of 80 mesh sieves; By the calcium carbonate of formula ratio, Heavy Magnesium Carbonate, magnesium trisilicate, sucrose, corn starch mix homogeneously;
(2) polyvidone of getting formula ratio is dissolved in the alcoholic solution that contains Oleum menthae, as binding agent;
(3) binding agent is added in the material of (1) step gained, mix homogeneously, crosses 16 mesh sieves and granulates, 70 ℃ of airpillow-dry 5-45 minute, 10-16 mesh sieve granulate;
(4) pre-composition (3) step being made adds Pulvis Talci, stearic acid, the carboxymethyl starch sodium of formula ratio, and mix homogeneously must be treated the drug particles of hyperchlorhydria.
Target level of product quality and the actual testing result of to pressing above-mentioned preparation technology, producing:
embodiment 3
Take the supplementary material of following recipe quantity:
Preparation method:
(1) each component in formula was ground into respectively to the fine powder of 80 mesh sieves; By the calcium carbonate of formula ratio, Heavy Magnesium Carbonate, magnesium trisilicate, sucrose mix homogeneously;
(2) polyvidone of getting formula ratio is dissolved in the alcoholic solution that contains Oleum menthae, as binding agent;
(3) binding agent is added in the material of (1) step gained, mix homogeneously, crosses 16 mesh sieves and granulates, 70 ℃ of airpillow-dry 5-45 minute, 10-16 mesh sieve granulate;
(4) pre-composition (3) step being made adds Pulvis Talci, magnesium stearate, the cross-linking sodium carboxymethyl cellulose of formula ratio, and mix homogeneously must be treated the drug particles of hyperchlorhydria.
Target level of product quality and the actual testing result of to pressing above-mentioned preparation technology, producing:
embodiment 4
Take the supplementary material of following recipe quantity:
Preparation method:
(1) each component in formula was ground into respectively to the fine powder of 80 mesh sieves; By the calcium carbonate of formula ratio, Heavy Magnesium Carbonate, magnesium trisilicate, sucrose, pregelatinized Starch mix homogeneously;
(2) corn starch of getting formula ratio is made 10% starch slurry, as binding agent;
(3) binding agent is added in the material of (1) step gained, mix homogeneously, crosses 16 mesh sieves and granulates, 70 ℃ of airpillow-dry 5-45 minute, 10-16 mesh sieve granulate;
(4) pre-composition (3) step being made adds Pulvis Talci, stearic acid, the carboxymethyl starch sodium of formula ratio, and mix homogeneously must be treated the drug particles of hyperchlorhydria.
Target level of product quality and the actual testing result of to pressing above-mentioned preparation technology, producing:
embodiment 5
Take the supplementary material of following recipe quantity:
Preparation method:
(1) each component in formula was ground into respectively to the fine powder of 80 mesh sieves; By the calcium carbonate of formula ratio, Heavy Magnesium Carbonate, magnesium trisilicate, sucrose mix homogeneously;
(2) polyvidone of getting formula ratio is dissolved in the alcoholic solution that contains Oleum menthae, as binding agent;
(3) binding agent is added in the material of (1) step gained, mix homogeneously, crosses 16 mesh sieves and granulates, 70 ℃ of airpillow-dry 5-45 minute, 10-16 mesh sieve granulate;
(4) pre-composition (3) step being made adds Pulvis Talci, the cross-linking sodium carboxymethyl cellulose of formula ratio, and mix homogeneously must be treated the drug particles of hyperchlorhydria.
Target level of product quality and the actual testing result of to pressing above-mentioned preparation technology, producing: