CN101023961B - Medicine composition containing sodium hyaluronate and zinc salt - Google Patents
Medicine composition containing sodium hyaluronate and zinc salt Download PDFInfo
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- CN101023961B CN101023961B CN2006100081644A CN200610008164A CN101023961B CN 101023961 B CN101023961 B CN 101023961B CN 2006100081644 A CN2006100081644 A CN 2006100081644A CN 200610008164 A CN200610008164 A CN 200610008164A CN 101023961 B CN101023961 B CN 101023961B
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Abstract
The present invention provides a medicine composition for effectively curing the diseases of gastritis, gastric ulcer and duodenal ulcer. Said medicine composition contains sodium hyaluronate, zinc salt and conventional medicinal auxiliary material.
Description
Technical field
The present invention relates to medicine, field of health care products, be specifically related to a kind of pharmaceutical composition that is used for the treatment of treatment gastritis, gastric ulcer, duodenal ulcer.The main component of this pharmaceutical composition is hyaluronate sodium and zinc salt, and its basic comprising is hyaluronate sodium, zinc salt and conventional dose adjuvant.This pharmaceutical composition can be given full play to the synergism of hyaluronate sodium and zinc salt treatment gastritis, gastric ulcer, duodenal ulcer, plays better antiulcer effect.
Technical background
The common gastroenteropathy that peptic ulcer is a kind of easy recurrence, heal than refractory; pathogeny is comparatively complicated; summary is got up; mainly be between local mucosa infringement (the causing ulcer) factor of stomach, duodenum and mucosa protection (mucosa opposing) factor due to the disequilibrium; when damage factor strengthen and (or) when the protection factor weakens; just ulcer can occur, this is the ultimate principle that ulcer takes place.Cause between mucosa infringement (causing ulcer) factor and mucosa protection (mucosa opposing) factor unbalanced reason more, wherein gastroxia and Helicobacter pylori infection, to take non-steroid antiinflammatory drug such as indomethacin, aspirin etc. for a long time be the main factor that causes gastric ulcer.The Western medicine for the treatment of gastric ulcer at present clinically mainly is to treat according to the pathogeny of ulcer, from stoping or reducing the mucosa infringement and strengthen mucosa and protect the treatment of two aspects.As antacid such as bismuth aluminate compound, the excretory H of gastric acid inhibitory
2Receptor antagonist such as famotidine replace and proton pump inhibitor such as omeprazole, gastric mucosal protection agent sucralfate, gastric Mucin, anti-helicobacter pylori antibiotic medicine such as metronidazole and clarithromycin etc.Antacid is cured the symptoms, not the disease, and causes electrolyte disturbance easily; The excretory H of gastric acid inhibitory
2Though receptor antagonist, proton pump inhibitor, medicine for anti Helicobacter pylori curative effect are better, side effect is bigger; Now use the gastric mucosal protection agent longer the course of treatment, curative effect is general.The treatment gastric ulcer does not also have ideal especially medicine at present.Hyaluronate sodium has the protection gastric mucosa and promotes gastric mucosa ulcer cell regeneration effect; the zincum salts medicine has the ulcer of making convergence, promotes the effect of ulcer healing; also has the effect that suppresses helicobacter pylori in addition; both combinations; have complementary advantages; have synergism, based on this we to have designed with hyaluronate sodium and zinc salt be the pharmaceutical composition that is used for the treatment of digestive tract ulcer of main component.
Hyaluronate sodium (having another name called hyaluronic acid sodium) is as the necessary material of Human Physiology, extensively be present between the organism inner cell in the matter, no species variation, the linear polymeric acidic mucopolysaccharide that its molecule is made up of for disaccharidase unit glucuronic acid-N-n acetylglucosamine n, mean molecule quantity are 10
5-10
7Da, aqueous solution have vicidity, water-retaining property and lubricity.Since its no species variation, non-immunogenicity, and safety non-toxic has good biodegradability and biocompatibility.Because of its special biopolymer structure, physicochemical property and physiologically active widely, in recent years, it constantly is developed and applied at field of medicaments, has been used for the operation of ophthalmology viscoelasticity, osteoarthritis, pharmaceutic adjuvant etc. at present.We test and find that hyaluronate sodium has better action to preventing and treating peptic ulcer disease in addition, its mechanism of action may be: (1) hyaluronate sodium has the height vicidity, but biology tack, and the pH value of gastric juice is 2-3, under this pH value, hyaluronate sodium becomes sticky gel, takes the easier glutinous surface attached to gastric ulcer of back hyaluronate sodium, plays powerful insulation blocking effect; (2) hyaluronate sodium has migration of the ulcer of inhibition inflammatory cell and phagocytosis, and promote the ulcer surface healing: (3) hyaluronate sodium can stimulate the growth and the differentiation of Gastric Mucosal Cells, makes ulcer reach the physiological reparation.
Zinc is that content is only second to one of 14 kinds of essential trace elements of ferrum in human body, participates in the synthetic and activation of plurality of enzymes such as carbonic anhydrase, respiratory enzyme, lactic acid dehydrogenase, superoxide dismutase, alkali phosphatase, promotes growth promoter; Can strengthen cytophagous ability, bring into play bactericidal action, and reduce free radical acceleration of wound, burn and ulcer healing by increasing superoxide dismutase; External has the convergence antisepsis, helps granulation tissue to form.The zinc salt that is used for zinc supplement and treatment oral ulcer clinically has zinc sulfate, zinc gluconate, zinc glycinate, zinc citrate, zinc taurine, zinc acetate (zinc acetate), zinc lactate etc.; Be used to prevent and treat burn infection and promote the zinc salt of burn-healing that Zn-PPA, Zinc Norfloxacin are arranged; In vitro tests confirms that zinc has wound and superficial ulcer and promotes the healing effect preferably, animal experiment confirms that zinc has good effect to animal ulcer model, but on the human gastric ulcer of treatment, make little progress, zinc glycyrrhetate once was used for the treatment of gastric ulcer, effect is relatively poor and side effect is big, existing usefulness seldom, and main cause may be: human on the one hand different with the stomach organ anatomical structure in vivo of animal, human stomach in vivo in vertical state, the stomach of general animal is parastate.The easier emptying of people's stomach, the zincum salts medicine is short in the gastric time of staying, and zinc salt can reach the treatment concentration of zinc to ulcer effectively attached to the gastric ulcer surface, and zinc salt promotes the effect of trauma ulcer healing to be not in full use.If reach zincum salts Drug therapy dosage on the other hand, the zincum salts medicine is too big to the stimulation of stomach, causes nausea easily, untoward reaction such as vomiting.
The research of polysaccharide zinc compound aspect treatment ulcer in recent years is more, people such as Wang Aiqin (CN 1403091A) have prepared the effective chitosan-zn of rat ulcer animal pattern, and (CN 1126548C) such as Lip river, Lars. Su Boni prepared the effective Curiosin of rat ulcer animal pattern.The antiulcer action of chitosan-zn, Curiosin mainly is to have utilized polysaccharide to the protective effect of stomach and the promotion healing effect of zinc.When the preparation Curiosin, need processes such as hyaluronic acid dissolving, adjust pH, zinc salt displacement, precipitation, purification, drying; technology is complicated; and most critical is that by the Curiosin of series of processes preparation, molecular weight significantly reduces; its viscosity also significantly reduces; be unfavorable for the protection to stomach, hyaluronic acid belongs to macromolecule mucopolysaccharide chemical compound in addition, and the content of zinc in whole molecule is relatively low; zinc and hyaluronic acid are complex status, are unfavorable for that zinc plays a role.We directly mix hyaluronate sodium with the zincum salts medicine, be easy to guarantee the treatment concentration of zinc to ulcer by the amount that increases zinc salt, and needn't prepare Curiosin by the chemical reaction and the purge process of complexity, avoid the degraded of Curiosin hyaluronan molecule in preparation process, kept hyaluronic polymer characteristics and stickiness.Zinc salt is entrenched in the hyaluronic acid macromole web frame, guarantees the time of contact and the concentration of zinc salt medicine and ulcer surface, plays long-acting.The zinc salt medicine is entrenched in the hyaluronan molecule, reached hyaluronic acid and zinc salt double therapeutic effect, and because hyaluronate sodium has biocompatibility admirably, hyaluronate sodium and zinc salt make up together to ulcer, can significantly reduce the stimulation of zinc salt, reduce the untoward reaction of zinc salt stomach.
Summary of the invention
The present invention utilizes hyaluronate sodium that the protection of ulcer surface and regeneration, zinc salt are promoted the ulcer healing effect and to the medicament slow release of the inhibitory action of helicobacter pylori, hyaluronate sodium with reduce the stimulation of zincum salts medicine; reach the purpose of treatment digestive tract ulcer, designed with hyaluronate sodium and zinc salt is the pharmaceutical composition of treatment gastritis, gastric ulcer and/or the duodenal ulcer of main component for this reason.
The used hyaluronate sodium molecular weight of the present invention is 2.0 * 10
5～5 * 10
6Da.
The used zinc salt of the present invention can be zinc sulfate, zinc glycyrrhetate, zinc gluconate, zinc glycinate, zinc citrate, zinc taurine, zinc acetate (zinc acetate), zinc lactate, Zn-PPA, Zinc Norfloxacin etc.
The weight ratio of hyaluronate sodium and zinc salt is 1: 99～99: 1 in the pharmaceutical composition of the present invention, and preferred weight ratio is 1: 20～20: 1, and more preferably weight ratio is 1: 10～10: 1, and most preferably weight ratio is 1: 5～5: 1.
The basic comprising of pharmaceutical composition of the present invention is hyaluronate sodium, zinc salt and conventional dose adjuvant, and these adjuvants are according to the difference of dosage form and difference.Conventional pharmaceutical necessities comprises diluent, adhesive, disintegrating agent, correctives, antioxidant etc.
Pharmaceutical composition of the present invention can be used for being prepared into any preparation that can be oral, comprises tablet, capsule, granule, liquid preparation.Because dissolution velocity was slower when hyaluronate sodium was water-soluble, and stickiness is very big, so only zinc salt being added proper auxiliary materials during the preparation solid preparation granulates, wet granular sieves or dried granule sieves, after granulation finishes, directly with zinc salt granule and hyaluronate sodium mixing, technology is made suitable tablet, capsule or granule and is got final product routinely again.During the preparation liquid preparation, earlier hyaluronate sodium, zinc salt are dissolved respectively, in zinc solution, add correctives, mix homogeneously, packing, sterilization gets final product.
The specific embodiment
Embodiment 1: the granule of the present composition
Hyaluronate sodium 200g, zinc sulfate 100g, sucrose 1500g, dextrin 1190g, low substituted hydroxy-propyl methylcellulose 10g makes 1000 bags.
Example 2: the granule of the present composition
Hyaluronate sodium 150g, zinc gluconate 200g, sucrose 1500g, dextrin 1140g, low substituted hydroxy-propyl methylcellulose 10g makes 1000 bags.
Embodiment 3: the liquid preparation of the present composition
Hyaluronate sodium 150g, zinc gluconate 250g, glycyrrhizin 40g makes 20000ml, is distributed into 1000 bottles, sterilization, promptly.
Embodiment 4: the liquid preparation of the present composition
Hyaluronate sodium 200g, zinc glycinate 200g, sodium citrate 20g makes 20000ml, is distributed into 1000 bottles, sterilization, promptly.
Test data
48 gastric ulcer volunteers are divided into A group and B group, every group 24 people at random.The A group is taken embodiment three times on the 2nd, one, each bag, and (medicine) being taken before meal is used (with taking after 40～60 ℃ about 100ml the eliminating cold for resuscitation water stirring and dissolving); The B group is taken the hyaluronic acid zinc solution, and (self-control, concentration is 0.15%.), three times on the one, each 100 milliliters.When treating one month, gastroscope and barivm meal fluoroscopy (screem) inspection.The result shows 18 of A group cured persons, accounts for 75%, and 5 of produce effects persons account for 21%, and 1 of improvement person accounts for 4%; 10 of B group cured persons account for 42%, and 6 of produce effects persons account for 25%, and 6 of improvement persons account for 25%, and 2 of nonresponders account for 8%.The A group is organized raising evident in efficacy than B.
Claims (8)
1. preparation of drug combination method that contains hyaluronate sodium and zinc salt that is used for the treatment of gastritis, gastric ulcer and/or duodenal ulcer, only zinc salt being added proper auxiliary materials when it is characterized in that being prepared into solid preparation granulates, sieve, after granulation finishes, directly with zinc salt granule and hyaluronate sodium mixing, technology is made suitable tablet, capsule or granule and is got final product routinely again.
2. preparation of drug combination method that contains hyaluronate sodium and zinc salt that is used for the treatment of gastritis, gastric ulcer and/or duodenal ulcer, earlier hyaluronate sodium, zinc salt are dissolved respectively when it is characterized in that being prepared into liquid preparation, after in zinc solution, adding the proper auxiliary materials mix homogeneously, again with the sodium hyaluronate solution mix homogeneously, packing, sterilization gets final product.
3. claim 1 or 2 described preparation methoies, the weight ratio of wherein said hyaluronate sodium and zinc salt is 1: 99～99: 1.
4. claim 1 or 2 described preparation methoies, the weight ratio of wherein said hyaluronate sodium and zinc salt is 1: 20～20: 1.
5. claim 1 or 2 described preparation methoies, the weight ratio of wherein said hyaluronate sodium and zinc salt is 1: 10～10: 1.
6. claim 1 or 2 described preparation methoies, the weight ratio of wherein said hyaluronate sodium and zinc salt is 1: 5～5: 1.
7. claim 1 or 2 described preparation methoies, the molecular weight of wherein said hyaluronate sodium is 2.0 * 10
5～5 * 10
6Da.
8. claim 1 or 2 described preparation methoies, wherein said zinc salt is zinc sulfate, zinc gluconate, zinc glycinate, zinc citrate, zinc taurine, zinc acetate or zinc lactate.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100081644A CN101023961B (en) | 2006-02-23 | 2006-02-23 | Medicine composition containing sodium hyaluronate and zinc salt |
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|---|---|---|---|
| CN2006100081644A CN101023961B (en) | 2006-02-23 | 2006-02-23 | Medicine composition containing sodium hyaluronate and zinc salt |
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|---|---|
| CN101023961A CN101023961A (en) | 2007-08-29 |
| CN101023961B true CN101023961B (en) | 2010-07-21 |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114191447A (en) * | 2020-09-18 | 2022-03-18 | 华熙生物科技股份有限公司 | Application of hyaluronic acid and salt thereof in improving intestinal flora disorder and composition thereof |
| CN112451540B (en) * | 2020-11-25 | 2022-03-01 | 华熙生物科技股份有限公司 | Hyaluronic acid with anti-helicobacter pylori digestive tract infection activity |
| CN112691049B (en) * | 2021-01-15 | 2022-08-02 | 拉芳家化股份有限公司 | Shampoo composition containing zinc hyaluronate |
| CN115518053A (en) * | 2022-10-27 | 2022-12-27 | 青岛国海生物制药有限公司 | A capsule containing vitamin, ginseng radix and zinc, and its preparation method |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1254285A (en) * | 1997-04-29 | 2000-05-24 | 里克特格登化工有限公司 | Use of zinc hyaluronate against peptic ulcer |
| CN1403091A (en) * | 2002-08-30 | 2003-03-19 | 中国科学院兰州化学物理研究所 | Prepn of ulcer-resisting chitosan zinc compound |
| JP2003160464A (en) * | 2001-11-28 | 2003-06-03 | Denki Kagaku Kogyo Kk | Stabilized aqueous solution composition of hyaluronic acid and/or its salt |
-
2006
- 2006-02-23 CN CN2006100081644A patent/CN101023961B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1254285A (en) * | 1997-04-29 | 2000-05-24 | 里克特格登化工有限公司 | Use of zinc hyaluronate against peptic ulcer |
| JP2003160464A (en) * | 2001-11-28 | 2003-06-03 | Denki Kagaku Kogyo Kk | Stabilized aqueous solution composition of hyaluronic acid and/or its salt |
| CN1403091A (en) * | 2002-08-30 | 2003-03-19 | 中国科学院兰州化学物理研究所 | Prepn of ulcer-resisting chitosan zinc compound |
Non-Patent Citations (3)
| Title |
|---|
| JP特开2003160464A 2003.06.03 |
| 刘高峰等.玻璃酸钠制剂研究进展及应用.中国生化药物杂志25 4.2004,25(4),252-254. |
| 刘高峰等.玻璃酸钠制剂研究进展及应用.中国生化药物杂志25 4.2004,25(4),252-254. * |
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