CN102283861A - Application of magnesium hydrate to pharmacy as well as magnesium hydrate preparation and preparation method thereof - Google Patents
Application of magnesium hydrate to pharmacy as well as magnesium hydrate preparation and preparation method thereof Download PDFInfo
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- CN102283861A CN102283861A CN2010102025005A CN201010202500A CN102283861A CN 102283861 A CN102283861 A CN 102283861A CN 2010102025005 A CN2010102025005 A CN 2010102025005A CN 201010202500 A CN201010202500 A CN 201010202500A CN 102283861 A CN102283861 A CN 102283861A
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Abstract
The invention relates to application of magnesium hydrate to pharmacy, which discloses application of the magnesium hydrate to preparation of a medicament for treating constipation in pregnant women. The effective component of the medicament is the magnesium hydrate. The preparation is tablets or turbid liquor. The magnesium hydrate medicinal preparation can be used for treating constipation in pregnant women, thus the constipation in pregnant women can be effectively relieved and treated, the safety is realized and the influence on pregnant women and fetus is avoided; and the magnesium hydrate medicinal preparation has the characteristics of definite curative effect, safety in use and the like.
Description
Technical field
The present invention relates to the medical usage aspect, relate in particular to the purposes of magnesium hydroxide in pharmacy.The invention still further relates to magnesium hydroxide preparation of treatment anemia of pregnant woman constipation and preparation method thereof.
Background technology
In world developed country, constipation is one of very general disease at present.Along with China's rapid development of economy, the improving constantly of people (particularly town dweller) living standard makes the sickness rate of many " modern diseasies " be the trend of continuous rising.Constipation---this seems " indisposition " not worth mentioning, becomes one of city resident's common disease gradually, and the morbidity patient is more and more.
Anti-treating constipation at first will be carried out diet and transfer, and especially will note cellulosic replenishing, and promptly polyphagia gourd, fruit and vegetable and mixed grain rice are eaten polished rice flour and high oils and fats goods less.Secondly can use caccagogue to the constipation that can not alleviate through dietary adjustments.
Laxative can be divided into following three classes by its mechanism of action:
1, osmotic laxative is difficult for being absorbed and salt preparation soluble in water by intestinal wall for some, and oral back forms hypertonic salt solution at enteral, makes moisture increase in the enteric cavity, and volume enlarges, and stimulates intestinal mucosa, causes that the intestinal tube wriggling strengthens and defecation.Medicine has magnesium hydroxide, magnesium sulfate, sodium sulfate etc.
2, this class of irritant laxative medicine itself or its metabolite in vivo stimulate intestinal wall, and enterokinesia is strengthened and the promotion defecation.Medicine has phenolphthalein, Oleum Ricini, phenolphthalein, Radix Et Rhizoma Rhei etc.
3, this class of emollient laxative medicine can lubricate intestinal wall, and softening stool makes feces be easy to discharge.Common drug has liquid Paraffin, glycone, glycerin, Fructus Cannabis Bolus etc.
Laxative also can be used for the intestinal mirror, cholangiography is checked preceding cleaning enteric cavity work.Catharsis strength is gentle to reach characteristics such as toxic and side effects is little because laxative has, thus be specially adapted to old many patients, also suitable especially to anemia of pregnant woman, child.
Constipation is very unfavorable to the anemia of pregnant woman, though be not any serious disease, but make the anemia of pregnant woman feel very uneasy and painful, also can bring out symptoms such as headache and dizzy, abdominal distention stomachache, insomnia are unable, bitter taste halitosis thus, anemia of pregnant woman's hemorrhoid, anal fissure, proctoptosis sickness rate are increased, also can increase the weight of pregnancy induced hypertension syndrome, gravidocardiac symptom endangers bigger.Therefore, never can adopt a casual attitude for constipation.
According to the degree of anemia of pregnant woman's constipation, the doctor can advise: at first improve diet, drink water more, eat the food of fibre-enrich; If diet can not be dealt with problems, the supplement of can having a try are such as fiber ball or fiber powder; The constipation due to most of pregnancy has been alleviated in some measures of front, does not solve the manure bate of can having a try if constipation still; If above measure is all invalid, take laxative again.The essentially no teratogenesis of cathartic, but the cathartic that effect is strong, zest is big can not use.
Liquid paraffin belongs to emollient laxative, oral after substantially without gastrointestinal absorption, be safe to anemia of pregnant woman and fetus, each oral 15-30ml is in the preceding clothes of sleeping every night.Because liquid paraffin can hinder the absorption of solubility vitamin and calcium phosphorus, therefore should not take for a long time;
Using sulfated magnesium: nausea and vomiting can occur, take in a large number and can cause dehydration;
Use phenolphthalein: can cause erythra, allergic colitis and bleeding tendency;
Use Oleum Ricini: anemia of pregnant woman and baby avoid usefulness.
Also there are deficiencies such as use is inconvenient, mouthfeel is bad, be not suitable for long term administration, zest is big in other laxative.
Magnesium hydroxide belongs to saline cathartic as aperient, in oral back and the gastric acid and after disengage magnesium ion, be difficult for being absorbed and soluble in water by intestinal wall, form hypertonic salt solution at enteral, absorb large quantity of moisture and stop intestinal absorption moisture, the intestinal volume is increased, increase enterokinesia and produce defecation.The advantage of its treatment constipation is not produce stimulation, gentle constipation relieving.
The single preparations of ephedrine listing of domestic no magnesium hydroxide.The hydrogeneous magnesian compound preparation of listing has famotidine calcium magnesium chewable tablet, aluminum-magnesium dimeticone chewable tablet etc.
Summary of the invention
The object of the present invention is to provide the purposes of magnesium hydroxide in treatment anemia of pregnant woman constipation medicine.
Pharmaceutical preparation that provides a kind of anemia of pregnant woman's of treatment constipation and preparation method thereof is provided.
In order to realize the foregoing invention purpose, the present invention adopts following technical scheme:
The application of magnesium hydroxide in preparation treatment anemia of pregnant woman constipation medicine.
A kind of pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation, its active constituents of medicine are magnesium hydroxide, and described preparation is tablet or suspension.
Described preparation is tablet or suspension.
Described tablet comprises 70%～90% magnesium hydroxide, 5%～20% diluent, 0～5% binding agent, 1%～20% disintegrating agent.
Described diluent is one or more in microcrystalline Cellulose, starch, lactose, the mannitol;
Described suspension comprises 5%～20% magnesium hydroxide, 0.5%～2% suspending agent, and 0.1%～20% correctives, 0.05%～0.2% antiseptic, all the other are water.Wherein said suspending agent is one or more in sodium alginate, sodium carboxymethyl cellulose, xanthan gum, the methylcellulose; Described correctives is one or more in sucrose, sorbitol, Fructus Citri Limoniae essence, orange flavor essence, the apple essence; Described antiseptic is a sodium benzoate.
Described binding agent is one or more in hydroxypropyl methylcellulose, methylcellulose, polyvidone, the low substituted hydroxy-propyl fiber.
Described disintegrating agent is one or more in hydroxypropyl methylcellulose, methylcellulose, polyvidone, the low substituted hydroxy-propyl fiber.
The invention provides a kind of preparation method of pharmaceutical preparation tablet of the anemia of pregnant woman's of treatment constipation, comprise the steps:
(1), magnesium hydroxide, diluent, disintegrating agent pulverize separately sieves, with three's mix homogeneously, lubricant sieves, and is standby;
(2), add binding agent granulation, drying;
(3), with above-mentioned granule hybrid lubricant, mix homogeneously;
(4), tabletting promptly.
A kind of preparation method for the treatment of the pharmaceutical preparation suspension of anemia of pregnant woman's constipation at first adds magnesium hydroxide in the purified water, after stirring, add orange flavor essence and sodium benzoate again, be stirred to dissolving, add again after sodium carboxymethyl cellulose is stirred to dissolving, add purified water quantitatively promptly.
The invention discloses the purposes of magnesium hydroxide in anemia of pregnant woman's constipation medicine, magnesium hydroxide pharmaceutical preparation of the present invention is in treatment anemia of pregnant woman constipation, and can not only effectively alleviate and treat anemia of pregnant woman's constipation, and safety, can not impact, have determined curative effect, characteristics such as safe in utilization anemia of pregnant woman and fetus.
The specific embodiment
Embodiment 1: preparation magnesium hydroxide medicinal tablet.
Prescription: magnesium hydroxide 300g (85.7%)
Microcrystalline Cellulose 28g (8%)
Cross-linking sodium carboxymethyl cellulose 18.5g (5.5%)
Calcium stearate 3.5g (1%)
Prepare 1000
Preparation technology:
(1) magnesium hydroxide was pulverized 200 orders, microcrystalline Cellulose and low-substituted hydroxypropyl cellulose were crossed 100 orders, mix homogeneously respectively;
(2), cross 40 orders with above-mentioned mixed powder dry granulation;
(3) calcium stearate is crossed 80 orders, with last step granule mix homogeneously;
(4) tabletting promptly.
Carry out disintegration according to 2010 editions two appendix X A of Chinese Pharmacopoeia inspection technique disintegration and detect, experimental liquid adopts water: the disintegration time of the hydroxide magnesium sheet of present embodiment is 18s.
Carry out dissolution according to 2010 editions two appendix X C of Chinese Pharmacopoeia dissolution method and detect, experimental liquid adopts water, the results are shown in following table 1.
Table 1 dissolution test result
| Time/min | Dissolution/% |
| 5 | 25.8 |
| 15 | 76.1 |
| 30 | 92.4 |
| 45 | 101.2 |
| 60 | 103.1 |
Embodiment 2:
Prescription:
Magnesium hydroxide 350g (83.3%)
Microcrystalline Cellulose 21g (5%)
Starch 8.4g (2%)
Low-substituted hydroxypropyl cellulose 36.5g (8.7%)
Magnesium stearate 4.2g (1%)
Prepare 1000
Preparation technology:
(1) magnesium hydroxide was pulverized 200 orders, microcrystalline Cellulose and starch were crossed 100 orders, mix homogeneously respectively;
(2) get 40% low-substituted hydroxypropyl cellulose and be mixed with solution, as binding agent, with above-mentioned mixed powder system soft material, 40 orders are granulated, drying;
(3) residue 60% low-substituted hydroxypropyl cellulose is crossed 100 orders, and calcium stearate is crossed 80 orders, with the second step granule mix homogeneously;
(4) tabletting
Carry out disintegration according to 2010 editions two appendix X A of Chinese Pharmacopoeia inspection technique disintegration and detect, experimental liquid adopts water: the disintegration time of the hydroxide magnesium sheet of present embodiment is 20s.
Carry out dissolution according to 2010 editions two appendix XC dissolution methods of Chinese Pharmacopoeia and detect, experimental liquid adopts water, the results are shown in following table 2.
Table 2 dissolution test result
| Time/min | Dissolution/% |
| 5 | 23.5 |
| 15 | 70.3 |
| 30 | 90.8 |
| 45 | 102.3 |
| 60 | 102.9 |
By disintegration and dissolution result of the test, show that magnesium hydroxide preparation of the present invention disintegrate is fast, i.e. disintegrate fully in the 20s all exceeds more than 85% in the dissolution 30min.
The pharmacodynamic experiment result shows that the magnesium hydroxide preparation shows the cathartic effect, and the anemia of pregnant woman is had no adverse reaction.
Embodiment 3:
Prescription:
Magnesium hydroxide 8g
Sodium carboxymethyl cellulose 1g
Orange flavor essence 1g
Sodium benzoate 0.05g
Purified water q.s 100ml
Preparation technology:
8g magnesium hydroxide is added in the 60ml purified water, after stirring, add orange flavor essence and sodium benzoate again, be stirred to dissolving, add again after sodium carboxymethyl cellulose is stirred to dissolving, add purified water quantitatively to 100ml.
Embodiment 4:
Prescription:
Magnesium hydroxide 10g
Xanthan gum 1.5g
Fructus Citri Limoniae essence 1g
Sodium benzoate 0.05g
Purified water q.s 100ml
Preparation technology:
10g magnesium hydroxide is added in the 60ml purified water, after stirring, add Fructus Citri Limoniae essence and sodium benzoate again, be stirred to dissolving, add again after xanthan gum is stirred to dissolving, add purified water quantitatively to 100ml.
Below by the purposes of description of test medicine of the present invention in treatment anemia of pregnant woman constipation.
Experiment: the magnesium hydroxide preparation is to the pharmacodynamic experiment of experimental rat (pregnancy) laxative action.
1, purpose is used when the compound recipe diphenoxylate prepares the rat constipation and is forced oral magnesium hydroxide preparation, observes the laxative action of magnesium hydroxide preparation to rat constipation due to the compound recipe diphenoxylate, for clinical trial provides reliable basis.
2, experiment material
Medicine
Be subjected to reagent: the hydroxide magnesium sheet, embodiment 1 prepares, lot number: 090825 batch (300mg), producer: Hainan Pulin Pharmaceutical Co., Ltd is suspended in it among 0.5%CMC the preparation measured matter after the pulverizing;
The magnesium hydroxide suspension, embodiment 3 prepares, lot number: 090912, producer: Hainan Pulin Pharmaceutical Co., Ltd.
Compound recipe diphenoxylate suspension: get 8 R-1132s, lot number: 081028, producer: changzhou Kang Pu pharmaceutcal corporation, Ltd, adding distil water 60ml is made into suspension.
Laboratory animal:
Kunming Healthy female rat (pregnant 6-15 days), body weight 250 ± 10g.
3, experimental technique and result
The preparation of constipation rat model:
Get 60 of rats, female, pregnant 6-15 days, be divided into 3 groups after weighing at random, 20 every group, the 24h feedwater of stopping eating before the experiment, each experimental group duplicates the constipation model by 10mg/kg compound recipe diphenoxylate suspension oral gavage.
Experimental technique:
Mice after the modeling, one group of magnesium hydroxide (specification 300ng) to the embodiment preparation, one group of magnesium hydroxide suspension of preparing for embodiment 3, one group is the blank group.
Observed 30 minutes before the administration, will be subjected to reagent to force oral administration, also continue to give feedstuff and water at duration of test with disposable syringe.Observe as follows:
(1) observes every 1h after the administration, observe 12h, the defecation state (soft stool-diarrheal time occurs and present soft stool-diarrheal number of individuals) of last instrumentation 24h;
(2) feed situation is observed weekly twice;
(3) divide puerperium, Mus son's sign situation.
The result is as follows:
The cathartic result of the test of table 3 rat
Be subjected to after the administration simultaneously of reagent hydroxide magnesium sheet 300mg and magnesium hydroxide suspension till 7 hours, all examples are all thought has soft stool to drain, the peak that manifests soft stool drainage effect is 3-4h, on the other hand, in the experimental observation of blank group, think soft stool in all examples, all not occur, take and show the cathartic effect behind the magnesium hydroxide preparation.
Table 4 rat cathartic test sign and death condition observed result
The constipation rat is given behind the magnesium hydroxide until childbirth, and sign is all normal, does not have deadly, and in addition, the blank group is all dead after 5 days, and the signify hydrogen magnesium oxide has no adverse reaction to pregnant cathartic.
Table 5 rat cathartic test feed situation observed result
The constipation rat is given behind the magnesium hydroxide until childbirth, and the feed situation is all normal, and in addition, the blank group is all dead after 5 days, and the signify hydrogen magnesium oxide has no adverse reaction to pregnant cathartic.
The young sign situation of table 6 rat cathartic test Mus observed result
The constipation rat gives magnesium hydroxide until a minute puerperium, and the young sign of Mus is all normal, and the signify hydrogen magnesium oxide is to Mus son's not influence of growth promoter.
From above-mentioned zoopery as can be known, the magnesium hydroxide preparation has significant curative effect to the treatment constipation, and safety is to trimester of pregnancy rat and the young no any untoward reaction of Mus of fertility thereof.
Claims (9)
1. the application of magnesium hydroxide in preparation treatment anemia of pregnant woman constipation medicine.
2. pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation is characterized in that its active constituents of medicine is a magnesium hydroxide, and described preparation is tablet or suspension.
3. a kind of pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation according to claim 2 is characterized in that described tablet comprises 70%～90% magnesium hydroxide, 5%～20% diluent, 0～5% binding agent, 1%～20% disintegrating agent.
4. a kind of pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation according to claim 2 is characterized in that described suspension comprises 5%～20% magnesium hydroxide, 0.5%～2% suspending agent, and 0.1%～20% correctives, 0.05%～0.2% antiseptic, all the other are water.
5. a kind of pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation according to claim 3 is characterized in that described diluent is one or more in microcrystalline Cellulose, starch, lactose, the mannitol;
6. a kind of pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation according to claim 3 is characterized in that described binding agent is one or more in hydroxypropyl methylcellulose, methylcellulose, polyvidone, the low substituted hydroxy-propyl fiber.
7. a kind of pharmaceutical preparation for the treatment of anemia of pregnant woman's constipation according to claim 3 is characterized in that described disintegrating agent is one or more in hydroxypropyl methylcellulose, methylcellulose, polyvidone, the low substituted hydroxy-propyl fiber.
8. a kind of preparation method for the treatment of the pharmaceutical preparation of anemia of pregnant woman's constipation according to claim 3 is characterized in that comprising the steps:
(1), magnesium hydroxide, diluent, disintegrating agent pulverize separately sieves, with three's mix homogeneously, lubricant sieves, and is standby;
(2), add binding agent granulation, drying;
(3), with above-mentioned granule hybrid lubricant, mix homogeneously;
(4), tabletting promptly.
9. a kind of preparation method for the treatment of the pharmaceutical preparation of anemia of pregnant woman's constipation according to claim 4, it is characterized in that at first magnesium hydroxide being added in the purified water, after stirring, add orange flavor essence and sodium benzoate again, be stirred to dissolving, add again after sodium carboxymethyl cellulose is stirred to dissolving, add purified water quantitatively promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2010102025005A CN102283861A (en) | 2010-06-17 | 2010-06-17 | Application of magnesium hydrate to pharmacy as well as magnesium hydrate preparation and preparation method thereof |
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| CN2010102025005A CN102283861A (en) | 2010-06-17 | 2010-06-17 | Application of magnesium hydrate to pharmacy as well as magnesium hydrate preparation and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727442A (en) * | 2012-05-17 | 2012-10-17 | 杭州天诚药业有限公司 | Oral magnesium hydroxide solid preparation |
| CN112386577A (en) * | 2019-08-16 | 2021-02-23 | 北京天衡药物研究院有限公司 | Composition for treating constipation |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1473049A (en) * | 2001-08-27 | 2004-02-04 | Э�ͻ�ѧ��ҵ��ʽ���� | Antiacid and laxative tablets |
| CN101087593A (en) * | 2003-11-19 | 2007-12-12 | 萨利克斯药物公司 | Colonic purgative composition with soluble binding agent |
-
2010
- 2010-06-17 CN CN2010102025005A patent/CN102283861A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1473049A (en) * | 2001-08-27 | 2004-02-04 | Э�ͻ�ѧ��ҵ��ʽ���� | Antiacid and laxative tablets |
| CN101087593A (en) * | 2003-11-19 | 2007-12-12 | 萨利克斯药物公司 | Colonic purgative composition with soluble binding agent |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727442A (en) * | 2012-05-17 | 2012-10-17 | 杭州天诚药业有限公司 | Oral magnesium hydroxide solid preparation |
| CN102727442B (en) * | 2012-05-17 | 2014-04-23 | 杭州天诚药业有限公司 | Oral magnesium hydroxide solid preparation |
| CN112386577A (en) * | 2019-08-16 | 2021-02-23 | 北京天衡药物研究院有限公司 | Composition for treating constipation |
| CN112386577B (en) * | 2019-08-16 | 2024-01-23 | 北京天衡药物研究院有限公司 | Composition for treating constipation |
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Application publication date: 20111221 |