CN101112387B - Smectite turbid liquor for treating non-infectious diarrhea and method for preparing the same - Google Patents
Smectite turbid liquor for treating non-infectious diarrhea and method for preparing the same Download PDFInfo
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Abstract
The present invention discloses a montmorillonite suspension to treat non-infectious diarrhea, which is made by montmorillonite, glucose, sodium saccharin, vanillin, sodium benzoate and purified water with certain mix ratio by weight. The preparation method is that the montmorillonite is placed in a preparation tank, the water is added for soaking; then the excipients which are glucose, sodium saccharin, vanillin, sodium benzoate are added and the purified water is supplemented to the prescription dose, fully agitated, the liquid is placed in a colloid mill for milling and refining, after that the liquid can pass through a 325 mesh screen, the screened liquid is cooled down to room temperature after the agitating under the heating condition, the purified water is supplemented to the prescription dose, then the invention is made by fully agitating. Montmorillonite is made into the suspension, thus having finer particles, greater absorption force, stronger effects of gastrointestinal mucosal protection and elimination of pathogens, and faster application of the pharmacological role.
Description
Technical field
The present invention relates to a kind of smectite turbid liquor for the treatment of noninfectious diarrhea and preparation method thereof.
Background technology
Diarrhoeal diseases can be divided into acute diarrhea disease (course of disease is in 2 weeks), persistent diarrhea disease (course of disease 2 thoughtful 2 months) and chronic diarrheal disease (course of disease is more than 2 months) by the course of disease.Can be divided into infectious diarrhea disease (as rotavirus, antibacterial etc.) and noninfectious diarrhea disease (as dietetic diarrhea, allergic diarrhea etc.) by the cause of disease.Dioctahedral smectite (Montmorillonitum powder) went on the market in France's registration in 1975, the treatments that are used for diarrhoeal diseases of more than 60 country's successes in the whole world in 2002.China is in nineteen ninety approval of import dioctahedral smectite, and credit number is X900065.Before domestic smectite powder was not asked the city, dioctahedral smectite reached 500,000,000 RMB in the annual sales amount of China, and clinical practice is very extensive.
Dioctahedral smectite had once been done a large amount of clinical trials in China, the treatment patient is totally 36356 examples, involvement aspect is very wide, comprise adult and the acute and chronic diarrhoea of child, peptic ulcer, reflux esophagitis, colonic diseases, stomatitis etc., the result is as follows: 1. diarrhoea property disease: adult and child's effective percentage is respectively 92.9% and 92.4%; 2. harmonization of the stomach esophagel disease: adult and child's peptic ulcer total effective rate are respectively 89.29% and 91.89%; 2. gastritis: effective percentage is 88.28%; 3. esophagitis: adult and child's effective percentage is respectively 88.07% and 87.13%; 4. colonic diseases: average effectiveness level is 85.95%.
At present, the Montmorillonitum powder of being sold on the market has dioctahedral smectite (the rich good fortune of France-beneficial general life (Tianjin) pharmacy), very (Hainan first sign Pharmaceutical), Kent make (sea, Zhejiang Lik-Sang), Si Maite (Shandong, Shandong silver chin or cheek and Pharmaceutical), think cut (Beijing ten thousand brightness Double-Crane Pharmaceutical Co., Ltds), also have Shandong Xian He Pharmaceutical and Yangtze River Pharmaceutical that this product is also arranged, but also do not apply for trade name, also have Montmorillonitum dispersible tablet: Sai Limai (Shandong greenery pharmacy) in addition.
Natural smectite structure unit is the synusia shape, and granule is very tiny, and surface area is huge.The surface area of every gram Montmorillonitum can reach 100m
2More than, though natural Montmorillonitum granule is thin, granule is easily assembled caking in dry run, makes sheet-like particle overlapping.In crushing process or in the spray-drying process, be difficult to reach natural fineness, this just makes the Montmorillonitum granule contact with adsorbate more fully, and particulate interlayer exchange ion of Montmorillonitum and end face electric charge fully expose in the smectite turbid liquor, bring into play adsorption rapidly.
Montmorillonitum is water insoluble, but it is inflatable to absorb water, the eclipsed sheet-like particle of Montmorillonitum is fully disperseed, interlayer ion and end face ion expose, this helps interlayer ion exchange absorption and end face absorption, can produce after the Montmorillonitum imbibition between visco-plasticity and layer and the layer slidably to make it cover the gastrointestinal mucosal surface continuously.
In sum, the visco-plasticity behind the granularity of Montmorillonitum, inhomogeneous charging property, the water-swellable is its performance gastrointestinal mucosal protection, removes the physics and chemistry basis of digestive tract disease substance.The thin more surface area of viscosity is big more, helps more and the contacting of adsorbate; Help the evengranular gastrointestinal mucosal surface that covers of Montmorillonitum more; Combine with digestive tract mucus, to increase mucous anchorage of digestive tract and thickness; Help absorbing pathogenic bacteria, virus and toxin more; Help suppressing pepsin chelating cholate more, so granule is tiny more, absorption affinity is big more, the effect of gastrointestinal mucosal protection and removing pathogen is strong more.The pharmacological action performance is strong more.
Summary of the invention
The object of the present invention is to provide a kind of preparation method for the treatment of smectite turbid liquor and this suspension thereof of noninfectious diarrhea.
A kind of smectite turbid liquor for the treatment of noninfectious diarrhea is characterized in that this suspension is made by following materials of weight proportions, presses the cubage among per 100 bottles of 9000ml:
Montmorillonitum 900g, glucose 224.7g, saccharin sodium 2.1g, vanillin 1.2g, sodium benzoate 27g, surplus are purified water.
A kind of method for preparing smectite turbid liquor is characterized in that preparation process is as follows:
(1), in preparing tank, add the purified water of recipe quantity 2/3, the Montmorillonitum raw material of recipe quantity is slowly joined in the preparing tank, flooded 30 minutes;
(2), respectively add the adjuvant of recipe quantity, promptly glucose, vanillin, saccharin sodium, sodium benzoate stir in preparing tank, and complement to the prescription water gaging,
(3), be refined to 325 mesh sieves excessively with milling in the aforesaid liquid suction colloid mill;
(4), the liquid after sieving, under agitation in 90 ℃-110 ℃ the heating 30-60 minute, be cooled to room temperature, in cooling procedure, add purified water to recipe quantity;
(5), after stirring medicinal liquid 9000ml, carry out packing, every bottle is 90ml.
The physicochemical property of Montmorillonitum performance pharmacological action is to select the fundamental basis of Montmorillonitum dosage form.The pharmacological action of Montmorillonitum is gastrointestinal mucosal protective effect and absorbing pathogenic bacteria, virus and bacteriotoxin effect; these two effects are directly related with the fineness of the particles and the absorption affinity of preparation again, make suspension, can make its granule more tiny; absorption affinity is bigger, can make Montmorillonitum give play to bigger drug effect.
Make suspension and more help the ion exchange absorption of Montmorillonitum, the absorption affinity of Montmorillonitum derives from its inhomogeneous charging property.In the Montmorillonitum Si-O tetrahedral sheet, quaternary Si is replaced by tervalent Al sometimes, in Al-0 octahedral sheet, tervalent Al is replaced by the Mg of bivalence sometimes, and this just causes the positive charge deficiency, the negative charge surplus, the negative charge of this surplus is compensated by the cation of absorption on the crystal layer surface, when having water to exist, the compensating cation on crystal layer surface is called exchange absorption easily by other cation exchange.Exchangeable cation is positioned at the both sides of crystal layer, in the particulate overlapping layer of Montmorillonitum, they do not exist only in particulate outside, and are present in title interlayer exchange ion in the middle of layer and the layer, these interlayer exchangeable cations must just can exchange attraction function after abundant dispersion exposes.
Granule is very tiny, and surface area is huge.Natural smectite structure unit is the synusia shape, and its major diameter is 1-3 μ m, and thickness is 1nm, and spacing is 1.4nm, so surface area is huge, the surface area of every gram Montmorillonitum can reach 100m
2More than, natural Montmorillonitum granule thin though (＜3 μ m), granule easily focuses on caking in dry run, makes sheet-like particle overlapping, in crushing process or in the spray-drying process, be difficult to reach natural fineness, so, be decided to be in the quality standard of dioctahedral smectite the granule of 45 μ m is no more than 1%, although claim in the operation instructions of dioctahedral smectite that its particle diameter is 1-3 μ m, but according to the selective examination chemical examination that sell in its city, the granule of 1-3 μ m have only 17%, 10 μ m following also have only 50%.The publicity materials of dioctahedral smectite claim its specific surface area to reach 1m
2More than/the g, but chemically examine according to the sampling of our commercially available product, specific surface area also has only 0.5m
2/ g, the granule of Montmorillonitum particle diameter 1-3 μ m reaches 60% in the smectite turbid liquor, and the following granule of particle diameter 10 μ m reaches 90%, and specific surface area is all at 1m
2More than/the g, this just makes the Montmorillonitum granule contact with adsorbate more fully, and particulate interlayer exchange ion of Montmorillonitum and end face electric charge are fully exposed, and brings into play adsorption rapidly.
Dilatancy.Montmorillonitum is water insoluble, but it is inflatable to absorb water, the eclipsed sheet-like particle of Montmorillonitum is fully disperseed, interlayer ion and end face ion expose, this helps interlayer ion exchange absorption and end face absorption, can produce after the Montmorillonitum imbibition sticking revive and layer and layer between slidably make it cover the gastrointestinal mucosal surface continuously.
In sum, the granularity of Montmorillonitum, inhomogeneous charging property, the visco-plasticity behind the water-swellable is its performance gastrointestinal mucosal protection, removes the physics and chemistry basis of digestive tract disease substance, the thin more surface area of viscosity is big more, helps more and the contacting of adsorbate; Help the evengranular gastrointestinal mucosal surface that covers of Montmorillonitum more; Combine with digestive tract mucus, to increase mucous anchorage of digestive tract and thickness; Help absorbing pathogenic bacteria, virus and toxin more; Help more suppressing pepsin bacterium chela and cholate, so granule is tiny more, absorption affinity is big more, and the effect of gastrointestinal mucosal protection, removing pathogen is strong more.The pharmacological action performance is fast more.
The specific embodiment
Embodiment 1 smectite turbid liquor and preparation method thereof
The non-infection diarrheal of a kind of treatment smectite turbid liquor, it is made by following materials of weight proportions, presses the cubage among per 100 bottles of 9000ml:
Montmorillonitum 900g, glucose 224.7g, saccharin sodium 2.1g, vanillin 1.2g, sodium benzoate 27g, surplus are purified water.
The preparation process of this smectite turbid liquor is as follows:
(1), in preparing tank, add the purified water of recipe quantity 2/3, the Montmorillonitum raw material of recipe quantity is slowly joined in the preparing tank, flooded 30 minutes;
(2), respectively add the adjuvant of recipe quantity, promptly glucose, vanillin, saccharin sodium, sodium benzoate stir in preparing tank, and complement to the prescription water gaging,
(3), be refined to 325 mesh sieves excessively with milling in the aforesaid liquid suction colloid mill;
(4), the liquid after sieving, under agitation in 90 ℃ the heating 30 minutes, be cooled to room temperature, in cooling procedure, add purified water to recipe quantity;
(5), after stirring medicinal liquid 9000ml, carry out packing, every bottle is 90ml.
The clinical trial of embodiment 2 smectite turbid liquors
For estimating the clinical efficacy and the safety of smectite turbid liquor treatment noninfectious diarrhea, by Shandong Qilu Hospital is the clinical research responsible department, Shandong Prov. Hospital and Affiliated Hospital of University Of Qingdao are participant, " provisions for new drugs approval " and the China " new drug (Western medicine) clinical research guideline " of abideing by National Drug Administration (SDA) issue, formulate this clinical research scheme
Multicenter is adopted in this clinical trial, at random, and double blinding dual analog, the design of positive drug parallel check experiment.63 routine non-infectious acute diarrheas have been observed altogether, test group 32 examples wherein, matched group 31 examples, 3 days courses of treatment.66 routine chronic diarrheas, test group 33 examples wherein, matched group 33 examples, 7 days courses of treatment. test group and two groups of patients' of matched group base case: have or not the equal not statistically significants of index comparing difference such as treatment, body temperature before sex, age, body weight, the test; Symptom, the equal not statistically significant of sign situation comparing difference before two groups of patient's medications.Show two groups of patients this several aspect equilibrium comparable.
This result of the test shows oral smectite turbid liquor to non-infectious acute diarrhea effective percentage 96.87%, and matched group dioctahedral smectite effective percentage is 87.10%; To non-infectious chronic diarrhea smectite turbid liquor effective percentage is 87.88%, and matched group dioctahedral smectite effective percentage is 90.91%.Statistic analysis result shows, non-infectious acute and chronic diarrhoea patient after the medication, and two groups of curative effects are basic identical.
Change comparative result from two groups of patient's medications front and back symptoms, every the keeping the score of sign, two groups of non-infectious acute and chronic diarrhoea, medication front and back symptom, sign are kept the score and are changed the interior front and back of each group relatively, difference all has statistical significance, smectite turbid liquor and dioctahedral smectite treatment diarrhoea is described effectively, during average decline divides relatively between two groups, the only state of an illness of acute diarrhea scoring, difference has statistical significance, and test group on average descends branch greater than matched group, illustrates that smectite turbid liquor and dioctahedral smectite curative effect are basic identical.
Relevant symptom, sign disappearance situation analysis result after two groups of patient's medications, the comparing difference not statistically significant of symptom, sign disappearance rate after two groups of acute and chronic diarrhoeal diseases people's medications.Symptom, sign on average disappear natural law relatively after two groups of patient's medications, the stomachache of acute diarrhea only, and two groups of natural law differences that on average disappear have statistics, and the test group natural law that on average disappears is shorter than matched group, illustrate that smectite turbid liquor and dioctahedral smectite curative effect are basic identical.
Before and after two groups of patient's medications,, symptom, sign divide relatively result about amounting to, smectite turbid liquor and dioctahedral smectite treatment curative effect are basic identical. and always keeping the score between two groups changes relatively, after the acute and chronic diarrhoea medication 1 day, the variation difference of always keeping the score all has statistical significance, and test group is always kept the score decline greater than matched group.The rate of change that symptom, sign are always kept the score before and after two groups of patient relatively, after the acute diarrhea medication 1 day, 5 days difference had statistical significance after the chronic diarrhea medication, and test group is always kept the score and descended greater than matched group.The rate of change difference of always keeping the score after all the other each day medications not statistically significant illustrates the smectite turbid liquor instant effect in dioctahedral smectite, the general curative effect zero difference.
This test shows, compares with dioctahedral smectite, and the smectite turbid liquor curative effect is fast, and its mechanism may be relevant with the Montmorillonitum pharmacological action.Montmorillonitum has gastrointestinal mucosal protection and pathogen adsorption, and the two is directly related with the fineness of the particles of preparation again.The research report is arranged, and nanoscale Montmorillonitum curative effect is more than three times of dioctahedral smectite.The particulate mean diameter of Montmorillonitum is approximately less than 1/3 of dioctahedral smectite in the smectite turbid liquor; specific surface area (cm) is more than 5 times of dioctahedral smectite; this helps covering stone granulate and covers the digestive tract surface; the protection gastrointestinal mucosal; help the Montmorillonitum granule to contact, accelerate adsorption with pathogen with adsorbate.Montmorillonitum is made suspension in addition, has reduced Montmorillonitum expansion dispersive process in vivo, also helps to bring into play faster its pharmacological action.
In this test, two kinds of medicines are all found a routine untoward reaction, and the untoward reaction symptom is nauseating, and degree is light, disappear after 3 days, and the every index ANOMALOUS VARIATIONS of laboratory before and after two kinds of drug administrations there is no the abnormal change of clinical meaning.
The result shows that it is safe that two kinds of clinical drugs are used.
Conclusion: this result of the test shows that it is sure, safe that oral smectite turbid liquor is treated the same curative effect with dioctahedral smectite of non-infectious acute and chronic diarrhea.
Claims (1)
1. one kind prepares the method for the treatment of the noninfectious diarrhea smectite turbid liquor, and its preparation process is as follows:
(1), be equipped with the prescription raw material, by the content among per 100 bottles of 9000ml
Montmorillonitum 900g, glucose 224.7g, saccharin sodium 2.1g, vanillin 1.2g, sodium benzoate 27g, surplus are purified water;
(2), in preparing tank, add the purified water of recipe quantity 2/3, the Montmorillonitum raw material of recipe quantity is slowly joined in the preparing tank, flooded 30 minutes;
(3), respectively add the adjuvant of recipe quantity, promptly glucose, vanillin, saccharin sodium, sodium benzoate stir in preparing tank, and complement to the prescription water gaging;
(4), be refined to 325 mesh sieves excessively with milling in the aforesaid liquid suction colloid mill;
(5), the liquid after sieving, under agitation in 90 ℃-110 ℃ the heating 30-60 minute, be cooled to room temperature, in cooling procedure, add purified water to recipe quantity;
(6), after stirring medicinal liquid 9000ml, carry out packing, every bottle is 90ml.
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| EP2386289A1 (en) * | 2010-04-29 | 2011-11-16 | Ipsen Pharma S.A.S. | Clay compositions |
| CN105055309B (en) * | 2015-09-14 | 2018-06-22 | 山东司邦得制药有限公司 | Hydroxy-alumium montmorillonite suspension and its preparation method and application |
| CN105193840B (en) * | 2015-10-30 | 2018-05-29 | 山东大学 | A kind of kaolin suspension for treating chronic diarrhea and preparation method thereof |
| CN108721325B (en) * | 2017-04-13 | 2020-03-06 | 辽宁大熊制药有限公司 | Montmorillonite suspension and preparation method thereof |
| CN110404058A (en) * | 2019-05-20 | 2019-11-05 | 河南普华基因科技有限公司 | It is a kind of to treat animal diarrhea and orectic biological agent |
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| CN1103585C (en) * | 1995-03-14 | 2003-03-26 | 普罗克特和甘保尔公司 | dispersed smectite clay as oil in water stabilizer for skin cleansing liquid composition |
| CN1927220A (en) * | 2006-08-24 | 2007-03-14 | 广东邦民制药厂有限公司 | Montmorillonite gelling preparation for treating diarrhea and gastritis and its preparation process |
| CN101002796A (en) * | 2006-01-18 | 2007-07-25 | 浙江海力生制药有限公司 | Application of nanometer montmorillonite for pharmaceutical use, and medicine compositions therewith |
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| CN1103585C (en) * | 1995-03-14 | 2003-03-26 | 普罗克特和甘保尔公司 | dispersed smectite clay as oil in water stabilizer for skin cleansing liquid composition |
| CN101002796A (en) * | 2006-01-18 | 2007-07-25 | 浙江海力生制药有限公司 | Application of nanometer montmorillonite for pharmaceutical use, and medicine compositions therewith |
| CN1927220A (en) * | 2006-08-24 | 2007-03-14 | 广东邦民制药厂有限公司 | Montmorillonite gelling preparation for treating diarrhea and gastritis and its preparation process |
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