CN109459543A - A method of the test external Antacid effectiveness of inorganic antacid containing magnesium - Google Patents
A method of the test external Antacid effectiveness of inorganic antacid containing magnesium Download PDFInfo
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Abstract
The present invention provides a kind of methods for testing the external Antacid effectiveness of inorganic antacid containing magnesium, belong to medical detection field.Liquid medium is mixed with inorganic antacid containing magnesium, shaken or stirred by this method, while detecting the pH value and magnesium ion dissolution situation of liquid, is realized to the more fully quality analysis of this kind of drug, is beneficial to assess its safety and inherent quality.The present invention has the advantages that easy to operate, easy to implement, is highly suitable for industrialized production.
Description
Technical field
The present invention relates to medical detection fields, and in particular to a kind of side for testing the external Antacid effectiveness of inorganic antacid containing magnesium
Method.
Background technique
Magnesium compound is widely used in field of medicaments, especially in antiacid field.These antiacids containing magnesium, in water
Based on insoluble inorganic compound, there is certain alkalinity more, take orally in rear and/or adsorb gastric acid, thus can weaken or release
Stimulation and corrosiveness of the gastric acid to ulcer surface.Common antiacid containing magnesium has heavy magnesium carbonate, magnesia, Hydrotalcite, aluminium
Magnesium adds, magnesium hydroxide, vitamin U, belladonna and aluminium magnesium sheet, compound radix aucklandiae alumina and magnesia, compound bismuth aluminate tablets, Alumini Hydroxide comp etc..It is antiacid
Agent is widely used in treatment taste-blindness rate stomach function regulating because having many advantages, such as that medical expense is low, effect is good, adverse reaction is small
Sour hypersecretion disease.One ideal antiacid should have following four features: 1) has and neutralizes speed faster, 2) and have
Higher buffer capacity, can maintain longer action time, and 3) gastric juice pH should be controlled between 3-5,4) without diarrhea, constipation
Or other ill-effects.First three items index belongs to the qualitative attribute of antiacid most critical --- and capacity antacid is mainly reflected in
Increase gastric juice pH.Section 4 index includes that constipation caused by the ill-effects such as diarrhea caused by magnesium ion, aluminium ion etc. is bad
Effect and drug change influence etc. of the pH value to enteron aisle.
In order to guarantee the anti-acid activity in human body of inorganic antacid containing magnesium, need to survey their external Antacid effectiveness
Examination.People have furtherd investigate the capacity antacid in Antacid effectiveness, mainly have static relieving haperacidity force method and dynamic to make at present
Two kinds of test methods of sour force method.In China's drug standards, the capacity antacid of antiacid characterization mostly using static relieving haperacidity force method into
Row is investigated.Although static relieving haperacidity force method is easy to operate, because static relieving haperacidity force method ignores the normally life such as gastric acid secretion, gastric emptying
Influence of the reason process to curative effect, so scientific and technical personnel devise increasingly complex dynamic relieving haperacidity force method (such as Rossett-Rice again
Method).Dynamic relieving haperacidity force method can assess different antiacid reaction speeds (measuring to reach time when pH value 3.0), buffering is held
Amount (amount that dose drug consumes when with pH value from 3.0~5.0 is measured).Dynamic relieving haperacidity force method can also draw different pharmaceutical dosage
Lower pH value versus time curve carries out curve comparison.Thus, which has very the evaluation of antiacid and internal anti-acid activity
Good correlation.But the operation of dynamic relieving haperacidity force method is excessively complicated cumbersome, application is confined in scientific research more, is seldom applied
In industrialized production detection.
Antacid effectiveness due to antiacid further includes evaluation diarrhea, constipation or other in addition to including above-mentioned capacity antacid
The contents such as ill-effect, but above-mentioned static relieving haperacidity force method and dynamic relieving haperacidity force method all cannot Section 4 index to antiacid
(no diarrhea, constipation or other ill-effects) carries out in-vitro evaluation.
Modern pharmacology research has defined, and large dosage, which takes inorganic antacid containing magnesium for a long time, will lead to diarrhea, serum electricity
Solve the adverse reactions such as qualitative change.These adverse reactions show that antiacid containing magnesium has magnesium ion dissolution in human body, especially
Be the magnesium ion in acid stronger situation the amount of dissolution it is more.This is determined by the property of magnesium ion.In addition, overdose
Inorganic antacid containing magnesium is dangerous.Risk can cause hypermagnesemia from excessive consumption of the human body to magnesium ion；Simultaneously
Magnesium ion has retardation to nerve conduction, can cause respiration inhibition, Cardiac depression, blood pressure rapid drawdown even dead when serious.
After inorganic antacid containing magnesium is oral, enteron aisle is entered after stomach only stops a few hours, then even by more than ten
It is excreted after tens hours.It is small that Chinese patent CN201711297440 takes Hydrotalcite montmorillonite front and back to subject
Intestines, the pH of large intestine are horizontal, are determined using BRAVO Radiotelemetry PH Capsules method, the results showed that aluminium
The significantly raised pH value of enteron aisle of magnesium carbonate montmorillonite.It can be seen that influence of the antiacid containing magnesium to gut pH be it will be evident that
But this method is vivo detection, cumbersome, performance difficulty complicated for operation, is not suitable for being applied in industrial production.
In summary, it is necessary to develop new testing in vitro method, realize and situation, drug are dissolved out to the magnesium of the antiacid containing magnesium
The detection that situation is influenced on gut pH assigns its ability for assessing the adverse reaction of inorganic antacid containing magnesium probability of happening, in turn
Help improves the safety and inherent quality of drug, promotes the research and development of novel drugs.
So far, research report in there is not yet in vitro test the magnesium ion of inorganic antacid containing magnesium dissolve out situation and its
The method of influence situation (safety and inherent quality that belong to the inorganic antacid containing magnesium) to gut pH, also there is not yet energy
It is enough to test the capacity antacid of inorganic antacid containing magnesium and magnesium ion dissolution situation and the influence situation to gut pH simultaneously in vitro
The method of equal Antacid effectiveness.
Summary of the invention
The object of the present invention is to provide a kind of methods for evaluating the external Antacid effectiveness of inorganic antacid containing magnesium, can be more comprehensively
The external Antacid effectiveness of inorganic antacid containing magnesium is more quickly detected, it is antiacid in vitro to solve prior art evaluation inorganic antacid containing magnesium
The defect that performance is not comprehensive enough, is not enough.
To reach above-mentioned technical purpose, technical solution of the present invention provides a kind of external for the performance of inorganic antacid containing magnesium
The method of research, includes the following steps:
Step 1. takes the liquid of pH value 0-8 to measure and record pH value after 32-42 DEG C of shaking or stirring, constant temperature；
Step 2. precision weighs inorganic antacid containing magnesium, in shaking or being added with stirring in the liquid, forms mixture
System；
Step 3. continues to shake or stir the mixed system, while measuring and recording its pH value and changing with time feelings
Condition；
Step 4. filters the mixed system at the time point of setting, takes the concentration of filtrate detection magnesium ion.
Liquid described in above method step 1 can be the dissolution of the dissolution medium, pH value 3.0-5.0 of pH value 1.0 or 1.2
The dissolution medium or water of medium, pH value 6.8.
The preferred aqueous hydrochloric acid solution of liquid described in above method step 1, the aqueous hydrochloric acid solution added with pepsin, phosphate
Buffered aqueous solution, phosphate-buffered aqueous solution or water added with pancreatin.
The preferred 20-1000ml of the volume of liquid described in above method step 1.
The time of constant temperature described in above method step 1 preferred 10-120min.
The parameter of shaking described in above method step 1-3 are as follows: frequency of oscillation 100-500rpm, amplitude 1-10mm.
The rate of stirring described in above method step 1-3 is 100-1000rpm.
The preferred 0.1-50.0g of quality of the inorganic antacid containing magnesium is weighed described in above method step 2.
Shaking described in above method step 3 or the time stirred are 0.5-96 hours preferred.
Compared with prior art, the beneficial effect comprise that the technical program realizes in vitro to inorganic containing magnesium
Antiacid magnesium ion dissolves out the detection of situation and its influence situation to gut pH, while it is inorganic antiacid containing magnesium to simplify test
The dynamic relieving haperacidity force method of the external capacity antacid of agent, realize comprehensive, abundant, quick evaluation inorganic antacid containing magnesium safety with it is interior
In the purpose of quality, and have the advantages that easy to operate, easy to implement, is highly suitable for industrialized production.
Detailed description of the invention
Fig. 1 is the curve that the pH value of embodiment 1,2,3 changes over time；
Fig. 2 is the magnesium the amount of dissolution curve of embodiment 1,2,3；
Fig. 3 is the curve that the pH value of embodiment 4,5,6 changes over time；
Fig. 4 is the magnesium the amount of dissolution curve of embodiment 4,5,6.
Specific embodiment
Below in conjunction with specific embodiment to the side of the test external Antacid effectiveness of inorganic antacid containing magnesium provided by the invention
Method is further described.The embodiments described below is exemplary, and for explaining only the invention, and should not be understood as to this
The limitation of invention.
Embodiment 1,2,3: taking three stripping rotors of RC12AD type dissolving-out tester, and successively compiling is No. 1, No. 2, No. 3, difference
The dilute hydrochloric acid 200ml that pH value is 1.0 (20 DEG C) is added, is placed in water-bath and stirs lower heating in 400rpm, reach 36 to temperature
Constant temperature 30min after DEG C -38 DEG C, measures and records pH value at this time.Three Hydrotalcite bulk pharmaceutical chemicals samples are taken, each precision weighs
4.0g, sequentially adds aforesaid liquid, starts timing, and record pH value changes with time situation, and dependence test the results are shown in Table 1 and figure
1。
Meanwhile the 5th minute, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 12 hours, 24 hours, 48 hours, it is 72 small
When, 96 hours when extract reaction solution 1ml with syringe respectively, after membrane filtration, using EDTA compleximetry detection filtrate in
Magnesium ion concentration, and calculate the amount of dissolution of magnesium ion.Specific testing result is shown in Table 2 and Fig. 2.
1 Hydrotalcite capacity antacid test result of table
Magnesium dissolves out situation in 2 Hydrotalcite of table
Pass through the comparison of three embodiments, it may be clearly seen that, the action of embodiment 3 is most slow, and pH value rises after action
Most fast highest, magnesium the amount of dissolution highest have certain stimulation to gastrointestinal tract, and the probability that ill-effect occurs is higher.Thus
As it can be seen that the bulk pharmaceutical chemicals in Examples 1 and 2 are in quality better than the bulk pharmaceutical chemicals in embodiment 3.
In short, this method stability is preferable, can evaluate the external capacity antacid for comparing each Hydrotalcite bulk pharmaceutical chemicals and
Magnesium ion dissolves out situation, there is preferable separating capacity.Therefore, this method can be evaluated well, compare Hydrotalcite raw material
The quality condition of medicine, the probability that assessment adverse reaction occurs, improves the safety and inherent quality of Hydrotalcite preparation.
Embodiment 4,5,6: taking three stripping rotors of RC12AD type dissolving-out tester, and successively compiling is No. 4, No. 5, No. 6, difference
The dilute hydrochloric acid 200ml containing 10g/1000ml pepsin that pH value is 1.0 (20 DEG C) is added, is placed in water-bath and is stirred in 400rpm
Lower heating is mixed, the constant temperature 30min after temperature reaches 36 DEG C -38 DEG C measures and records pH value at this time.3 groups of hydrotalcite tablets are taken,
Every group 8 (specification 0.5g is crushed, and crosses 80 meshes), aforesaid liquid is sequentially added, starts timing, the change of record pH value at any time
Change situation, dependence test result is as shown in table 3 and figure 3.
Meanwhile the 5th minute, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 12 hours, 24 hours, 48 hours, it is 72 small
When, 96 hours when extract reaction solution 1ml with syringe respectively, after membrane filtration, using EDTA compleximetry detection filtrate in
Magnesium ion concentration, and calculate the amount of dissolution of magnesium ion.Specific testing result is as shown in table 4 and figure 4.
3 Hydrotalcite capacity antacid test result of table
Magnesium dissolves out situation in 4 Hydrotalcite of table
Pass through above three embodiments, it may be clearly seen that the action of embodiment 6 is most slow, and pH value rises most after action
Height, magnesium the amount of dissolution highest maximum to the stimulation of gastrointestinal tract, the probability that ill-effect occurs are higher.It can be seen that embodiment
Preparation in 4 and 5 is in safety and quality better than the preparation in embodiment 6.
In short, this method stability is preferable, the external capacity antacid and magnesium for comparing each Hydrotalcite preparation can be evaluated
Ion release situation has preferable separating capacity.Therefore, this method can be evaluated well, compare Hydrotalcite preparation
Quality condition, the probability that assessment adverse reaction occurs, improves the safety and inherent quality of Hydrotalcite preparation.
Embodiment 7,8,9: taking 3 100ml conical flasks successively to compile is No. 7, No. 8, No. 9, and sequentially adding pH value is 1.0 (20
DEG C) dilute hydrochloric acid 25ml, the dilute hydrochloric acid 25ml that pH value is the dilute hydrochloric acid 25ml of 1.0 (20 DEG C), pH value is 3.0 (20 DEG C), be placed in
Lower heating is stirred in 100rpm in water-bath, the constant temperature 15min after temperature reaches 36 DEG C -38 DEG C measures and records pH value at this time.
Successively precision weighs 0.5g, 1.0g, 0.5g almagate bulk pharmaceutical chemicals, sequentially adds aforesaid liquid, starts timing, record pH value is at any time
Between situation of change, specific testing result is as shown in table 5.
After continuing stirring 24 hours, filtration takes filtrate to be examined successively the dissolution situation of magnesium ion, the detection method used for
EDTA compleximetry.Specific testing result is as shown in table 6.
5 almagate bulk pharmaceutical chemicals capacity antacid test result of table
6 almagate bulk pharmaceutical chemicals of table magnesium at 24 hours dissolves out situation
| Number | Magnesium density (mg/L) | Magnesium the amount of dissolution (mg) |
| 7 | 935.3 | 23.4 |
| 8 | 923.0 | 23.0 |
| 9 | 52.27 | 1.31 |
It can be clearly seen that the capacity antacid of almagate bulk pharmaceutical chemicals is related to dosage, molten with magnesium by embodiment 7,8,9
There are positive correlations for output.When more than 0.5g dosage, magnesium dissolution is unrelated with bulk pharmaceutical chemicals additional amount in almagate.So in order to increase
When dosing imitates and increases almagate dosage, the probability that diarrhea occurs, which has no, to be obviously increased.But excessive almagate will
A stronger alkaline environment is formed, certain stimulation is generated to gastrointestinal tract.So should be infused when clinically applying this drug
Meaning is appropriate, the rational use of medicines.
In short, this method can evaluate almagate capacity antacid and its relationship with magnesium dissolution well, almagate is prejudged
The case where generating stimulation to gastrointestinal tract, the probability that assessment adverse reaction occurs improve the safety of almagate, and guidance is reasonable
Medication.In addition, these data can also be used for the quality condition of evaluation, comparison different manufacturers almagate bulk pharmaceutical chemicals.
Embodiment 10,11,12: taking 3 1000ml conical flasks, and successively compiling is No. 10, No. 11, No. 12, is separately added into pH value
For dust technology 1000ml that the distilled water 1000ml of 7.0 (20 DEG C), pH value are 1.0 (20 DEG C), dilute second that pH value is 3.0 (20 DEG C)
Sour 1000ml is placed in water-bath and stirs lower heating, the constant temperature 100min after temperature reaches 34 DEG C~39 DEG C, measurement in 1000rpm
And the pH value of record at this time.Precision weighs 3 parts of 20.0g magnesium hydroxide bulk pharmaceutical chemicals, sequentially adds aforesaid liquid, starts timing, note
Record pH value changes with time situation, and the results are shown in Table 7 for dependence test.
After continuing stirring 48 hours, filtration takes filtrate that the dissolution situation of magnesium ion is examined successively, using EDTA complexometry
Method is detected.Specific testing result is as depicted in figure 8.
PH value changes used time table after magnesium hydroxide bulk pharmaceutical chemicals are added in 7 different medium of table
Magnesium dissolves out situation table to 8 magnesium hydroxide bulk pharmaceutical chemicals of table in different media
| Number | Magnesium density (mg/L) | Magnesium the amount of dissolution (mg) |
| 10 | 39.73 | 39.73 |
| 11 | 1036 | 1036 |
| 12 | 88.97 | 88.97 |
It can be seen that, this method can obtain magnesium hydroxide bulk pharmaceutical chemicals in different media to the shadow of pH value from table 7 and 8
Ring situation, the dissolution situation of magnesium ion.It can be seen that ability of the magnesium hydroxide almost without control gastric juice pH between 3-5,
Diarrhea effect is more apparent, does not meet the feature of ideal antiacid.In addition, these data can also be used for evaluation, comparison different manufacturers
The quality condition of magnesium hydroxide bulk pharmaceutical chemicals.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (9)
1. a kind of method for testing the external Antacid effectiveness of inorganic antacid containing magnesium, which comprises the steps of:
Step 1. takes the liquid of pH value 0-8 to measure and record pH value after 32-42 DEG C of shaking or stirring, constant temperature；
Step 2. precision weighs inorganic antacid containing magnesium, in shaking or being added with stirring in the liquid, forms mixed system；
Step 3. continues to shake or stir the mixed system, while measuring and recording its pH value and changing with time situation；
Step 4. filters the mixed system at the time point of setting, takes the concentration of filtrate detection magnesium ion.
2. the method according to claim 1, wherein the dissolution that liquid described in step 1 is pH value 1.0 or 1.2 is situated between
Matter, the dissolution medium of pH value 3.0-5.0, pH value 6.8 dissolution medium or water.
3. the method according to claim 1, wherein liquid described in step 1 is aqueous hydrochloric acid solution, added with stomach cardia
Aqueous hydrochloric acid solution, phosphate-buffered aqueous solution, the phosphate-buffered aqueous solution or water added with pancreatin of enzyme.
4. the method according to claim 1, wherein the volume of liquid described in step 1 is 20-1000ml.
5. the method according to claim 1, wherein the time of constant temperature described in step 1 is 10-120min.
6. the method according to claim 1, wherein the parameter of shaking described in step 1-3 are as follows: frequency of oscillation
100-500rpm, amplitude 1-10mm.
7. the method according to claim 1, wherein the rate of stirring described in step 1-3 is 100-
1000rpm。
8. the method according to claim 1, wherein the quality for weighing the inorganic antacid containing magnesium described in step 2 is
0.1-50.0g。
9. the method according to claim 1, wherein shaking or the time stirred described in step 3 are that 0.5-96 is small
When.
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| CN105055355A (en) * | 2015-09-14 | 2015-11-18 | 山东司邦得制药有限公司 | Hydroxy-aluminum montmorillonite chewable tablet as well as preparation method and application thereof |
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