CN102626402A - Monolauryl phosphate-containing lithontriptic for litholysis of cholesterol gallstone - Google Patents
Monolauryl phosphate-containing lithontriptic for litholysis of cholesterol gallstone Download PDFInfo
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- CN102626402A CN102626402A CN2012100652307A CN201210065230A CN102626402A CN 102626402 A CN102626402 A CN 102626402A CN 2012100652307 A CN2012100652307 A CN 2012100652307A CN 201210065230 A CN201210065230 A CN 201210065230A CN 102626402 A CN102626402 A CN 102626402A
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Abstract
The invention relates to a monolauryl phosphate-containing lithontriptic for litholysis of cholesterol gallstone. The monolauryl phosphate-containing lithontriptic comprises methyl tertiary butyl ether and monolauryl phosphate, wherein based on 1mL of methyl tertiary butyl ether, the mass of used monolauryl phosphate is in a range of 0.05 to 0.60g. The monolauryl phosphate-containing lithontriptic can correspondingly reduce saturated vapor pressure and smell irritation of methyl tertiary butyl ether and thus the novel monolauryl phosphate-containing lithontriptic can be used in non-operative clinical therapies for patients suffering from cholesterol gallstone.
Description
Technical field
The present invention relates to a kind of novel lithodialysis agent that is used for dissolving cholesterol type calculus, particularly contain single Tryfac 5573 in this lithodialysis agent.
Background technology
Along with growth in the living standard, the sickness rate of cholelithiasis raises year by year, according to statistics, has the crowd about 10% standing the misery that calculus is brought both at home and abroad at present, and it is anxious when being sure to therefore to explore the Iithiasic method of a kind of effective treatment.
At present the excision gallbladder is the main means of treatment cholelithiasis, but cholecystectomy not only medical expense is high, operation risk is big, excising gallbladder simultaneously can bring some inconvenience to people's life from now on.In addition, some patients such as old, fat and suffer from other important organ diseases, are not fit to carry out the treatment of cholecystectomy, and therefore, the Iithiasic method of development non-operative treatment is significant.
Oral drug therapy is ideal Therapeutic Method, and since nineteen thirty-seven Neubridge attempted treating calculus with the method for oral bile acid, some other medicine was also by developing in succession; Such as chenodeoxy cholic acid; Ursodeoxycholic acid, Pravastatin, Chinese herbal and crude drugs preparations etc.But in general, the oral drugs lithodialysis has weak curative effect, and the course of treatment is long, and expense is high, and shortcomings such as relapse rate height are demanded further development urgently.
Directly perfusion lithodialysis method also is the Iithiasic method of a kind of comparatively ideal treatment; Owing to put pipe (PTCD) through the liver and gall road or retrograde gallbladder intubate approach such as (ERCG) under scope through percutaneous; Lithodialysis agent perfusion gets into gallbladder; Can directly contact with cholelithiasis, therefore directly pour into lithodialysis method treatment time weak point, it is fast to produce effects.But the popularization of this Therapeutic Method need be sought a kind of lithodialysis agent to human body safety.Ether is the lithodialysis agent that is employed the earliest, but because the ether boiling point is lower than body temperature, advances in the human body back vaporization and produces high pressure, makes patient produce tormina and is not widely accepted.Dextrorotation hesperidene subsequently, single caprylin, propionic acid ethyl etc. are used as the lithodialysis agent of direct perfusion lithodialysis method in succession, but more or less there are problems such as the not high or toxic and side effects of lithodialysis rate is big in they not by further application.
At present, the most effectively the lithodialysis agent is a methyl tert-butyl ether, and its litholytic effect is strong 50 times than caprylin, is 90～96% to the complete lithodialysis rate of cholesterol calculus.Since methyl tert-butyl ether is used as the lithodialysis agent; Lot of domestic and international scholar has carried out relevant research to the toxic and side effects of methyl tert-butyl ether, and experimental result shows that methyl tert-butyl ether is safe to human body basically, and agent exists certain defective but it is separately as lithodialysis; Although the boiling point such as methyl tert-butyl ether is 55.7 ℃; The body temperature that is higher than the people, but the volatility of methyl tert-butyl ether is more intense still exists when being applied to human body because of volatilization to produce highly compressed problem.Simultaneously, methyl tert-butyl ether can produce and make the very uncomfortable penetrating odor of people.
Summary of the invention
In order to overcome the problems referred to above of existing lithodialysis agent; The inventor discovers, through in methyl tert-butyl ether, adding single Tryfac 5573, and saturated vapor pressure that not only can corresponding reduction methyl tert-butyl ether; And owing to reduced the percentage composition of methyl tert-butyl ether comparatively speaking; So the also corresponding zest that reduces its abnormal smells from the patient, thereby obtain a kind of novel lithodialysis agent that is used for dissolving cholesterol type calculus, accomplished the present invention on this basis.
Therefore, theme of the present invention provides a kind of mixing lithodialysis agent that is used for dissolving cholesterol type calculus, and it comprises methyl tert-butyl ether and single Tryfac 5573, and based on the methyl tert-butyl ether meter of 1mL, the quality of single Tryfac 5573 is 0.05～0.60g.
The inventor has carried out lot of experiments to the dissolving situation of cholesterol; The result finds; Along with the increase of single Tryfac 5573 addition, mixed solution increases the meltage of cholesterol gradually in a certain amount of methyl tert-butyl ether, and the abnormal smells from the patient of mixed solution then diminishes gradually.
When the quality of single Tryfac 5573 was 0.05g for the methyl tert-butyl ether of 1mL, mixed solution did not have existing significantly increase under single Tryfac 5573 situation to the meltage ratio of cholesterol; When the quality of single Tryfac 5573 for the methyl tert-butyl ether of 1mL was 0.10g, mixed solution did not have promptly to have increased by 50% under single Tryfac 5573 situation to the meltage ratio of cholesterol.
Along with the increase of single Tryfac 5573 addition in the mixed solution, stablely always keeping the meltage bigger to cholesterol, decrease again then.
When being 0.20g, 0.30g and 0.40g such as the quality when single Tryfac 5573 for the methyl tert-butyl ether of 1mL, mixed solution does not have all to increase about 50% under single Tryfac 5573 situation to the meltage ratio of cholesterol; When the quality of single Tryfac 5573 for the methyl tert-butyl ether of 1mL was 0.50g, mixed solution did not have still to increase more than 30% under single Tryfac 5573 situation to the meltage ratio of cholesterol, but decreases than maximum solubility value; And when the quality of single Tryfac 5573 for the methyl tert-butyl ether of 1mL was 0.60g, mixed solution did not have to increase about 20% under single Tryfac 5573 situation to the meltage ratio of cholesterol.
Therefore, according to the present invention, the said mixing lithodialysis agent that is used for dissolving cholesterol type calculus, based on the methyl tert-butyl ether meter of 1mL, the quality of single Tryfac 5573 is 0.05～0.60g, preferred 0.10～0.50g, more preferably 0.10～0.40g.
The inventor finds that single Tryfac 5573 has solubilization to cholesterol, and therefore when a small amount of single Tryfac 5573 of adding in methyl tert-butyl ether, mixed solution just shows than highly dissoluble cholesterol; When single Tryfac 5573 addition increases in the methyl tert-butyl ether; Mixed solution is to the meltage of the cholesterol higher level that stays relatively constant at; But this moment, the viscosity of mixed solution also increased gradually; After viscosity reached a certain numerical value, the viscosity of increase will hinder the dissolving of cholesterol to a certain extent.
Though in fact when the dissolution time long enough, the content of single Tryfac 5573 is high more in the lithodialysis agent, its meltage to cholesterol is big more.But in practical application, we not only will consider the meltage of the lithodialysis agent of unit volume to cholelithiasis, also need consider the dissolution velocity of lithodialysis agent to cholelithiasis.Comprehensive above two factors, the relation of single Tryfac 5573 and methyl tert-butyl ether amount is in the lithodialysis agent that we select in practical application: based on the methyl tert-butyl ether meter of 1mL, the amount of single Tryfac 5573 most preferably is 0.20～0.30g.
According to the preferred embodiment of the present invention, said lithodialysis agent becomes branch to form by the methyl tert-butyl ether of the above amount for two kinds with single Tryfac 5573.
Another theme of the present invention is the purposes that the above lithodialysis agent is used for dissolving cholesterol type calculus.
Another theme of the present invention is the purposes of the above lithodialysis agent in the medicine of preparation treatment cholesterol type calculus.
With lithodialysis agent of the present invention the cholesterol type calculus is carried out dissolution in vitro, the result finds that cholelithiasis is dissolved basically, only stays a small amount of insoluble sludge.Right through in the ultrared spectrum storehouse, the infrared spectrum of residue being carried out matching ratio, find the infrared spectrum and bilirubinic spectrogram matching degree maximum of residue.And reported once in the pertinent literature that the main component in people's cholelithiasis was cholesterol and bilirubin, and cholesterol level surpasses 70% in the cholesterol type calculus, have in addition up to more than 90%.Therefore, lithodialysis agent of the present invention is better for the litholytic effect of cholesterol type calculus.Though lithodialysis agent according to the present invention is not good to bilirubinic solute effect; But the cholesterol type calculus is dissolved the last residue diameter in back basically basically less than 1mm; And directly pour in the lithodialysis operation employed conduit diameter generally about 2mm; The average diameter of bile duct probably is 2 to 3mm, so these insoluble residues are enough little, can extracted out or gone out by biliary system by conduit fully.
Lithodialysis agent of the present invention can be adopted the administering mode of direct perfusion lithodialysis method; Put pipe (PTCD) through the liver and gall road or retrograde gallbladder intubate approach such as (ERCG) under scope through percutaneous; Lithodialysis agent perfusion is got into gallbladder; It is directly contacted with cholelithiasis, the cholesterol type calculus is demonstrated obvious curative effects, except having given play to direct perfusion lithodialysis method treatment time weak point, the fast effect of producing effects; The stomachache sense that the high pressure of also having avoided vaporization or volatilization to produce brings to patient, also corresponding penetrating odor and other side effect that has reduced methyl tert-butyl ether.
The experiment in vitro research that is used to novel lithodialysis agent of the present invention to dissolve human gallstones shows that this novel lithodialysis agent is better than any lithodialysis agent on the market to the solvability of human gallstones.Because single Tryfac 5573 has no toxicity to human body; Document in conjunction with in the past relevant methyl tert-butyl ether toxicity research; Owing to reach the consumption that same litholytic effect has correspondingly reduced methyl tert-butyl ether; The abdominal part distending pain sense that can suppress its volatilization to a certain extent and possibly bring has thus weakened its penetrating odor simultaneously, and therefore novel lithodialysis agent of the present invention can be used in the treatment of clinical cholesterol type calculus patient's non-operative treatment fully.
Description of drawings
Fig. 1: the comparison of the infrared spectrogram of cholelithiasis sample and cholesterol standard infrared spectrogram, wherein last figure is the cholelithiasis sample spectra, figure below is the cholesterol standard spectrum;
Fig. 2: the infrared spectrogram of cholelithiasis sample and cholelithiasis be the fully comparison of the infrared spectrogram of the last residue in dissolving back in the lithodialysis agent, and wherein last figure is the cholelithiasis sample spectra, and figure below is the infrared spectrum of the last residue in dissolving back;
Fig. 3: cholelithiasis is by the preceding photo of lithodialysis agent dissolving;
Fig. 4: cholelithiasis is mixed the photo after the lithodialysis agent that forms is fully dissolved by lauryl phosphoric acid fat and MTBE;
Fig. 5 a: be the structural formula of methyl tertiary butyl ether(MTBE), wherein the carbon atom at methyl is marked with *;
Fig. 5 b: be the structural formula of cholesterol, wherein * be marked on the corresponding carbon atom of position as shown in the figure; With
After Fig. 5 c:MTBE dissolving cholesterol, the pairing nuclear-magnetism of the carbon atom spectrum of band * in the cholesterol is labeled as the b peak with wherein peak; Embodiment 2 prepare lithodialysis agent dissolving cholesterol after, the pairing nuclear-magnetism of the carbon atom spectrum of band * in the cholesterol is labeled as a peak with wherein peak.
The specific embodiment
The present invention is elaborated through the specific embodiment below in conjunction with accompanying drawing.Characteristics of the present invention and advantage will become more clear, clear and definite along with these descriptions.
Embodiment 1:
The agent of preparation lithodialysis:
In order to measure the solvability of the different lithodialysis agent of single at the appointed time Tryfac 5573 amount to cholesterol; The methyl tert-butyl ether that in the color-comparison tube of 6 10mL, adds 3mL respectively adds 0.00g, 0.30g more respectively; 0.60g; 0.90g, 1.20g, single Tryfac 5573 of 1.50g is processed solution.
Dissolving cholesterol:
In these 6 test tubes, add cholesterol gradually, vortex oscillation was calculated the meltage of cholesterol respectively after 3 minutes.
Experimental result:
Listed in the table 1 and increased the dissolving situation of cholesterol in this lithodialysis agent along with single Tryfac 5573 amount.
Table 1:
| The amount of methyl tert-butyl ether (mL) | 3 | ?3 | ?3 | ?3 | ?3 | ?3 |
| The amount (g) of single Tryfac 5573 | 0.00 | 0.30 | 0.60 | 0.90 | 1.20 | 1.50 |
| The amount of dissolving cholesterol (g) | 0.42 | 0.63 | 0.64 | 0.64 | 0.63 | 0.56 |
Can find out from the experimental result of table 1; When in the 3mL methyl tert-butyl ether, adding 0.30g list Tryfac 5573, the amount of mixed solution dissolving cholesterol does not just increase by 50% than having under single Tryfac 5573 situation, along with the increase of single Tryfac 5573 addition in the mixed solution; Until adding the single Tryfac 5573 of 1.20g; Also stablely always keeping the meltage bigger to cholesterol, along with the increase of solution viscosity, meltage decreases then.
Embodiment 2:
The agent of preparation lithodialysis:
Ratio according to single Tryfac 5573 of the corresponding 0.60g of the methyl tert-butyl ether of 3mL is prepared the lithodialysis agent.
The dissolving human gallstones:
Get a cholelithiasis sample that from human body, takes out, its infrared spectrum is shown in last figure among Fig. 1, and figure below is a cholesterol standard infrared spectrogram.Confirm that by Fig. 1 this sample is the cholesterol type calculus.This cholelithiasis is said by lithodialysis agent dissolving preceding form photo such as Fig. 3.
This cholelithiasis sample is added in the lithodialysis agent of being prepared gradually, and under ultrasonic, cholelithiasis is dissolved basically after 18 to 20 minutes, only stays a spot of insoluble residue.
Fig. 2 is infrared spectrogram and cholelithiasis fully comparison of the infrared spectrogram of the last residue in dissolving back in the lithodialysis agent of cholelithiasis sample, and wherein last figure is the cholelithiasis sample spectra, and figure below is the infrared spectrum that fully dissolves the last residue in back.Two spectrum peaks have than big difference, and the main component in the cholesterol type calculus sample is described, promptly cholesterol is dissolved basically, and remainder can not be by the dissolved residue of lithodialysis agent.Right through in the ultrared spectrum storehouse, the infrared spectrum of residue being carried out matching ratio, find the infrared spectrum and bilirubinic spectrogram matching degree maximum of residue.Therefore, lithodialysis agent of the present invention is better for the litholytic effect of cholesterol type calculus.
Form photo after this cholelithiasis is fully dissolved by the lithodialysis agent of present embodiment is as shown in Figure 4.It is thus clear that cholelithiasis is dissolved basically; Remaining residue diameter is basically less than 1mm; Because the conduit diameter that directly uses in the operation of perfusion lithodialysis is about 2mm, the average diameter of bile duct is 2 to 3mm, so these insoluble residues can be extracted out or gone out by biliary system by conduit.
Embodiment 3:
The agent of preparation lithodialysis:
Ratio preparation lithodialysis agent according to single Tryfac 5573 of the corresponding 1.20g of the methyl tert-butyl ether of 3mL.
The dissolving human gallstones:
Get a cholesterol type cholelithiasis sample as embodiment 2 from human body.This cholelithiasis sample is added in the lithodialysis agent of being prepared gradually, and down cholelithiasis is dissolved basically after 13 to 15min, only stays a small amount of insoluble residue ultrasonic, and the similar Fig. 4 of its form photo is such, and the diameter of these residues is basically all less than 1mm.
Test case:
Carbon spectrum: the carbon atom with band asterisk * in the cholesterol of the methyl tertiary butyl ether(MTBE) of Fig. 5 a and Fig. 5 b is an object of study.
Steps A:In MTB E, add abundant cholesterol, fully get a certain amount of supernatant after the dissolving, the solution after the dilution is carried out the mensuration of quantitative carbon spectrum with MTB E dilution.Be decided to be 1 to the area at the corresponding peak of carbon atom of band asterisk * in Fig. 5 a methyl tert-butyl ether, the area at the pairing nuclear-magnetism spectrum of the carbon atom peak of band asterisk * in the survey map 5b cholesterol, this called after b peak, peak is shown in Fig. 5 c figure below.
Step B:In the lithodialysis agent of Tryfac 5573 that embodiment 2 is prepared and MTBE, add abundant cholesterol, fully get a certain amount of supernatant after the dissolving,, the solution after the dilution is carried out the mensuration that quantitative carbon is composed with the MTBE dilution multiple identical with steps A.Be decided to be 1 to the area at the corresponding peak of carbon atom of band asterisk * in Fig. 5 a methyl tert-butyl ether, the area at the pairing nuclear-magnetism spectrum of the carbon atom peak of band asterisk * in the survey map 5b cholesterol, this called after a peak, peak is shown in the last figure of Fig. 5 c.
The integral area at a peak is 0.052 among Fig. 5 c, and the integral area at b peak is 0.041.Therefore, through quantitative carbon spectrum further verified in MTBE, add Tryfac 5573 after, mixed solvent further increases the solvability of cholesterol.And by the nuclear-magnetism graph discovery; After in MTB E, adding Tryfac 5573; The peak position of cholesterol has taken place to move to High-Field; Explain between Tryfac 5573 and the cholesterol to have interaction force, and this active force possibly be to cause the immediate cause of novel lithodialysis agent to the solvability increase of cholesterol.
More than through the preferred specific embodiment the present invention has been carried out exemplary explanation.What but need statement is; These specific embodiment only are to illustrative explanation of the present invention; Protection scope of the present invention is not constituted any restriction; Under the situation that does not exceed the present invention's spirit and protection domain, those skilled in the art can carry out various improvement, replacement of equal value or modification to technology contents of the present invention and embodiment thereof, and these all fall in protection scope of the present invention.
Claims (8)
1. a lithodialysis agent that is used for dissolving cholesterol type calculus is characterized in that, this lithodialysis agent comprises methyl tert-butyl ether and single Tryfac 5573, and based on the methyl tert-butyl ether meter of 1mL, the quality of single Tryfac 5573 is 0.05～0.60g.
2. according to the lithodialysis agent of claim 1, it is characterized in that,
Based on the methyl tert-butyl ether meter of 1mL, the quality of single Tryfac 5573 is 0.10～0.50g.
3. according to the lithodialysis agent of claim 1 or 2, it is characterized in that,
Based on the methyl tert-butyl ether meter of 1mL, the quality of single Tryfac 5573 is 0.10～0.40g.
4. according to the lithodialysis agent of one of claim 1 to 3, it is characterized in that,
Based on the methyl tert-butyl ether meter of 1mL, the quality of single Tryfac 5573 is 0.20～0.30g.
5. according to the described lithodialysis agent of one of claim 1 to 4, it is characterized in that said lithodialysis agent is made up of methyl tert-butyl ether and single Tryfac 5573 of said amount.
6. described lithodialysis agent is used for the purposes of dissolving cholesterol type calculus according to one of claim 1 to 5.
7. according to the purposes of the described lithodialysis agent of one of claim 1 to 5 in the medicine of preparation treatment cholesterol type calculus.
8. according to the administering mode of the described lithodialysis agent of one of claim 1 to 5, comprise that percutaneous is put pipe (PTCD) through the liver and gall road or under scope retrograde gallbladder intubate approach such as (ERCG), lithodialysis agent perfusion is got into gallbladder, it is directly contacted with cholelithiasis.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1091011A (en) * | 1993-02-15 | 1994-08-24 | 张国栋 | A kind of lithodialysis Chinese traditional medicines depressing lipid electuary and manufacture method |
| CN1123269A (en) * | 1994-11-19 | 1996-05-29 | 浙江九洲制药厂 | Method for preparation of ethyl tert-butyl ether and prdouct thereof and application thereof |
| CN101550607A (en) * | 2009-05-16 | 2009-10-07 | 太原理工大学 | Hemp fiber degumming boiling-off additive, preparing method and application thereof |
| CN102206350A (en) * | 2011-03-29 | 2011-10-05 | 湖南科技大学 | Method for preparing ionic oxidized polyethylene wax emulsion by using single emulsifier |
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2012
- 2012-01-13 CN CN2012100652307A patent/CN102626402B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1091011A (en) * | 1993-02-15 | 1994-08-24 | 张国栋 | A kind of lithodialysis Chinese traditional medicines depressing lipid electuary and manufacture method |
| CN1123269A (en) * | 1994-11-19 | 1996-05-29 | 浙江九洲制药厂 | Method for preparation of ethyl tert-butyl ether and prdouct thereof and application thereof |
| CN101550607A (en) * | 2009-05-16 | 2009-10-07 | 太原理工大学 | Hemp fiber degumming boiling-off additive, preparing method and application thereof |
| CN102206350A (en) * | 2011-03-29 | 2011-10-05 | 湖南科技大学 | Method for preparing ionic oxidized polyethylene wax emulsion by using single emulsifier |
Non-Patent Citations (1)
| Title |
|---|
| 张志坚等: "体外胆石的CT 分类和甲基叔丁醚溶石的关系", 《第二军医大学学报》, vol. 18, no. 3, 30 June 1997 (1997-06-30), pages 247 * |
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