CN109646427A - Application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification - Google Patents
Application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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Abstract
The invention discloses application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification.The present invention has found after using the sodium tetradecyl sulfate injection prepared by sodium tetradecyl sulfate to test, confirm that the anastalsis of sodium tetradecyl sulfate injection is irreversible in a variety of in vitro test systematic researches, recurrence after hemostasis can be reduced, with good hemostatic healing efficacy, and sodium tetradecyl sulfate may be directly applied to tissue, there is good organization security and compatibility.
Description
Technical field
The present invention relates to field of medicinal chemistry, and in particular to drug of the sodium tetradecyl sulfate in preparation treatment hepar damnification
In application.
Background technique
Sodium tetradecyl sulfate with the advantages of its curative effect height and Small side effects make injection of sclerosing agent treatment achieve it is breakthrough
Progress.Sodium tetradecyl sulfate structural formula is as shown in following formula I:
Currently, sodium tetradecyl sulfate is widely used in clinical treatment varix of lower limb, and significant in efficacy.Patent
CN104840419B is prepared for a kind of sodium tetradecyl sulfate injection that stability is good.
Liver is one of the organ for being easiest to damage in body, often with bleeding profusely after liver damage wound, is led
Individual is caused to occur dead.Its lethality is related to hepar damnification degree, and degree of injury is higher, and case fatality rate is higher.Liver is also to be permitted
The position that more tumours shift frequent occurrence, lesion part cutting is the main method for extending life cycle, therefore often needs surgery hand
Art carries out hepatotomy, and controlling bleeding is the severe challenge that operative doctor is faced.To find out its cause, liver possesses widely
Rete vasculosum, but lack smooth muscle fibers, huge effect can be provided in vessel retraction.Therefore, complete when liver
Property when being destroyed, it occur frequently that uncontrollable severe haemorrhage.Many methods are attempted for treatment hepar damnification bleeding, part
It is exactly one of them using haemostatic medicament.
Clinically the drug for liver hemostasis includes gelfoam, oxycellulose, fibrinogen etc., these drugs
Preparation be it is absorbable, i.e. their effect is reversible, monitor cannot be inhibited, after hemostasis be easy recurrence.
Therefore, a kind of drug for effectively treating hepar damnification especially liver bleeding is needed.
Summary of the invention
The technical problem to be solved by the present invention is to be that can inhale to overcome the drug for the treatment of hepar damnification in the prior art
It is receiving, the defects of recurrence is easy after monitor, hemostasis cannot be inhibited, provide a kind of sodium tetradecyl sulfate in preparation and treat liver
Application in application in the drug of dirty damage, the especially drug for the treatment of liver bleeding, sodium tetradecyl sulfate can be obvious
Improve coagulation factor level and reaches ideal haemostatic effect.
The present invention mainly solves above-mentioned technical problem by following technological means:
The present invention provides application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification.
In the present invention, the hepar damnification preferably includes open injury and Liver trauma, and more preferably liver goes out
Blood.
Wherein, as known to those skilled in the art, the open injury can be blindgut wound and/or penetrating wound, generally by knife
Hepar damnification caused by thorn or firearm.
Wherein, as known to those skilled in the art, the closed injury is usually management of blunt injuries, is primarily due to hit, squeeze
Caused by pressure, it is common in road traffic accident, building landslide, is fallen occasionally in eminence, wound, the damage are hurt or hit in sports
Caused bleeding is often not noticeable, and diagnosis is opposite to have some difficulty to lead to treatment delay, and risk is higher than open injury.
Wherein, as known to those skilled in the art, the liver bleeding can be for by fibrinolysis increase, anticoagulant substances increasing
More, platelet counts are reduced, platelet function abnormality or cirrhosis medium vessels damage caused liver bleeding.
In the present invention, the form of the drug is preferably injection, more preferably injection.
In the present invention, the sodium tetradecyl sulfate be preferably one of active constituent of the drug or sole active at
Point.
When the active constituent that the sodium tetradecyl sulfate is the drug for the moment, the sodium tetradecyl sulfate can be with
The substance of the hemostasis of this field routine is used cooperatively, and the substance can be gelfoam, oxycellulose or fibrinogen.
When the sodium tetradecyl sulfate is the sole active agent of the drug, the drug may include myristyl
Sodium sulphate and pharmaceutically acceptable auxiliary material.Preferably, the drug can be for such as specification in patent CN201510333589.1
The sodium tetradecyl sulfate injection of [0009]-[0024] segment description.
Wherein, the composition of raw materials of the sodium tetradecyl sulfate injection may include following component: disodium hydrogen phosphate, 14
Sodium alkyl sulfate, benzyl alcohol, water and pH adjusting agent；The pH=7.5-7.9 of the sodium tetradecyl sulfate injection.
Wherein, the composition of raw materials of the sodium tetradecyl sulfate injection can be made of following component: disodium hydrogen phosphate,
Sodium tetradecyl sulfate, benzyl alcohol, water and pH adjusting agent；The pH=7.5-7.9 of the sodium tetradecyl sulfate injection.
Preferably, in the composition of raw materials, the quality of the benzyl alcohol accounts for the total matter of sodium tetradecyl sulfate injection
The 2%-8% of amount, more preferably 3%-6%, such as 4% and 5%.
Preferably, in the composition of raw materials, the quality of the disodium hydrogen phosphate accounts for the sodium tetradecyl sulfate injection
The 0.2%-2% of gross mass；More preferably 0.4%-0.9%, such as 0.5%.
Preferably, in the composition of raw materials, the quality of the sodium tetradecyl sulfate accounts for the sodium tetradecyl sulfate note
Penetrate the 0.5%-5% of liquid gross mass；More preferably 1%-3%, such as 1.2%.
Preferably, in the composition of raw materials, it is total that the quality of the pH adjusting agent accounts for the sodium tetradecyl sulfate injection
The 0.01%-0.08% of quality；More preferably 0.02%-0.06%.
Preferably, in the composition of raw materials, the pH adjusting agent is sodium hydroxide and/or sodium dihydrogen phosphate.
Preferably, the water in the composition of raw materials is water for injection.
Wherein, according to common sense in the field, the disodium hydrogen phosphate can be the form of its hydrate, be also possible to anhydrous phosphorus
Sour disodium hydrogen.The hydrate can be one of dihydrate, heptahydrate and dodecahydrate of disodium hydrogen phosphate or more
Kind.
Wherein, the preparation method of the sodium tetradecyl sulfate injection may include following step: by pH=8.4-8.8's
The mixed liquor of the aqueous solution of the disodium hydrogen phosphate and the benzyl alcohol is uniformly mixed with the sodium tetradecyl sulfate, is added
The pH adjusting agent makes the pH of mixed system to 7.5-7.9.
Preferably, the pH=8.5-8.7 of the mixed liquor of the aqueous solution of the disodium hydrogen phosphate and the benzyl alcohol, such as
8.6。
Preferably, the preparation method of the sodium tetradecyl sulfate injection, further includes following steps: by the benzyl alcohol
It is added in the aqueous solution of the disodium hydrogen phosphate, the sodium tetradecyl sulfate is then added, add the pH adjusting agent
Make the pH of mixed system to 7.5-7.9.
Preferably, the preparation method of the sodium tetradecyl sulfate injection, further includes following steps: by the benzyl alcohol
It is added in the aqueous solution of the disodium hydrogen phosphate, the sodium tetradecyl sulfate is then added and is dispersed with stirring, add institute
Stating pH adjusting agent makes the pH of mixed system to 7.5-7.9.
It is highly preferred that the preparation method of the sodium tetradecyl sulfate injection, further includes following steps: by the benzene first
Alcohol is added in the aqueous solution of the disodium hydrogen phosphate and stirring and dissolving, and the sodium tetradecyl sulfate is then added and stirs and divides
It dissipates, adding the pH adjusting agent makes the pH of mixed system to 7.5-7.9.
Preferably, described " making the pH of mixed system to 7.5-7.9 " is to make the pH of mixed system to 7.5-7.7.
Preferably, the preparation method of the sodium tetradecyl sulfate injection, the step of further including the steps that constant volume, filter
With filling one or more of step.
Preferably, the administration mode of the sodium tetradecyl sulfate injection is intravenous injection.
Preferably, the dosage of the sodium tetradecyl sulfate injection is each 0.5-2mL, and daily maximum dose is not
It obtains more than 10mL.
On the basis of common knowledge of the art, above-mentioned each optimum condition, can any combination to get each preferable reality of the present invention
Example.
The reagents and materials used in the present invention are commercially available.
The positive effect of the present invention is that:
The present invention has found after using the sodium tetradecyl sulfate injection that is prepared by sodium tetradecyl sulfate to test,
The anastalsis of confirmation sodium tetradecyl sulfate injection is irreversible in a variety of in vitro test systematic researches, can be reduced
Recurrence after hemostasis has good hemostatic healing efficacy, and sodium tetradecyl sulfate may be directly applied to tissue, have good
Organization security and compatibility.
Detailed description of the invention
Fig. 1 is the relationship of liver surface of a wound size and time after each group administration in the embodiment of the present invention 2.
Specific embodiment
The present invention is further illustrated below by the mode of embodiment, but does not therefore limit the present invention to the reality
It applies among a range.In the following examples, the experimental methods for specific conditions are not specified, according to conventional methods and conditions, or according to quotient
The selection of product specification.
Experimental material and method used in following embodiment are as follows:
36 cleaning grade male SD rats, 320~350g of weight are purchased from Shanghai Experimental Animal Center, are divided into 3 groups, every group
12, respectively sodium tetradecyl sulfate group (A group), blank control group (B group), chitosan styptic powder group (C group)
Sodium tetradecyl sulfate injection (2mL:20mg) purchased from the biochemical pharmaceutcal corporation, Ltd of Shanghai medicine-feeding first (lot number:
141203)
The external preliminary experiment of embodiment 1
Blood is taken from rat eye socket, is moved into equipped in sodium citrate anticoagulant tube, every pipe 1mL blood takes 36 pipes altogether, and random point
For 3 groups, respectively A, B, C group is not added any drug in B group, and records blood coagulation time；Myristyl sulfate is added in A group
Sodium injection 1mL immediately begins to timing to blood clotting；Chitosan styptic powder 10mg is added in C group, immediately begins to timing to blood
Solidification.
2 liver Hemorrhage Model of embodiment is established and Wound treatment
Give rat to 3% yellow Jackets 40mg/kg intraperitoneal injection anesthesia, abdomen preserved skin, the operation of 5% iodine disinfection
Region.A 25cm stringer notch is just being taken in rat abdomen with scalpel, is successively being separated, sufficiently exposure liver lobus dexter, on the liver right side
Leaf lower edge cuts one 1.0cm × 0.2cm × 0.5cm surface of a wound, removes tissue.
It gets sterile gauze ready in advance, and measures gauze initial weight using electronic balance.It hepatectomizes after tissue, B group is vertical
When drawing the blood of outflow using sterile gauze, and opening timer；C group uniformly smears rapidly chitosan hemostasis in the surface of a wound
After powder 10mg, when drawing the blood of outflow using sterile gauze, and opening timer；A group is in the rapid injection 14 of the surface of a wound
After alkylsurfuric acid sodium injection 1mL, when drawing the blood of outflow using sterile gauze, and opening timer.Each group waits for bleeding
When stopping completely, abort timer, the time at this time is the bleeding time of each group.Measure the final weight of each group sterile gauze
Amount, subtracts respective initial weight, the as amount of bleeding of each group.It is postoperative by liver Hui Na into abdomen, successively close abdomen with suture
Chamber, the 5% iodine disinfection surface of a wound.Every rat single cage raising, postoperative 3 days daily intraperitoneal injection 80,000 units of Benzylpenicillin sodium salt, observation are big
Whether there is or not infection signs for mouse.
All rats are anaesthetized after postoperative 1 week, abdominal aortic blood again, measures serum in strict accordance with method on kit
Middle liver function and inflammatory factor are horizontal.Liver wound healing tissue is cut, is fixed through formaldehyde, ethanol dehydration, paraffin embedding waited
Liver organization is cut into 5 μ m thicks slice using slicer and saved by Cheng Hou.By slice dewaxing aquation when to be dyed, use
Hematoxylin-eosin stains (HE dyeing) can be in microscope through ethanol dehydration, after dimethylbenzene is transparent, neutral gum carries out mounting
Lower observation pathological section.
The external blood coagulation of effect example 1 and amount of bleeding and bleeding time
It is found by external preliminary experiment, compared with B group, A combines the external reduced clotting time of C group (error P < 0.05)；And
Compared with C group, the A group external clotting time is shorter (error P < 0.05), the tentative confirmation hemostasia effect of sodium tetradecyl sulfate,
It the results are shown in Table 1.3 days after modeling, each group rat is apathetic, does not like, and drinks water, feeds not good enough, the surface of a wound is without tables such as red and swollen ulcerations
It is existing.But rat is gradually brought to normal condition after 3 days, and the surface of a wound restores good, 7 days whens all survival of rats, survival rate reaches
100%, each group modeling operation smoothly completes.Compared with B group, A group and C group bleeding time shorten, amount of bleeding reduction (error P <
0.05), and compared with C group, the A group bleeding time is shorter, and amount of bleeding is less (error P < 0.05), show sodium tetradecyl sulfate with
Chitosan styptic powder can promote the hemostasis of the liver surface of a wound, especially best with sodium tetradecyl sulfate effect, the results are shown in Table 1.
1 each group of table hemostasis index of correlation
| Group | The external clotting time (min) | Bleeding time (min) | Amount of bleeding (g) |
| A | 3.37±0.35ab | 2.86±0.16ab | 1.09±0.15ab |
| B | 2837.53±152.63 | 5.25±0.15 | 2.84±0.20 |
| C | 4.62±0.31a | 3.49±0.12a | 2.24±0.14a |
Note: a refers to that error P < 0.05 compared with B group, b refer to error P < 0.05 compared with C group.
2 liver function of effect example and the measurement of inflammatory factor level
Compared with B group, glutamic-pyruvic transaminase (ALT) in A and C group, glutamic-oxalacetic transaminease (AST), IL (interleukins) -1,
IL (interleukins) -6, IL (interleukins) -8 is horizontal to be reduced, and there is significant difference in P < 0.05；And liver between A group and C group
There was no significant difference with horizontal similar P > 0.05 of inflammatory factor for function, is shown in Table 2.
2 each group liver function of table and inflammatory factor are horizontal
| Group | ALT(U/L) | AST(U/L) | IL-1(ng/L) | IL-6(ng/L) | IL-8(ng/L) |
| A group | 78.06±9.48a | 180.71±13.12a | 25.35±4.40a | 64.71±5.10a | 298.15±7.20a |
| B group | 127.93±8.32 | 199.68±13.51 | 29.25±4.07 | 73.54±5.31 | 313.35±11.57 |
| C group | 75.83±8.52a | 186.53±12.16a | 24.07±4.83a | 63.92±4.82a | 300.10±10.03a |
Note: a refers to error P < 0.05 compared with B group
The form of 3 liver callus of effect example
The size of postoperative 1 week observation liver wound healing, the result is shown in Figure 1, as time increases, A and C group surface of a wound size
Obviously become smaller, shows that A and C group has apparent haemostatic effect, and A group better effect for the bleeding of liver, while contaminating by HE
Color observation, the visible granulation tissue filling of the B group surface of a wound, fibroblast arrangement is not close, there is more inflammatory cell infiltration；A group, C
Group it is similar to its result, but fibroblast queueing discipline, closely, inflammatory cell has no hepatic necrosis tissue without increased significantly,
Demonstrating sodium tetradecyl sulfate may be directly applied to tissue, there is good organization security and compatibility.
Although specific embodiments of the present invention have been described above, it will be appreciated by those of skill in the art that this is only
For example, protection scope of the present invention is to be defined by the appended claims.Those skilled in the art without departing substantially from
Under the premise of the principle and substance of the present invention, many changes and modifications may be made, but these change and
Modification each falls within protection scope of the present invention.
Claims (10)
1. application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification.
2. application as described in claim 1, which is characterized in that the hepar damnification includes open injury and closed wounds of liver damage
Wound.
3. application as described in claim 1, which is characterized in that the hepar damnification is liver bleeding.
4. application as described in claim 1, which is characterized in that the form of the drug is injection.
5. such as application of any of claims 1-4, which is characterized in that the sodium tetradecyl sulfate is the drug
One of active constituent or sole active agent.
6. such as application of any of claims 1-4, which is characterized in that when the sodium tetradecyl sulfate is the medicine
For the moment, the active constituent of the drug further includes gelfoam, oxycellulose or fibrinogen to the active constituent of object.
7. such as application of any of claims 1-4, which is characterized in that when the sodium tetradecyl sulfate is the medicine
When the sole active agent of object, the drug is sodium tetradecyl sulfate injection.
8. the use as claimed in claim 7, which is characterized in that the sodium tetradecyl sulfate injection includes myristyl sulphur
Sour sodium, disodium hydrogen phosphate, benzyl alcohol, water and pH adjusting agent.
9. application as claimed in claim 8, which is characterized in that the pH of the sodium tetradecyl sulfate injection is 7.5-7.9；
And/or the pH adjusting agent is sodium hydroxide and/or sodium dihydrogen phosphate.
10. application as claimed in claim 8, which is characterized in that the quality of the benzyl alcohol accounts for the sodium tetradecyl sulfate
The 2%-8% of injection gross mass；
And/or the quality of the disodium hydrogen phosphate accounts for the 0.2%-2% of the sodium tetradecyl sulfate injection gross mass；
And/or the quality of the sodium tetradecyl sulfate accounts for the 0.5%- of the sodium tetradecyl sulfate injection gross mass
5%；
And/or the quality of the pH adjusting agent accounts for the 0.01%-0.08% of the sodium tetradecyl sulfate injection gross mass.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4851324A (en) * | 1987-07-27 | 1989-07-25 | Hoechst Celanese Corporation | Phenoxy propanol containing developer compositions for lithographic plates having neutral pH |
| WO1998055105A9 (en) * | 1997-06-05 | 1999-04-08 | Hemosphere Inc | Fibrinogen-coated microspheres |
| CN1739550A (en) * | 2005-09-16 | 2006-03-01 | 陕西天宇制药有限公司 | Polycinnamic alcohol injection and its prepn |
| CN104840419A (en) * | 2015-06-16 | 2015-08-19 | 上海上药第一生化药业有限公司 | Sodium tetradecyl sulphate injection and preparation method thereof |
| CN106336364A (en) * | 2016-08-19 | 2017-01-18 | 上海紫源制药有限公司 | Sodium tetradecyl sulfate crystal form and preparation method, application and pharmaceutical composition containing sodium tetradecyl sulfate crystal form |
-
2019
- 2019-01-28 CN CN201910081377.7A patent/CN109646427A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4851324A (en) * | 1987-07-27 | 1989-07-25 | Hoechst Celanese Corporation | Phenoxy propanol containing developer compositions for lithographic plates having neutral pH |
| WO1998055105A9 (en) * | 1997-06-05 | 1999-04-08 | Hemosphere Inc | Fibrinogen-coated microspheres |
| CN1739550A (en) * | 2005-09-16 | 2006-03-01 | 陕西天宇制药有限公司 | Polycinnamic alcohol injection and its prepn |
| CN104840419A (en) * | 2015-06-16 | 2015-08-19 | 上海上药第一生化药业有限公司 | Sodium tetradecyl sulphate injection and preparation method thereof |
| CN106336364A (en) * | 2016-08-19 | 2017-01-18 | 上海紫源制药有限公司 | Sodium tetradecyl sulfate crystal form and preparation method, application and pharmaceutical composition containing sodium tetradecyl sulfate crystal form |
Non-Patent Citations (1)
| Title |
|---|
| AYSAN,E等: ""Efficacy of local sclerosing agents on hemostasis of hepatic bleeding"", 《HEPATO-GASTROENTEROLOGY》 * |
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Application publication date: 20190419 |
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