CN1537641A - Sodium hyaluronate anti-adhesion film, and its prepn. method - Google Patents
Sodium hyaluronate anti-adhesion film, and its prepn. method Download PDFInfo
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- CN1537641A CN1537641A CNA031164749A CN03116474A CN1537641A CN 1537641 A CN1537641 A CN 1537641A CN A031164749 A CNA031164749 A CN A031164749A CN 03116474 A CN03116474 A CN 03116474A CN 1537641 A CN1537641 A CN 1537641A
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- hyaluronate sodium
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- pain
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Abstract
An anti-adhesive sodium hyaluronated film with anti inflammatory, antalgic and anti-adhesive functions is prepared from sodium hyaluronated, valoron, carragheenin and carboxymethyl cellulose sodium through respectively preparing three kinds of solution, mixing, pouring in filming device, freeze drying and forming film.
Description
Technical field
The present invention relates to a kind of intraperitoneal anti thin film, more specifically relate to hyaluronate sodium, that pain is gone out is fixed, carrageenan is a main component, is aided with sodium carboxymethyl cellulose, has the intraperitoneal anti thin film of antiinflammatory, analgesic effect.
The invention still further relates to the preparation method of this thin film.
Background technology
In the laparotomy ventrotomy field, especially very easily produce intestinal adhesion in the operation on digestive tract field, along with development of science and technology, the raising of medical level, this adhesion tendency gradually reduces, but still is difficult to so far prevent and solve.Sticking in the gynecological surgery field of surgery is a ten minutes stubborn problem, produce in the operation the woman, owing to tending to produce oviducal obturation, the adhesion of postoperative causes infertility, simultaneously toward the concurrent intestinal adhesion of contact, Intraabdominal adhesion not only brings the misery of postoperative to patient, also can produce intestinal obstruction sometimes, and patient often need carry out the operation second time, postoperative poor prognosis concerning the patient easily worsens.Tissue adhesion is the pathological phenomenon that must take place in the agglutination; so far people seek the whole bag of tricks and are intended to the prevention of postoperative adhesion; example: control intraperitoneal inflammation; tight hemostasis; soft operation; protection serous coat etc.; use dextran (special permission discloses flat 7-101866) at intraperitoneal simultaneously; paraffin oil; sodium alginate (special permission discloses clear 57-167919); Fibrin Glue; chondroitin sulfate (Oelsener G. etc.; j.Repred Med.1987; 32:812); hyaluronate sodium (Clrman B. etc.; Fertil steril; 1991; 56:563) etc., clinical effectiveness is all not really desirable.Though can alleviate adhesion area and degree slightly, can not reach ideal clinical requirement.
According to the literature, though hyaluronate sodium can reduce tissue adhesion, particularly adhesion of tendon more effectively, antiinflammatory, haemostatic effect general (Bai Xiaohong, Ling Peixue, Wang Fengshan, Chinese biochemical drug research magazine 1998,19 (4): 205～208).Pain is gone out calmly, and (Tolmentin Sodium) is the derivant of pyrroles's acetic acid, it is a kind of NSAID (non-steroidal anti-inflammatory drug), and antiinflammatory, analgesia and refrigeration function are arranged, because the intravital Cycloxygenase of its selective inhibition of energy, make prostaglandin biosynthesis block in the body, play analgesia, antiinflammatory, antipyretic effect rapidly.Carrageenan (Carrageenan) is made up of calcium, potassium, sodium, magnesium salt and the 3.6 Anhydrogalactose. straight chain polymers of galactose and the formed polysaccharide sulfuric ester of Anhydrogalactose., main at present thickening agent, stabilizing agent and flocculating agent as food, it is reported that it also has preventing adhesiving effect (special permission discloses flat 7-101865) preferably.Sodium carboxymethyl cellulose is a kind of high-hydrophilic polymer substance.
Developed the anti thin film that contains hyaluronate sodium and go out fixed bitterly at present abroad and be used for clinical three phases test, but the someone develops the hyaluronate sodium anti thin film that contains carrageenan as yet.
Summary of the invention
The object of the present invention is to provide a kind of hyaluronate sodium thin film with effective antiinflammatory, pain relieving, anti effect.
Another object of the present invention is to provide the preparation method of this hyaluronate sodium thin film.
The present invention is by studying intensively the macromolecule polysaccharide body, discovery with hyaluronate sodium, that pain is gone out is fixed, carrageenan is a main component, with the sodium carboxymethyl cellulose is the anti thin film that auxiliary element is produced, and its antiinflammatory, pain relieving and preventing adhesiving effect are better than single use hyaluronate sodium.
Though hyaluronate sodium can reduce tissue adhesion, particularly adhesion of tendon more effectively, antiinflammatory, haemostatic effect are general; Pain is gone out and is decided to be the derivant of pyrroles's acetic acid, and it is a kind of NSAID (non-steroidal anti-inflammatory drug), and antiinflammatory, analgesia and antipyretic effect are arranged; Carrageenan is made up of calcium, potassium, sodium, magnesium salt and the 3.6 Anhydrogalactose. straight chain polymers of galactose and the formed polysaccharide sulfuric ester of Anhydrogalactose., has preventing adhesiving effect preferably; Sodium carboxymethyl cellulose is as a kind of high-hydrophilic polymer substance, and under the certain humidity condition, the thin film of being produced with the high-molecular weight sodium carboxymethyl cellulose of high viscosity has good high strength and high-flexibility.The present invention finds, being used go out fixed, carrageenan, sodium carboxymethyl cellulose of pain and can not only giving hyaluronate sodium thin film antiinflammatory, analgesic effect, and can significantly improve its tissue adhesion effect and film-formation result.The medical hyaluronic acid sodium that the present invention produces with the cockscomb extraction, pain are gone out calmly, carrageenan is a main component, are that the hyaluronate sodium thin film that auxiliary element is made has good antiinflammatory, pain relieving and preventing adhesiving effect with the sodium carboxymethyl cellulose.
The composition (in solute weight/solvent volume (W/V) percentage ratio) of the hyaluronate sodium anti thin film that the present invention proposes is as follows:
Hyaluronate sodium 0.1 2.0%W/V
Pain is gone out and is decided 0.03-1.0%W/V
Carrageenan 0.1-1.5%W/V
Sodium carboxymethyl cellulose 1.0-1.5%W/V
The molecular weight of hyaluronate sodium should adopt 100-250 ten thousand among the present invention, and solvent is phosphate buffer (PBS) or other suitable electrolyte solution.Wherein the PBS buffer was with reference to version Pharmacopoeia of People's Republic of China preparation in 2000; Other suitable electrolyte solution can adopt Tris buffer, woods Ge Shi buffer and BSS buffer etc.
Hyaluronate sodium anti thin film of the present invention can spread on intraperitoneal after laparotomy ventrotomy, preferably spread on intraperitoneal surgical procedure portion, and the big small size that applies epiphragma can be by age, the area of body weight, sex, symptom and intraperitoneal damage and in addition selection arbitrarily.The ratio of wound area and area coverage is generally 1: 1.0～2.0, is the best with 1: 1.3～1.7.
The preparation method of hyaluronate sodium anti thin film of the present invention is: by formula proportion take by weighing hyaluronate sodium, that pain is gone out is fixed, carrageenan and sodium carboxymethyl cellulose.With hyaluronate sodium and 1/3rd measure 1/2nd the amount pains go out be dissolved in surely 1/3rd measure 1/2nd the amount the PBS buffer in be mixed with solution 1; Then the pain of sodium carboxymethyl cellulose and half surplus is gone out in the PBS buffer that is dissolved in half surplus surely, room temperature or water-bath heating (below 60 ℃) dissolving are stirred simultaneously, are mixed with solution 2; The pain of carrageenan and surplus is gone out in the PBS buffer that is dissolved in surplus surely, room temperature or water-bath heating (below 60 ℃) dissolving are stirred simultaneously, are mixed with solution 3 again; Solution 1,2,3 mixed slowly stirred 4～6 hours, full and uniform after, pour in the film forming device, put into refrigerator under-10 ℃～-20 ℃, carried out lyophilization 24～36 hours, treat that film is shaped after, skinning obtains membrane.
The tissue adhesion effect of hyaluronate sodium thin film of the present invention is described below by animal experiment.
The reagent that this test is adopted comprises: the hyaluronate sodium (molecular weight 1,750,000) that Shanghai Jianhua fine biological products Co.ltd produces, the pain that Minsheng Pharmaceutical Group Co., Hangzhou produces is gone out and is decided (10101), the carrageenan (K type) that the multi-ring health product company limited North Sea, Hainan branch company produces, the sodium carboxymethyl cellulose that Zhangjagang City's three favour chemical industry company limiteies are produced.Solvent adopts the PBS buffer agent.The membrane (in solute weight/solvent volume (W/V) percentage ratio) of test usefulness comprises 1.0%W/V hyaluronate sodium+1.0%W/V sodium carboxymethyl cellulose (HA-Na+CMC); 1.0%W/V hyaluronate sodium+0.1%W/V goes out bitterly and decides+1.0%W/V sodium carboxymethyl cellulose (HA-Na+TS+CMC); 1.0%W/V hyaluronate sodium+1.0%W/V carrageenan+1.0%W/V sodium carboxymethyl cellulose (HA-Na+CAR+CMC); 1.0%W/V hyaluronate sodium+1.0%W/V carrageenan+0.1%W/V goes out bitterly and decides+1.0%W/V sodium carboxymethyl cellulose (HA-Na+CAR+TS+CMC)
Select 12 of healthy buck, body weight 1.5-2.0 kilogram uses the laparotomy ventrotomy of urethane anesthesia postmedial line, dissects 3 * 5 centimetres body wall peritoneum (about 1 millimeters thick) from one side peritoneal wall, the serosa surface of contiguous large intestine is swiped with a dissecting knife, until the bleeding that the speckle redness occurs.Part is used to estimate preventing adhesiving effect between the large intestine serous coat of excision body wall peritoneum and vicinity, the place carries out the excision of the second block parietal peritoneum (15 square centimeters of equal area) in the corresponding peritoneal wall of opposite side, contiguous large intestine serous coat is also done above-mentioned treatment place and is similarly swiped, the side that scrape in the erasure both sides is used membrane, opposite side is done blank contrast and is used, in order to eliminate the randomness of test, all buck are all numbered, the odd numbers buck is at the left side pad pasting, the even numbers buck is at the right side pad pasting, abrade back 7 days and kill with excessive pentobarbital, adhesion evaluation degree is: 1 no adhesion; 2 film like adhesions (separable); 3 slight adhesions (inseparable, coverage is below 35% of test area); 4 moderate adhesions (inseparable, coverage is the 35-60% of test area); 5 serious adhesions (inseparable, coverage is more than 60% of test area).Result of the test sees Table 1
The tissue adhesion effect of table 1 hyaluronate sodium thin film of the present invention
| Rabbit number | The membrane type | Adhesion area % | The degree of degradation of film | The adhesion grade | ||||
| The pad pasting side | Control sides | The pad pasting side | Control sides | |||||
| Single | On average | Single | On average | |||||
| ??1 | ????HA-Na+CMC | ????40 | ????80 | ????100 | ????4 | ????3.5 | ????5 | ????5.0 |
| ??2 | ????- | ????- | ????- | ????- | ????- | |||
| ??3 | ????35 | ????100 | ????100 | ????3 | ????5 | |||
| ??4 | ??HA-Na+TS+CMC | ????10 | ????50 | ????100 | ????2 | ????2.0 | ????4 | ????3.3 |
| ??5 | ????0 | ????80 | ????100 | ????1 | ????5 | |||
| ??6 | ????30 | ????0 | ????100 | ????3 | ????1 | |||
| ??7 | ????HA-Na+CAR ????+CMC | ????10 | ????40 | ????100 | ????2 | ????2.0 | ????4 | ????4.0 |
| ??8 | ????15 | ????50 | ????100 | ????2 | ????4 | |||
| ??9 | ????- | ????- | ????- | ????- | ????- | |||
| ??10 | ????HA-Na+CAR ????+TS+CMC | ????0 | ????30 | ????100 | ????1 | ????1.3 | ????3 | ????4.0 |
| ??11 | ????5 | ????70 | ????100 | ????2 | ????5 | |||
| ??12 | ????0 | ????40 | ????100 | ????1 | ????4 | |||
Annotate :-expression rabbit death (acute)
As known from Table 1, in 10 buck of survival, the adhesion incidence rate of blank group is 90%, and the adhesion incidence rate of HA-Na membrane group is 70%, and the area and the order of severity that HA-Na membrane group sticks together obviously are lighter than the blank group, also can find out simultaneously, the average adhesion grade minimum of HA-Na+CAR+TS+CMC membrane, preventing adhesiving effect is best, is HA-Na+CAR+CMC membrane and HA-Na+TS+CMC membrane secondly, and its average adhesion grade is 2.0; The adhesion grade of HA-Na+CMC membrane is 3.5, preventing adhesiving effect is relatively poor, and the grand mean adhesion grade of blank group is 4.0, the adhesion degree is serious, preventing adhesiving effect is the poorest, this shows preventing adhesiving effect the best of hyaluronate sodium anti thin film of the present invention (HA-Na+CAR+TS+CMC membrane).
Beneficial effect:
1, the present invention has been used to go out bitterly in hyaluronate sodium anti film formulation and has reached cheap carrageenan and sodium carboxymethyl cellulose surely, hyaluronate sodium thin film antiinflammatory, analgesic effect can not only be given, and its tissue adhesion effect and film-formation result can be significantly improved.
2, hyaluronate sodium anti thin film provided by the invention follows dry, the hemorrhage and operation of tissue to have good antiinflammatory, pain relieving, anti function during tissue injury in laparotomy ventrotomy, postoperative can prevent the bonding and intestinal obturation of intestinal, postoperative patient prognosis bona effectively.
The specific embodiment:
The present invention is further elaborated below in conjunction with specific embodiment, but do not limit the present invention.
Employed raw material is among the following embodiment: the hyaluronate sodium that Shanghai Jianhua fine biological products Co.ltd produces, the pain that Minsheng Pharmaceutical Group Co., Hangzhou produces is gone out and is decided (10101), the carrageenan (K type) that the multi-ring health product company limited North Sea, Hainan branch company produces, the sodium carboxymethyl cellulose that Zhangjagang City's three favour chemical industry company limiteies are produced.Solvent is phosphate buffer (PBS).
Used film forming device is the rectangle poly (methyl methacrylate) plate of homemade 10 * 6cm size among the embodiment.
Embodiment 1
Hyaluronate sodium (molecular weight 1,570,000) 1.0g, the pain go out decide 0.1g, carboxymethyl cellulose 1.0g, carrageenan 1.0g is dissolved in the 100mlPBS buffer.Preparation method: 1.0g hyaluronate sodium and 0.033g gone out bitterly to be dissolved in the 33.3mlPBS buffer surely, is mixed with solution 1; 1.0g carboxymethyl cellulose and 0.033g gone out bitterly to be dissolved in the 33.3mlPBS buffer surely, and water-bath heating for dissolving (40 ℃) stirs simultaneously, is mixed with solution 2; 1.0g carrageenan and 0.033g being gone out bitterly is dissolved in the 33.3mlPBS buffer surely again, and water-bath heating for dissolving (40 ℃) stirs simultaneously, is mixed with solution 3; 1,2,3 solution mix were stirred 5 hours, and full and uniform back becomes gel, pours in the film forming device, puts into refrigerator and carry out lyophilization 24 hours under-10 ℃, treat the film molding after, with scraper skinning gently, obtain membrane.
Embodiment 2
Hyaluronate sodium (molecular weight 2,020,000) 1.2g, the pain go out decide 0.12g, carboxymethyl cellulose 1.2g, carrageenan 1.0g is dissolved in the 120mlPBS buffer.Preparation method: 1.2g hyaluronate sodium and 0.04g gone out bitterly to be dissolved in the 60mlPBS buffer surely, is mixed with solution 1; 1.2g carboxymethyl cellulose and 0.04g gone out bitterly to be dissolved in the 30mlPBS buffer surely, and water-bath heating for dissolving (60 ℃) stirs simultaneously, is mixed with solution 2; 1.0g carrageenan and 0.04g gone out bitterly to be dissolved in the 30mlPBS buffer surely, and water-bath heating for dissolving (60 ℃) stirs simultaneously, is mixed with solution 3; 1,2,3 solution mix were stirred 5 hours, and full and uniform back becomes gel, pours in the film forming device, puts into refrigerator and carry out lyophilization 24 hours under-20 ℃, treat the film molding after, with scraper skinning gently, obtain membrane.
Embodiment 3
Hyaluronate sodium 1.4g (molecular weight 1,150,000), the pain go out decide 0.10g, carboxymethyl cellulose 1.4g, carrageenan 1.4g is dissolved in the 100mlPBS buffer.Preparation method: 1.4g hyaluronate sodium and 0.04g gone out bitterly to be dissolved in the 40mlPBS buffer surely, is mixed with solution 1; 1.4g carboxymethyl cellulose and 0.03g gone out bitterly to be dissolved in the 30mlPBS buffer surely, and water-bath heating for dissolving (40 ℃) stirs simultaneously, is mixed with solution 2; 1.4g carrageenan and 0.03g gone out bitterly to be dissolved in the 30mlPBS buffer surely, and water-bath heating for dissolving (40 ℃) stirs simultaneously, is mixed with solution 3; 1,2,3 solution mix were stirred 4.5 hours, and full and uniform back becomes gel, pours in the self-control film forming device, puts into refrigerator and carries out lyophilization 36 hours at-10 ℃, treat the film molding after, with scraper skinning gently, obtain membrane.
Claims (3)
1, a kind of hyaluronate sodium anti thin film is characterized in that containing the carrageenan composition.
2, hyaluronate sodium anti thin film according to claim 1, it consists of (in solute weight/solvent volume (W/V) percentage ratio):
Hyaluronate sodium 0.1-2.0%W/V
Pain is gone out and is decided 0.03-1.0%W/V
Carrageenan 0.1-1.5%W/V
Sodium carboxymethyl cellulose 1.0-1.5%W/V
3, the preparation method of the described hyaluronate sodium anti of claim 1 thin film comprises the following steps:
(1) takes by weighing various raw materials by formula proportion
(2) hyaluronate sodium and 1/3rd is measured 1/2nd the amount pains go out be dissolved in surely 1/3rd measure 1/2nd the amount solvents in be mixed with solution 1;
(3) pain of sodium carboxymethyl cellulose and half surplus is gone out be dissolved in surely in the solvent of half surplus, the limit at normal temperatures or with water-bath heating (below 60 ℃) dissolving, stir on the limit, is mixed with solution 2;
(4) pain of carrageenan and surplus is gone out be dissolved in surely in the solvent of surplus, the limit at normal temperatures or with water-bath heating (below 60 ℃) dissolving, stir on the limit, is mixed with solution 3;
(5) solution 1,2,3 mixed slowly stirred 4～6 hours, full and uniform after, pour in the film forming device;
(6) put into refrigerator under-10 ℃～-20 ℃, carried out lyophilization 24～36 hours;
(7) treat that film is shaped after, skinning obtains membrane.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101318036B (en) * | 2008-06-10 | 2011-11-23 | 杭州协合医疗用品有限公司 | Medical antiblocking intelligent gel rubber material and preparation thereof |
| CN103717242A (en) * | 2011-08-03 | 2014-04-09 | 郡是株式会社 | Anti-adhesion membrane |
| CN104958790A (en) * | 2015-07-27 | 2015-10-07 | 大连大学 | Composite membrane for preventing postoperative adhesion |
| CN104958789A (en) * | 2015-07-27 | 2015-10-07 | 大连大学 | Preparation method of composite film for preventing postoperative adhesion |
| CN106852907A (en) * | 2015-12-08 | 2017-06-16 | 董玲 | A kind of production method of soluble lyophilized film and products thereof |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4303676A (en) * | 1980-03-21 | 1981-12-01 | Balazs Endre A | Hyaluronate based compositions and cosmetic formulations containing same |
| GR920100122A (en) * | 1991-04-05 | 1993-03-16 | Ethicon Inc | Ionically crosslinked carboxyl-containing polysaccharides for adhension prevention. |
| JP3545789B2 (en) * | 1993-09-30 | 2004-07-21 | 味の素ファルマ株式会社 | Intraperitoneal adhesion inhibitor |
| CN1085106A (en) * | 1993-10-27 | 1994-04-13 | 吴亮 | The ophthalmologic operation visco-elastic material that has fluorescence |
| CN1116044C (en) * | 1998-06-24 | 2003-07-30 | 凌沛学 | Antisticking particle and powder containing sodium hyaluronate and their preparation process |
| CN1137681C (en) * | 2000-11-21 | 2004-02-11 | 国家医药管理局上海医药工业研究院 | Asiaticoside antisticking film and its preparation method |
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2003
- 2003-04-18 CN CNB031164749A patent/CN100333804C/en not_active Expired - Lifetime
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101318036B (en) * | 2008-06-10 | 2011-11-23 | 杭州协合医疗用品有限公司 | Medical antiblocking intelligent gel rubber material and preparation thereof |
| CN103717242A (en) * | 2011-08-03 | 2014-04-09 | 郡是株式会社 | Anti-adhesion membrane |
| CN103717242B (en) * | 2011-08-03 | 2015-09-30 | 郡是株式会社 | Antiadhesive film |
| CN104958790A (en) * | 2015-07-27 | 2015-10-07 | 大连大学 | Composite membrane for preventing postoperative adhesion |
| CN104958789A (en) * | 2015-07-27 | 2015-10-07 | 大连大学 | Preparation method of composite film for preventing postoperative adhesion |
| CN104958789B (en) * | 2015-07-27 | 2018-01-23 | 大连大学 | Prevent the preparation method of the composite membrane of postoperative intestinal adhesion |
| CN104958790B (en) * | 2015-07-27 | 2018-01-23 | 大连大学 | Prevent the composite membrane of postoperative intestinal adhesion |
| CN106852907A (en) * | 2015-12-08 | 2017-06-16 | 董玲 | A kind of production method of soluble lyophilized film and products thereof |
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| CN100333804C (en) | 2007-08-29 |
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