CN1116044C - Antisticking particle and powder containing sodium hyaluronate and their preparation process - Google Patents
Antisticking particle and powder containing sodium hyaluronate and their preparation process Download PDFInfo
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- CN1116044C CN1116044C CN98110311A CN98110311A CN1116044C CN 1116044 C CN1116044 C CN 1116044C CN 98110311 A CN98110311 A CN 98110311A CN 98110311 A CN98110311 A CN 98110311A CN 1116044 C CN1116044 C CN 1116044C
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- hyaluronate sodium
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Abstract
The present invention belongs to the field of medicines, and relates to a preparation in the form of granules and powder for mainly preventing and treating adhesions formed after surgical operations. The preparation is prepared from sodium hyaluronate as a main component, and can be prepared into a compound preparation for application through compounding with other isolating agents and pharmacological active substances, such as anticaking agents, anti-inflammatory agents, calcium channel blocking agents, cell growth inhibiting agents, proteolytic enzymes, etc. The formula and the dosage measured by 100g as a unit of the preparation in the form of the granules and the powder of the present invention comprise the components of 1 to 100g of sodium hyaluronate, 0 to 99g of isolating agent, and active component of which the quantity is added according to the pertinent regulations of the pharmacopeia. The preparation in the form of the granules and the powder of the present invention has obvious effects when used for preventing the adhesions formed after ordinary abdominal cavity operations, gynecological and obstetrical operations, orthopedics specialty operations, cardio-thoracic surgery operations and orthopedic operations. Compared with other adhesion preventing medicines and isolating agents, the present invention has the advantages of good functional effect, stable quality, convenient use, etc.
Description
Technical field
The invention belongs to field of pharmaceutical technology, is granule and the powder spray of tissue adhesion behind a kind of prevention and the treatment surgical operation.
Background technology
Adhesion often betides after abdominal cavity, gynecological, orthopaedics, cardiothoracic surgery and the orthopaedic surgery, can cause serious clinical complication, as intestinal obstruction, abdominal cavity and pelvic cavity pain, infertility etc., increased the difficulty of operation once more, and further complication may take place, Film with Preventing Adhesion is mainly by two approach at present: improve operation skill and use adjuvant.Improve operation skill and comprise directly operation of minimizing, reduce the wound in the operation process and avoid the interior foreign body that imports of body.Play the effect that reduces adhesion to a certain extent by improving operation skill, but because its limitation can not effectively prevent adhesion.Adjuvant divides medicine and interleaving agent again, once medicine such as the hyaluronidase of using in the past, streptokinase, urokinase, ibuprofen, dexamethasone etc., and interleaving agent such as dextran, polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (CMC) etc., though obtain certain effect, do not have a kind of method of determined curative effect to prevent the postoperative tissue adhesion yet.The special hydrodynamic characteristics of hyaluronate sodium (English Sodium Hyaluronate claims hyaluronic acid sodium again) makes it have height viscoelasticity, plasticity, permeability and good biocompatibility.Use hyaluronate sodium to prevent the postoperative tissue adhesion, the incidence rate of adhesion is reduced greatly, zoopery both domestic and external and clinical data proof hyaluronate sodium are effective anti-blocking agents.
A kind of linear polyanionic polysaccharide that hyaluronate sodium is made up of the disaccharidase recurring unit of (1 → 3)-2-acetylaminohydroxyphenylarsonic acid 2-deoxidation-β-D-glucose-(1 → 4)-O-D-glucuronic acid, as the necessary material of Human Physiology, it extensively is present in the various tissues of animal, comprises connective tissue, skin, cartilage, vitreum and synovial fluid etc.Hyaluronate sodium and tissue fibrin have viscoelasticity, protectiveness, lubricity and stable substrate in conjunction with formation, and cell is inlayed wherein, the effect that has tytosis space, stabilized cell structure, covers cell and protection cell.The hyaluronate sodium molecular weight can reach 400 ten thousand to 5 megadaltons, in aqueous solution, exists with random spiral form, and very big molecule volume is arranged, and (＜0.01%) can be woven and penetrate mutually under low concentration, makes it have specific rheological properties.Hyaluronate sodium prevents that but postoperative tissue adhesion's mechanism reduction from for 1. forming the polymolecular network structure after the dissolving, separating wounded tissue with normal serous coat, plays space obstacle effect and lubrication, reduces friction; 2. suppress hemorrhage and ooze out, reduce the clot quantity that can form permanent adhesion skeleton, the Profilin calmness; 3. suppress post-operation inflammatory cell migration and phagocytosis, suppress hematoblastic deposition, promote wound healing; 4. stimulate the growth and the differentiation of serous coat cell, make the wound serous coat reach the physiological reparation.In addition, hyaluronic acid sodium granules and powder spray are preventing to be better than sodium hyaluronate solution and gel aspect the tissue adhesion.Sodium hyaluronate solution and gel are because concentration is low, molecular weight is little, be absorbed degraded in vivo soon, weakened its iris action, and hyaluronic acid sodium granules and powder spray spray behind tissue surface, a course of dissolution is progressively arranged at tissue surface, form the high concentration gel simultaneously in the part, retention time is long in local viscoelasticity height and the body, forms effective barrier in the serous coat reparation phase, so its preventing adhesiving effect is remarkable.Hyaluronic acid sodium granules and powder spray steady quality, using method is easy, meets the requirement of clinical use.
The chemical property of hyaluronate sodium is stable, does not produce physical and chemical reaction with the most drug compatibility, and it can use existing many example proofs with compatibilities such as many anticoagulant, hormone, anti-inflammatory analgesics.
Summary of the invention
Purpose of the present invention: tissue adhesion's granule and powder spray after providing a kind of prevention and treating surgical operation, also can same anticoagulant, antiinflammatory, proteolytic enzyme, calcium channel blocker, cytostatic agent and interleaving agent are made into compound preparation, constituting a series of is the anti-blocking agent of carrier with the hyaluronate sodium, be used for abdominal surgery, department of obstetrics and gynecology, operation such as cardiothoracic surgery back prevention peritoneal tissues or pericardium adhesion, also can be used for preventing arthroscopy, around the nervous tissue, tissue adhesion behind the bone surgeries such as tendon repair, it is long to have the interior retention time of body, preventing adhesiving effect significantly and significantly reduce the effect of post-operative complication, the promotion wound healing is arranged simultaneously, reduce the advantage of cicatrix; And provide the preparation method of this class granule and powder spray.
The basic comprising of granule of the present invention and powder spray is: hyaluronate sodium, or hyaluronate sodium and dextran, or hyaluronate sodium and polyvinylpyrrolidone (PVP), or hyaluronate sodium and carboxymethyl cellulose.Tissue adhesion after being used for prevention and treating surgical operation reduces post-operative complication.
Also can on the basis of basic comprising, add pharmacological active substance, as required as anticoagulant, antiinflammatory, calcium channel blocker, cytostatic agent, proteolytic enzyme and other interleaving agent.Anticoagulant such as dicoumarol, heparin, hirudin etc., antihistaminics such as antiinflammatory such as promethazine, hormones such as dexamethasone, hydrocortisone, andrographolide, NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen, oxyphenbutazone, tolmetin; Calcium channel blocker example hydrochloric acid diltiazem, nifedipine, verapamil hydrochloride; Cytostatic agent such as fluorouracil; Proteolytic enzyme such as hyaluronidase, streptokinase, urokinase, pepsin, trypsin, cytoplastin, plasminogen (tPA), interleaving agent such as agar, albumin, Oleum Camphora, chondroitin sulfate, fat, Radix Acaciae senegalis, olive oil, paraffin, phospholipid, polysiloxanes, vaseline, gelatin, oxidized regenerated cellulose, chitin and derivant, expanded polytetrafluoroethylsealing etc.
The prescription and the amount ranges of granule of the present invention and powder spray are: in 100 gram granule and powder sprays, and hyaluronate sodium 1-100 gram wherein, in the time of need be with interleaving agent, its amount ranges 0-99 gram.In the time of need adding medicine, its consumption is according to the pharmacopeia pertinent regulations.
The prescription and the consumption of granule master powder spray of the present invention are: in 100 gram granule and powder sprays, and hyaluronate sodium 100 grams.
The prescription and the consumption of granule of the present invention and powder spray are: in 100 gram granule and powder sprays, and hyaluronate sodium 10 grams, dextran 90 grams.
The prescription and the consumption of granule of the present invention and powder spray are: in 100 gram granule and powder sprays, and hyaluronate sodium 20 grams, carboxymethyl cellulose 80 grams.
The prescription and the consumption of granule of the present invention and powder spray are: in 100 gram granule and powder sprays, and hyaluronate sodium 10 grams, chondroitin sulfate 3 grams, all the other are dextrans.
The prescription and the consumption of granule of the present invention and powder spray are: in 100 gram granule and powder sprays, and hyaluronate sodium 10 grams, heparin sodium 0.1 gram (is tired and is no less than that 150 units/mg), all the other are dextrans.
The prescription and the consumption of granule of the present invention and powder spray are: in 100 gram granule and powder sprays, and hyaluronate sodium 10 grams, dexamethasone sodium phosphate 0.1 gram, all the other are dextrans.
The manufacture method one of granule of the present invention and powder spray: by the prescription and the consumption of granule of the present invention and powder spray, the accurate weighing of each components in certain proportion, after the mixing, coating-dividing sealing promptly gets granule of the present invention and powder spray with oxirane or microwave degerming.
The manufacture method two of granule of the present invention and powder spray: by the prescription and the consumption of granule of the present invention and powder spray, with oxirane or microwave degerming, coating-dividing sealing promptly gets granule of the present invention and powder spray to each composition in proportion more respectively.
Owing to contain hyaluronate sodium in granule of the present invention and the powder spray, can act on the adhesion position effectively, be easy to use, do not influence normal wound healing, have biocompatibility and degradability, and granule of the present invention and powder spray hyaluronate sodium molecular weight are big, retention time is long in the body, barrier action during wound tissue repairs is obvious, so its preventing adhesiving effect is remarkable.Implement and clinic trial through animal, prevention and the posterior synechiae of treatment surgical operation, it is all better than the effect of other medicines and barrier to reduce post-operative complication.
The specific embodiment
Embodiments of the invention:
1. granule of the present invention and powder spray in 100 grams, are got hyaluronate sodium 100 grams, prepare according to the method for the invention.
2. granule of the present invention and powder spray in 100 grams, are got hyaluronate sodium 10 grams, and dextran 90 grams prepare according to the method for the invention.
3. granule of the present invention and powder spray in 100 grams, are got hyaluronate sodium 20 grams, and carboxymethyl cellulose 80 grams prepare according to the method for the invention.
4. granule of the present invention and powder spray in 100 grams, are got hyaluronate sodium 10 grams, chondroitin sulfate 3 grams, and all the other are dextrans, prepare according to the method for the invention.
5. granule of the present invention and powder spray in 100 grams, are got hyaluronate sodium 10 gram, and (tire is no less than that 150 units/mg), all the other are dextrans to heparin sodium 0.1 gram, prepares according to the method for the invention.
6. granule of the present invention and powder spray in 100 grams, are got hyaluronate sodium 10 grams, dexamethasone sodium phosphate 0.1 gram, and all the other are dextrans, prepare according to the method for the invention.
Claims (3)
1. granule that contains the hyaluronate sodium Main Ingredients and Appearance, be characterised in that with the hyaluronate sodium to be Main Ingredients and Appearance, also contain other active substance and interleaving agent, described active substance is an anticoagulant, antiinflammatory, calcium channel blocker, cytostatic agent, proteolytic enzyme, described interleaving agent is a carboxymethyl cellulose, chondroitin sulfate, dextran, prevention and the posterior synechiae of treatment surgical operation, the prevention abdominal surgery, operation posterior peritoneum tissue such as department of obstetrics and gynecology and cardiothoracic surgery or pericardium adhesion, and prevention arthroscopy, around the nervous tissue, bone surgery infectious-related complications such as tendon repair.
2. one kind contains the powder spray that hyaluronate sodium is a Main Ingredients and Appearance, be characterised in that with the hyaluronate sodium to be Main Ingredients and Appearance, also contain other active substance and interleaving agent, described active substance is an anticoagulant, antiinflammatory, calcium channel blocker, cytostatic agent, proteolytic enzyme, described interleaving agent is a carboxymethyl cellulose, chondroitin sulfate, dextran, prevention and the posterior synechiae of treatment surgical operation, the prevention abdominal surgery, operation posterior peritoneum tissue such as department of obstetrics and gynecology and cardiothoracic surgery or heart film coalescence, and prevention arthroscopy, around the nervous tissue, bone surgery infectious-related complications such as tendon repair.
3. claim 1 or 2 arbitrary described granule and powder sprays, its feature are that also the interleaving agent of hyaluronate sodium and adding and active ingredient all mix with solid particle or dust cloud form.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN98110311A CN1116044C (en) | 1998-06-24 | 1998-06-24 | Antisticking particle and powder containing sodium hyaluronate and their preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN98110311A CN1116044C (en) | 1998-06-24 | 1998-06-24 | Antisticking particle and powder containing sodium hyaluronate and their preparation process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1239657A CN1239657A (en) | 1999-12-29 |
| CN1116044C true CN1116044C (en) | 2003-07-30 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN98110311A Expired - Fee Related CN1116044C (en) | 1998-06-24 | 1998-06-24 | Antisticking particle and powder containing sodium hyaluronate and their preparation process |
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| Country | Link |
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| CN (1) | CN1116044C (en) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100333804C (en) * | 2003-04-18 | 2007-08-29 | 上海建华精细生物制品有限公司 | Sodium hyaluronate anti-adhesion film, and its prepn. method |
| CA2789262C (en) * | 2005-04-28 | 2016-10-04 | Proteus Digital Health, Inc. | Pharma-informatics system |
| CN100386090C (en) * | 2006-07-08 | 2008-05-07 | 青岛博益特生物材料有限公司 | Medical dust cloud agent or granular agent and its use |
| IT1397246B1 (en) * | 2009-05-14 | 2013-01-04 | Fidia Farmaceutici | NEW MEDICATIONS FOR TOPIC USE BASED HYALURONIC ACID SULFATED AS AN ACTIVATING OR INHABITING CITHOCINIC ACTIVITY |
| CN103961710A (en) * | 2014-05-04 | 2014-08-06 | 青岛市城阳区人民医院 | Anti-adhesion dry powder inhalation for orthopedics department postoperative joint tissues, and preparation of anti-adhesion dry powder inhalation |
| CN103961708A (en) * | 2014-05-04 | 2014-08-06 | 青岛市城阳区人民医院 | Anti-adhesion dry powder inhaler used after orthopedic surgeries and preparing method thereof |
| CN103961366A (en) * | 2014-05-04 | 2014-08-06 | 青岛市城阳区人民医院 | Anti-adhesion dry powder inhalation for orthopedics department post operation, and preparation of anti-adhesion dry powder inhalation |
| CN103948623B (en) * | 2014-05-04 | 2016-08-31 | 青岛市城阳区人民医院 | A kind of bone surgery anti powder spray and preparation method thereof |
| WO2015183230A1 (en) * | 2014-05-30 | 2015-12-03 | Наталия Мыколаивна ДЕРКАЧ | Composition based on a stabilized solution of active ingredients |
| CN110840894B (en) * | 2019-12-19 | 2020-06-02 | 温州医科大学附属第一医院 | Composite scar-resistant silicone spray and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0444492A1 (en) * | 1990-02-21 | 1991-09-04 | RICERFARMA Srl | Topically administered compositions based on high molecular weight hyaluronic acid for treating inflammations of the oral cavity, and for oral cavity hygiene and cosmetic treatment |
| EP0480189A1 (en) * | 1990-10-05 | 1992-04-15 | Altergon S.A. | Pharmaceutical compositions for topical use comprising hyaluronic acid sodium salt and disinfectant substances |
| WO1997025051A1 (en) * | 1996-01-11 | 1997-07-17 | Hyal Pharmaceutical Corporation | Oral administration of effective amounts of forms of hyaluronic acid |
-
1998
- 1998-06-24 CN CN98110311A patent/CN1116044C/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0444492A1 (en) * | 1990-02-21 | 1991-09-04 | RICERFARMA Srl | Topically administered compositions based on high molecular weight hyaluronic acid for treating inflammations of the oral cavity, and for oral cavity hygiene and cosmetic treatment |
| EP0480189A1 (en) * | 1990-10-05 | 1992-04-15 | Altergon S.A. | Pharmaceutical compositions for topical use comprising hyaluronic acid sodium salt and disinfectant substances |
| WO1997025051A1 (en) * | 1996-01-11 | 1997-07-17 | Hyal Pharmaceutical Corporation | Oral administration of effective amounts of forms of hyaluronic acid |
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| Publication number | Publication date |
|---|---|
| CN1239657A (en) | 1999-12-29 |
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Granted publication date: 20030730 Termination date: 20100624 |