CN101028280A - Lavage liquor preparation for operation and its production - Google Patents
Lavage liquor preparation for operation and its production Download PDFInfo
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- CN101028280A CN101028280A CN 200610024263 CN200610024263A CN101028280A CN 101028280 A CN101028280 A CN 101028280A CN 200610024263 CN200610024263 CN 200610024263 CN 200610024263 A CN200610024263 A CN 200610024263A CN 101028280 A CN101028280 A CN 101028280A
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Abstract
A lavation liquid for ophthalmic operation, surgical operation, or abdominal chemicotherapy is proportionally prepared from sodium hyaluronate, water-soluble chitose and buffering phosphate solution. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to medical science medicine technology, relate in particular to lavage liquor preparation for operation.
Background technology
Adhesion is that connective fiber band and adjacent tissue or organ combine and the anomalous structure that forms.The postoperative tissue adhesion is one of the most serious post-operative complication of causing of operation process.1980, Goldberg etc. just reported and have used some hydrophilic polymers solution (PVP and dextran) to wrap up the tissue that is caused the peritoneum wound by contact drying and operation that contact tissue prevents adhesion before operation or in the art.Molecular weight is more than 50000, and the hydrophilic polymer weak solution of mass concentration between 0.01～15% is coated with tissue before art or in the art can prevent the tissue adhesion effectively.
Prevent the postoperative tissue adhesion.This be one in the last hundred years the clinician seeking the problem that solves and pay for this reason continuous effort and hardships always, sum up the experience of decades.Tissue adhesion's idealized model or basic demand after the proposition iatrotechnics: 1. can prevent tissue adhesion's formation effectively, but can not influence wound healing; 2. can stop blooding effectively; 3. can suppress growth of microorganism; 4. do not influence the normal function of cell and cell; 5. avirulence, non-sensitization, good biocompatibility.It is very difficult that obvious a certain material satisfies above-mentioned several requirements simultaneously, but chitosan is but with its unique biological function, comparatively intactly adapt to above-mentioned requirements, that is: chitosan can suppress growth of fibroblasts, play a role one of from the source of adhesion, can regulate hemostatic function effectively again, be controlled from two of the source of adhesion.Simultaneously, it not only promotes epithelial cell growth in the process that prevents the postoperative tissue adhesion, can also promote wound healing, improves healing quality.As its safety of a kind of bio-medical material, all confirmed it is foolproof through detection and practice decades.Therefore, prevent postoperative tissue adhesion aspect on the current clinical medicine, chitosan naturally becomes first-selection with its complete multi-functional synergism.
Glutinous being connected in of the pre-preventing tissue of hyaluronic acid carried out a large amount of research both at home and abroad.After intra-operative or operation, introduce between the tissue of operative site that hyaluronic acid weak solution, gel, thin film or sponge separate the tissue that is just healing or organizing of preventing from just healing postoperative is glutinous to be connected, and do not influence the healing of wound.Hyaluronic acid prevents that the glutinous operation that connects from comprising: in the operation that abdomen area is carried out, prevent that intestinal or mesentery are even glutinous; In the operation that relates to tendon, between postoperative fixation phase, prevent tendon and stndon sheath or the glutinous company between film or other surrounding tissues on every side; In ophthalmologic operation, be used in camera oculi anterior and prevent that the iris between cornea and iris is even glutinous, degradable or permanent implant prevents glutinous effect also more satisfied behind operation for glaucoma or strabotomy.
Summary of the invention
Technical problem to be solved by this invention is the biological characteristics in conjunction with hyaluronate sodium and chitosan, with a kind of operation irrigating solution that had not only contained hyaluronate sodium but also contained chitosan of different proportioning preparation, to be widely used in operation such as ophthalmology, surgical operation, intraperitoneal chemotherapy and the production technology of this lavage liquor preparation for operation is provided.
In order to solve the problems of the technologies described above, lavage liquor preparation for operation of the present invention is characterized in that: contain the hyaluronate sodium of mass percent concentration 0.01～0.60%, and the water soluble chitose of mass percent concentration 0.10～2.0%, all the other are phosphate buffer.
In preferred version of the present invention, contain the hyaluronate sodium of mass percent concentration 0.01～0.10%, the water soluble chitose of mass percent concentration 0.40～0.60%.The operation of this proportioning is used for ophthalmologic operation with irrigating solution, has good effect.
In another preferred version of the present invention, contain the hyaluronate sodium of mass percent concentration 0.10～0.50%, the water soluble chitose of mass percent concentration 0.1～1.0%.The operation of this proportioning is used for surgical operation with irrigating solution, has good effect.
Again in another preferred version, contain the hyaluronate sodium of mass percent concentration 0.40～0.60%, the water soluble chitose of mass percent concentration 1.0～1.5% in the present invention.The operation of this proportioning is used for intraperitoneal chemotherapy with irrigating solution, has good effect.
Described phosphate buffer contains the sodium chloride of mass percent concentration 0.755 ± 0.50%, the sodium dihydrogen phosphate of mass percent concentration 0.01～0.02%, the sodium hydrogen phosphate of mass percent concentration 0.10～0.20%, and all the other are water for injection.
The production technology of above-mentioned lavage liquor preparation for operation is:
1. phosphate buffer preparation:
In the stainless steel cask container, sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate are added in the water for injection, and must not carry out aseptic filtration with 0.22 μ m filter element after the sterilization above under the 0.25Mpa condition in high pressure under hundred grades of laminar flow hood according to compound concentration;
2. goods preparation:
Under hundred grades of laminar flow hood, medical hyaluronic acid sodium degerming dry powder and medical chitose degerming dry powder are added phosphate buffer and sealing, shake the goods that prepare every day, dissolve fully until goods according to compound concentration.
3. fill:
Under the condition that under hundred grades of laminar flow hood at pressure is 0.12Mpa～0.15Mpa, carry out cannedly, carry out heat sealing after the fill with filling machine.
Adopt technique scheme, lavage liquor preparation for operation of the present invention has following advantage:
1, at different requirements of operation, adopt variable concentrations preparation lavage liquor preparation for operation, can better satisfy the clinical practice requirement;
2, lavage liquor preparation for operation combines the biological characteristics of medical hyaluronic acid sodium and medical chitose; in the prevention of postoperative adhesion, also have hemostasis, antibacterial, the effect that promotes epithelial cell growth, be suppressed to the function of fibroblast growth, the tissue (tissue and cells such as corneal endothelium, corneal epithelium, peritoneal mesothelium, articular cartilage) that is poured is had good protection and repair and promotes the healing of wound.
3, raw material medical hyaluronic acid sodium that lavage liquor preparation for operation adopted and medical chitose are a kind of polysaccharide materials of natural absorbability, have excellent biological compatibility, nontoxic to organizing, no immunogenicity.
4, can unite use with anti-inflammatory agent and anesthetics at different operations, play the triple role of local anaesthesia, antiinflammatory and organization protection.
The specific embodiment
Embodiment 1
The lavage liquor preparation for operation of present embodiment, contain mass percent concentration and be 0.80% sodium chloride, the sodium dihydrogen phosphate of mass percent concentration 0.015%, the sodium hydrogen phosphate of mass percent concentration 0.134%, the hyaluronate sodium of mass percent concentration 0.07%, the water soluble chitose of mass percent concentration 0.5%, all the other are water for injection.
As shown in table 1 below, this table has shown the specification requirement that lavage liquor preparation for operation should satisfy:
| Project | Requirement |
| Osmotic pressure | 300±40mOsmol/L |
| pH | 6.8~7.5 |
| Intrinsic viscosity | ≥100cm3/g |
| The ethanol residual quantity | ≤200ug/ml |
| Uv absorption | 280nm≤1.0 260nm≤1.0 |
| Content of beary metal | ≤10ug/ml |
| Sterility test | Should be aseptic |
| Bacterial endotoxin is limited the quantity of | ≤0.5 |
Table 1
But pass through test to the lavage liquor preparation for operation of present embodiment, detection draws: osmotic pressure is 284mOsmol/L, pH value is that 7.01 intrinsic viscosities are 982.61cm3/g, the ethanol residual quantity is 48.04ug/ml, uv absorption is 280nm:0.052,260nm:0.067, content of beary metal is less than 10ug/ml, and sterility test shows aseptic, and bacterial endotoxin is limited the quantity of less than 0.19EU/mg.Compare with table 1, meet the requirement of table 1 fully.
This lavage liquor preparation for operation makes by following production technology:
1. phosphate buffer preparation:
In the stainless steel cask container, sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate are added in the water for injection, and must not carry out aseptic filtration with 0.22 μ m filter element after the sterilization above under the 0.25Mpa condition in high pressure under hundred grades of laminar flow hood according to compound concentration;
2. goods preparation:
Under hundred grades of laminar flow hood, medical hyaluronic acid sodium degerming dry powder and medical chitose degerming dry powder are added phosphate buffer and sealing, shake the goods that prepare every day, dissolve fully until goods according to compound concentration.
3. fill:
Under the condition that under hundred grades of laminar flow hood at pressure is 0.12Mpa～0.15Mpa, carry out cannedly, carry out heat sealing after the fill with filling machine.
Embodiment 2
The lavage liquor preparation for operation of present embodiment, contain mass percent concentration and be 0.80% sodium chloride, the sodium dihydrogen phosphate of mass percent concentration 0.015%, the sodium hydrogen phosphate of mass percent concentration 0.134%, the hyaluronate sodium of mass percent concentration 0.15%, the water soluble chitose of mass percent concentration 0.6%, all the other are water for injection.
The lavage liquor preparation for operation of present embodiment detects by test and draws: osmotic pressure is 273mOsmol/L, pH value is that 7.02 intrinsic viscosities are 927.76cm3/g, the ethanol residual quantity is 44.30ug/ml, uv absorption is 280nm:0.067,260nm:0.088, content of beary metal is less than 10ug/ml, sterility test shows aseptic, and bacterial endotoxin is limited the quantity of less than 0.15EU/mg.Compare with table 1, meet the requirement of table 1 fully.
The production technology of this this lavage liquor preparation for operation is identical with enforcement 1.
Embodiment 3
The lavage liquor preparation for operation of present embodiment, contain mass percent concentration and be 0.80% sodium chloride, the sodium dihydrogen phosphate of mass percent concentration 0.015%, the sodium hydrogen phosphate of mass percent concentration 0.134%, the hyaluronate sodium of mass percent concentration 0.50%, the water soluble chitose of mass percent concentration 1.1%, all the other are water for injection.
The lavage liquor preparation for operation of present embodiment detects by test and draws: osmotic pressure is 290mOsmol/L, pH value is that 6.98 intrinsic viscosities are 1036.10cm3/g, the ethanol residual quantity is 83.55ug/ml, uv absorption is that 280nm:0.126,260nm:0.165 content of beary metal are less than 10ug/ml, sterility test shows aseptic, and bacterial endotoxin is limited the quantity of less than 0.07EU/mg.Compare with table 1, meet the requirement of table 1 fully.
The production technology of this lavage liquor preparation for operation is identical with enforcement 1.
Claims (5)
1, a kind of lavage liquor preparation for operation is characterized in that: contain the hyaluronate sodium of mass percent concentration 0.0 1～0.60%, and the water soluble chitose of mass percent concentration 0.10～2.0%, all the other are phosphate buffer.
2, according to the described lavage liquor preparation for operation of claim 1, it is characterized in that: contain the hyaluronate sodium of mass percent concentration 0.01～0.10%, the water soluble chitose of mass percent concentration 0.40～0.60%.
3, according to the described lavage liquor preparation for operation of claim 1, it is characterized in that: contain the hyaluronate sodium of mass percent concentration 0.10～0.50%, the water soluble chitose of mass percent concentration 0.1～1.0%.
4, according to the described lavage liquor preparation for operation of claim 1, it is characterized in that: contain the hyaluronate sodium of mass percent concentration 0.40～0.60%, the water soluble chitose of mass percent concentration 1.0～1.5%.
5, the production technology according to the described lavage liquor preparation for operation of the arbitrary claim of claim 1 to 4 is:
1. phosphate buffer preparation
In the stainless steel cask container, sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate are added in the water for injection, and must not carry out aseptic filtration with 0.22 μ m filter element after the sterilization above under the 0.25Mpa condition in high pressure under hundred grades of laminar flow hood according to compound concentration;
2. goods preparation
Under hundred grades of laminar flow hood, press compound concentration medical hyaluronic acid sodium degerming dry powder and medical chitose degerming dry powder are added phosphate buffer and sealing, shake the goods that prepare every day, dissolve fully until goods.
3. fill
Under the condition that under hundred grades of laminar flow hood at pressure is 0.12Mpa～0.15Mpa, carry out cannedly, carry out heat sealing after the fill with filling machine.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2006100242631A CN101028280B (en) | 2006-03-01 | 2006-03-01 | Lavage liquor preparation for operation and its production |
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| CN2006100242631A CN101028280B (en) | 2006-03-01 | 2006-03-01 | Lavage liquor preparation for operation and its production |
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| CN101028280A true CN101028280A (en) | 2007-09-05 |
| CN101028280B CN101028280B (en) | 2010-12-29 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102309776A (en) * | 2011-09-05 | 2012-01-11 | 北京博恩康生物科技有限公司 | A kind of powdery absorbable hemostatics and preparation method thereof |
| CN102552120A (en) * | 2010-12-31 | 2012-07-11 | 上海长征富民金山制药有限公司 | Surgical anti-adhesion flushing liquid |
| CN103432160A (en) * | 2013-08-16 | 2013-12-11 | 江苏省健尔康医用敷料有限公司 | Broad spectrum contact type medical surgical lavage fluid and preparation method thereof |
| CN104606224A (en) * | 2015-01-13 | 2015-05-13 | 河北柯瑞生物医药有限公司 | Cleaning liquid and preparation method thereof |
| CN114984045A (en) * | 2022-07-01 | 2022-09-02 | 扬州航富医疗器械有限公司 | Lavage liquid preparation for surgical operation |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1132585C (en) * | 2000-02-01 | 2003-12-31 | 上海其胜生物制剂有限公司 | Water soluble medical chitose preparation and its preparation |
| CN1228054C (en) * | 2000-07-25 | 2005-11-23 | 凌沛学 | Artificial skin powder prepn containing sodium hyaluronate and its prepn |
| KR20040009891A (en) * | 2002-07-26 | 2004-01-31 | 주식회사 엘지생명과학 | Hyaluronic Acid Derivative Gel and Method for Preparing the Same |
| KR100523953B1 (en) * | 2002-08-27 | 2005-10-25 | 주식회사 엘지생명과학 | Microbeads of natural polysaccharide and hyaluronic acid and processes for preparing the same |
| CN1965854A (en) * | 2005-11-17 | 2007-05-23 | 上海其胜生物制剂有限公司 | Moisturizing eye drop and preparation process therof |
-
2006
- 2006-03-01 CN CN2006100242631A patent/CN101028280B/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552120A (en) * | 2010-12-31 | 2012-07-11 | 上海长征富民金山制药有限公司 | Surgical anti-adhesion flushing liquid |
| CN102309776A (en) * | 2011-09-05 | 2012-01-11 | 北京博恩康生物科技有限公司 | A kind of powdery absorbable hemostatics and preparation method thereof |
| CN103432160A (en) * | 2013-08-16 | 2013-12-11 | 江苏省健尔康医用敷料有限公司 | Broad spectrum contact type medical surgical lavage fluid and preparation method thereof |
| CN104606224A (en) * | 2015-01-13 | 2015-05-13 | 河北柯瑞生物医药有限公司 | Cleaning liquid and preparation method thereof |
| CN114984045A (en) * | 2022-07-01 | 2022-09-02 | 扬州航富医疗器械有限公司 | Lavage liquid preparation for surgical operation |
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| Publication number | Publication date |
|---|---|
| CN101028280B (en) | 2010-12-29 |
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Owner name: SHANGHAI JIANHUA FINE BIOLOGICAL PRODUCT CO., LTD. |
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Effective date of registration: 20110810 Address after: 201106 Shanghai city Minhang District Wu Caojing Road No. 1008 Co-patentee after: Shanghai Jianhua Fine Biological Products Co., Ltd. Patentee after: Qisheng Biopreparations Co., Ltd., Shanghai Co-patentee after: Shanghai Haohai Biological Technology Co., Ltd. Address before: 201106 Shanghai city Minhang District Wu Caojing Road No. 1008 Patentee before: Qisheng Biopreparations Co., Ltd., Shanghai |