CN101849900A - Preparation technology for medicine-containing catgut - Google Patents
Preparation technology for medicine-containing catgut Download PDFInfo
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- CN101849900A CN101849900A CN200910131516A CN200910131516A CN101849900A CN 101849900 A CN101849900 A CN 101849900A CN 200910131516 A CN200910131516 A CN 200910131516A CN 200910131516 A CN200910131516 A CN 200910131516A CN 101849900 A CN101849900 A CN 101849900A
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Abstract
The invention relates to a preparation technology for medicine-containing catgut. The catgut is soaked in water for injection to swell the catgut first and then the content of the medicine components in mixture for soaking the catgut is gradually increased to replace water in the swelled catgut. Thereby, water in the swelled catgut can be replaced to the maximum extent, the medicine carrying capacity of the catgut is fully exerted and the medicine carrying amount of the catgut is increased. Especially the method of using a capillary as a container for soaking the catgut till solvent is evaporated to be dry can enable the medicine components in the mixture for soaking the catgut to be fully soaked in the catgut and even to form a coating layer outside the catgut, thereby accurately controlling the medicine carrying amount of the catgut and avoiding medicine wastage. Thereby, the invention has the advantages that the preparation method can improve the medicine carrying amount of the catgut, the medicine carrying amount of the catgut can be accurately controlled, the clinical efficacy is improved, the resource is saved and the scale production and the scale application are facilitated.
Description
Technical field
The present invention relates to the preparation technology of a kind of used medicated line of sunkening cord in the acupuncture, relate in particular to a kind of preparation method of pastille catgut.
Background technology:
Medicated line is meant the line that contains medicine, the pastille catgut is meant the catgut that is adsorbed with a certain amount of medicine, the catgut that is loaded with medicine is implanted to human body, degraded along with catgut, its contained medicine also discharges gradually, thereby playing the slow release treatment effect of medicine, is the further developing of catgut embedding therapy in the Chinese medicine acupuncture, imbeds the category of medicated line.
The pastille catgut belongs to the implant category of modern medicine, and implant is the dosage form in forward position relatively at present, characteristics such as have that dosage is little, drug effect is high, targeting, side effect are little.Therefore implant has vast potential for future development.The implant drug loading of utilization high polymer adjuvant preparation can reach 50% at present, even it is higher, but its complicated process of preparation, and make carrier with catgut, the drug loading less than 2% of present preparation method gained pastille catgut, the drug loading that therefore how to improve the pastille catgut has great importance.
The preparation technology of existing pastille catgut:
As a kind of Chinese medicine stype that is used for the treatment of cervical spondylosis of patent and manufacture method (patent No. 200610052021.3), a kind of medicated line and preparation method thereof and this medicated line in the application (patent No. 202132660.6) aspect treatment hyperosteogeny and the relevant disease etc., the basic technology of its preparation pastille catgut is that catgut be impregnated in the medicinal liquid, use after dipping a period of time, take out catgut during use, the direct use that has, use the dry back that has, and the medicinal liquid that is used for flooding catgut abandons need not.The drawback of its existence has following 3 aspects:
1, the catgut drug loading is low
The catgut of the dipping moist direct use in back contains solvent moisture content, so the catgut drug loading is low, the dipping after drying uses, catgut loses moisture content in dry run, not catgut this part ability of carrying water be used for the medicine carrying thing in other words catgut also have the medicine carrying space not to be used for medicine carrying, this in a word method is not given full play to the medicine carrying ability of catgut.
2, the drug loading of catgut can not accurately be controlled
Owing to catgut is to be immersed in the medicinal liquid, the medicine that is penetrated in the catgut realizes also there is medicine in the medicinal liquid after dipping is finished by the molecule freely-movable, and the medicine that every catgut of therefore very difficult control obtains is the same.Do not meet controlled principle in the pharmacy.This shortcoming was more outstanding when especially preparation contained drug toxicity.
3, drug waste
Also have medicine in the medicinal liquid of dipping catgut, but medicinal liquid has been dropped in use, causes very big waste like this, especially more apparent outstanding to the rare medicinal herbs waste, Moschus etc. for example.
Patent again: technology of its preparation pastille catgut of medicinal catgut (patent No. 01129449.3) is earlier catgut to be flooded, and then medication powder is stifling, the stifling medicine of medication powder is difficult to be deep into catgut inside, so the inner drug loading of catgut still exists not enough and drug loading is difficult to control, and the lost drug waste that seriously causes of stifling medicine steam.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of pastille catgut.The method that the present invention preparation contains medicated line can improve the drug loading of catgut, drug component in the mixture of dipping catgut is all soaked into or is adsorbed onto on the catgut to reach the drug loading of accurate control catgut, has avoided the waste of medicine simultaneously.
The concept defining that relates among the present invention is as follows:
The mixture of dipping catgut: drug component, appearance agent.
Drug component: Chinese medicine, Western medicine, pharmaceutic adjuvant, antiseptic, additive etc.
Hold agent: organic solvents such as water and ethanol, ether, chloroform.
Drug component contains dose rate: the quality of drug component quality/mixture.
Catgut swelling phenomenon: catgut is a collagen protein, albumen suction back swelling, and catgut is made up of the thinner line of multiply, therefore after the suction, per share slit increases, the diameter chap of whole strand of catgut, volume increases, and this phenomenon claims the swelling phenomenon of catgut.
Drug component increment infusion process: increase the method that is impregnated into medicine in the catgut gradually by the ratio that increases dipping catgut mixture Chinese medicine component gradually, the method that increases the ratio of dipping catgut mixture Chinese medicine component has: catgut successively be impregnated in drug component contain in the different mixture of dose rate, along with the increase of dipping number of times, the drug component that is used for flooding the mixture of catgut contains dose rate and also increases; Perhaps catgut be impregnated in the mixture, in mixture, increase gradually drug component or gradually the solvent in the evaporating mixture make drug component in the mixture contain dose rate to increase; Perhaps above three kinds of methods are used in combination, and make catgut obtain dipping that drug component contains the more and more higher mixture of dose rate in a word and are impregnated into medication amount in the catgut with increase.
The inner drug loading of catgut: catgut is to be made of several strands thinner catgut, per share catgut swelling simultaneously after the catgut swelling, it is big that per share slit becomes, therefore will be impregnated into per share catgut inside, and the medicine total amount between per share catgut slit is called the inner drug loading of catgut.
The outside drug loading of catgut: the medication amount of whole thigh catgut outer interface coating or coating.
A kind of preparation method for preparing the pastille catgut of the present invention, its step is as follows:
The first step: preparation swelling catgut
Catgut is flooded with water for injection, get the swelling catgut;
Second step: the moisture content in the medicament component increment infusion process displacement swelling catgut
Replace water in the swelling catgut gradually by the ratio that increases dipping catgut mixture Chinese medicine component gradually
Divide, the method that increases the ratio of dipping catgut mixture Chinese medicine component has:
1) increases progressively the replacing method
Impregnated in the swelling catgut in the mixture that contains drug component, take out catgut after dipping a period of time, continue
Continuous impregnated in drug component and contain dose rate, like this repeated impregnations than in the high mixture of front mixture Chinese medicine constituent content rate
, flood the drug component content in the mixture of swelling catgut accordingly along with the increase of dipping number of times n time, and n 〉=2
Rate a also increases, and 0＜a≤100%;
This replacing method that increases progressively is suitable for various drug components, is particularly suitable for containing volatile drug component, because
Mixture and catgut can be in the airtight container in the dipping process, and the volatile ingredient loss is very little, for example contains Moschus
Drug component;
2) directly add the drug component method
The swelling catgut be impregnated in the mixture that contains drug component, in mixture, add one after dipping a period of time
Quantitative drug component so that drug component contain that dose rate a increases and 0＜a≤100%, when mixing continues one section of dipping
Between, and then in mixture, add a certain amount of drug component, and continue dipping a period of time, repeat to add medicine like this
Component n time and n 〉=1 gets the pastille catgut;
This method also is suitable for containing volatile drug component, is particularly suitable for being exsiccant drug component.
3) reduce solvent method
The swelling catgut be impregnated in the mixture that contains drug component, and after dipping a period of time, evaporating solvent, the degree of evaporation can be down to drying, the pastille catgut;
It is not the drug component of main medicine with volatile ingredient that this method is suitable for, and its advantage is simple to operate, soaks into
Fully, because in evaporation process gradually, the drug component displacement that the solvent in the catgut is concentrated gradually, and at medicine
Under the adjusting of amount, can also be when medicine soaks into catgut at outside coating or the coating of forming of catgut;
4) combined method
The swelling catgut is flooded catgut with increasing progressively the replacing method or directly adding the drug component method earlier, and then molten with reducing
The agent method gets the pastille catgut.
Catgut mainly is made of protein, protein has the characteristic of water absorption and swelling, catgut is that the finer line of multiply is woven into simultaneously, therefore between per share certain space is arranged, especially this space becomes bigger after soaking, and attenuating again after chap after being soaked in water from catgut, the drying just can illustrate this point.The technology of above-mentioned preparation pastille catgut is at first with the abundant swelling of catgut, and then medicament component is replaced the interior moisture content of swelling catgut gradually, especially adopt evaporating solvent method gradually, increase along with solution concentration, the drug level in slit also then can medicament component cement out the moisture content in the swelling catgut until drying to greatest extent in increase between the per share catgut, at this moment its diameter of medication coat that the exsiccant medicine carrying catgut that is obtained scrapes off whole burst of catgut surface is the same with the swollen diameter in immersion back, illustrate that the moisture content in the swelling catgut fully replaced by drug component, thereby the inner drug loading of catgut is reached capacity, the few drawback of medicine carrying catgut drug loading of then effectively having avoided present dipping catgut to be obtained:, be not medicine entirely if promptly used macerate is to contain the liquid of solvent then catgut after flooding contains solvent.Can not swelling if the mixture of dipping catgut is pressed powder then catgut, therefore the medicine that is impregnated in the catgut is just not enough, reach with the medicament fumigating catgut and to make the technology of catgut medicine carrying purpose can not make the catgut swelling equally, so drug loading is still not enough.
In the step of preparation swelling catgut, in used water for injection, add ethanol, and make alcoholic acid content reach 20%.Can play antisepsis like this.
Directly catgut is added in the mixture that contains moisture content and drug component and flood a period of time, and then proceed dipping by the method in second step.Can simplify the operation like this, raise the efficiency.
The mixture states of matter of second step initial dipping catgut is liquid at normal temperatures.Liquid molecular mobility is strong, and the moisture content that is absorbed in the swelling catgut also for liquid, replace easily in the swollen catgut like this by the drug component in the mixture; If mixture is pulverulence then just easily the moisture content in the swelling catgut is adsorbed, and drug component is not replaced in the catgut.
A period of time of dipping catgut is 10-90 days; The temperature of dipping catgut: room temperature-60 degree centigrade, the temperature of evaporating solvent: room temperature-60 degree centigrade; It is 10-90 days that evaporation begins to finish required time to evaporation.Temperature rising molecular motion is quickened, help medicine and impregnated in displacement moisture content or accelerated evaporation speed wherein in the catgut, simultaneously because catgut is that protein is when surpassing 60 degrees centigrade, containing the easy degeneration contracture that takes place under the situation of water, just can not well keep linearity is the shape of acupuncture needle, therefore the effect of acupuncture will weaken behind the implant into body, and the temperature when dipping or evaporation is advisable to be no more than 60 degrees centigrade.Speed needs slowly when evaporating solvent, and drug component is penetrated in the catgut when helping like this concentrating, and evaporation begins to finish to be advisable at 10-90 days to evaporation.
Employing is the mixture that the mode of thermal source heats the dipping catgut with the microwave.Because molecule is done violent motion under microwave action, can reach with the billions of inferior vibration at high speed of per second, help drug component like this and be penetrated in the catgut, thereby improve dipping efficient.
The container of dipping catgut adopts the tubule of lumen diameter smaller or equal to 5mm.
Warp is C with the difference of catgut diameter in the tubule tube chamber of dipping catgut, and C≤1mm.
The container of dipping catgut is a capillary tube.
Manage horizontal positioned in dipping or the evaporation process.
Itself has capillarity tubule, it is generally acknowledged the pipe of caliber smaller or equal to 1mm, and capillarity is obvious.Catgut is in the linear pipe of packing into and forms thinner capillarity between the tube wall, when evaporating solvent, medicinal liquid is assembled towards the position at catgut place under the effect of capillarity, therefore along with the evaporation of solvent until drying, to such an extent as to the whole medicines in the pipe are penetrated into gradually and form coating in the catgut outside catguts, can reduce the medicine branch uneven problem on catgut that causes because of gravity during the pipe horizontal positioned, simultaneously owing to the tube wall beyond the reason catgut position of capillarity, can reach no drug deposition in the tube chamber, thereby effectively avoid the drawback of dipping catgut residue liquid waste medicine among the preparation technology in the past, it is more meaningful that this point especially contains the preparation of famous and precious medicine to preparation; This employing tubule especially capillary tube floods the drug loading that catgut and evaporating solvent to exsiccant method can guarantee accurate catgut as container, it is the amount that the drug loading of catgut equals to pour into contained drug in the liquid in pipe, therefore the amount that pours into liquid in pipe by accurate control just can accurately be controlled the drug loading of catgut, and the amount and the interior drug ratios of liquid that pour into liquid in pipe can accurately be controlled.Thereby avoided in the past the unmanageable drawback of medicated line drug loading among the preparation technology, more meaningful when this point contains toxic pharmaceutical preparation to preparation; Provide possibility for large-scale production and application simultaneously.
The employing lumen diameter is 0.9-1,8mm, and one of long tubule dipping for 5-10cm is long to be the catgut of 5-30mm.Catgut embedding acupuncture external diameter commonly used at present is 0.7-1.2mm, catgut need not take out after dipping was finished like this, during use the end of catgut embedding acupuncture from pipe extend in the pipe, pin hole is aimed at an end of pastille catgut, and the promotion needle body, then the pastille catgut enters in the pin hole under another blind end of pipe, apparatus folder are pinched the stopping of temporary transient blind end of tube chamber that flexible pipe forms or the blind end by being enclosed within the pipe outside the pipe.Bring very big convenience to operation like this.
Used tubule tubing is polyfluortetraethylene pipe.The polyfluortetraethylene pipe coefficient of friction is little and have good not viscosity, helps medicinal liquid like this and assembles to catgut, avoids the waste of medicine to greatest extent.
Mixture row defoaming treatment before the dipping catgut to the dipping catgut.Can avoid dipping during catgut gas enter in the catgut and reduce soaking into or in tubule, form gas embolism and having stopped that medicinal liquid assembles to catgut of drug component.
Dipping catgut or operating under the inert gas environment of evaporating solvent are carried out.Avoid easy oxidized drug component oxidation.
Adopt existing coating or packaging technique that above-mentioned prepared pastille catgut is carried out coating or coating again.
Coating can reduce to be impregnated into when volatile medicine is stored in the catgut to be lost; Coating can increase the overall drug loading of catgut, satisfies clinical demand.If catgut is not soaked into fully and with the moisture content in the medicine displacement swelling catgut, directly adopt the then inner drug loading deficiency of catgut of coating, because present existing coating technology is just to the surface of catgut spraying medicinal liquid, dry rapidly then, therefore medicine is difficult to be deep in the per share catgut and between the per share slit, can not make the surface of per share catgut all obtain coating.After will occurring catgut face coat medicament elution so clinically, the dose that catgut continues to discharge in the degradation process obviously reduces, thereby has reduced curative effect.
More than operation is all carried out under aseptic dustless environment, and material therefor, utensil are aseptic, apyrogeneity, and gained pastille catgut is sterilized.
The specific embodiment
Embodiment 1
The present invention prepares the preparation method of pastille catgut:
The first step: it is long that catgut is cut into 2cm, is immersed in the water for injection 3 days, and dipping temperature is a room temperature, the swelling catgut;
Second step: the swelling catgut be impregnated in drug component, and to contain dose rate be in 20% the solution 1 day, dipping temperature is 60 degrees centigrade, take out catgut then and impregnated in drug component to contain dose rate be in 30% the solution 30 days, 45 degrees centigrade of dipping temperatures, the pastille catgut.
Embodiment 2
The first step: it is long that catgut is cut into 2cm, is immersed in to contain in the 20% alcoholic acid water for injection 30 days, and dipping temperature is a room temperature, the swelling catgut;
Second step: the swelling catgut be impregnated in drug component, and to contain dose rate be in 10% the solution, dipping temperature is 60 degrees centigrade, flood after 1 day to, adding medicine in the solution makes medicine constituent content rate reach 20%, continuation adding medicine in solution makes medicine constituent content rate reach 40% after 15 days, floods to get the pastille catgut after 20 days again.
Embodiment 3
Catgut be impregnated in drug component, and to contain dose rate be in 10% the solution, after 10 days, and evaporating solvent under room temperature, normal pressure, evaporation beginning to evaporation finishes to get the pastille catgut with 15 days.
Embodiment 4
1 is longly packed in the tube chamber through being 1.9mm for the catgut of 2cm, long in the medical glass pipe of 9cm, and inject the solution that contains medicine of 10 microlitres, flood after 15 days,, evaporate beginning to evaporation and finish to get the pastille catgut until drying at evaporating solvent under 30 degrees centigrade, under the normal pressure with 30 days.
Embodiment 5
100 longly are respectively charged in the tube chamber through being 1.0mm for the catgut of 2cm, long in the medical ptfe pipe of 30cm, in every pipe and inject the drug solns that contains of 20 microlitres, lie in a horizontal plane in the microwave drying oven, airtight dipping 10 days, temperature are 30 degrees centigrade, in case, charge into the mobile noble gas solvent in the evaporating liquid gradually then, 30 degrees centigrade of evaporating temperatures, after 20 days exsiccant pastille catgut.
Embodiment 6
Catgut was flooded 10 days with containing under the 20% alcoholic acid water for injection room temperature; Then catgut is taken out and join drug component to contain dose rate be in 15% the mixed liquor, room temperature is dipping 20 days down; Take out then and join drug component to contain dose rate be in 50% the mixed liquor, room temperature is dipping 20 days down; Directly add drug component then and make medicine constituent content rate reach 90% in mixture, room temperature flooded 20 days down, and evaporating solvent gets the pastille catgut until drying under room temperature, the normal pressure then.
Claims (15)
1. preparation method for preparing the pastille catgut, its step is as follows:
The first step: preparation swelling catgut
Catgut is flooded with water for injection, get the swelling catgut;
Second step: the moisture content in the medicament component displacement swelling catgut, replace moisture content in the swelling catgut gradually by the ratio that increases dipping catgut mixture Chinese medicine component gradually, the method that increases the ratio of dipping catgut mixture Chinese medicine component has
1) increases progressively the replacing method
Impregnated in the swelling catgut in the mixture that contains drug component, take out Intestinum caprae seu ovis after dipping a period of time
Line continues impregnated in drug component and contains dose rate than in the high mixture of front mixture Chinese medicine constituent content rate,
Repeated impregnations is n time like this, and n 〉=2, along with mixing of swelling catgut flooded in the increase of dipping number of times accordingly
Drug component in the compound contains dose rate a and also increases, and 0＜a≤100%;
2) directly add the drug component method
The swelling catgut be impregnated in the mixture that contains drug component, the dipping a period of time after to mixture
In add a certain amount of drug component and contain dose rate a and 0＜a≤100% with what increase drug component, mixing continues
Continuous dipping a period of time, and then in mixture, add a certain amount of drug component, continue dipping a period of time,
Repeat to add drug component n time like this and n 〉=1 the pastille catgut;
3) reduce solvent method
The swelling catgut be impregnated in the mixture that contains drug component, the dipping a period of time after, the evaporation molten
Agent, the degree of evaporation can get the pastille catgut down to drying;
4) combined method
The swelling catgut is flooded catgut with changing the mixture method or directly adding the drug component method earlier, then
Reuse evaporating solvent method gets the pastille catgut.
2. prepare the preparation method of pastille catgut according to claim 1, it is characterized in that, in used water for injection, add ethanol in the step of preparation swelling catgut, and make alcoholic acid content reach 20%.
3. prepare the preparation method of pastille catgut according to claim 1, it is characterized in that, directly catgut is added in the mixture that contains moisture content and drug component and flood a period of time, and then proceed dipping by the method in second step.
4. prepare the preparation method of pastille catgut according to claim 1, it is characterized in that, the mixture states of matter of second step initial dipping catgut is liquid at normal temperatures.
5. as the preparation method of preparation pastille catgut as described in the claim 1,3,4, it is characterized in that a period of time of dipping catgut is 10-90 days, dipping temperature is a room temperature-60 degree centigrade, temperature is a room temperature-60 degree centigrade during evaporation, and it is 10-90 days that evaporation begins to finish required time to evaporation.
6. as the preparation method of preparation pastille catgut as described in the claim 5, it is characterized in that, is the mixture that the mode of thermal source heats the dipping catgut with the microwave.
7. as the preparation method of preparation pastille catgut as described in the claim 1,3,4, it is characterized in that the container of dipping catgut adopts the tubule of lumen diameter smaller or equal to 5mm.
8. as the preparation method of preparation pastille catgut as described in the claim 7, it is characterized in that, is C through the difference with the catgut diameter in the tubule tube chamber that the container of dipping catgut adopts, and C≤1mm.
9. as the preparation method of preparation pastille catgut as described in the claim 7, it is characterized in that the container of dipping catgut is a capillary tube.
10. as the preparation method of preparation pastille catgut as described in the claim 7, it is characterized in that the employing lumen diameter is 0.9-1,8mm, one of long tubule dipping for 5-10cm is long to be the catgut of 5-30mm.
11. the preparation method as preparation pastille catgut as described in the claim 7-10 is characterized in that, manages horizontal positioned in dipping or the evaporation process.
12. the preparation method as preparation pastille catgut as described in the claim 7-10 is characterized in that the tubing of used tubule is polyfluortetraethylene pipe.
13. the preparation method as preparation pastille catgut as described in the claim 1 to 10 is characterized in that, to mixture row defoaming treatment before the dipping catgut of dipping catgut.
14. the preparation method as preparation pastille catgut as described in the claim 1 to 11 is characterized in that, dipping catgut or operating under the inert gas environment of evaporating solvent are carried out.
15. the preparation method as preparation pastille catgut as described in the claim 1 to 14 is characterized in that, will make catgut and adopt existing coating or packaging technique to carry out coating or coating again.
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| CN2009101315169A CN101849900B (en) | 2009-04-03 | 2009-04-03 | Preparation process of medicated catgut |
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| CN2009101315169A CN101849900B (en) | 2009-04-03 | 2009-04-03 | Preparation process of medicated catgut |
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| CN101849900A true CN101849900A (en) | 2010-10-06 |
| CN101849900B CN101849900B (en) | 2012-04-18 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022095028A1 (en) * | 2020-11-07 | 2022-05-12 | 单县华宇缝合制品有限公司 | High-strength biological suture line and preparation method therefor |
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2009
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022095028A1 (en) * | 2020-11-07 | 2022-05-12 | 单县华宇缝合制品有限公司 | High-strength biological suture line and preparation method therefor |
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