CN1739550A - Polycinnamic alcohol injection and its prepn - Google Patents

Polycinnamic alcohol injection and its prepn Download PDF

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Publication number
CN1739550A
CN1739550A CN 200510096039 CN200510096039A CN1739550A CN 1739550 A CN1739550 A CN 1739550A CN 200510096039 CN200510096039 CN 200510096039 CN 200510096039 A CN200510096039 A CN 200510096039A CN 1739550 A CN1739550 A CN 1739550A
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injection
adds
polycinnamic
preparation
polycinnamic alcohol
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CN100364546C (en
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杨军营
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SHAANXI TIANYU PHARMACEUTICAL CO Ltd
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SHAANXI TIANYU PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to one kind of polycinnamic alcohol injection and its preparation. The polycinnamic alcohol injection is used mainly in treating esophagus varication hemorrhage and esophagus varication cirrhosis under endoscope. The polycinnamic alcohol injection contains in each 100 ml polycinnamic alcohol 1 g and alcohol 5 ml. Alcohol can dissolve polycinnamic alcohol easily and has slight narcosis, so that the polycinnamic alcohol injection has no pain caused, low viscosity for easy injecting, no side effect and less complication.

Description

Polycinnamic alcohol injection and preparation method thereof
One, technical field:
The present invention relates to a kind of polycinnamic alcohol injection and preparation method thereof.
Two, background technology:
At present, hepatopathy is in second of malignant disease mortality rate, has 300,000 new discovery patients and 110,000 people's hepatopathy deaths every year at least.The whole nation only hepatocarcinoma and serious symptom liver cirrhosis patient just is no less than 3,000,000, has 1/3rd patients can produce esophageal varicosis approximately; The esophageal varicosis patient has about 250,000 approximately, the digestive tract hemorrhage that causes because of gastric cancer, esophageal carcinoma and portal hypertension reason 300,000 people are arranged approximately, the gastrorrhagia patient that other reasons causes is also about 500,000 people.
At increasing sharply of present massive hemorrhage of gastrointestinal tract sickness rate, national each province, city, autonomous region hospital are exploring always and are seeking more effective Therapeutic Method.At present, a lot of hospitals have set up the endoscope treatment center in succession, have carried out the Minimally Invasive Surgery treatment, remove slight illness and reduce the human body wound for extensive patients as far as possible, the patient is made the best of one's way go up the road of rehabilitation.Simultaneously, also can make over the poor crowd of abandoning cure obtains life.
Existing domestic and international medicine polycinnamic alcohol injection does not have play-by-play at present;
Existing domestic and international medicine polycinnamic alcohol injection is compared as follows with clinical similar medicine:
(1) natrium tetradecylsulfuricum (STD)
Clinical application research is found, compare curative effect with the polidocanol injection and equate, but the incidence rate of side effect is apparently higher than polycinnamic alcohol injection, clinically abandons, has not had enterprise's production.
(2) ethamolin (EO)
The gross hemostasis rate of its treatment esophagus and stomach varicosis acute hemorrhage is 72%--80%, need inject 4-5 time repeatedly, the patient's of 80%--90% cirso-can disappear, but this medicine is used for the treatment of except that common complication takes place, it is weak also can renal function to occur, so this product has tangible detrimental effect to kidney.
(3) sodium morrhuate (SM)
SM treatment esophageal varicosis is hemorrhage for many years, and existing seldom application abroad because side effect such as chest pain, dark ulcer, heating take place behind the injection SM, and than other sclerosing agent height, also has cirso-to eliminate unconspicuous report.
Polycinnamic alcohol injection is compared with similar clinical medicine: curative effect is sure, not only the hemorrhage gross hemostasis rate of emergency treatment is 100%, and the cirso-disappearance rate is higher than other products, simultaneously frequency injection is few, viscosity is little, easily inject, available fine needle head, do not have pain in the injection process, the postoperative side effect is little, seldom has complication to take place, and does not still have death and anaphylactoid report.
Three, summary of the invention:
First purpose of the present invention is to provide a kind of alcoholic acid polycinnamic alcohol injection and preparation method thereof that contains.
For achieving the above object, the technical solution used in the present invention is:
Polycinnamic alcohol injection is characterized in that its prescription is:
Polidocanol 1g
Ethanol 5ml
Water for injection adds to 100ml
The preparation method of above-mentioned polycinnamic alcohol injection is as follows:
The polidocanol that adds 1g in pure container made adds the ethanol of 5ml again, stirs polidocanol is dissolved fully, adds water for injection again to 100ml; Content is surveyed in sampling behind the stirring and evenly mixing, after PH is qualified, 0.05～0.3% amount of pressing the solution total amount adds needle-use activated carbon, logical Steam Heating is boiled, when being cooled to 45～50 ℃ again, with solution through 0.45 μ m filtering with microporous membrane carbon removal, adsorption time was at 20～30 minutes, again filtrate, is filled in cillin bottle or the ampoule during to the clear and bright no foreign body of solution through 0.22 μ m filtering with microporous membrane, seals.
In the preparation method of polycinnamic alcohol injection:
Different model and technical parameter thereof according to water-bath sterilization cabinet are selected sterilising conditions for use; Water-bath type sterilization or flowing steam sterilization, cillin bottle adopts 115.5 ℃ of 30min, 121.5 ℃ of 20min, 126.5 ℃ of 15min, and ampoule bottle adopts 115 ℃ of 30min, 121 ℃ of 20min, 126 ℃ of 15min.
The present invention is with respect to prior art, and its advantage is as follows:
The present invention adopt ethanol be according to the principal agent character ethanol very easily the dissolving, can effectively guarantee product quality.Simultaneously, ethanol has slight anesthetic action concurrently, does not have pain in the injection process, and patient's peace and quiet are easy to treatment.
Four, the specific embodiment:
In preparation polycinnamic alcohol injection process, the polycinnamic alcohol injection of preparation is:
Medicine common name: polycinnamic alcohol injection
English name: Lauromacrogol Injection
Former name: aethoxysklerol injection, polidocanol injection
This product Main Ingredients and Appearance: polidocanol
Chemical name: Brij30
Molecular formula: C 12H 25(OCH 2CH 2) n0H (n=9)
Molecular weight: 582.8
1, polycinnamic alcohol injection prescription and preparation technology's method:
1. write out a prescription:
Polidocanol 1g
Ethanol 5ml
Water for injection adds to 100ml
2. detailed process key points for operation:
The polidocanol that adds 1g in pure container made adds the ethanol of 5ml again, stirs polidocanol is dissolved fully, adds water for injection again to 100ml; Content is surveyed in sampling behind the stirring and evenly mixing, after PH is qualified, 0.05～0.3% amount of pressing the solution total amount adds needle-use activated carbon, logical Steam Heating is boiled, when being cooled to 45～50 ℃ again, with solution through 0.45 μ m filtering with microporous membrane carbon removal, adsorption time was at 20～30 minutes, again filtrate, is filled in cillin bottle or the ampoule during to the clear and bright no foreign body of solution through 0.22 μ m filtering with microporous membrane, seals; Water-bath type sterilization or flowing steam sterilization, cillin bottle adopts 115.5 ℃ of 30min, 121.5 ℃ of 20min, 126.5 ℃ of 15min, and ampoule bottle adopts 115 ℃ of 30min, 121 ℃ of 20min, 126 ℃ of 15min.Different model and technical parameter thereof according to water-bath sterilization cabinet are selected sterilising conditions for use.
2, be equipped with polidocanol content in the standard curve determination injection with the UV legal system.
(1), the preparation of reference substance solution: get the about 0.8g of polidocanol reference substance, accurately claim surely, put in the 250ml measuring bottle, be dissolved in water and be diluted to scale, shake up, promptly.
(2), the preparation of standard curve: get 6 of separatory funnels, respectively accurately add 20ml dichloromethane and 20ml ammonium cobalt thiocyanate test solution, and then add 0.0,2.0,4.0,6.0,8.0 successively, 10.0ml reference substance solution and 20.0,18.0,16.0,14.0,12.0,10.0ml water.Jolting was extracted 1 minute, standing demix, discard dichloromethane extraction liquid a little (about 1～2ml), get each precision of dichloromethane layer respectively and get 15ml and put respectively in the 25ml measuring bottle.Add isopropanol respectively to scale, shake up, measure trap according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2005) respectively at the wavelength place of 640nm immediately.With the trap is vertical coordinate, and concentration is abscissa, the drawing standard curve.
(3), algoscopy: precision is measured this product 25ml, puts in the 50ml measuring bottle, and thin up shakes up to scale, and precision is measured need testing solution 3ml and water 17ml, operates with method from the preparation of " the accurate respectively again 20ml dichloromethane that adds " sighting target directrix curve.Trap according to need testing solution is read polidocanol concentration from standard curve, calculates, promptly.
The research of content assaying method
(1) its principle is: nonionic active matter and dense ammonium cobalt thiocyanate reaction in the sample solution, generate blue color complex, use dichloromethane extraction then, after isopropanol, survey its delustring at the 640nm wavelength, its delustring intensity is directly proportional with the nonionic active matter content.
1. specificity:
(1) from principle: nonionic active matter the sample solution and the reaction of dense ammonium cobalt thiocyanate, generate blue color complex, use dichloromethane extraction then.Get a certain amount of dichloromethane extraction liquid, after isopropanol, survey its delustring at the 640nm wavelength, its delustring intensity is directly proportional with the nonionic active matter content.
(2) from synthetic reaction process:
Discuss: have only C in the reacting final product 12H 26(OCH 2CH 2) nOH (n average out to 9) series compound, this point can find out and do not have other chemical compound from raw material color one matter coupling collection of illustrative plates, purer, utilizes this method to carry out assay like this, the specificity basic feasible solution.
2. precision: precision takes by weighing a certain amount of reference substance, measures according to aethoxysklerol injection pertinent regulations under the assay item, the results are shown in following table:
Numbering Sample size (labelled amount) % Meansigma methods (%) Relative standard deviation (%)
1 98.31
2 95.70
3 96.33 96.49 1.33(RSD)
4 94.97
5 97.13
More than can find out, this method repeated feasible, relative standard deviation＜2% reaches the pertinent regulations of " new drug (Western medicine) study of pharmacy guideline ".
3. the investigation of linear relationship: according to the method for drafting of standard curve under the assay item, accurately prepare reference substance solution, measure the trap of wavelength then, the results are shown in following table at 640nm:
Trap A 0.170 0.370 0.559 0.787 0.984
Concentration (mg/ml) C 0.192 0.384 0.576 0.768 0.960
Obtain regression equation, C (mg/ml)=show more than the 0.03696+0.9396A (r=0.9996) that the content of aethoxysklerol injection is the better linearity relation with trap in 0.192～0.960mg/ml scope.
(2) foundation of method:
Be selected from the rapid test method of relevant nonionic active matter in Wuxi Light Industry College's " fine chemistry industry analysis " book.
(3) recovery test of method:
In the process for preparation of polycinnamic alcohol injection, used adjuvant has only ethanol, and concentration is 5%, and the content assaying method of this preparation is to utilize sample and ammonium cobalt thiocyanate reaction to generate blue color complex, measures trap at the 640nm place again after extraction, dilution and carries out.Therefore analyze theoretically, adjuvant does not have influence to Determination on content.By 5% alcoholic acid blank determination has also been proved this point.
Recovery test: the precision weighing reference substance, put in the volumetric flask, by the ethanol of prescription proportioning adding amount of calculation, thin up is measured then to scale in accordance with the law, the results are shown in following table:
Numbering Addition (mg) The amount of recording (mg) Recovery degree (%) Average recovery rate (%) RSD(％)
6.0 6.15 102.50
9.0 9.20 102.22
12.0 11.72 97.67 100.89 1.82
15.0 14.98 99.87
18.0 18.27 101.50
21.0 21.34 101.62
(4) study on the stability: according to the polycinnamic alcohol injection determination, respectively at 0.0h, 0.5h, 1.0h, 2.0h, 4.0h, the working sample content results sees the following form:
The sample lot number 0.0h 0.5h 1.0h 2.0h 4.0h
961225 100.2％ 100.3％ 98.3％ 91.0％ 36.1％
970109 107.2％ 106.5％ 104.8％ 96.5％ 40.7％
970110 106.5％ 105.8％ 104.4％ 96.5％ 42.6％
Data show in the last table, polycinnamic alcohol injection are in the assay process, and along with the prolongation of time, changes of contents is bigger, so, after testing sample prepares, should measure immediately, to reduce error.
3, the bacterial endotoxins test quality standard of the method for bacterial endotoxin interference test, step and formulation this product:
It is an amount of to get this product, behind 40 times of bacterial endotoxin inspection dilute with waters, checks (two appendix P of Chinese Pharmacopoeia version in 2005 in accordance with the law 85XIE), containing the bacterial endotoxin amount among every 1mg should be less than 0.75EU.
Its concrete grammar step: (one) is by " two appendix P of Chinese pharmacopoeia version in 2005 85XIE) the sensitivity of the limulus reagent inspection test is carried out in inspection in accordance with the law, should be up to specification.Polycinnamic alcohol injection adopts bacterial endotoxins test control pyrogen, and this method is highly sensitive, favorable reproducibility, and easy saving time saved experimental expenses, controls pyrogen material in polycinnamic alcohol injection with this method, quality that can more effective control this product.
(2) the bacterial endotoxin interference test of polycinnamic alcohol injection
1. test sample bacterial endotoxin limit value (L) is definite, and according to formula L=K/M, K is regulation route of administration, the per hour maximum acceptable endotoxin dosage of human per kilogram of body weight, K=5EU/ during intravenously administrable (Kgh); M is clinical human maximal dose, by people's consumption per kilogram of body weight per hour the maximum dosage of polycinnamic alcohol injection be 400mg/60kg, calculate: L=K/M=5EU (Kgh)/6.67mg=0.75EU/mg, so the limit value of polycinnamic alcohol injection (L) is defined as 0.75EU/mg.
2. interference test trial test: select two producer's tachypleus amebocyte lysate, with polycinnamic alcohol injection serial dilution in 5-60 scope doubly, make its test liquid concentration be respectively stock solution, 5 times, 10 times, 15 times, 20 times, 30 times, 40 times, 60 times diluents (being designated as the NPC pipe) with BET water; Other prepares the test liquid of same concentration, and the sample solution that makes each concentration all contains the endotoxin (being designated as the PPC pipe) of 2 λ, selection sensitivity is the tachypleus amebocyte lysate of 0.5EU/ml, 0.25EU/ml, 0.125EU/ml, and each concentration is got 0.1ml respectively, adds to fill in the test tube of 0.1ml tachypleus amebocyte lysate, each concentration is done 2 pipes, establish negative control pipe (NC) simultaneously, positive control pipe (PC), mixing gently, seal, be placed on 37 ± 1 ℃ of insulations 60 ± 2 minutes.
3. interference test formal test: pre-test result shows, the stock solution of polycinnamic alcohol injection, 5 times, 10 times have interference to two producers, 15 times of diluents have interference to producer's tachypleus amebocyte lysate, being diluted to 20 times, 30 times, 40 times, 60 times again disturbs trial test all noiseless, because disturb two results of producer of formal test inconsistent at 20 times, 30 times, so select 40 times, 60 times to carry out formal test.With 40 times of diluents of 3 batches of test samples, respectively thin castor endotoxin working standard is diluted to 2 λ, 1 λ, 0.5 λ, 4 series concentration of 0.25 λ, i.e. 0.25EU/ml, 0.125EU/ml, 0.0625EU/ml, 0.03125EU/ml; With bacterial endotoxin inspection water the bacterial endotoxin working standard is made same diluted concentration in addition, parallel 4 pipes of doing of each concentration; Respectively do 2 pipe negative control pipes with test sample diluent and bacterial endotoxin inspection water respectively simultaneously.Carry out interference experiment by (two appendix XIE of Chinese Pharmacopoeia version in 2000).Tachypleus amebocyte lysate with different manufacturers repeats above-mentioned test.
(3) the bacterial endotoxin inspection of test sample
3 batch samples are used the tachypleus amebocyte lysate of 0.125EU/ml respectively, check by (two appendix XIE of Chinese Pharmacopoeia version in 2000) in accordance with the law, the result shows that 3 batches of test sample pipes and negative control pipe are all negative, the positive pipe and the positive control pipe of test sample are all positive, 3 batches of test sample bacterial endotoxins test inspections, the result is all up to specification.
(4) conclusion
1. it is an amount of to get this product, behind 40 times of bacterial endotoxin inspection dilute with waters, checks in accordance with the law (two appendix XIE of Chinese Pharmacopoeia version in 2000) that containing the endotoxin amount among every 1mg should be less than 0.75EU.
2. 3 batch samples are carried out interference test with the tachypleus amebocyte lysate of two producers, the result shows: after polycinnamic alcohol injection dilutes 40 times, got rid of interference factor, all noiseless effect, use the tachypleus amebocyte lysate of λ=0.125EU/ml to check with bacterial endotoxin, the result is all up to specification, thus this product to control pyrogen with the bacterial endotoxin inspection method be feasible.
3. the polycinnamic alcohol injection pyrogen test can replace the rabbit pyrogen test with bacterial endotoxins test.
(5) points for attention
1. when the prescription of the source of tachypleus amebocyte lysate, test sample, test sample or production technology change, must carry out interference test again.
2. run into above-mentioned any situation, should use the tachypleus amebocyte lysate of at least two producers to carry out the interference test of same sample, every kind is made the interference test of three different lot numbers at least, find out not interferential concentration range after, can check with Bacterial endotoxins.
4, the indication of this product, hardening technique and usage and dosage
The indication of this product: be used for esophageal variceal vein is hemorrhage under the scope the emergency treatment hemostasis and the sclerotherapy of cirso-.
When esophageal variceal vein is movable hemorrhage, adopt around petechia+place, petechia direct injection technology hemostasis, about a local consumption 10ml in petechia, maximal dose is no more than 15ml.The cirso-sclerotherapy, when adopting simple intravenous injection technology, 2～4 points of per injection, every some injected dose 3～15ml; When adopting vein side one intravenous joint injection technology, penetrate based on the vein sidenote, from distance esophagus pectinate line 1～2cm beginning antidromicity sclerotherapy, multi-point injection under the other mucosa of vein, it is standard that every some injection volume the canescence protuberance occurs with injection site, usually consumption is no more than 1ml, every 1～2ml of intravenous injection; One time the sclerotherapy accumulated dose is no more than 35ml.After the movable hemorrhage hemostasis of cirso-, other visible cirso-adopts the other intravenous joint injection technical cue treatment of vein, and the accumulated dose of hemostasis and sclerotherapy also is no more than 35ml.The cirso-sclerotherapy was finished in 4～6 weeks; The treatment back is no more than a week at interval with treatment for the second time first, and is weekly later on, up to visible cirso-complete obiteration.

Claims (3)

1, polycinnamic alcohol injection is characterized in that its prescription is:
Polidocanol 1g
Ethanol 5ml
Water for injection adds to 100ml
2, polycinnamic alcohol injection preparation method, its preparation method is as follows:
The polidocanol that adds 1g in pure container made adds the ethanol of 5ml again, stirs polidocanol is dissolved fully, adds water for injection again to 100ml; Content is surveyed in sampling behind the stirring and evenly mixing, after PH is qualified, 0.05～0.3% amount of pressing the solution total amount adds needle-use activated carbon, logical Steam Heating is boiled, when being cooled to 45～50 ℃ again, with solution through 0.45 μ m filtering with microporous membrane carbon removal, adsorption time was at 20～30 minutes, again filtrate, is filled in cillin bottle or the ampoule during to the clear and bright no foreign body of solution through 0.22 μ m filtering with microporous membrane, seals.
3, the preparation method of polycinnamic alcohol injection according to claim 2, in its preparation method:
Different model and technical parameter thereof according to water-bath sterilization cabinet are selected sterilising conditions for use; Water-bath type sterilization or flowing steam sterilization, cillin bottle adopts 115.5 ℃ of 30min, 121.5 ℃ of 20min, 126.5 ℃ of 15min, and ampoule bottle adopts 115 ℃ of 30min, 121 ℃ of 20min, 126 ℃ of 15min.
CNB2005100960399A 2005-09-16 2005-09-16 Polycinnamic alcohol injection and its prepn Active CN100364546C (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102198089A (en) * 2011-05-19 2011-09-28 陕西天宇制药有限公司 Application of lauromacrogol injection as medicament for treating internal hemorrhoid
CN102240264A (en) * 2011-05-19 2011-11-16 陕西天宇制药有限公司 Application of poly(cinnamic alcohol) injection used as cyst treatment medicament
CN102836169A (en) * 2011-06-24 2012-12-26 上海方恩医疗用品有限公司 Application of surfactant chemical ablation agent and preparation method in medicines for treating tumors
CN103768090A (en) * 2014-02-19 2014-05-07 南通大学附属医院 Medicine for interventional treatment of uterine myoma
CN107530359A (en) * 2015-02-27 2018-01-02 约翰·丹尼尔·杜巴克 The reduction of adipose tissue
CN109414385A (en) * 2016-05-30 2019-03-01 德国克施乐制药股份有限公司 For reducing the nonionic surfactant of adipose tissue
CN109646427A (en) * 2019-01-28 2019-04-19 上海上药第生化药业有限公司 Application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification
CN114159388A (en) * 2021-12-17 2022-03-11 陕西天宇制药有限公司 Application of lauromacrogol injection in preparation of medicine for treating bronchial cyst
CN114306375A (en) * 2021-12-17 2022-04-12 陕西天宇制药有限公司 Application of lauromacrogol injection in preparing medicine for treating cardia laceration

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102198089A (en) * 2011-05-19 2011-09-28 陕西天宇制药有限公司 Application of lauromacrogol injection as medicament for treating internal hemorrhoid
CN102240264A (en) * 2011-05-19 2011-11-16 陕西天宇制药有限公司 Application of poly(cinnamic alcohol) injection used as cyst treatment medicament
CN102836169A (en) * 2011-06-24 2012-12-26 上海方恩医疗用品有限公司 Application of surfactant chemical ablation agent and preparation method in medicines for treating tumors
CN103768090A (en) * 2014-02-19 2014-05-07 南通大学附属医院 Medicine for interventional treatment of uterine myoma
CN103768090B (en) * 2014-02-19 2015-11-25 南通大学附属医院 A kind of medicine of Uterine Fibroids by Intervention Therapy
US10485767B2 (en) 2015-02-27 2019-11-26 John Daniel Dobak, III Reduction of adipose tissue
CN110339159A (en) * 2015-02-27 2019-10-18 约翰·丹尼尔·杜巴克 The reduction of adipose tissue
CN107530359A (en) * 2015-02-27 2018-01-02 约翰·丹尼尔·杜巴克 The reduction of adipose tissue
CN107530359B (en) * 2015-02-27 2020-02-18 10X生物有限责任公司 Reduction of adipose tissue
US11065210B2 (en) 2015-02-27 2021-07-20 10Xbio, Llc Reduction of adipose tissue
CN109414385A (en) * 2016-05-30 2019-03-01 德国克施乐制药股份有限公司 For reducing the nonionic surfactant of adipose tissue
CN109646427A (en) * 2019-01-28 2019-04-19 上海上药第生化药业有限公司 Application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification
CN114159388A (en) * 2021-12-17 2022-03-11 陕西天宇制药有限公司 Application of lauromacrogol injection in preparation of medicine for treating bronchial cyst
CN114306375A (en) * 2021-12-17 2022-04-12 陕西天宇制药有限公司 Application of lauromacrogol injection in preparing medicine for treating cardia laceration

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Denomination of invention: Polycinnamic alcohol injection and its prepn

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