CN1965959A - Method for preparing dampness-removing itching-relieving ointment - Google Patents

Method for preparing dampness-removing itching-relieving ointment Download PDF

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CN1965959A
CN1965959A CN 200510022093 CN200510022093A CN1965959A CN 1965959 A CN1965959 A CN 1965959A CN 200510022093 CN200510022093 CN 200510022093 CN 200510022093 A CN200510022093 A CN 200510022093A CN 1965959 A CN1965959 A CN 1965959A
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rhizoma
ointment
herba
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CN100522206C (en
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牛锐
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Sichuan Tak Feng Pharmaceutical Co., Ltd.
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牛锐
唐萍
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Abstract

Disclosed is a process for preparing ointment for removing dampness and relieve itching, wherein the raw materials include cnidium fruit 150-180, coptis root 30-50, phellodendron bark 30-50, Chinese dittany bark 40-70, flavescent sophora root 40-70, giant knotweed rhizome 60-90, Philippine violet herb 60-90, broom cypress fruit 80-110, knotgrass 30-50, oriental wormwood 30-50, atractylodes rhizome 20-40, Chinese prickly ash 15-35, borneol 10-25, vaseline 230-060, cetyl alcohol 150-180, sodium dodecylsulfate 5-15, glycerin 200-250, and ethyl hydroxylbenzoate 0.5-3. The preparing process consists of steps of extracting medicinal materials and concentrating, making aqueous phase and oil phase, charging aqueous phase into oil phase and stirring, cooling down and dissolving volatile oil, baras camphor into 20ml ethanol, charging into the mixture, stirring till condensation.

Description

Method for preparing dampness-removing itching-relieving ointment
The technical field pharmaceutical technology
That background technology is used for is acute, the subacute eczema card is clinical common disease, Chinese traditional treatment removing damp-heat, dispelling wind for relieving itching.Removing damp to relieve itching washing liquid using method is bathing behind 10 times of the dilute with waters, and the medicine contact skin time is short, can't bring into play curative effect preferably, and we screen adjuvant by experiment and are prepared into ointment, and skin is fully contacted with medicine.
Summary of the invention
Dampness-removing itching-relieving ointment prescription: the above prescription of Fructus Cnidii 150-180g Rhizoma Coptidis 30-50g Cortex Phellodendri 30-50g Cortex Dictamni 40-70g Radix Sophorae Flavescentis 40-70g Rhizoma Polygoni Cuspidati 60-90g Herba Violae 60-90g Fructus Kochiae 80-110g Herba Polygoni Avicularis 30-50g Herba Artemisiae Scopariae 30-50g Rhizoma Atractylodis 20-40g Pericarpium Zanthoxyli 15-35g Borneolum Syntheticum 10-25g vaseline 230-060g hexadecanol 150-180g sodium lauryl sulphate 5-15g glycerol 200-250g ethyl hydroxybenzoate 0.5-3g, except that Borneolum Syntheticum, Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis add the water of 16 times of amounts, distillation extraction 6 hours, collect volatile oil, medicinal liquid filters other device and preserves; Medicinal residues and all the other nine flavors decoct with water twice, each 1 hour, add 12 times of amounts for the first time, add for the second time 8 times of amounts, collecting decoction filters, and merges with distillation back medicinal liquid, be concentrated into relative density 1.10~1.20 (60 ℃ of surveys), regulate pH5 in right amount with citric acid, add sodium lauryl sulphate, glycerol, ethyl hydroxybenzoate, be heated to 70 ℃, stir 30 minutes to the whole suspendibles of content, make water.Get vaseline, hexadecanol, mix, be heated to 70 ℃, filter, make oil phase.With water impouring oil phase slowly, the limit edged stirs, and treats that temperature reduces to 38~40 ℃, and volatile oil, Borneolum Syntheticum are dissolved in the 20ml ethanol, adds in the said mixture, is stirred to condensation, check, and packing, promptly.
Accompanying drawing is the dampness-removing itching-relieving ointment process chart
Technical study
1 dosage form selection
Acute, subacute eczema is commonly encountered diseases, frequently-occurring disease.Long-term clinical practice proof removing damp to relieve itching washing liquid determined curative effect, reliable.But washing liquid is owing to be in a liquid state, and viscosity is low, and is mobile big, short in the medication Local Residence Time, thus the performance that affects the treatment, and be not easy to store, carry, transport.Ointment is semi-solid, is applied in the affected part, but prolong drug helps giving full play to of curative effect in the partial time of staying of medication.It is also comparatively convenient that the while ointment carries, stores, transports.For this reason,, the removing damp to relieve itching washing liquid is carried out dosage form change research, make ointment, to satisfy the requirement of clinical application according to the specification requirement of study of tcm new drug.
2 process routes are determined
Full side 13 herbal medicines, Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis contain volatile oil; Rhizoma Coptidis, Cortex Phellodendri, Cortex Dictamni, Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati, Herba Violae, the Fructus Kochiae, Herba Polygoni Avicularis, Herba Artemisiae Scopariae effective ingredient be water soluble all; Borneolum Syntheticum tool volatility dissolves in ethanol [2~3].Therefore, according to removing damp to relieve itching washing liquid process route, characteristics and dosage form requirement in conjunction with ointment, determine that process route is: Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis adopt the way of distillation to extract volatile oil, medicinal liquid is standby, medicinal residues and Rhizoma Coptidis, Cortex Phellodendri, Cortex Dictamni, Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati, Herba Violae, the Fructus Kochiae, Herba Polygoni Avicularis, Herba Artemisiae Scopariae merges, water is carried, extracting solution and Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis distillation back medicinal liquid merges, and concentrates, add in the substrate, add the ethanol liquid that is dissolved with volatile oil and Borneolum Syntheticum at last, mixing, check, packing does not promptly have the change of matter to guarantee dampness-removing itching-relieving ointment technology and removing damp to relieve itching washing liquid technology.
3 Study on extraction
Experiment available from Chengdu Chinese crude drug company, verifies as qualified medical material through doctor's Zhou Xiaojiang evaluation, Xu Yuan with Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis, Rhizoma Coptidis, Cortex Phellodendri, Cortex Dictamni, Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati, Herba Violae, the Fructus Kochiae, Herba Polygoni Avicularis, Herba Artemisiae Scopariae, Borneolum Syntheticum medical material.
3.1 the medical material processing and the process of preparing Chinese medicine
Fructus Cnidii: be the dry mature fruit of samphire cnidium monnieri Cnidium monnieri (L.) Cuss..
Fructus Cnidii is by " 256 pages " Fructus Cnidii " item of Chinese pharmacopoeia version in 2000 method of assay regulation is down measured, three crowdes of Fructus Cnidii medical material osthole assay results show that three batches of Fructus Cnidii medical material osthole content meet pharmacopeia this product and contain osthole (C 15H 16O 3) must not be less than 1.0% regulation, be qualified medical material.
The Fructus Cnidii medical material is removed impurity, and is standby.
Rhizoma Coptidis: be the dry rhizome of cohosh Rhizoma Coptidis Coptis chinensis Feanch., Coptis deltoidea C.Y.Cheng et Hsiao Coptisdeltoidea C.Y.Cheng et Hisao or Coptis Teeta Wall Coptis teeta Wall.By " Rhizoma Coptidis item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, runs through the back shave, airing.
Cortex Phellodendri: be the dry bark of rutaceae wampee Phellondendron chinense Schneid. or Cortex Phellodendri Phellondendronamurense Rupr..By " Cortex Phellodendri item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, and the spray clear water runs through shredding, drying.
Cortex Dictamni: be the dry root bark of rutaceae dittany Dictamnus dasycarpus Turcz..By " Cortex Dictamni item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, cleans, and profit is cut sheet, drying slightly.
Radix Sophorae Flavescentis: be the dry root of the Sophora flavescens Ait. of leguminous plant Radix Sophorae Flavescentis.By " Radix Sophorae Flavescentis item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and smashs to pieces.By " Radix Sophorae Flavescentis item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and runs through, and cuts sheet, drying.
Rhizoma Polygoni Cuspidati: be dry rhizome and the root of polygonaceae plant Rhizoma Polygoni Cuspidati Polygonum cuspidatum Sieb.et Zucc..By " Rhizoma Polygoni Cuspidati item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, cleans, and runs through, and cuts sheet, drying.
Herba Violae: be the dry herb of Violaceae Chinese violet Viola yedoensis Makino.By " Herba Violae item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, cleans chopping, drying.
The Fructus Kochiae: be the dry mature fruit of chenopod Fructus Kochiae Kochia scoparia (L.) Schrad..By " Fructus Kochiae subitem of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity.
Herba Polygoni Avicularis: be the dry aerial parts of the Zhi Wu of Liao section Herba Polygoni Avicularis Polygonum aviculare L..By " Herba Polygoni Avicularis item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, cleans cutting, drying.
Herba Artemisiae Scopariae: be the dry aerial parts of feverfew BINHAO Artemisia scoparia Waldst.et Kil. or Herba Artemisiae Scopariae Artemisiacapillaris Thunb..By " Herba Artemisiae Scopariae item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes undesirable root and impurity, chopping.
Rhizoma Atractylodis: be the dry rhizome of feverfew Atractylodes lancea (Thunb.) DC. Atractylodes lancea (Thunb.) DC. or Atractylis chinensis Atractylodeschinensis (DC.) Koidz..By " Rhizoma Atractylodis item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity, cleans, and runs through, and cuts sheet, drying.
Pericarpium Zanthoxyli: be the dry mature skin of rutaceae green pepper Zanthoxylum schinifolium Sieb.et Zucc. or Pericarpium Zanthoxyli Zanthoxylum bungeanum Maxim..By " Pericarpium Zanthoxyli item of Chinese pharmacopoeia version in 2000 method of regulation is down concocted, and removes impurity such as Semen zanthoxyli, fruit stem.
Borneolum Syntheticum: be water white transparency or the crisp crystallization of white translucent lamellar.
3.2 volatile oil extraction conditions examination
Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis contain volatile oil in the side, adopt the way of distillation to extract, and for this reason, are evaluation index with the volatile oil oil-collecting ratio, examine or check carrying the oil time.
Take by weighing Fructus Cnidii 90g, Pericarpium Zanthoxyli 10g by prescription, Rhizoma Atractylodis 20g (three parts), adding 8 times of water gagings respectively and soaked 1 hour, is evaluation index with the oil-collecting ratio, extracts volatile oil 10h, the receipts oil mass of record different time, and the calculating oil-collecting ratio, by result of the test as seen, oil-collecting ratio substantially no longer increases after 6 hours, if in the oil-collecting ratio of 10h be 100%, three batch carry oil samples 6h accumulation oil-collecting ratio (%) (ml/g)=(6h receives oil mass ÷ 10h and receives oil mass) * 100%
As seen: the accumulation oil-collecting ratio of Fructus Cnidii, Pericarpium Zanthoxyli, Rhzoma Atractylodis Lanceae volatile oil surpasses 95% when carrying oily 6h, determines that therefore extracting the volatile oil time is 6h.The oil-collecting ratio average out to 1.95% of 6h is considered the situation of big production, must not be lower than 1.5% so fix tentatively oil extracting rate.
3.3 water is put forward condition
According to removing damp to relieve itching washing liquid technology, medicinal residues after Rhizoma Coptidis, Cortex Phellodendri, Cortex Dictamni, Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati, Herba Violae, the Fructus Kochiae, Herba Polygoni Avicularis, Herba Artemisiae Scopariae and Fructus Cnidii, Pericarpium Zanthoxyli, the Rhizoma Atractylodis distillation merge, and decoct with water twice, each 1 hour, add for the first time 12 times of amounts, add 8 times of amounts for the second time.Filter with 350 mesh sieves, collect filtrate.Medicinal liquid after filtrate and Fructus Cnidii, Pericarpium Zanthoxyli, the Rhizoma Atractylodis distillation merges.
The medicinal residues that take by weighing after Rhizoma Coptidis, Cortex Phellodendri, Cortex Dictamni, Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati, Herba Violae, the Fructus Kochiae, Herba Polygoni Avicularis, Herba Artemisiae Scopariae and Fructus Cnidii, Pericarpium Zanthoxyli, the Rhizoma Atractylodis distillation in the prescription ratio merge, decoct with water according to above-mentioned condition, collect filtrate, and merge with Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis distillation back medicinal liquid, investigated the paste-forming rate of water extract, as a result water extract paste-forming rate meansigma methods 54.4.
3.4 concentrate
Compared that normal pressure concentrates and concentrating under reduced pressure to the influence of effective component of osthole content, as a result extracting solution determine to adopt concentrating under reduced pressure (75 ℃ ,-0.07Mpa) mode to be concentrated into the clear paste relative density be 1.10~1.20 (60 ℃ of surveys), collect clear paste.
4. Study on Forming
The substrate screening
Selecting suitable adjuvant for use is the key factor of control ointment quality.Because O/W type ointment requires that suitable viscosity and pH value are arranged, and helps the stripping of effective ingredient, and stability and appearance character are preferably arranged, and therefore, determines to select for use O/W type ointment base.
In conjunction with documents and materials, select principle for use according to chemical inertness, adjuvant cheap and easy to get etc., the fat-soluble substrate of dampness-removing itching-relieving ointment has mainly been investigated vaseline, hexadecanol etc., and water-soluble base is selected glycerol for use, emulsifying agent is selected sodium lauryl sulphate for use, and antiseptic is selected ethyl hydroxybenzoate for use.With outward appearance, stable centrifugal test, heat resistant test, low temperature resistant test is the ointment quality evaluation index.
Test apparatus: the water bath with thermostatic control SY11-1 of medical centrifuge factory of magnetic stirring apparatus CJ-1 type Beijing type Beijing desk centrifuge 800 type Shanghai Surgical Operation Equipment Factory of medical cryogenic refrigerator MDF-U332 Sanyo of electric drying oven with forced convection CS101-3 Chongqing testing equipment factory of Chang Yuan experimental apparatus factory Medical Equipment Plant
The sample preparation water: get extractum 564g (being equivalent to crude drug 1025g), regulate pH5 in right amount with citric acid, glycerol adding 215g, sodium lauryl sulphate 14g are heated to 70 ℃ of insulations, stir 30min to whole suspendibles, make water, are divided into three equal parts.
Oil phase:
Prescription 1: get vaseline 110g, hexadecanol 50g is heated to 70 ℃, filters, and is incubated 2 hours, and is standby.
Prescription 2: get vaseline 110g, hexadecanol 72g, be heated to 70 ℃, filter, be incubated 2 hours, standby.
Prescription 3: get vaseline 110g, hexadecanol 90g is heated to 70 ℃, filters, and is incubated 2 hours, and is standby.
With water impouring oil phase slowly, the limit edged stirs, and treats that temperature reduces to 38~40 ℃, and volatile oil, Borneolum Syntheticum are dissolved in the ethanol, adds in the said mixture, is stirred to condensation, promptly.
Ointment quality evaluating method and result:
Texture (color and luster, colourity, sophistication) directly perceived: it is poor slightly that three groups of sample naked eyes and microscopically are observed prescription 3 colourities, and sophistication is not as good as prescription 1 and write out a prescription 2.2 soft durometer of writing out a prescription are comparatively suitable.
The stability centrifugal test: respectively get ointment sample 8g, adding has in the graduated centrifuge tube, and with the centrifugal 30min of 2500rpm speed, observation has or not lamination.The result writes out a prescription and 3 lamination is arranged, and other two groups are not had layering.
The stability heat resistant test: 5 of each sample thiefs, placed 55 ℃ of baking ovens 6 hours, observation has or not the oil-water separation phenomenon.Three groups of samples are all stable as a result, no lamination.
The stability low temperature resistant test: 5 of each sample thiefs, placed-15 ℃ of cryogenic refrigerators 24 hours, observation has or not the oil-water separation phenomenon.Three groups of samples are all stable as a result, no lamination.
Comprehensively judge according to above result of the test, select prescription 2 as dampness-removing itching-relieving ointment substrate.
The test of oil phase temperature process conditional filtering
Compared 65 ℃, 70 ℃, 75 ℃, 80 ℃ with water slowly the impouring oil phase prepare sample, the result shows, 65, the finished product character no significant difference of 70,75 ℃, 80 ℃ insulations, it is slightly long only to show as 65 ℃ of complete fusing times of oil phase, so the oil phase heating-up temperature is defined as 70 ℃.
5. preparation prescription is determined
Fructus Cnidii, Pericarpium Zanthoxyli, Rhzoma Atractylodis Lanceae volatile oil oil-collecting ratio are in 1.5%; The paste-forming rate average out to 55% of the medicinal liquid after Rhizoma Coptidis, Cortex Phellodendri, Cortex Dictamni, Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati, Herba Violae, the Fructus Kochiae, Herba Polygoni Avicularis, Herba Artemisiae Scopariae and Fructus Cnidii, Pericarpium Zanthoxyli, the Rhizoma Atractylodis distillation, the fried liquid that medicinal residues merge, calculate with 1000g ointment, then the finished product preparation prescription is:
Fructus Cnidii 167g Rhizoma Coptidis 37g Cortex Phellodendri 37g Cortex Dictamni 56g Radix Sophorae Flavescentis 56g Rhizoma Polygoni Cuspidati 74g Herba Violae 74g Fructus Kochiae 93g Herba Polygoni Avicularis 56g Herba Artemisiae Scopariae 56g Rhizoma Atractylodis 37g Pericarpium Zanthoxyli 19g Borneolum Syntheticum 15g vaseline 245g hexadecanol 160g sodium lauryl sulphate 10g glycerol 160g ethyl hydroxybenzoate 1.5g
The specific embodiment
The above prescription of Fructus Cnidii 167g Rhizoma Coptidis 37g Cortex Phellodendri 37g Cortex Dictamni 56g Radix Sophorae Flavescentis 56g Rhizoma Polygoni Cuspidati 74g Herba Violae 74g Fructus Kochiae 93g Herba Polygoni Avicularis 56g Herba Artemisiae Scopariae 56g Rhizoma Atractylodis 37g Pericarpium Zanthoxyli 19g Borneolum Syntheticum 15g vaseline 245g hexadecanol 160g sodium lauryl sulphate 10g glycerol 160g ethyl hydroxybenzoate 1.5g, except that Borneolum Syntheticum, Fructus Cnidii, Pericarpium Zanthoxyli, Rhizoma Atractylodis add the water of 16 times of amounts, distillation extraction 6 hours, collect volatile oil, medicinal liquid filters other device and preserves; Medicinal residues and all the other nine flavors decoct with water twice, each 1 hour, add 12 times of amounts for the first time, add for the second time 8 times of amounts, collecting decoction filters, and merges with distillation back medicinal liquid, be concentrated into relative density 1.10~1.20 (60 ℃ of surveys), regulate pH5 in right amount with citric acid, add sodium lauryl sulphate, glycerol, ethyl hydroxybenzoate, be heated to 70 ℃, stir 30 minutes to the whole suspendibles of content, make water.Get vaseline, hexadecanol, mix, be heated to 70 ℃, filter, make oil phase.With water impouring oil phase slowly, the limit edged stirs, and treats that temperature reduces to 38~40 ℃, and volatile oil, Borneolum Syntheticum are dissolved in the 20ml ethanol, adds in the said mixture, is stirred to condensation, check, and packing promptly gets 1000g ointment.

Claims (1)

1, the ratio of holding 30-50 Herba Artemisiae Scopariae 30-50 Rhizoma Atractylodis 20-40 Pericarpium Zanthoxyli 15-35 Borneolum Syntheticum 10-25 vaseline 230-060 16 pure 150-180 12 alkyl sodium sulfate 5-15 glycerol 200-250 ethyl hydroxybenzoate 0.5-3 with the Fructus Cnidii 150-180 Rhizoma Coptidis 30-50 Cortex Phellodendri 30-50 Cortex Dictamni 40-70 Radix Sophorae Flavescentis 40-70 Rhizoma Polygoni Cuspidati 60-90 Herba Violae 60-90 Fructus Kochiae 80-110  preparation ointment that feeds intake.
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101797298A (en) * 2010-04-22 2010-08-11 潘�清 Ointment for treating eczema and preparation method thereof
CN101862400A (en) * 2010-04-09 2010-10-20 成都天宇联盟医药科技有限责任公司 Dehumidifying itching-relieving gels and preparation method thereof
CN106474384A (en) * 2015-09-01 2017-03-08 马金丹 A kind of Conjoined gloves handss film and preparation method thereof
CN114099623A (en) * 2021-10-14 2022-03-01 辽宁中医药大学 Dehumidifying and itching-relieving ointment and preparation method thereof
CN115381884A (en) * 2021-05-09 2022-11-25 房继全 A Chinese medicinal ointment for external application and its preparation method

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Publication number Priority date Publication date Assignee Title
CN101933997B (en) * 2010-09-29 2011-11-30 李婷 Compound anti-inflammatory antipruritic ointment

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101862400A (en) * 2010-04-09 2010-10-20 成都天宇联盟医药科技有限责任公司 Dehumidifying itching-relieving gels and preparation method thereof
CN101862400B (en) * 2010-04-09 2011-12-14 无锡鸿泰投资有限公司 Dehumidifying itching-relieving gels and preparation method thereof
CN101797298A (en) * 2010-04-22 2010-08-11 潘�清 Ointment for treating eczema and preparation method thereof
CN101797298B (en) * 2010-04-22 2011-08-10 潘�清 Ointment for treating eczema and preparation method thereof
CN106474384A (en) * 2015-09-01 2017-03-08 马金丹 A kind of Conjoined gloves handss film and preparation method thereof
CN115381884A (en) * 2021-05-09 2022-11-25 房继全 A Chinese medicinal ointment for external application and its preparation method
CN115381884B (en) * 2021-05-09 2023-11-28 房继全 A topical Chinese medicinal unguent for treating diseases, and its preparation method
CN114099623A (en) * 2021-10-14 2022-03-01 辽宁中医药大学 Dehumidifying and itching-relieving ointment and preparation method thereof

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