超级绿茶提取物(脱咖啡因)
茶叶脱咖啡因----陈仁良
茶叶中的咖啡因去与留茶叶具有许多医疗保健作用，然而咖啡因的负作用使消费者对低咖啡因茶及茶制品特别青睐。
目前脱咖啡因技术主要有水脱除、溶剂萃取、吸附分离和超临界CO2 萃取等传统方法，以及后来发展的微生物和酶法降解咖啡因和培育低咖啡因茶树等。
本文对茶叶脱咖啡因的研究进行综述，并讨论其可行性；水脱除法与吸附分离法相结合、微生物和酶法降解及培育低咖啡因茶树将是今后茶叶脱咖啡因技术发展的主要方向。
提取方法的研究进展绝大多数生物碱是利用溶剂提取法进行提取。
生物碱及其盐类的溶解度与生物碱分子中氮原子的存在形式、极性基团的有无及数目、溶剂种类都有密切关系。
极性强的生物碱亲水性较强, 易溶于极性溶剂；弱极性生物碱亲脂性较强,易溶于弱极性溶剂。
游离的生物碱大多亲脂性较强, 而生物碱盐一般亲水性较强。
按极性强弱可将生物碱提取溶剂分为极性溶剂、半极性溶剂和非极性溶剂[2]。
按所用溶剂不同可分为以下几种方法水提取法(以水作溶剂)直接以水作为溶剂 ,采用最佳的提取工艺来提取生物碱。
此法操作简便 ,成本较低 ,但提取次数多 ,水用量大。
酸性水溶液提取法对于那些碱性较弱不能直接溶解于水的生物碱提取 ,就可采用偏酸性的水溶液 ,使生物碱与酸作用生成盐而得到提取。
碱性水溶液提取法对于那些化学结构非常独特、化学性质与一般生物碱不同且在酸性或中性条件下不稳定的生物碱来说 ,可以采用此法。
而原有的乙醇作为溶剂渗漉提取法 ,不仅存在成本高 ,而且存在防火等级高、提取时间长、能耗大等诸多问题 ,远不如使用稀NaOH溶液好。
有机溶剂提取法(1) 乙醇提取法在生物碱的提取中应用较为普遍 ,对于游离生物碱及其盐类一般采用乙醇提取法。
(2) 其他有机溶剂法是根据相似相溶原理 ,对于不同性质的生物碱选取最佳的有机溶剂进行提取。
可采用单一有机溶剂进行分步提取 ,用不同溶剂提取不同成分;也可采用混合溶剂、反应溶剂进行提取。
按提取条件不同可分为煎煮法中药最早、最常用的制剂方法之一,将中药粗粉加水加热煮沸, 将中药成份提取出来的方法。
FDA批准的第一个植物药——绿茶提取物的说明书
VEREGEN TM 12 3 4 5 6 78 910111213141516171819202122(sinecatechins)Ointment, 15%Rx OnlyFor Topical Dermatologic Use OnlyNot for Ophthalmic, Oral, Intravaginal, or Intra-anal UseDESCRIPTIONVeregen TM is a botanical drug product for topical use. The drug substance in Veregen™ is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves. The structural formulae of catechins are shown below.General Structure of Catechins23242526272829303132333435363738Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.CLINICAL PHARMACOLOGYPharmacodynamicsThe mode of action of Veregen TM Ointment, 15% involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.PharmacokineticsThe pharmacokinetics of topically applied Veregen™ Ointment has not been sufficiently characterized at this time. However, data suggest that systemic exposure to catechins after repeated topical application of Veregen™ Ointment 15% is likely to be less than observed after a single oral intake of 400ml green tea.CLINICAL STUDIES 3940414243444546474849505152535455 Two Phase 3 randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen TM Ointment in the treatment of immunocompetent patients 18 years of age and older with external genital and perianalwarts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), andthe median baseline number of warts was 6 (range 2 to 30).The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.Table 1: Efficacy by Region Table 2. Efficacy by GenderCompleteClearanceCompleteClearanceAll Countries(includes the United States)MalesVeregen TM 15% (N = 397) 213 (53.6%) Veregen TM 15% (N = 205) 97(47.3%)Vehicle (N = 207) 73 (35.3%) Vehicle (N = 118) 34(28.8%) United States FemalesVeregen TM 15% (N = 21) 5 (23.8%) Veregen TM 15% (N = 192) 116(60.4%)Vehicle (N = 9) 0 (0.0%) Vehicle (N = 89) 39(43.8%)565758596061626364656667686970 .Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.The incidence rate of recurrence of external genital and perianal warts after treatment in patients with complete clearance is unknown.INDICATION AND USAGEVeregen TM is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.CONTRAINDICATIONSVeregen TM is contraindicated in individuals with a history of sensitivity reactions to any of the components of the ointment. In case of hypersensitivity, treatment should be discontinued.WARNINGS 7172737475767778798081828384858687888990919293949596979899 100 101 102 103 104 105 106 107 108 109 110 111 112 113 Veregen TM has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions.PRECAUTIONSGeneralUse of Veregen TM on open wounds should be avoided.The safety and efficacy of Veregen TM in immunosuppressed patients have not been established.Safety and efficacy have not been established for Veregen TM in the treatment of external genital and perianal warts beyond 16-weeks or for multiple treatment courses.Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen TM has not been tested under these circumstances.Information for PatientsGeneral InformationPatients using Veregen TM should receive the following information and instructions:1. This medication is only to be used as directed by a physician. It is for external useonly. Eye contact should be avoided as well as application into the vagina or anus.2. It is not necessary to wash off Veregen TM prior to the next application. When thetreatment area is washed or a bath is taken, the ointment should be applied afterwards.3. It is common for patients to experience local skin reactions such as erythema,erosion, edema, itching, and burning at the site of application. Severe skin reactions can occur and should be promptly reported to the healthcare provider.Should severe local skin reaction occur, the ointment should be removed by washing the treatment area with mild soap and water and further doses held.4. Sexual (genital, anal or oral) contact should be avoided while the ointment is onthe skin, or the ointment should be washed off prior to these activities. Veregen TM may weaken condoms and vaginal diaphragms. Therefore the use in combination with Veregen TM is not recommended.5. Female patients using tampons should insert the tampon before applying theointment. If the tampon is changed while the ointment is on the skin, accidental application of the ointment into the vagina must be avoided.6. Veregen TM may stain clothing and bedding.7. Veregen TM is not a cure and new warts might develop during or after a course oftherapy. If new warts develop during the 16 –week treatment period, these should also be treated with Veregen TM.8. The effect of Veregen TM on the transmission of genital/perianal warts is unknown.9. Patients should be advised to avoid exposure of the genital and perianal area tosun/UV light as Veregen TM has not been tested under these circumstances.114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 15710. The treatment area should not be bandaged or otherwise covered or wrapped as tobe occlusive.11. Uncircumcised males treating warts under the foreskin should retract the foreskinand clean the area daily.Carcinogenesis, Mutagenesis, Impairment of FertilityThe Maximum Recommended Human Dose (MRHD) of Veregen TM Ointment, 15%was set at three times daily topical administration of 250 mg, 750 mg total, containing 112.5 mg sinecatechins for the animal multiple of human exposure calculations presented in this labeling. Dose multiples were calculated based on the human equivalent dose (HED).In an oral (gavage) carcinogenicity study, sinecatechins was administered daily for 26 weeks to p53 transgenic mice at doses up to 500 mg/kg/day (22-fold MRHD). Treatment with sinecatechins was not associated with an increased incidence of either neoplastic or non-neoplastic lesions in the organs and tissues examined. Veregen TM Ointment, 15% has not been evaluated in a dermal carcinogenicity study.Sinecatechins was negative in the Ames test, in vivo rat micronucleus assay, UDS test, and transgenic mouse mutation assay, but positive in the mouse lymphoma mutation assay.Daily vaginal administration of Veregen TM Ointment, 15% to rats from Day 4 before mating and throughout mating until Day 17 of gestation did not cause adverse effects on mating performance and fertility at doses up to 0.15 mL/rat/day. This dose corresponds to approximately 150 mg/rat/day (8-fold MRHD).Pregnancy Category: CEmbryo-fetal development studies were conducted in rats and rabbits using intravaginal and systemic routes of administration, respectively. Oral administration of sinecatechins during the period of organogenesis (gestational Days 6 to 15 in rats or 6 to 18 in rabbits) did not cause treatment related effects on embryo-fetal development or teratogenicity at doses of up to 1,000 mg/kg/day (86-fold MRHD in rats; 173-fold MRHD in rabbits).In the presence of maternal toxicity (characterized by marked local irritation at the administration sites and decreased body weight and food consumption) in pregnant female rabbits, subcutaneous doses of 12 and 36 mg/kg/day of sinecatechins during the period of organogenesis (gestational Days 6 to 19) resulted in corresponding influences on fetal development including reduced fetal body weights and delays in skeletal ossification. No treatment related effects on embryo-fetal development were noted at 4 mg/kg/day (0.7-fold MRHD). There was no evidence of teratogenic effects at any of the doses evaluated in this study.A combined fertility / embryo-fetal development study using daily vaginal administration of Veregen TM Ointment, 15% to rats from Day 4 before mating and throughout mating158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 until Day 17 of gestation did not show treatment-related effects on embryo-fetal development or teratogenicity at doses up to 0.15 mL/rat/day (8-fold MRHD).A pre- and post-natal development study was conducted in rats using vaginal administration of Veregen TM Ointment, 15% at doses of 0.05, 0.10 and 0.15 mL/rat/day from Day 6 of gestation through parturition and lactation. The high and intermediate dose levels of 0.15 (8-fold MRHD) and 0.10 mL/rat/day resulted in an increased mortality of the F0 dams, associated with indications of parturition complications. The high dose level of 0.15 mL/rat/day also resulted in an increased incidence of stillbirths. There were no other treatment-related effects on pre- and post-natal development, growth, reproduction and fertility at any dose tested.There are no adequate and well-controlled studies in pregnant women. Veregen TM Ointment, 15% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing MothersIt is not known whether topically applied Veregen TM is excreted in breast milk.Pediatric UseSafety and efficacy in pediatric patients have not been established.Geriatric useSeven patients (1.4%), older than 65 years of age were treated with Veregen TM in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.ADVERSE REACTIONSAdverse Events / Local Skin ReactionsIn Phase 3 clinical trials, a total of 397 subjects received Veregen™Ointment, 15% three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.In clinical trials, the incidence of local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simples, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.199 200 201 202 203 204 205 206 207 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.Local and regional reactions (includes adenophathy) occurring at >1% in the treated group are presented in Table 3.Table 3: Local and Regional Adverse Reactions DuringTreatment (% Subjects)Veregen™(N=397)Vehicle(N=207)Erythema7032Pruritus6945Burning6731Pain/discomfort56 14Erosion/Ulceration49 10Edema4511 Induration3511Rash vesicular 20 6Regional Lymphadenitis 3 1Desquamation5<1Discharge3<1Bleeding2<1 Reaction2Scar10 Irritation1Rash1208209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 A total of 266/397 (67%) of subjects in the Veregen™, 15% group had either a moderate or a severe reaction that was considered probably related and of these 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen™ and in 1% (1/99) in vehicle.The maximum mean severity of erythema, erosion, edema and induration was observed by week 2 of treatment.Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less225226227228229230231 232 233234 235 236237238239240241242243244245246247248249250251 252 253254 255 256257 258259 260261 262 263264265 266 common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash and staphylococcemia.In a dermal sensitization study of Veregen™ Ointment in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.OVERDOSAGEOverdosage with Veregen TM has not been reported.DOSAGE AND ADMINISTRATIONVeregen TM Ointment, 15% is to be applied three times per day to all external genital and perianal warts.It is recommended to wash the hands before and after application of Veregen TM. About a 0.5 cm strand of the Veregen TM Ointment, 15% should be applied to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts.It is not necessary to wash off the ointment from the treated area prior to the next application.Treatment with Veregen TM should be continued until complete clearance of all warts, however no longer than 16 weeks.Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable. HOW SUPPLIEDVeregen TM Ointment, 15% is a brown ointment and is supplied in aluminium tubes containing 15 gram ointment per tube.Storage ConditionsPrior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.Keep out of reach of childrenNDC # 10337-450-15The VEREGEN trademark is used by Bradley Pharmaceuticals, Inc. under license from MediGene AG.Manufactured by:267 268 269 270 271 272 C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7D-83620 Feldkirchen-Westerham GermanyManufactured for:273274 275 276 277 278 279 280 281 383 Route 46 WestFairfield, NJ 07004 2402 USACo-marketed with Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc. December 2006PATIENT INFORMATION 123 4 5 6 7 8 9101112131415161718192021222324252627282930313233343536373839404142Veregen™(sinecatechins)Ointment, 15%Rx OnlyRead this leaflet carefully before you start using Veregen™ Ointment, 15% and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice. If you have any questions about Veregen™ Ointment, 15% or your condition ask your doctor or pharmacist. Only your doctor can prescribe Veregen™ and determine if it is right for you.What is Veregen™ Ointment, 15%?Veregen™ Ointment, 15% is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.Who should not use Veregen™ Ointment, 15%?Do not use Veregen™ Ointment, 15% if you are allergic to an ingredient in Veregen™ Ointment, 15%. The list of ingredients is at the end of this leaflet.What should I tell my doctor before taking Veregen™ Ointment, 15%?Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals. Be sure to tell your doctor if you are:•pregnant or planning to become pregnant, as it is not known if Veregen™ Ointment, 15% can harm your unborn baby. Your doctor will determine whether the benefit outweighs the risk.•breastfeeding, as it is not known if Veregen™ Ointment, 15% can pass into your milk and if it can harm your baby.•using any other type of skin product or have open wounds on the area to be treated. Veregen™ Ointment, 15% should not be used until your skin has healed from other treatments applied to the same area.•immunocompromised. This means that your immune system cannot fight infections as well as it should.4445464748495051525354555657585960616263646566676869707172737475767778798081828384 How should I use Veregen™ Ointment, 15%?•Use Veregen™ Ointment, 15% only on the area affected exactly as prescribed by your doctor.•Wash your hands before and after application of Veregen™ Ointment, 15%.A small amount of the ointment should be applied to all wart using your finger(s),dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts as directed by your doctor.•Apply Veregen™ Ointment, 15%three times per day ---in the morning, at noontime and in the evening.•Do not wash off the ointment from the treated area before the next application.When you wash the treatment area or bathe, apply the ointment afterwards.•Treatment with Veregen™ Ointment, 15% should be continued until complete clearance of all warts, however no longer than 16 weeks. If your warts do not go away, or if they come back after treatment call your doctor.•Veregen™ Ointment, 15% is not a cure for warts on your genitals or around your anus with certainty. New warts may develop during or after treatment, and may need treatment.What should I avoid while using Veregen™ Ointment, 15%?•Do not apply Veregen™ Ointment, 15% on open wounds or into the vagina or into the anus.•Genital warts are a sexually transmitted disease, and you may infect your partner.•Avoid sexual contact (genital, anal or oral) when Veregen™ Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms. Talk to your doctor about safe sex practices.•Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).•Women using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina.8687888990919293949596979899 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127•Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily.•Do not expose the genital area treated with Veregen™ Ointment, 15% to sunlight, sunlamps or tanning beds.•Do not cover the treated area. Loose-fitting undergarments can be worn after applying Veregen™ Ointment, 15%.•Veregen™ Ointment, 15% may stain your light colored clothes and bedding. It is recommended to wear darker colored undergarments while using Veregen™ Ointment, 15%.What are the possible side effects of Veregen™ Ointment, 15%?The most common side effects with Veregen™ Ointment, 15%are local skin and application site reactions including:•redness•swelling•sores or blisters•burning•itching•painMany patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied Veregen™, stop treatment and call your doctor right away.You may experience other side effects of Veregen™ Ointment, 15%, which are not mentioned here. Ask your doctor or pharmacist for more information.Patients should be aware that new warts may develop during treatment as Veregen™ Ointment, 15% is not a cure.How should I store Veregen™ Ointment, 15%?•Store Veregen™ Ointment, 15% refrigerated or up to 77ºF (25 ºC).•Do not freeze.•Make sure the cap on the tube is tightly closed.•Safely throw away Veregen™ Ointment, 15% tubes that are out of date or are empty.Keep Veregen™Ointment, 15% and all medicines out of the reach of children.129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 General advice about prescription medicinesMedicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen™ Ointment, 15% for a condition for which it was not prescribed. Do not give Veregen™ Ointment, 15% to other people, even if they have the same symptoms you have. It may harm them. Do not use Veregen™ Ointment, 15% after the expiration date on the tube.This leaflet summarizes the most important information about Veregen™ Ointment, 15%. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Veregen™ Ointment, 15% that is written for the doctor.What are the ingredients in Veregen™ Ointment, 15%?Active ingredient:A defined green tea extract named sinecatechins.Inactive ingredients:Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.Veregen™ is a trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany. Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG, Frühlingstrasse 7, D-83620 Feldkirchen-Westerham, Germany.Manufactured for:156 157 158 159 160 383 Route 46 West Fairfield, NJ 07004 2402 USACo-marketed with:161162163164 December 2006Text for the Outer Carton Label 1NDC # 10337-450-xx 2Rx OnlyVEREGEN TM(sinecatechins) Ointment15%For Topical Dermatologic Use Only.Not for Opthalmic, Oral, Intravaginal, or Intra-anal Use.Keep out of reach of children.Description: Veregen TM is a botanical drug product. The drug substance in Veregen TM is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves of Camellia sinensis (L.) O Kuntze, and is a mixture of catechins, their derivatives and other green tea components.Active ingredient: sinecatechins (150 mg/g).Excipients: isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.Usual Adult dose: See accompanying package insert for full Prescribing Information. Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG, Frühlingstrasse 7, D-83620 Feldkirchen-Westerham, Germany.Manufactured for:383 Route 46 West, Fairfield, NJ 07004-2402 USACo-marketed with Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc. Lot:Exp:UPC/Bar CodeYY 3gStore in a refrigerator at 2-8°C (36-46°F) until dispensed to the patient.Patient can store refrigerated or up to 25°C (77°F). Do not freeze.U.S. Patent Nos. 5795911 and 5968973________________________________________________________________________1 Text presented on the outer carton may not appear in the order outlined in this document.2 xx = 15 for the 15g ointment size, xx = 03 for the 30g ointment size3Text for the Immediate Container (Tube) Label 4NDC # 10337-450-xx 5Rx OnlyVeregen TM(sinecatechins) Ointment15%YY 6 gFor Topical Dermatologic Use Only.Not for Opthalmic, Oral, Intravaginal, or Intra-anal Use.Keep out of reach of children. Keep tightly closed.Description: Veregen TM is a botanical drug product. The drug substance in Veregen TM is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves of Camellia sinensis (L.) O Kuntze, and is a mixture of catechins, their derivatives and other green tea components.Active ingredient: sinecatechins (150 mg/g).Excipients: isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.Usual Adult dose: See accompanying package insert for full Prescribing Information.Store in a refrigerator at 2-8°C (36-46°F) until dispensed to the patient.Patient can store refrigerated or up to 25°C (77°F). Do not freeze.For control number and expiration date, see crimp of tube.Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG, Frühlingstrasse 7, D-83620 Feldkirchen-Westerham, Germany.Manufactured for:383 Route 46 West, Fairfield, NJ 07004-2402 USACo-marketed with Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc. SAMPLE. NOT FOR SALE. 7U.S. Patent Nos. 5795911 and 5968973________________________________________________________________________4 Text presented on the outer carton may not appear in the order outlined in this document.5 xx = 15 for the 15 g ointment size, xx = 03 for the 30 g ointment size, xx = 99 for the 4 g ointment (physician sample) size.6 YY = 15 for the 15 g ointment size, YY = 30 for the 30 g ointment size, YY = 4 for the 4 g ointment (physician sample) size.7 This statement only applicable for the 4 g ointment (physician sample) size.。
超级绿茶提取物(脱咖啡因)
商品名称：超级绿茶提取物（脱咖啡因）
产品目录号：00954
主要成分：每份含绿茶脱咖啡因提取物（叶）[标准化至98％多酚UV（710.5毫克），45％的EGCG HPLC （326.25毫克）] 725毫克
其他成分：植物纤维素（胶囊）、米粉、蔬菜硬脂酸。
规格型号：100颗
用法用量：每天一颗，空腹服用，或听从医嘱。
注意事项：●本品不能代替药品
●每一份的量含有少量的咖啡因（大概3.6毫克），由于一杯不含咖啡因的茶中至少含9毫克的咖啡因，所以补充剂中这样的含量的咖啡因产生刺激效果的可能性很小。
贮藏：保持阴凉密封
有效期：24个月
生产企业：High Quality Vitamins Supplement Inc.（高品质维生素膳食补充剂公司）
产品介绍：保持健康的体重、增强免疫功能、保持健康的胆固醇水平
不适宜人群：无。
2024年脱咖啡因绿茶市场前景分析
2024年脱咖啡因绿茶市场前景分析概述脱咖啡因绿茶是一种经过特殊处理去除咖啡因的绿茶品种。
由于人们对健康生活方式的重视，脱咖啡因绿茶市场近年来呈现出良好的增长趋势。
本文将对脱咖啡因绿茶市场的前景进行分析。
市场需求健康意识提升随着现代社会人们对健康生活方式的关注度与日俱增，饮食健康成为现代人追求的目标之一。
脱咖啡因绿茶不仅具备绿茶的保健功效，同时去除了咖啡因的刺激作用，受到越来越多健康意识提升的消费者欢迎。
咖啡因敏感人群由于某些人体质原因，对咖啡因过敏或敏感。
他们无法享受普通绿茶的好处，而脱咖啡因绿茶则成为他们的首选。
这一人群的存在为脱咖啡因绿茶市场提供了良好的消费群体。
饮料多样化需求消费者对饮料的需求越来越多样化，他们希望尝试新颖独特的味道和口感。
脱咖啡因绿茶作为一种新型的绿茶品种，与传统绿茶口感有所不同，更符合现代消费者喜好，满足了市场多样化需求。
市场竞争竞争对手分析目前脱咖啡因绿茶市场上的主要竞争对手包括传统绿茶品牌和其他新型茶饮品牌。
传统绿茶品牌在市场上具有一定的知名度和消费者基础，但脱咖啡因绿茶的独特卖点使其能够与传统绿茶品牌进行差异化竞争。
与此同时，其他新型茶饮品牌通过创新包装、口味等方面，也构成了市场的竞争威胁。
市场发展趋势随着人们健康意识的提高，脱咖啡因绿茶市场有望继续保持良好的发展势头。
同时，消费者对于产品的品质和健康价值要求也越来越高，市场竞争将进一步加剧。
市场推广策略品牌宣传在市场推广方面，脱咖啡因绿茶品牌需要加大品牌宣传的力度，提升消费者对品牌的认知度和好感度。
可以通过线上线下结合的方式，进行广告宣传、品牌活动等。
同时，与社交媒体和知名健康博主等合作，提高品牌的曝光度。
产品创新在产品方面，脱咖啡因绿茶品牌应不断进行创新，推出新口味、新包装等，满足消费者对多样化饮品的需求。
还可以进行产品线扩展，推出相关产品，如脱咖啡因绿茶饮料、脱咖啡因绿茶粉等，进一步拓展市场份额。
渠道拓展脱咖啡因绿茶品牌可以通过与超市、便利店等零售商的合作，拓展销售渠道，增加产品的覆盖面。
2024年绿茶提取物市场前景分析
2024年绿茶提取物市场前景分析概述绿茶提取物是从绿茶中提取的一种含有丰富活性成分的天然产品。
它具有多种保健功能和药用价值，因此在食品、保健品和医药等领域得到广泛应用。
本文将对绿茶提取物市场的前景进行分析。
市场规模绿茶提取物市场在过去几年中快速增长。
根据市场调研报告，2019年全球绿茶提取物市场规模超过10亿美元，并且预计到2025年将达到数十亿美元。
市场的快速增长可以归因于消费者对健康食品和天然产品的日益关注。
市场驱动因素健康境况改善的意识增加随着人们对健康的认识增强，他们越来越关注预防疾病和提高生活质量。
绿茶提取物因其抗氧化、抗炎症、降血脂、降血糖等多种保健功能备受追捧。
泛素食主义的流行越来越多的人选择素食主义或减少肉食摄入，这导致对植物性食品的需求增加。
作为一种天然的植物提取物，绿茶提取物符合泛素食主义者的需求。
传统草药的复兴传统草药疗法在个人健康管理方面获得了广泛认可。
绿茶提取物作为一种经过科学验证的传统草药，成为许多人倾向的选择。
市场应用绿茶提取物在多个领域中有广泛的应用，包括食品、保健品和医药。
### 食品行业绿茶提取物常被用于饮料、糕点、冰淇淋、巧克力等食品中，赋予其抗氧化和滋补功能。
保健品行业绿茶提取物因其抗氧化、养生、减肥等功能而在保健品行业中得到广泛应用，如绿茶提取物胶囊、口服液等。
医药行业绿茶提取物在医药领域的用途日益广泛，如用于心脑血管疾病、肿瘤、糖尿病等疾病的预防和治疗。
市场前景与机遇随着人们对健康意识的提高，对绿茶提取物的需求将持续增长。
此外，科技创新和研发投资将进一步拓宽绿茶提取物的应用领域，为市场带来更多机遇。
挑战和风险绿茶提取物市场在发展过程中也面临一些挑战和风险。
例如，市场竞争激烈，产品同质化情况较为严重。
此外，绿茶提取物的市场监管和质量标准也是一个重要问题。
总结总体而言，绿茶提取物市场具有广阔的发展前景。
随着消费者对健康和天然产品的需求不断增长，绿茶提取物将成为市场焦点。
绿茶咖啡因测定方法(H)
编号:FZD-0122 绿茶提取物中咖啡因（Caffeine）含量测定方法
一、色谱条件
色谱柱：Inertsil ODS-3 4.6×150mm 5μm
流动相：乙腈∶水(10∶90，V/V)
检测波长：273nm
流速：1mL/min
柱温：室温
进样量：10μL
二、溶液制备
1．对照品溶液制备精密称取咖啡因对照品约5mg于50mL容量瓶中，用甲醇溶解定容。
2．样品溶液制备精密称取约15mg样品（样品中咖啡因含量约50%）于50mL容量瓶中，加入约40mL甲醇超声振荡20min后，放置至室温，以甲醇定容，用0.45μm微孔滤膜过滤即为供试样品溶液。
三、样品测定
在上述色谱条件下，待仪器稳定基线平稳后，进样测定，约为11min，含量按外标法计算。
注：样品中咖啡因后有杂质峰干扰测定，色谱运行时间应约为咖啡因保留时间的二倍。
2024年脱咖啡因绿茶市场分析报告
2024年脱咖啡因绿茶市场分析报告引言市场分析是任何产品或服务成功推出的关键步骤之一。
本文旨在对脱咖啡因绿茶市场进行全面分析，以提供有关该市场的详细信息和洞察力。
市场概述脱咖啡因绿茶是一种非常受欢迎的茶饮品，深受健康意识逐渐增强的人群的青睐。
它的主要特点是具有绿茶的天然味道和营养价值，但不含咖啡因。
这使得它成为许多人在日常生活中的健康选择。
市场规模脱咖啡因绿茶市场在过去几年中呈现出稳步增长的趋势。
根据市场研究公司的数据，2019年全球脱咖啡因绿茶市场规模约为X亿美元，预计到2025年将增长至X亿美元。
该市场在北美、欧洲和亚太地区的增长最为显著。
市场驱动因素1.健康意识的兴起：随着人们对健康意识的增强，他们更加注重饮食和饮品对健康的影响。
脱咖啡因绿茶作为一种健康的选择，迎合了这一需求。
2.生活方式的变化：现代生活方式快节奏和工作压力大，导致人们寻求一种能够提供放松和舒缓效果的饮品。
脱咖啡因绿茶被认为是一种能够缓解压力的饮品，因此受到许多人的喜爱。
3.广告和宣传推广：脱咖啡因绿茶品牌通过各种广告和宣传活动增加了品牌知名度和市场渗透率。
这些活动有助于吸引更多的消费者，并增加他们对脱咖啡因绿茶的兴趣。
市场竞争格局脱咖啡因绿茶市场存在着激烈的竞争。
主要竞争者包括国际知名品牌和本土品牌。
这些品牌通过提供不同口味、包装和定价策略来竞争市场份额。
此外，高品质和天然成分的脱咖啡因绿茶在市场上受到欢迎。
消费者越来越倾向于选择那些采用有机种植和天然制造工艺的产品。
因此，与传统茶叶市场相比，对高质量、可持续发展和绿色生产的要求也在不断增加。
市场机会尽管脱咖啡因绿茶市场已经得到广泛开发，但仍存在一些未满足的市场机会。
以下是一些具有潜力的市场机会：1.新兴市场的开拓：脱咖啡因绿茶在一些新兴市场的普及率相对较低，但随着对健康生活方式的关注逐渐增加，这些市场也将成为潜在的增长点。
2.创新产品的开发：通过推出新口味、新包装以及针对特定消费者群体的定制产品，可以进一步满足不同消费者的需求，并吸引更多的消费者。
绿茶提取物的作用有哪些
绿茶提取物即茶叶中三十多种多酚类物质的总称，是一种从绿茶中提取的纯天然混合物，主要由儿茶素、黄酮类、花色素和酚酸等四大类物质组成。
那么该产品的作用有哪些呢？1、抗过敏及消炎研究表明茶多酚对透明酸酶具有显着的抑制作用，其中茶黄素灭没食子酸的抑制活性达99．1％。
儿茶素主要抑制快速过敏反应，而对迟发性的过敏反应作用不大。
2、胃肠保护功能儿茶素能够抑制胃粘膜上的H－K－ATP酶，从而从根本上抑制了胃酸的分泌，减轻了胃酸对胃粘膜的刺激和损伤同时儿茶素还能够治疗溃疡。
此外儿茶素对于胃肠痉挛也具有一定的缓解作用。
茶多酚在用于治疗便秘、控制肠道内菌群、改善调节肠道内环境方面也有相当疗效。
3、降血糖多个试验数据证实茶多酚是蔗糖酶的抑制剂，因此它可以抑制蔗糖向葡萄糖的转化，而使得血糖下降。
另外，还有少量报道表明，茶多酚可用于抗龋、清除口臭、减肥、美容等。
茶多酚的抗癌、抗衰老、降血糖、防治动脉硬化、保肝护肝等作用可能与其抗氧化、清除机体内有害自由基的作用有关。
4、抗病毒作用日本的研究人员发现：绿茶和红茶的提取物具有抑制甲、乙型流感病毒的作用，而瑞士也有研究表明儿茶素对人体呼吸系统合孢体病毒（RSV）有抑制作用。
除此之外，茶多酚对于胃肠炎病毒、甲型肝炎病毒、植物病毒也有较强的对抗抑制作用。
5、抗癌、抗突变对茶叶能防癌、抗癌、抗突变的研究在国内外许多国家都有报道。
大量的研究证实，茶叶不仅可抑制多种化学致癌物诱致的突变，还能够抑制一些混合致癌物（雾浓缩药、煤焦油、熏鱼提取物，X射线）的致突变作用。
因此茶叶对于多种癌症：食道癌、胃癌、肝癌、肠癌、肺癌、皮肤癌、乳腺癌、克隆癌等均有不同程度的预防和治疗作用。
6、抗氧化人在正常的生命活动中，体内会代谢而不断产生有害的自由基。
自由基的性质活泼，具有极强的氧化能力，可以诱发体内不饱和脂肪酸的氧化，产生过氧化脂质。
它的产生和积累，会制约和破坏生物膜的正常功能，影响活性物质的正常代谢，促发肝炎、癌症、衰老及心血管等许多方面的疾患。
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商品名称：超级绿茶提取物（脱咖啡因）
产品目录号：00954
主要成分：每份含绿茶脱咖啡因提取物（叶）[标准化至98％多酚UV（710.5毫克），45％的EGCG HPLC （326.25毫克）] 725毫克
其他成分：植物纤维素（胶囊）、米粉、蔬菜硬脂酸。
规格型号：100颗
用法用量：每天一颗，空腹服用，或听从医嘱。
注意事项：●本品不能代替药品
●每一份的量含有少量的咖啡因（大概3.6毫克），由于一杯不含咖啡因的茶中至少含9毫克的咖啡因，所以补充剂中这样的含量的咖啡因产生刺激效果的可能性很小。
贮藏：保持阴凉密封
有效期：24个月
生产企业：High Quality Vitamins Supplement Inc.（高品质维生素膳食补充剂公司）
产品介绍：保持健康的体重、增强免疫功能、保持健康的胆固醇水平
不适宜人群：无。