WO2012160569A1 - "process for extraction of ashwagandha (withania somnifera) roots" - Google Patents
"process for extraction of ashwagandha (withania somnifera) roots" Download PDFInfo
- Publication number
- WO2012160569A1 WO2012160569A1 PCT/IN2011/000894 IN2011000894W WO2012160569A1 WO 2012160569 A1 WO2012160569 A1 WO 2012160569A1 IN 2011000894 W IN2011000894 W IN 2011000894W WO 2012160569 A1 WO2012160569 A1 WO 2012160569A1
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- WO
- WIPO (PCT)
- Prior art keywords
- withanoside
- roots
- extraction
- followed
- ashwagandha
- Prior art date
Links
- 240000004482 Withania somnifera Species 0.000 title claims abstract description 52
- 235000001978 Withania somnifera Nutrition 0.000 title claims abstract description 50
- 238000000605 extraction Methods 0.000 title claims abstract description 28
- DBRXOUCRJQVYJQ-CKNDUULBSA-N withaferin A Chemical compound C([C@@H]1[C@H]([C@@H]2[C@]3(CC[C@@H]4[C@@]5(C)C(=O)C=C[C@H](O)[C@@]65O[C@@H]6C[C@H]4[C@@H]3CC2)C)C)C(C)=C(CO)C(=O)O1 DBRXOUCRJQVYJQ-CKNDUULBSA-N 0.000 title claims abstract description 27
- 239000009405 Ashwagandha Substances 0.000 title claims abstract description 25
- 238000000034 method Methods 0.000 title claims abstract description 20
- SASUFNRGCZMRFD-JCUIILOWSA-N withanolide D Chemical compound C1C(C)=C(C)C(=O)O[C@H]1[C@](C)(O)[C@@H]1[C@@]2(C)CC[C@@H]3[C@@]4(C)C(=O)C=C[C@H](O)[C@@]54O[C@@H]5C[C@H]3[C@@H]2CC1 SASUFNRGCZMRFD-JCUIILOWSA-N 0.000 title description 21
- ZBLWKSUMHLVXAM-UHFFFAOYSA-N Withanoside V Natural products C1C(C)=C(C)C(=O)OC1C(C)C(C1(CCC2C3(C)C(O)C4)C)CCC1C2CC=C3CC4OC(C(C(O)C1O)O)OC1COC1OC(CO)C(O)C(O)C1O ZBLWKSUMHLVXAM-UHFFFAOYSA-N 0.000 claims abstract description 28
- VUQQGHSDHGOYRH-IFUSOADVSA-N (2r)-2-[(1s)-1-[(1s,3r,8s,9s,10r,13s,14s,17r)-1-hydroxy-10,13-dimethyl-3-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-[[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxy-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1h-cyclopenta[a] Chemical compound C([C@H]1O[C@H]([C@@H]([C@@H](O)[C@@H]1O)O)O[C@@H]1CC2=CC[C@H]3[C@@H]4CC[C@@H]([C@]4(CC[C@@H]3[C@@]2(C)[C@@H](O)C1)C)[C@H](C)[C@@H]1OC(=O)C(CO)=C(C)C1)O[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VUQQGHSDHGOYRH-IFUSOADVSA-N 0.000 claims abstract description 15
- UVFCEKPEVQCPCQ-UHFFFAOYSA-N withanoside IV Natural products CC(C1CC(=C(CO)C(=O)O1)C)C2CCC3C4C5OC5C6(O)CC(CC(O)C6(C)C4CCC23C)OC7OC(COC8OC(CO)C(O)C(O)C8O)C(O)C(O)C7O UVFCEKPEVQCPCQ-UHFFFAOYSA-N 0.000 claims abstract description 15
- ZBLWKSUMHLVXAM-KFJRISAASA-N (2r)-2-[(1s)-1-[(1s,3r,8s,9s,10r,13s,14s,17r)-1-hydroxy-10,13-dimethyl-3-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-[[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxy-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1h-cyclopenta[a] Chemical compound C([C@H]1O[C@H]([C@@H]([C@@H](O)[C@@H]1O)O)O[C@@H]1CC2=CC[C@H]3[C@@H]4CC[C@@H]([C@]4(CC[C@@H]3[C@@]2(C)[C@@H](O)C1)C)[C@H](C)[C@@H]1OC(=O)C(C)=C(C)C1)O[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O ZBLWKSUMHLVXAM-KFJRISAASA-N 0.000 claims abstract description 13
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 11
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 9
- 239000000843 powder Substances 0.000 claims description 24
- 239000000284 extract Substances 0.000 claims description 23
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 21
- 239000002798 polar solvent Substances 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 13
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 235000011837 pasties Nutrition 0.000 claims description 11
- 238000010438 heat treatment Methods 0.000 claims description 10
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 10
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 10
- 238000010298 pulverizing process Methods 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 9
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 8
- 239000000356 contaminant Substances 0.000 claims description 7
- 239000000428 dust Substances 0.000 claims description 7
- 239000000706 filtrate Substances 0.000 claims description 7
- ZWEHNKRNPOVVGH-UHFFFAOYSA-N 2-Butanone Chemical compound CCC(C)=O ZWEHNKRNPOVVGH-UHFFFAOYSA-N 0.000 claims description 6
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims description 6
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 6
- 238000005119 centrifugation Methods 0.000 claims description 6
- 238000007873 sieving Methods 0.000 claims description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 5
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 5
- 229940095079 dicalcium phosphate anhydrous Drugs 0.000 claims description 5
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 5
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 5
- 229960002216 methylparaben Drugs 0.000 claims description 5
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 5
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 5
- 229960003415 propylparaben Drugs 0.000 claims description 5
- 238000010992 reflux Methods 0.000 claims description 5
- LCGLNKUTAGEVQW-UHFFFAOYSA-N Dimethyl ether Chemical compound COC LCGLNKUTAGEVQW-UHFFFAOYSA-N 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- FDPIMTJIUBPUKL-UHFFFAOYSA-N pentan-3-one Chemical compound CCC(=O)CC FDPIMTJIUBPUKL-UHFFFAOYSA-N 0.000 claims description 4
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims description 4
- 239000002775 capsule Substances 0.000 claims description 3
- 239000003826 tablet Substances 0.000 claims description 3
- 150000001298 alcohols Chemical class 0.000 claims description 2
- 238000004821 distillation Methods 0.000 claims description 2
- 150000002170 ethers Chemical class 0.000 claims description 2
- NGAZZOYFWWSOGK-UHFFFAOYSA-N heptan-3-one Chemical compound CCCCC(=O)CC NGAZZOYFWWSOGK-UHFFFAOYSA-N 0.000 claims description 2
- 150000002576 ketones Chemical class 0.000 claims description 2
- 239000006186 oral dosage form Substances 0.000 claims description 2
- 239000006188 syrup Substances 0.000 claims description 2
- 235000020357 syrup Nutrition 0.000 claims description 2
- 229930189303 withanoside Natural products 0.000 abstract description 18
- 208000019901 Anxiety disease Diseases 0.000 abstract description 6
- 230000036506 anxiety Effects 0.000 abstract description 6
- 239000000470 constituent Substances 0.000 description 9
- -1 withasomine Chemical compound 0.000 description 6
- 230000035882 stress Effects 0.000 description 5
- 238000001914 filtration Methods 0.000 description 4
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- 241000588724 Escherichia coli Species 0.000 description 3
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- 238000004128 high performance liquid chromatography Methods 0.000 description 3
- QIZDQFOVGFDBKW-DHBOJHSNSA-N Pseudotropine Natural products OC1C[C@@H]2[N+](C)[C@H](C1)CC2 QIZDQFOVGFDBKW-DHBOJHSNSA-N 0.000 description 2
- 241000208292 Solanaceae Species 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- FOJCJLSJZFQCID-UHFFFAOYSA-N Withasomnine Chemical compound C1=NN2CCCC2=C1C1=CC=CC=C1 FOJCJLSJZFQCID-UHFFFAOYSA-N 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- ZEBIACKKLGVLFZ-TXEJJXNPSA-N cuscohygrine Chemical compound CN1CCC[C@@H]1CC(=O)C[C@H]1N(C)CCC1 ZEBIACKKLGVLFZ-TXEJJXNPSA-N 0.000 description 2
- 239000003085 diluting agent Substances 0.000 description 2
- 239000007884 disintegrant Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229940032147 starch Drugs 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- CYHOMWAPJJPNMW-JIGDXULJSA-N tropine Chemical compound C1[C@@H](O)C[C@H]2CC[C@@H]1N2C CYHOMWAPJJPNMW-JIGDXULJSA-N 0.000 description 2
- YCGBUPXEBUFYFV-UHFFFAOYSA-N withaferin A Natural products CC(C1CC(=C(CO)C(=O)O1)C)C2CCC3C4CC5OC56C(O)C=CC(O)C6(C)C4CCC23C YCGBUPXEBUFYFV-UHFFFAOYSA-N 0.000 description 2
- PQZVBIJEPVKNOZ-PCLZMVHQSA-N (2R)-2-[(1S)-1-hydroxy-1-[(5R,6R,8R,9S,10R,13S,14R,17S)-5,6,14,17-tetrahydroxy-10,13-dimethyl-1-oxo-6,7,8,9,11,12,15,16-octahydro-4H-cyclopenta[a]phenanthren-17-yl]ethyl]-4,5-dimethyl-2,3-dihydropyran-6-one Chemical class C1C(C)=C(C)C(=O)O[C@H]1[C@](C)(O)[C@@]1(O)[C@@]2(C)CC[C@@H]3[C@@]4(C)C(=O)C=CC[C@]4(O)[C@H](O)C[C@H]3[C@]2(O)CC1 PQZVBIJEPVKNOZ-PCLZMVHQSA-N 0.000 description 1
- XQJMXPAEFMWDOZ-UHFFFAOYSA-N 3exo-benzoyloxy-tropane Natural products CN1C(C2)CCC1CC2OC(=O)C1=CC=CC=C1 XQJMXPAEFMWDOZ-UHFFFAOYSA-N 0.000 description 1
- 208000000044 Amnesia Diseases 0.000 description 1
- 206010065369 Burnout syndrome Diseases 0.000 description 1
- 206010006895 Cachexia Diseases 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 208000036119 Frailty Diseases 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 208000026139 Memory disease Diseases 0.000 description 1
- 208000010428 Muscle Weakness Diseases 0.000 description 1
- 206010049816 Muscle tightness Diseases 0.000 description 1
- 206010028372 Muscular weakness Diseases 0.000 description 1
- QQXLDOJGLXJCSE-UHFFFAOYSA-N N-methylnortropinone Natural products C1C(=O)CC2CCC1N2C QQXLDOJGLXJCSE-UHFFFAOYSA-N 0.000 description 1
- 206010063493 Premature ageing Diseases 0.000 description 1
- 206010039966 Senile dementia Diseases 0.000 description 1
- 235000000340 Solanum pseudocapsicum Nutrition 0.000 description 1
- JQGBUIZIHWUPHT-CSVNJIPGSA-N Somniferine Chemical compound C([C@@H](N(CC1)C)[C@]2(O)C=C(C3=O)[C@@H]4C[C@]56[C@H]7OC=8C(OC)=CC=C(C6=8)C[C@@H](N4C)C5=CC=C7OC)C4=CC=C(O)C5=C4[C@@]21[C@H]3O5 JQGBUIZIHWUPHT-CSVNJIPGSA-N 0.000 description 1
- 206010041497 Spermatorrhoea Diseases 0.000 description 1
- JAVFSUSPBIUPLW-QEWGJZFKSA-N Withanolide Natural products O=C1[C@@H](C)[C@H](C)C[C@H]([C@@H](C)[C@@H]2[C@@]3(C)[C@H]([C@@H]4[C@@H]([C@]5(C)[C@@H](CC4)CCCC5)CC3)CC2)O1 JAVFSUSPBIUPLW-QEWGJZFKSA-N 0.000 description 1
- 208000031900 Woolly hair Diseases 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 229930014344 anaferine Natural products 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000003048 aphrodisiac agent Substances 0.000 description 1
- 230000002509 aphrodisiac effect Effects 0.000 description 1
- 229910052785 arsenic Inorganic materials 0.000 description 1
- RQNWIZPPADIBDY-UHFFFAOYSA-N arsenic atom Chemical compound [As] RQNWIZPPADIBDY-UHFFFAOYSA-N 0.000 description 1
- 206010003549 asthenia Diseases 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 description 1
- 229960001231 choline Drugs 0.000 description 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 208000026500 emaciation Diseases 0.000 description 1
- 208000019692 familial woolly hair syndrome Diseases 0.000 description 1
- 206010016256 fatigue Diseases 0.000 description 1
- 238000004817 gas chromatography Methods 0.000 description 1
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- 230000003179 granulation Effects 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 208000026847 isolated familial woolly hair disease Diseases 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 150000002596 lactones Chemical class 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
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- 235000016709 nutrition Nutrition 0.000 description 1
- 239000002831 pharmacologic agent Substances 0.000 description 1
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- 238000002360 preparation method Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- CYHOMWAPJJPNMW-RNLVFQAGSA-N pseudotropine Chemical compound C1[C@H](O)C[C@H]2CC[C@@H]1N2C CYHOMWAPJJPNMW-RNLVFQAGSA-N 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 210000004994 reproductive system Anatomy 0.000 description 1
- 239000013557 residual solvent Substances 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 230000035922 thirst Effects 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- FAZIYUIDUNHZRG-PCTWTJKKSA-N withanone Chemical compound C([C@@H]1[C@@H](C)[C@]2(O)[C@]3(CC[C@@H]4[C@@]5(C)C(=O)C=CC[C@]5(O)[C@H]5O[C@H]5[C@H]4[C@@H]3CC2)C)C(C)=C(C)C(=O)O1 FAZIYUIDUNHZRG-PCTWTJKKSA-N 0.000 description 1
- FAZIYUIDUNHZRG-BIILLMFASA-N withanone Natural products C[C@H]([C@@H]1CC(=C(C)C(=O)O1)C)[C@@]2(O)CC[C@H]3[C@@H]4[C@@H]5O[C@@H]5[C@@]6(O)CC=CC(=O)[C@]6(C)[C@H]4CC[C@]23C FAZIYUIDUNHZRG-BIILLMFASA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
Definitions
- the present invention relates to a process for extraction of active constituents from Ashwagandha (Withania somnifera) roots.
- the present invention further relates to a pharmaceutical composition comprising active constituents from Ashwagandha (Withania somnifera) roots along with pharmaceutically acceptable excipient, useful for the treatment of relieving anxiety and stress.
- Withania somnifera also known as Ashwagandha, Indian ginseng, Winter cherry, is a plant in the Solanaceae or nightshade family. It grows as a short shrub (35-75 cm) with a central stem from which branch extend radially in a star pattern (stellate) and covered with a dense matte of wooly hairs (tomentose). The flowers are small and green, while the ripe fruit is orange-red and has milk-coagulating properties. The plant also has long brown tuberous roots that are used for medicinal purposes. It is cultivated in many of the drier regions of India such as Manasa, Neemuch, and Jawad tehsils of the Mandsaur District of Madhya Pradesh, Punjab, Sind and Bengal.
- US Patent Publication No. US20100285064 discloses a process for preparing a Withania somnifera fraction rich in withanolides and a vaccine comprising a " Withania somnifera fraction" as an adjuvant.
- US Patent No. 6153198 discloses a high purity Withania somnifera extract composition, process for obtaining extract composition and pharmaceutical and nutritional use products thereof.
- US Patent No. 7108870 discloses an improved process of analytical and quantitative isolation of withaferin-A from Withania somnifera.
- WIPO Publication No. WO2010013254 (corresponding of Indian Patent Application No. 1775/MUM/2008) relates to a Withania somnifera plant extract, composition comprising the extract and process for preparation of the extract.
- Indian Patent Application No. 1283/MUM/2009 describes a method of extraction from Withania somnifera (WS) and one or more fractions containing the pharmacologically active ingredients extracted from WS using the method of extraction.
- WS Withania somnifera
- Roots of Ashwagandha contains steroidal Lactones, Withanosides I, II, III, Glycowithanolides A, D, E, F, G, H, I, J, K, L, M, WS-1 P and S, alkaloids like withanone, withaferin A, withasomine, somniferine, withanine, cuscohygrine, anhygrine, tropine, pseudotrophine, anaferine, choline, tropanol, pseudotropanol, isopelletriene, withasomnine, starch etc.
- Withania somnifera is used in many diseases because its constituents have good effect on immune system, nervous system, reproductive system, circulatory system, respiratory system, digestive system, excretory/ urinary system etc.
- the quantity/amount of desired/active Withanosides will be more when compared to the same amount of crude drug (root) powder. Moreover, crude drug powder loses its effect in 6 to 12 months, whereas extract remain stable for 5 to 7 years, even if stored at room temperature. Hence, the present inventors have come up with a process wherein the enriched extract of Ashwagandha (Withania somnifera) roots containing Withanosides IV and Withanosides V can be achieved.
- the invention further discloses a pharmaceutical composition comprising Withanosides IV and Withanosides V along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
- the object of the present invention is to provide a process for extraction of active constituents i.e. Withanosides IV and Withanosides V from Ashwagandha (Withania somnifera) roots and a pharmaceutical composition comprising said Withanosides, along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
- active constituents i.e. Withanosides IV and Withanosides V from Ashwagandha (Withania somnifera) roots
- a pharmaceutical composition comprising said Withanosides, along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
- the present invention discloses a process for extraction of Withanosides JV and Withanosides V from Ashwagandha (Withania somnifera) roots, comprising the following six major steps:-
- the present invention further discloses the pharmaceutical composition comprising Withanosides IV and Withanosides V, along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
- FIG 1 Flow chart for Extraction of Ashwagandha. DETAILED DESCRIPTION OF THE INVENTION:
- the plant material used in the present invention i.e. Ashwagandha ⁇ Withania somnifera) roots are collected from northern, western and central parts of India.
- the present invention provides a process for extraction of active constituents i.e. Withanoside IV and Withanoside V from Ashwagandha ⁇ Withania somnifera) roots.
- the extract is standardized to contain Withanoside IV and Withanoside
- V within the range of not less than 0.8 % and not less than 0.4 % respectively.
- V from Ashwagandha ⁇ Withania somnifera) roots comprises following steps ⁇
- step (b) cold extraction of pulverized powder of step (b) with polar solvent followed by centrifuging to obtain the residue;
- step (c) subjecting to hot extraction of residue obtained in step (c) by adding it to polar solvent followed by refluxing and centrifuging;
- step (c) collecting the filtrates of step (c) and step (d) after centrifugation, followed by distillation to obtain an extract
- step (e) adding and mixing methyl paraben IP, Propyl paraben IP, dicalcium phosphate anhydrous IP and Colloidal silicone Dioxide IP to the extract of step (e) to obtain pasty mass;
- step (f) transferring the pasty mass of step (f) to evaporator, followed by stirring and heating to obtain granular powder of 30 to 60 mesh.
- the present invention provides a process for extraction of active constituents i.e. Withanoside IV and Withanoside V from Ashwagandha ⁇ Withania somnifera) roots, comprises the following steps:- Step 1: Sorting and sieving of roots to remove dust and contaminants
- Ashwagandha roots are cut into small pieces and spread on SS sieve of size 10 mesh to 30 mesh.
- the contaminants, infected roots or adhered dust etc. from the roots are removed by sieving or simply by hand picking. After sorting and sieving, roots are filled in clean bag for Pulverization.
- Step 2 Pulverization of roots
- Suitable commercial pulverization machine with 30 to 60 mesh sieve is used for pulverization and plastic bag is used for collecting the pulverized material.
- Step 3 Cold extraction and filtration
- Step 4 Hot extraction and filtration
- Step 3 The residue obtained from Step 3 is added to the first vessel containing enough of polar solvent (as used before) (30% recovered polar solvent and 70% fresh polar solvent, wherein the recovered polar solvent is from Ashwagandha of previous batch), followed by heating and refluxing at from 60°C to 100°C over a period of 1 to 4 hours.
- the mixture is cooled to R.T and discharged the mass in SS tank followed by centrifugation (11). After centrifuge, the filtrate is added to the second vessel of Step 3.
- the filtrates of Step 3 and Step 4 are collecting in second vessel and heating slowly and further raising the temperature of mixture to distill out polar solvent, followed by cooling to R.T. Discharging pasty mass in previously weighed SS storage tank.
- the test sample is sent for quality control and to the extract obtained is added methyl paraben IP, Propyl paraben IP and mixed well followed by addition of Dicalcium phosphate anhydrous IP and Colloidal silicon dioxide IP in the quantity based on analysis of test sample and total quantity of the extract, and further mixing well to get the pasty mass.
- Step 5 Transferring the pasty mass of Step 5 to evaporator, followed by stirring and heating from RT to 100°C, till it is converted into granular powder. Cool to R.T. Passing the granular powder from pulvarizer or multimill, to get the final dry powder of 30 to 60 mesh.
- the polar solvent used in the abovementioned process is selected from lower alcohols such as methanol, ethanol, acetone, isopropyl alcohol etc., ketones such as acetone, methyl ethyl ketone, diethyl ketone, ethyl butyl ketone etc., ethers such as dimethyl ether, diethyl ether, tetrahydrofuran (THF) etc.
- lower alcohols such as methanol, ethanol, acetone, isopropyl alcohol etc.
- ketones such as acetone, methyl ethyl ketone, diethyl ketone, ethyl butyl ketone etc.
- ethers such as dimethyl ether, diethyl ether, tetrahydrofuran (THF) etc.
- the polar solvent used in the abovementioned process is preferably methanol.
- the desired percentages of Withanoside IV and Withanoside V extracted from Ashwagandha (Withania somniferd) roots are NLT 0.8 % and NLT 0.4 % respectively.
- the active constituents Withanoside IV and Withanoside V, along with pharmaceutically acceptable excipients are formulated into pharmaceutical composition and oral dosage form.
- the pharmaceutically acceptable excipients are selected from the group comprising diluents, binders, wetting agents, disintegrants and lubricants.
- Suitable excipients such as Lactose, Starch, Sodium starch glycolate, AC.Disol, Talcum, Magnesium stearate etc. can be used.
- the active constituents Withanoside IV and Withanoside V are mixed with other suitable diluents and disintegrants; followed by granulation with appropriate binding agent, dried, lubricated and compressed into tablet or capsule.
- pharmaceutical composition of the present invention is in the form of tablet, powder, syrup or capsule.
- compositions comprising Withanoside IV and Withanoside V are used for relieving anxiety and stress.
- the amounts of active constituents such as Withanoside IV and Withanoside V are analyzed by using HPLC method. The results are shown in Table 1.
- the presence of residual polar solvent, in final dried extract is analyzed by using GC method.
- the specifications of residual solvents are shown in Table 2.
- Ashwagandha roots were cut into small pieces and spread on 20 mesh SS sieve to remove dust and contaminants. Pulverize the said roots through pulverization machine with 50 mesh sieve to obtain pulverized powder. Mixed and stirred the said pulverized powder with methanol and heated to about 40°C for 12 hours with continuous stirring. Cool the mixture at R.T and centrifuged (1) it, to obtain the residue. Then subjecting to hot extraction of the residue by adding methanol, followed by heating and refluxing at 95°C for 2 hrs. The mixture is cooled to R.T and discharged the mass followed by centrifugation (II). Collected both the filtrates and heated to distill out methanol, followed by cooling to R.T. to obtain an extract.
- II centrifugation
- Ashwagandha extract Added and mixed methyl paraben IP, Propyl paraben IP, dicalcium phosphate anhydrous IP and Colloidal silicone Dioxide IP to the extract and mixed well to obtain pasty mass. Transferred the said pasty mass to evaporator, followed by stirring and heating to 90 - 95°C, till it is converted into granular powder. Passed the granular powder from pulvarizer or multimill, to get the final dry powder of 50 to 60 mesh. Specification of Ashwagandha extract:
- Ashwagandha roots were cut into small pieces and spread on 20 mesh SS sieve to remove
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Abstract
Discloses a process for extraction of Withanoside IV and Withanoside V from Ashwagandha (Withania somniferd) roots and a pharmaceutical composition containing the Withanosides IV and V along with pharmaceutically acceptable excipients, for the treatment of relieving anxiety and stress.
Description
PROCESS FOR EXTRACTION OF ASHWAGANDHA
(WITHANIA SOMNIFERA) ROOTS"
TECHNICAL FIELD OF THE INVENTION;
The present invention relates to a process for extraction of active constituents from Ashwagandha (Withania somnifera) roots. The present invention further relates to a pharmaceutical composition comprising active constituents from Ashwagandha (Withania somnifera) roots along with pharmaceutically acceptable excipient, useful for the treatment of relieving anxiety and stress.
BACKGROUND OF THE INVENTION:
Withania somnifera, also known as Ashwagandha, Indian ginseng, Winter cherry, is a plant in the Solanaceae or nightshade family. It grows as a short shrub (35-75 cm) with a central stem from which branch extend radially in a star pattern (stellate) and covered with a dense matte of wooly hairs (tomentose). The flowers are small and green, while the ripe fruit is orange-red and has milk-coagulating properties. The plant also has long brown tuberous roots that are used for medicinal purposes. It is cultivated in many of the drier regions of India such as Manasa, Neemuch, and Jawad tehsils of the Mandsaur District of Madhya Pradesh, Punjab, Sind and Rajasthan.
In Ayurveda, the roots of W. somnifera are used to prepare many herbal medicines. It is claimed to possess aphrodisiac, sedative, rejuvenative and life prolonging properties. It is traditionally used to treat the symptoms and conditions associated with chronic fatigue, dehydration, bone weakness, muscle weakness and tension, loose teeth, thirst, impotency, premature ageing, emaciation, debility, constipation, senility, rheumatism, nervous exhaustion, memory loss, neurodegenerative disorders, spermatorrhoea.
US Patent Publication No. US20100285064 discloses a process for preparing a Withania somnifera fraction rich in withanolides and a vaccine comprising a " Withania somnifera fraction" as an adjuvant.
US Patent No. 6153198 discloses a high purity Withania somnifera extract composition, process for obtaining extract composition and pharmaceutical and nutritional use products thereof.
US Patent No. 7108870 discloses an improved process of analytical and quantitative isolation of withaferin-A from Withania somnifera.
WIPO Publication No. WO2010013254 (corresponding of Indian Patent Application No. 1775/MUM/2008) relates to a Withania somnifera plant extract, composition comprising the extract and process for preparation of the extract.
Indian Patent Application No. 1283/MUM/2009 describes a method of extraction from Withania somnifera (WS) and one or more fractions containing the pharmacologically active ingredients extracted from WS using the method of extraction.
Roots of Ashwagandha contains steroidal Lactones, Withanosides I, II, III, Glycowithanolides A, D, E, F, G, H, I, J, K, L, M, WS-1 P and S, alkaloids like withanone, withaferin A, withasomine, somniferine, withanine, cuscohygrine, anhygrine, tropine, pseudotrophine, anaferine, choline, tropanol, pseudotropanol, isopelletriene, withasomnine, starch etc.
The taste of roots used to be bitter and sweet astringent. Roots used to be 1/3 to 1/2 m long, thin to thick whitish brown from outside, creamish from inside. Withania somnifera is used in many diseases because its constituents have good effect on immune system, nervous system, reproductive system, circulatory system, respiratory system, digestive system, excretory/ urinary system etc.
The quantity/amount of desired/active Withanosides will be more when compared to the same amount of crude drug (root) powder. Moreover, crude drug powder loses its effect in 6 to 12 months, whereas extract remain stable for 5 to 7 years, even if stored at room temperature.
Hence, the present inventors have come up with a process wherein the enriched extract of Ashwagandha (Withania somnifera) roots containing Withanosides IV and Withanosides V can be achieved. The invention further discloses a pharmaceutical composition comprising Withanosides IV and Withanosides V along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
OBJECT OF THE INVENTION:
Thus, the object of the present invention is to provide a process for extraction of active constituents i.e. Withanosides IV and Withanosides V from Ashwagandha (Withania somnifera) roots and a pharmaceutical composition comprising said Withanosides, along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
SUMMARY OF THE INVENTION:
The present invention discloses a process for extraction of Withanosides JV and Withanosides V from Ashwagandha (Withania somnifera) roots, comprising the following six major steps:-
1. Sorting and sieving of roots, to remove dust & contaminants
2. Pulverization of roots
3. Cold extraction and filtration
4. Hot extraction and filtration
5. Concentration of extract
6. Drying of extract
The present invention further discloses the pharmaceutical composition comprising Withanosides IV and Withanosides V, along with pharmaceutically acceptable excipients, useful for relieving anxiety and stress.
BRIEF DESCRIPTION OF FIGURE:
FIG 1 : Flow chart for Extraction of Ashwagandha.
DETAILED DESCRIPTION OF THE INVENTION:
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated.
The plant material used in the present invention i.e. Ashwagandha {Withania somnifera) roots are collected from northern, western and central parts of India.
In an embodiment, the present invention provides a process for extraction of active constituents i.e. Withanoside IV and Withanoside V from Ashwagandha {Withania somnifera) roots. The extract is standardized to contain Withanoside IV and Withanoside
V within the range of not less than 0.8 % and not less than 0.4 % respectively.
In a preferred embodiment, a process for extraction of Withanoside IV and Withanoside
V from Ashwagandha {Withania somnifera) roots comprises following steps^
a) Sorting and sieving of roots to remove dust and contaminants;
b) pulverizing of roots to obtain pulverized powder;
c) cold extraction of pulverized powder of step (b) with polar solvent followed by centrifuging to obtain the residue;
d) subjecting to hot extraction of residue obtained in step (c) by adding it to polar solvent followed by refluxing and centrifuging;
e) collecting the filtrates of step (c) and step (d) after centrifugation, followed by distillation to obtain an extract;
f) adding and mixing methyl paraben IP, Propyl paraben IP, dicalcium phosphate anhydrous IP and Colloidal silicone Dioxide IP to the extract of step (e) to obtain pasty mass;
g) transferring the pasty mass of step (f) to evaporator, followed by stirring and heating to obtain granular powder of 30 to 60 mesh.
Accordingly, in another preferred embodiment, the present invention provides a process for extraction of active constituents i.e. Withanoside IV and Withanoside V from Ashwagandha {Withania somnifera) roots, comprises the following steps:-
Step 1: Sorting and sieving of roots to remove dust and contaminants
Ashwagandha roots are cut into small pieces and spread on SS sieve of size 10 mesh to 30 mesh. The contaminants, infected roots or adhered dust etc. from the roots are removed by sieving or simply by hand picking. After sorting and sieving, roots are filled in clean bag for Pulverization.
Step 2: Pulverization of roots
Suitable commercial pulverization machine with 30 to 60 mesh sieve is used for pulverization and plastic bag is used for collecting the pulverized material.
Step 3: Cold extraction and filtration
Mixing and stirring fixed quantity of pulverized Ashwagandha powder of Step 2 with sufficient quantity of polar solvent in first vessel. Heating the mixture from RT to below boiling point and maintain there for a period of 8 to 15 hours with continuous stirring. Cool the mixture at room temperature followed by centrifugation (I) to obtained residue. The filtrate of centrifuge (I) is taken in a second vessel for concentration. The residue is charged to first vessel for hot extraction.
Step 4: Hot extraction and filtration
The residue obtained from Step 3 is added to the first vessel containing enough of polar solvent (as used before) (30% recovered polar solvent and 70% fresh polar solvent, wherein the recovered polar solvent is from Ashwagandha of previous batch), followed by heating and refluxing at from 60°C to 100°C over a period of 1 to 4 hours. The mixture is cooled to R.T and discharged the mass in SS tank followed by centrifugation (11). After centrifuge, the filtrate is added to the second vessel of Step 3.
Step 5: Concentration of extract
The filtrates of Step 3 and Step 4 are collecting in second vessel and heating slowly and further raising the temperature of mixture to distill out polar solvent, followed by cooling to R.T. Discharging pasty mass in previously weighed SS storage tank. The test sample is sent for quality control and to the extract obtained is added methyl paraben IP, Propyl paraben IP and mixed well followed by addition of Dicalcium phosphate anhydrous IP and
Colloidal silicon dioxide IP in the quantity based on analysis of test sample and total quantity of the extract, and further mixing well to get the pasty mass.
Step 6: Drying of extract
Transferring the pasty mass of Step 5 to evaporator, followed by stirring and heating from RT to 100°C, till it is converted into granular powder. Cool to R.T. Passing the granular powder from pulvarizer or multimill, to get the final dry powder of 30 to 60 mesh.
The polar solvent used in the abovementioned process is selected from lower alcohols such as methanol, ethanol, acetone, isopropyl alcohol etc., ketones such as acetone, methyl ethyl ketone, diethyl ketone, ethyl butyl ketone etc., ethers such as dimethyl ether, diethyl ether, tetrahydrofuran (THF) etc.
The polar solvent used in the abovementioned process is preferably methanol.
The desired percentages of Withanoside IV and Withanoside V extracted from Ashwagandha (Withania somniferd) roots are NLT 0.8 % and NLT 0.4 % respectively.
In another embodiment of the present invention, the active constituents Withanoside IV and Withanoside V, along with pharmaceutically acceptable excipients are formulated into pharmaceutical composition and oral dosage form.
Accordingly, the pharmaceutically acceptable excipients are selected from the group comprising diluents, binders, wetting agents, disintegrants and lubricants.
Suitable excipients such as Lactose, Starch, Sodium starch glycolate, AC.Disol, Talcum, Magnesium stearate etc. can be used.
In another embodiment of the present invention, the active constituents Withanoside IV and Withanoside V are mixed with other suitable diluents and disintegrants; followed by granulation with appropriate binding agent, dried, lubricated and compressed into tablet or capsule.
Accordingly, pharmaceutical composition of the present invention is in the form of tablet, powder, syrup or capsule.
In another embodiment of the present invention, the pharmaceutical compositions comprising Withanoside IV and Withanoside V are used for relieving anxiety and stress.
In another embodiment of the present invention, the amounts of active constituents such as Withanoside IV and Withanoside V are analyzed by using HPLC method. The results are shown in Table 1.
In another embodiment of the present invention, the presence of residual polar solvent, in final dried extract is analyzed by using GC method. The specifications of residual solvents are shown in Table 2.
In another embodiment of the present invention, trial batches using various polar solvents were analyzed for the presence of Withanoside IV and Withanoside V. The results are shown in Table 3.
Table 1 : Results of HPLC Analysis:
EXAMPLES:-
The following example, which includes preferred embodiments, will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purpose of illustrative discussion of preferred embodiments of the invention.
Example 1: Extraction of Ashwagandha roots
Ashwagandha roots were cut into small pieces and spread on 20 mesh SS sieve to remove dust and contaminants. Pulverize the said roots through pulverization machine with 50 mesh sieve to obtain pulverized powder. Mixed and stirred the said pulverized powder with methanol and heated to about 40°C for 12 hours with continuous stirring. Cool the mixture at R.T and centrifuged (1) it, to obtain the residue. Then subjecting to hot extraction of the residue by adding methanol, followed by heating and refluxing at 95°C for 2 hrs. The mixture is cooled to R.T and discharged the mass followed by centrifugation (II). Collected both the filtrates and heated to distill out methanol, followed by cooling to R.T. to obtain an extract. Added and mixed methyl paraben IP, Propyl paraben IP, dicalcium phosphate anhydrous IP and Colloidal silicone Dioxide IP to the extract and mixed well to obtain pasty mass. Transferred the said pasty mass to evaporator, followed by stirring and heating to 90 - 95°C, till it is converted into granular powder. Passed the granular powder from pulvarizer or multimill, to get the final dry powder of 50 to 60 mesh.
Specification of Ashwagandha extract:
Results of 3 trials based on HPLC analysis are summarized as follows:
Solvent by (Limit: NLT 3000ppm) (Limit: NLT 3000ppm) (Limit: NLT 3000ppm) GC
7. Withanoside 1.50% 1.31% 1.15%
(a) IV (Limit: NLT 0.8%) (Limit: NLT 0.8%) (Limit: NLT 0.8%)
7. Withanoside 0.92% 0.82% 0.91%
(b) V (Limit: NLT 0.4) (Limit: NLT 0.4) (Limit: NLT 0.4)
8. Arsenic Less than 7ppm Less than 7ppm Less than 7ppm
(Limit: Less than 7ppm) (Limit: Less than 7ppm) (Limit: Less than 7ppm
9. Heavy metal ί Less than 50ppm Less than 50ppm Less than 50ppm
(Limit: Less than 50 ppm) (Limit: Less than 50 ppm) (Limit: Less than 50 ppm)
10. Microbial Complies as per Report No. Complies as per Report Complies as per Report Limit Test MGB/BED/430 No. MGB/BED/431 No. MGB/BED/432
(Limit: (Limit: (Limit:
Total Aerobic count: Total Aerobic count: Total Aerobic count:
<1000cfu/gm <1000cfu/gm <1000cfu/gm Yeast and mound: Yeast and mound: Yeast and mound: <100cfu/gm <100cfu/gm <100cfu/gm Coliforms: Should be Coliforms: Should be Coliforms: Should be negative negative negative
Salmonella/Shigolla/E.coli Salmonella/Shigolla/E.coli Salmonella/Shigolla/E.coli Should be negative Should be negative Should be negative
Example 2: Extraction of Ashwagandha roots
Ashwagandha roots were cut into small pieces and spread on 20 mesh SS sieve to remove
dust and contaminants. Pulverize the said roots through pulverization machine with 50
mesh sieve to obtain pulverized powder. Mixed and stirred the said pulverized powder
with ethanol and heated to about 40°C for 12 hours with continuous stirring. Cool the
mixture at R.T and centrifuged (I) it, to obtain the residue. Then subjecting to hot
extraction of the residue by adding ethanol, followed by heating and refluxing at 95°C for
2 hrs. The mixture is cooled to R.T and discharged the mass followed by centrifugation
(II). Collected both the filtrates and heated to distill out ethanol, followed by cooling to
R.T. to obtain an extract. Added and mixed methyl paraben IP, Propyl paraben IP,
dicalcium phosphate anhydrous IP and Colloidal silicone Dioxide IP to the extract and
mixed well to obtain pasty mass. Transferred the said pasty mass to evaporator, followed
by stirring and heating to 90 - 95°C, till it is converted into granular powder. Passed the
granular powder from pulvarizer or multimill, to get the final dry powder of 50 to 60
mesh.
Claims
1. A process for extraction of Withanoside IV and Withanoside V from Ashwagandha (Withania sotnnifera) roots comprises following steps:- a) Sorting and sieving of roots to remove dust and contaminants;
b) pulverizing of roots to obtain pulverized powder;
c) cold extraction of pulverized powder of step (b) with polar solvent followed by centrifuging to obtain the residue;
d) subjecting to hot extraction of residue obtained in step (c) by adding it to polar solvent followed by refluxing and centrifuging;
e) collecting the filtrates of step (c) and step (d) after centrifugation, followed by distillation to obtain an extract;
f) adding and mixing methyl paraben IP, Propyl paraben IP, dicalcium phosphate anhydrous IP and Colloidal silicone Dioxide IP to the extract of step (e) to obtain pasty mass;
g) transferring the pasty mass of step (f) to evaporator, followed by stirring and heating to obtain granular powder of 30 to 60 mesh.
2. The process for extraction of Withanoside IV and Withanoside V as claimed in claim 1 , wherein said polar solvent is selected from lower alcohols such as methanol, ethanol, acetone, isopropyl alcohol etc., ketones such as acetone, methyl ethyl ketone, diethyl ketone, ethyl butyl ketone etc., ethers such as dimethyl ether, diethyl ether, tetrahydrofuran (THF) etc.
3. The process for extraction of Withanoside IV and Withanoside V as claimed in claim 1, wherein said polar solvent is preferably methanol.
4. The pharmaceutical composition comprising Withanoside IV and Withanoside V obtained by process according to claim 1, along with pharmaceutically acceptable excipients.
5. The pharmaceutical composition according to claim 4, wherein said composition is formulated into oral dosage form.
6. The pharmaceutical composition according to claim 5, wherein said oral composition is in the form of tablet, powder, syrup or capsule.
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US12201641B2 (en) * | 2021-06-21 | 2025-01-21 | SpecNova LLC | Compositions comprising Withania Somnifera extract for mammalian consumption |
US20220409635A1 (en) * | 2021-06-21 | 2022-12-29 | SpecNova LLC | Novel composition |
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