CN1876009A - Hemostatic notoginseng chewing tablet and preparation method thereof - Google Patents
Hemostatic notoginseng chewing tablet and preparation method thereof Download PDFInfo
- Publication number
- CN1876009A CN1876009A CN 200610039982 CN200610039982A CN1876009A CN 1876009 A CN1876009 A CN 1876009A CN 200610039982 CN200610039982 CN 200610039982 CN 200610039982 A CN200610039982 A CN 200610039982A CN 1876009 A CN1876009 A CN 1876009A
- Authority
- CN
- China
- Prior art keywords
- extract
- herba euphorbiae
- notoginseng
- euphorbiae humifusae
- preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 235000003143 Panax notoginseng Nutrition 0.000 title claims abstract description 52
- 241000180649 Panax notoginseng Species 0.000 title claims abstract description 52
- 230000001055 chewing effect Effects 0.000 title claims abstract description 26
- 230000002439 hemostatic effect Effects 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 239000000284 extract Substances 0.000 claims abstract description 51
- 239000000463 material Substances 0.000 claims abstract description 12
- 239000000945 filler Substances 0.000 claims abstract description 9
- 239000000796 flavoring agent Substances 0.000 claims abstract description 8
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 3
- 239000003826 tablet Substances 0.000 claims description 31
- 239000000843 powder Substances 0.000 claims description 27
- 239000007962 solid dispersion Substances 0.000 claims description 17
- 239000008187 granular material Substances 0.000 claims description 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 12
- 235000003181 Panax pseudoginseng Nutrition 0.000 claims description 10
- 244000131316 Panax pseudoginseng Species 0.000 claims description 10
- 239000007910 chewable tablet Substances 0.000 claims description 10
- 229940068682 chewable tablet Drugs 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 10
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 9
- 229930195725 Mannitol Natural products 0.000 claims description 9
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 claims description 9
- 239000000594 mannitol Substances 0.000 claims description 9
- 235000010355 mannitol Nutrition 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 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 claims description 7
- 239000008101 lactose Substances 0.000 claims description 7
- 108010010803 Gelatin Proteins 0.000 claims description 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 6
- 239000011230 binding agent Substances 0.000 claims description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 6
- 239000008273 gelatin Substances 0.000 claims description 6
- 229920000159 gelatin Polymers 0.000 claims description 6
- 235000019322 gelatine Nutrition 0.000 claims description 6
- 235000011852 gelatine desserts Nutrition 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
- 239000008118 PEG 6000 Substances 0.000 claims description 5
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims description 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- 241001597008 Nomeidae Species 0.000 claims description 4
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- 229920003081 Povidone K 30 Polymers 0.000 claims description 4
- -1 Stepanol MG Chemical compound 0.000 claims description 4
- 239000000706 filtrate Substances 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 229920000642 polymer Polymers 0.000 claims description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 4
- 239000002904 solvent Substances 0.000 claims description 4
- 230000006837 decompression Effects 0.000 claims description 3
- 238000004108 freeze drying Methods 0.000 claims description 3
- 239000007921 spray Substances 0.000 claims description 3
- 238000001694 spray drying Methods 0.000 claims description 3
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 229920001661 Chitosan Polymers 0.000 claims description 2
- 239000004375 Dextrin Substances 0.000 claims description 2
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 229920003082 Povidone K 90 Polymers 0.000 claims description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims description 2
- 235000010489 acacia gum Nutrition 0.000 claims description 2
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 2
- 230000002378 acidificating effect Effects 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims description 2
- 125000003118 aryl group Chemical group 0.000 claims description 2
- 239000001913 cellulose Substances 0.000 claims description 2
- 235000010980 cellulose Nutrition 0.000 claims description 2
- 229920002678 cellulose Polymers 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 2
- PXEDJBXQKAGXNJ-QTNFYWBSSA-L disodium L-glutamate Chemical compound [Na+].[Na+].[O-]C(=O)[C@@H](N)CCC([O-])=O PXEDJBXQKAGXNJ-QTNFYWBSSA-L 0.000 claims description 2
- 238000006253 efflorescence Methods 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 235000013923 monosodium glutamate Nutrition 0.000 claims description 2
- 229920005615 natural polymer Polymers 0.000 claims description 2
- 206010037844 rash Diseases 0.000 claims description 2
- 239000000741 silica gel Substances 0.000 claims description 2
- 229910002027 silica gel Inorganic materials 0.000 claims description 2
- 235000010413 sodium alginate Nutrition 0.000 claims description 2
- 239000000661 sodium alginate Substances 0.000 claims description 2
- 229940005550 sodium alginate Drugs 0.000 claims description 2
- 229940073490 sodium glutamate Drugs 0.000 claims description 2
- 235000013599 spices Nutrition 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- 229940013618 stevioside Drugs 0.000 claims description 2
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims description 2
- 235000019202 steviosides Nutrition 0.000 claims description 2
- 238000001291 vacuum drying Methods 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 9
- 241000221079 Euphorbia <genus> Species 0.000 abstract 1
- 239000007767 bonding agent Substances 0.000 abstract 1
- 235000019634 flavors Nutrition 0.000 description 5
- 238000002156 mixing Methods 0.000 description 5
- 230000001476 alcoholic effect Effects 0.000 description 4
- 239000006071 cream Substances 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000004078 waterproofing Methods 0.000 description 4
- UFNDONGOJKNAES-UHFFFAOYSA-N Ginsenoside Rb1 Natural products CC(=CCCC(C)(OC1OC(COC2OC(CO)C(O)C(O)C2O)C(O)C(O)C1O)C3CCC4(C)C3C(O)CC5C6(C)CCC(OC7OC(CO)C(O)C(O)C7OC8OC(CO)C(O)C(O)C8O)C(C)(C)C6CC(O)C45C)C UFNDONGOJKNAES-UHFFFAOYSA-N 0.000 description 3
- GZYPWOGIYAIIPV-JBDTYSNRSA-N ginsenoside Rb1 Chemical compound C([C@H]1O[C@H]([C@@H]([C@@H](O)[C@@H]1O)O)O[C@@](C)(CCC=C(C)C)[C@@H]1[C@@H]2[C@@]([C@@]3(CC[C@H]4C(C)(C)[C@@H](O[C@H]5[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O5)O[C@H]5[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O5)O)CC[C@]4(C)[C@H]3C[C@H]2O)C)(C)CC1)O[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O GZYPWOGIYAIIPV-JBDTYSNRSA-N 0.000 description 3
- TXEWRVNOAJOINC-UHFFFAOYSA-N ginsenoside Rb2 Natural products CC(=CCCC(OC1OC(COC2OCC(O)C(O)C2O)C(O)C(O)C1O)C3CCC4(C)C3C(O)CC5C6(C)CCC(OC7OC(CO)C(O)C(O)C7OC8OC(CO)C(O)C(O)C8O)C(C)(C)C6CCC45C)C TXEWRVNOAJOINC-UHFFFAOYSA-N 0.000 description 3
- YURJSTAIMNSZAE-HHNZYBFYSA-N ginsenoside Rg1 Chemical compound O([C@@](C)(CCC=C(C)C)[C@@H]1[C@@H]2[C@@]([C@@]3(C[C@@H]([C@H]4C(C)(C)[C@@H](O)CC[C@]4(C)[C@H]3C[C@H]2O)O[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)C)(C)CC1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O YURJSTAIMNSZAE-HHNZYBFYSA-N 0.000 description 2
- 239000008678 sanqi Substances 0.000 description 2
- RWXIFXNRCLMQCD-CZIWJLDFSA-N (20R)-ginsenoside Rg3 Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@H]1CC[C@]2(C)[C@H]3C[C@@H](O)[C@H]4[C@@]([C@@]3(CC[C@H]2C1(C)C)C)(C)CC[C@@H]4[C@](C)(O)CCC=C(C)C)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O RWXIFXNRCLMQCD-CZIWJLDFSA-N 0.000 description 1
- RWXIFXNRCLMQCD-JBVRGBGGSA-N (20S)-ginsenoside Rg3 Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@H]1CC[C@]2(C)[C@H]3C[C@@H](O)[C@H]4[C@@]([C@@]3(CC[C@H]2C1(C)C)C)(C)CC[C@@H]4[C@@](C)(O)CCC=C(C)C)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O RWXIFXNRCLMQCD-JBVRGBGGSA-N 0.000 description 1
- CKUVNOCSBYYHIS-SUEBGMEDSA-N (2r,3r,4s,5s,6r)-2-[[(3s,5r,8r,9r,10r,12r,13r,14r,17s)-12-hydroxy-17-[(2r)-2-hydroxy-6-methylhept-5-en-2-yl]-4,4,8,10,14-pentamethyl-2,3,5,6,7,9,11,12,13,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-3-yl]oxy]-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O([C@H]1CC[C@]2(C)[C@H]3C[C@@H](O)[C@H]4[C@@]([C@@]3(CC[C@H]2C1(C)C)C)(C)CC[C@@H]4[C@](C)(O)CCC=C(C)C)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O CKUVNOCSBYYHIS-SUEBGMEDSA-N 0.000 description 1
- XIRZPICFRDZXPF-GCIIHGAUSA-N 20(R)-Ginsenoside Rg3 Natural products CC(=CCC[C@](C)(O)[C@H]1CC[C@]2(C)[C@@H]1[C@H](O)C[C@@H]3[C@@]4(C)CC[C@H](O[C@@H]5O[C@H](CO)[C@@H](O)[C@H](O)[C@H]5O[C@H]6O[C@@H](CO)[C@H](O)[C@@H](O)[C@@H]6O)C(C)(C)[C@@H]4[C@@H](O)C[C@@]23C)C XIRZPICFRDZXPF-GCIIHGAUSA-N 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- XIRZPICFRDZXPF-UHFFFAOYSA-N Ginsenoside Rg3 Natural products CC(C)=CCCC(C)(O)C1CCC(C2(CC(O)C3C4(C)C)C)(C)C1C(O)CC2C3(C)CCC4OC1OC(CO)C(O)C(O)C1OC1OC(CO)C(O)C(O)C1O XIRZPICFRDZXPF-UHFFFAOYSA-N 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- YURJSTAIMNSZAE-UHFFFAOYSA-N UNPD89172 Natural products C1CC(C2(CC(C3C(C)(C)C(O)CCC3(C)C2CC2O)OC3C(C(O)C(O)C(CO)O3)O)C)(C)C2C1C(C)(CCC=C(C)C)OC1OC(CO)C(O)C(O)C1O YURJSTAIMNSZAE-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 229940089161 ginsenoside Drugs 0.000 description 1
- 229930182494 ginsenoside Natural products 0.000 description 1
- CBEHEBUBNAGGKC-UHFFFAOYSA-N ginsenoside Rg1 Natural products CC(=CCCC(C)(OC1OC(CO)C(O)C(O)C1O)C2CCC3(C)C2C(O)CC4C5(C)CCC(O)C(C)(C)C5CC(OC6OC(CO)C(O)C(O)C6O)C34C)C CBEHEBUBNAGGKC-UHFFFAOYSA-N 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 210000001779 taste bud Anatomy 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a hemostatic chewing tablet and method for preparation, wherein the chewing tablet comprises (by weight percent) notoginseng 5.0-15%, creeping euphorbia extract 20-40%, macromolecular material 15-40%, filling agent 15-40%, flavoring agent 0.5-2.5%, bonding agent 1.5-2.5% and flow aid 0.4-1.0%.
Description
Technical field:
The invention belongs to pharmaceutical field, relate to a kind of hemostatic notoginseng chewing tablet and preparation method thereof.
Background technology:
Radix Notoginseng hemostasis and pain-relieving, blood circulation promoting and blood stasis dispelling, Herba Euphorbiae Humifusae heat-clearing and toxic substances removing, anti-inflammation, astringing to arrest bleeding, the compound preparation of being made up of this two flavors medicine mainly contains SANQI ZHIXUE PIAN (coated tablet), hemostatic notoginseng capsuel.The ordinary tablet prescription and the method for making of SANQI ZHIXUE PIAN are: Herba Euphorbiae Humifusae 1250g, Radix Notoginseng 62g, method for making: Radix Notoginseng powder is broken into fine powder, Herba Euphorbiae Humifusae decocts with water secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is condensed into cream, adds Radix Notoginseng fine powder and right amount of auxiliary materials, mixing, make granule, dry below 60 ℃, be pressed into 1000 promptly.Conventional tablet, capsule are thick extractum and directly granulate, through the dissolution test, and all not disintegrates in the 1hr, bioavailability is low, and taste hardship, puckery, makes the patient be difficult to adhere to taking for a long time.
Summary of the invention:
The purpose of this invention is to provide the hemostatic notoginseng chewing tablet that a kind of mouthfeel is good, bioavailability is high.
A further object of the invention provides the preparation method of above-mentioned hemostatic notoginseng chewing tablet.
The objective of the invention is to realize by following technical measures:
A kind of hemostatic notoginseng chewing tablet, this chewable tablet prescription is by weight percentage:
Radix Notoginseng 5.0～15%
Herba Euphorbiae Humifusae extract 20～40%
Macromolecular material 15～40%
Filler 15～40%
Correctives 0.5～2.5%
Binding agent 1.5～2.5%
Fluidizer 0.4～1.0%.
Described hemostatic notoginseng chewing tablet, wherein the form of being used as medicine of Herba Euphorbiae Humifusae extract is the solid dispersion or the wrappage of Herba Euphorbiae Humifusae water extract; The form of being used as medicine of Radix Notoginseng is the ultra micro efflorescence fine powder of pseudo-ginseng, and fine powder is crossed 200 orders～400 mesh sieves.
Described hemostatic notoginseng chewing tablet, wherein macromolecular material is selected from one or more in the following natural or synthetic high polymer pharmaceutic adjuvant, and natural polymer medical adjuvant comprises gelatin, arabic gum, sodium alginate, cellulose or cellulosic derivant, chitosan; The synthetic high polymer pharmaceutic adjuvant comprises Polyethylene Glycol, polyvinylpyrrolidone or beta-schardinger dextrin-and derivant thereof.These macromolecular materials are as the solid dispersion carrier or the lapping of preparation Herba Euphorbiae Humifusae extract solid dispersion or wrappage.
Described hemostatic notoginseng chewing tablet, wherein Polyethylene Glycol is PEG4000, PEG6000, PEG12000 or PEG60000; Polyvinylpyrrolidone is PVP-K15, PVP-K30, PVP-K60 or PVP-K90.
Described hemostatic notoginseng chewing tablet, wherein filler is one or several in lactose, mannitol, microcrystalline Cellulose, dextrin, the starch; Binding agent is PVP-K30; Correctives is sweeting agent, acidic flavoring agent or the aromatic of natural or synthetic; Fluidizer is magnesium stearate, micropowder silica gel, Stepanol MG, Pulvis Talci.
Described hemostatic notoginseng chewing tablet, wherein correctives is one or several in stevioside, Aspartane, citric acid, essence, spice or the sodium glutamate.
The preparation method of described hemostatic notoginseng chewing tablet, this method comprises the following steps:
(1) preparation of Herba Euphorbiae Humifusae extract:
Getting Herba Euphorbiae Humifusae adds 8～10 times of decoctings and boils secondary, decocting time is 2～2.5 hours for the first time, 1～1.5 hour for the second time, collecting decoction filters, and filtrate decompression is condensed into thick extractum (60 ℃ time relative density be 1.25～1.30), again 60～80 ℃ of drying under reduced pressure of thick extractum are become dry extract, pulverized 100 mesh sieves and got the extract dry extract, or thick extractum was spray dried to dry extract, standby;
(2) preparation of the solid dispersion of Herba Euphorbiae Humifusae extract or wrappage:
Earlier macromolecular material is dissolved in solvent, solvent is a water, the macromolecular material of the every 10ml dissolving of consumption 150～300mg, again Herba Euphorbiae Humifusae extract dry extract and an amount of filler, correctives are added, stir, make to be uniformly dispersed, the liquid that obtains maintains the temperature under 40～60 ℃ of conditions standby, dry then, obtain Herba Euphorbiae Humifusae extract solid dispersion or wrappage;
(3) with micronizing technology pseudo-ginseng is handled preparation Radix Notoginseng fine powder:
Pseudo-ginseng is cleaned up, dry in the rearmounted super micron mill and pulverize, cross 200 orders～400 mesh sieves and promptly get the Radix Notoginseng fine powder;
(4) preparation hemostatic notoginseng chewing tablet:
With Herba Euphorbiae Humifusae extract solid dispersion or wrappage and the adding of Radix Notoginseng fine powder filler, correctives and binding agent, granulate oven dry with 75～95% concentration ethanol solution, bake out temperature is at 60～70 ℃, and granulate adds fluidizer, compacting is wrapped with the waterproof film-coat promptly in flakes then.
The preparation method of described hemostatic notoginseng chewing tablet, wherein drying means is spray drying, lyophilization, vacuum drying or microwave drying in the preparation process of the solid dispersion of Herba Euphorbiae Humifusae extract or wrappage.
Beneficial effect of the present invention:
Through the chewable tablet that technology of the present invention is made, good mouthfeel in vivo, disintegrate rapidly in external 1 minute, improves bioavailability and drug effect greatly, and can improve stability of drug.
(1) the Herba Euphorbiae Humifusae extract flavor is bigger, use drying process with atomizing to prepare the solid dispersion or the wrappage of Herba Euphorbiae Humifusae extract, wrap up Herba Euphorbiae Humifusae extract with macromolecular material, reducing extract and the direct of taste bud contacts, thereby improve mouthfeel, reach the purpose of flavoring, can make the patient be easy to accept.
(2) Radix Notoginseng changes into fine powder through superfine powder, improves bioavailability;
(3) hemostatic notoginseng chewing tablet has improved bioavailability on the whole:
Test group: chewable tablet; (preparing) according to embodiment 1
Matched group: ordinary tablet
Instructions of taking: chewable tablet is chewed and is taken after broken or swallow; Ordinary tablet is swallowed.
Result of the test:
1, the pharmacokinetic study of Radix Notoginseng total arasaponins
With ginsenoside Rb1 and ginsenoside Rg1 is object of study, and both can both describe with two Room models as a result, the results are shown in Table 1.
Table 1 Radix Notoginseng total arasaponins pharmacokinetics result
| Chewable tablet | Ordinary tablet | ||
| The ginsenoside Rb1 | t max | 30min | 1.5h |
| t 1/2(α) | 36.7min | 22.4min | |
| t 1/2(β) | 21.5h | 17.06h | |
| Bioavailability | 55.47％ | 39.22％ | |
| The ginsenoside Rg 1 | t max | 22min | 1.0h |
| t 1/2(α) | 32.4min | 24.0min | |
| t 1/2(β) | 16.7h | 14.3h | |
| Bioavailability | 28.2％ | 16.7％ | |
2,20 (R)-ginsenoside Rgs
3Pharmacokinetic study
The ginsenoside Rg3 is ginsenoside Rb1's an acid degradation product.Studied 20 (R)-ginsenoside Rg3 human body internal dynamics processes with high performance liquid chromatography, drug-time curve is the two-compartment model that time lag is arranged in the time of oral 3 after absorbing, and the results are shown in Table 2.
Table 2 ginsenoside Rg
3Pharmacokinetics result
| Chewable tablet | Ordinary tablet | |
| t max | (0.32±0.04)h | (0.66±0.10)h |
| C max | (32±3)ng/mL | (16±6)ng/mL |
| t 1/2(α) | (0.51±0.14)h | (0.46±0.12)h |
| t 1/2(β) | (5.3±0.7h | (4.9±1.1)h |
| t 1/2(ka) | (0.31±0.06)h | (0.28±0.04)h |
| AUC | (109±234)ng/mL/h | (77±266)ng/mL/h |
By experimental result as can be known, this chewable tablet is compared with ordinary tablet, peak time (t
Max) fast, maximum plasma concentration (C
Max) height, the area under curve during peak (AUC) is also big, hence one can see that, make chewable tablet after, rapid-action, the bioavailability height.
Bioavailability according to the Radix Notoginseng chewable tablet of embodiment 2-4 preparation also has similar result.
The specific embodiment
The present invention is described further by the following non-limiting example that provides.
Herba Euphorbiae Humifusae extract prepares according to following method in following examples:
Get Herba Euphorbiae Humifusae 125g, add 8～10 times of decoctings and boil secondary, decocting time is 2～2.5 hours for the first time, 1～1.5 hour for the second time, collecting decoction filters, and filtrate decompression is condensed into thick extractum (60 ℃ time relative density be 1.25～1.30), again 60～80 ℃ of drying under reduced pressure of thick extractum are become dry extract, pulverized 100 mesh sieves and get the extract dry extract; Or thick extractum is spray dried to dry extract, standby.
Embodiment 1:
Pseudo-ginseng is cleaned up, dry in the rearmounted super micron mill and pulverize, it is standby that mistake 200 mesh sieves get the Radix Notoginseng fine powder;
Get gelatin 15g, add 900ml water heated and stirred gelatin is dissolved fully, again Herba Euphorbiae Humifusae extract 25g is added, stir, make to be uniformly dispersed; Add 10g mannitol again, 4g lactose and 0.6g Aspartane are stirred to dissolving fully; Maintain the temperature at 40～60 ℃, be dried to fine powder, get the Herba Euphorbiae Humifusae extract wrappage with spray drying method;
The Herba Euphorbiae Humifusae extract wrappage of gained is added 6.2g Radix Notoginseng fine powder, 4g lactose, 10g mannitol, 1.8gPVP-K30,0.2g Aspartane, 0.2g coffee aroma mix homogeneously is granulated with an amount of 95% alcoholic solution, 60 ℃ of oven dry, granulate adds 0.4g magnesium stearate mixing then; Be pressed into 100, wrap up the waterproofing membrane clothing more promptly.
Embodiment 2:
Pseudo-ginseng is cleaned up, dry in the rearmounted super micron mill and pulverize, it is standby that mistake 200 mesh sieves get the Radix Notoginseng fine powder;
Get gelatin 25g, add 900ml water heated and stirred gelatin is dissolved fully, again Herba Euphorbiae Humifusae extract 20g is added, stir, make to be uniformly dispersed; Add 10g mannitol again, 4g lactose and 0.6g Aspartane maintain the temperature at 40～60 ℃, are stirred to dissolving fully; Be dried to fine powder with freeze-drying, get the Herba Euphorbiae Humifusae extract wrappage;
The Herba Euphorbiae Humifusae extract wrappage is added 8g Radix Notoginseng fine powder, 4g lactose, 5g microcrystalline Cellulose, 1.8g PVP-K30,0.2g Aspartane, 0.2g cream flavour mix homogeneously; Granulate with an amount of 95% alcoholic solution, 60 ℃ of oven dry, granulate adds 0.4g magnesium stearate mixing then; Be pressed into 100, wrap up the waterproofing membrane clothing more promptly.
Embodiment 3:
Pseudo-ginseng is cleaned up, dry in the rearmounted super micron mill and pulverize, it is standby that mistake 200 mesh sieves get the Radix Notoginseng fine powder;
Get PEG600030g, add 900ml water heated and stirred PEG6000 is dissolved fully, again Herba Euphorbiae Humifusae extract 25g is added, stir, make to be uniformly dispersed; Add 5g mannitol again, the 0.6g Aspartane is stirred to dissolving fully; Maintain the temperature at 40～60 ℃, use the boulton process drying, be ground into fine powder again, get the Herba Euphorbiae Humifusae extract solid dispersion;
The Herba Euphorbiae Humifusae extract solid dispersion is added 10g Radix Notoginseng fine powder, 5g mannitol, 5g lactose, 5g microcrystalline Cellulose, 1.8g PVP-K30,0.2g Aspartane, 0.3g cream flavour mix homogeneously; Granulate with an amount of 95% alcoholic solution, 60 ℃ of oven dry, granulate adds 0.4g magnesium stearate mixing then; Be pressed into 100, wrap up the waterproofing membrane clothing more promptly.
Embodiment 4:
Pseudo-ginseng is cleaned up, dry in the rearmounted super micron mill and pulverize, it is standby that mistake 200 mesh sieves get the Radix Notoginseng fine powder;
Get PEG6000 15g, PEG4000 10g adds 900ml water heated and stirred PEG6000, PEG4000 is dissolved fully, Herba Euphorbiae Humifusae extract 30g is added again, and stirs, and makes to be uniformly dispersed; Add 5g mannitol again, the 0.6g Aspartane is stirred to dissolving fully; Maintain the temperature at 40～60 ℃, use the boulton process drying, be ground into fine powder again, get the Herba Euphorbiae Humifusae extract solid dispersion;
The Herba Euphorbiae Humifusae extract solid dispersion is added 10g Radix Notoginseng fine powder, 5g mannitol, 5g microcrystalline Cellulose, 1.8gPVP-K30,0.3g Aspartane, 0.2g cream flavour mix homogeneously; Granulate with an amount of 95% alcoholic solution, 60 ℃ of oven dry, granulate adds 0.4g magnesium stearate mixing then; Be pressed into 100, wrap up the waterproofing membrane clothing more promptly.
Claims (8)
1, a kind of hemostatic notoginseng chewing tablet is characterized in that this chewable tablet prescription is by weight percentage:
Radix Notoginseng 5.0～15%
Herba Euphorbiae Humifusae extract 20～40%
Macromolecular material 15～40%
Filler 15～40%
Correctives 0.5～2.5%
Binding agent 1.5～2.5%
Fluidizer 0.4～1.0%.
2, hemostatic notoginseng chewing tablet according to claim 1, the form of being used as medicine that it is characterized in that Herba Euphorbiae Humifusae extract is the solid dispersion or the wrappage of Herba Euphorbiae Humifusae water extract; The form of being used as medicine of Radix Notoginseng is the ultra micro efflorescence fine powder of pseudo-ginseng, and fine powder is crossed 200 orders～400 mesh sieves.
3, hemostatic notoginseng chewing tablet according to claim 1, it is characterized in that macromolecular material is selected from one or more in the following natural or synthetic high polymer pharmaceutic adjuvant, natural polymer medical adjuvant comprises gelatin, arabic gum, sodium alginate, cellulose or cellulosic derivant, chitosan; The synthetic high polymer pharmaceutic adjuvant comprises Polyethylene Glycol, polyvinylpyrrolidone or beta-schardinger dextrin-and derivant thereof.
4, hemostatic notoginseng chewing tablet according to claim 3 is characterized in that Polyethylene Glycol is PEG4000, PEG6000, PEG12000 or PEG60000; Polyvinylpyrrolidone is PVP-K15, PVP-K30, PVP-K60 or PVP-K90.
5, hemostatic notoginseng chewing tablet according to claim 1 is characterized in that filler is one or several in lactose, mannitol, microcrystalline Cellulose, dextrin, the starch; Binding agent is PVP-K30; Correctives is sweeting agent, acidic flavoring agent or the aromatic of natural or synthetic; Fluidizer is magnesium stearate, micropowder silica gel, Stepanol MG, Pulvis Talci.
6, hemostatic notoginseng chewing tablet according to claim 5 is characterized in that correctives is one or several in stevioside, Aspartane, citric acid, essence, spice or the sodium glutamate.
7, the preparation method of the described hemostatic notoginseng chewing tablet of claim 1 is characterized in that being achieved through the following technical solutions:
(1) preparation of Herba Euphorbiae Humifusae extract:
Getting Herba Euphorbiae Humifusae adds 8～10 times of decoctings and boils secondary, decocting time is 2～2.5 hours for the first time, 1～1.5 hour for the second time, collecting decoction filters, and filtrate decompression is condensed into thick extractum (60 ℃ time relative density be 1.25～1.30), again 60～80 ℃ of drying under reduced pressure of thick extractum are become dry extract, pulverized 100 mesh sieves and got the extract dry extract, or thick extractum was spray dried to dry extract, standby;
(2) preparation of the solid dispersion of Herba Euphorbiae Humifusae extract or wrappage:
Earlier macromolecular material is dissolved in solvent, solvent is a water, the macromolecular material of the every 10ml dissolving of consumption 150～300mg, again Herba Euphorbiae Humifusae extract dry extract and an amount of filler, correctives are added, stir, make to be uniformly dispersed, the liquid that obtains maintains the temperature under 40～60 ℃ of conditions standby, dry then, obtain Herba Euphorbiae Humifusae extract solid dispersion or wrappage;
(3) with micronizing technology pseudo-ginseng is handled preparation Radix Notoginseng fine powder:
Pseudo-ginseng is cleaned up, dry in the rearmounted super micron mill and pulverize, cross 200 orders～400 mesh sieves and promptly get the Radix Notoginseng fine powder;
(4) preparation hemostatic notoginseng chewing tablet:
With Herba Euphorbiae Humifusae extract solid dispersion or wrappage and the adding of Radix Notoginseng fine powder filler, correctives and binding agent, granulate oven dry with 75～95% concentration ethanol solution, bake out temperature is at 60～70 ℃, and granulate adds fluidizer, compacting is wrapped with the waterproof film-coat promptly in flakes then.
8, the preparation method of hemostatic notoginseng chewing tablet according to claim 7 is characterized in that drying means is spray drying, lyophilization, vacuum drying or microwave drying in the preparation process of the solid dispersion of Herba Euphorbiae Humifusae extract or wrappage.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100399820A CN100536832C (en) | 2006-04-28 | 2006-04-28 | Hemostatic notoginseng chewing tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100399820A CN100536832C (en) | 2006-04-28 | 2006-04-28 | Hemostatic notoginseng chewing tablet and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1876009A true CN1876009A (en) | 2006-12-13 |
| CN100536832C CN100536832C (en) | 2009-09-09 |
Family
ID=37508678
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100399820A Active CN100536832C (en) | 2006-04-28 | 2006-04-28 | Hemostatic notoginseng chewing tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100536832C (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104257893A (en) * | 2014-10-13 | 2015-01-07 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of fructus mume and green tea antidiarrheal chewable tablet |
| CN104482720A (en) * | 2014-11-26 | 2015-04-01 | 浙江尖峰健康科技有限公司 | Low-temperature and low-pressure freeze-drying method of pseudo-ginseng chewable tablets |
| CN106176841A (en) * | 2016-08-17 | 2016-12-07 | 四川理工学院 | A kind of Penthorum chinense whole part mixing chewable tablet and preparation method thereof |
| CN108159294A (en) * | 2017-12-29 | 2018-06-15 | 河南健特生物科技集团有限公司 | Chewable tablets for improving gums healthy and preparation method thereof |
| CN110833561A (en) * | 2019-12-24 | 2020-02-25 | 正大制药（青岛）有限公司 | Omeprazole compound chewable tablet |
| CN112674300A (en) * | 2020-12-15 | 2021-04-20 | 四川安岳中柠柠檬产业技术研究有限公司 | Lemon chewable tablet and preparation method thereof |
-
2006
- 2006-04-28 CN CNB2006100399820A patent/CN100536832C/en active Active
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104257893A (en) * | 2014-10-13 | 2015-01-07 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of fructus mume and green tea antidiarrheal chewable tablet |
| CN104482720A (en) * | 2014-11-26 | 2015-04-01 | 浙江尖峰健康科技有限公司 | Low-temperature and low-pressure freeze-drying method of pseudo-ginseng chewable tablets |
| CN104482720B (en) * | 2014-11-26 | 2016-07-06 | 浙江尖峰健康科技有限公司 | A kind of low-temp low-pressure freeze-drying method of Radix Notoginseng chewable tablet |
| CN106176841A (en) * | 2016-08-17 | 2016-12-07 | 四川理工学院 | A kind of Penthorum chinense whole part mixing chewable tablet and preparation method thereof |
| CN108159294A (en) * | 2017-12-29 | 2018-06-15 | 河南健特生物科技集团有限公司 | Chewable tablets for improving gums healthy and preparation method thereof |
| CN110833561A (en) * | 2019-12-24 | 2020-02-25 | 正大制药（青岛）有限公司 | Omeprazole compound chewable tablet |
| CN112674300A (en) * | 2020-12-15 | 2021-04-20 | 四川安岳中柠柠檬产业技术研究有限公司 | Lemon chewable tablet and preparation method thereof |
| CN112674300B (en) * | 2020-12-15 | 2023-06-09 | 四川安岳中柠柠檬产业技术研究有限公司 | Lemon chewable tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100536832C (en) | 2009-09-09 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100536832C (en) | Hemostatic notoginseng chewing tablet and preparation method thereof | |
| JP2016539955A (en) | Drug composition, method for producing the same, and use | |
| WO2015081703A1 (en) | Solid dispersion containing desmodium styracifolium (osb.) merr. flavonoids, method of preparing same, and use thereof | |
| WO2022028084A1 (en) | Solid dispersion for treating cervical spondylosis and use thereof in preparation of sustained-release preparation | |
| CN1723945A (en) | Novel oral liquor for invigorating spleen, and prepn. method and quality control therefor | |
| CN1857587A (en) | Compound Chinese medicine preparation for clearing stomach heat, nourishing Yin and cooling blood and its preparing process | |
| CN1857650A (en) | Compound Chinese medicine preparation with function of clearing away heat and toxic matter, softening dry feces, dissipating mass, etc and its preparing process | |
| CN1823959A (en) | Heart vessel free flowing dispersion tablet and its preparation method | |
| CN1739601A (en) | Anticancer Chinese medicine prepn and its prepn process | |
| CN108272847A (en) | Fuxuekang granules and its preparation process | |
| CN1939410A (en) | Musk medicinal preparation | |
| CN1723959A (en) | Method for preparing medicine for treating cataclasis and soft tissue injury | |
| CN1857482A (en) | Compound Chinese medicine preparation for clearing away heat, drying damp, disinsecting and stopping itch and its preparing process | |
| CN111110642A (en) | Anoectochilus roxburghii polysaccharide dispersible tablet and preparation method thereof | |
| CN101919919A (en) | Fukean dispersible tablet and preparation method thereof | |
| CN111450138A (en) | Astragalus root effervescent tablet and preparation process thereof | |
| CN101766683B (en) | Salvia dispersible tablet and application thereof | |
| CN1850171A (en) | Method for preparing rhubarb formula granules | |
| CN1682966A (en) | Yunnan Manyleaf paris Rhizome extract ora disintegration tablet and its preparing process | |
| CN101579396A (en) | Euphorbia humifusa dispersing tablet and preparation process thereof | |
| CN101647930A (en) | Peltate leaf perhexiline oral cavity disintegrating tablet and preparation method thereof | |
| CN1562239A (en) | Lingdancao dispersion tablet and preparation method | |
| CN1723944A (en) | Traditional Chinese medicinal prepn. for tonifying kidney Yang and promoting the circulation of qi and water, and its prepn. method | |
| CN101890057A (en) | Herba Pteridis Multifidae preparation that treatment gastrointestinal tract, urinary tract infection and the heart, cerebrovascular disease are used and preparation method thereof | |
| CN1840030A (en) | Effervescence granule of beautyberry and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: HAINAN SELECTION PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: GUO PING Effective date: 20110518 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 210008 3/F, JINQIAO BUSINESS CENTER, NO. 77-2, BEIJING EAST ROAD, NANJING CITY, JIANGSU PROVINCE TO: 571124 NO. 6, SHUNDA ROAD, MEILAN DISTRICT, HAIKOU CITY, HAINAN PROVINCE |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20110518 Address after: 571124, Shunda Road, Meilan District, Hainan, Haikou, 6 Patentee after: Hainan sailike Pharmaceutical Co., Ltd. Address before: 210008, Jiangsu, Nanjing, Beijing East Road No. 77-2 Jinqiao business center on the third floor Patentee before: Guo Ping |