CN104585743B - A kind of Herba Cistanches effervescent tablet and its preparation process - Google Patents
A kind of Herba Cistanches effervescent tablet and its preparation process Download PDFInfo
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- CN104585743B CN104585743B CN201310534891.4A CN201310534891A CN104585743B CN 104585743 B CN104585743 B CN 104585743B CN 201310534891 A CN201310534891 A CN 201310534891A CN 104585743 B CN104585743 B CN 104585743B
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- herba cistanches
- lactose
- sodium bicarbonate
- effervescent tablet
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- 241000005787 Cistanche Species 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000007938 effervescent tablet Substances 0.000 title claims abstract description 13
- 239000000284 extract Substances 0.000 claims abstract description 27
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 34
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 33
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 27
- 235000019441 ethanol Nutrition 0.000 claims description 23
- 239000000843 powder Substances 0.000 claims description 23
- 238000002156 mixing Methods 0.000 claims description 22
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 18
- 239000002253 acid Substances 0.000 claims description 17
- 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 16
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 16
- 239000008101 lactose Substances 0.000 claims description 15
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 14
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 13
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 12
- 238000000605 extraction Methods 0.000 claims description 11
- 229960003511 macrogol Drugs 0.000 claims description 11
- 238000005469 granulation Methods 0.000 claims description 10
- 230000003179 granulation Effects 0.000 claims description 10
- 239000011975 tartaric acid Substances 0.000 claims description 10
- 235000002906 tartaric acid Nutrition 0.000 claims description 10
- 238000010992 reflux Methods 0.000 claims description 8
- 239000002245 particle Substances 0.000 claims description 6
- 239000000377 silicon dioxide Substances 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 5
- 230000002829 reductive effect Effects 0.000 claims description 5
- 238000007711 solidification Methods 0.000 claims description 5
- 230000008023 solidification Effects 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- 108010011485 Aspartame Proteins 0.000 claims description 4
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 4
- 239000000605 aspartame Substances 0.000 claims description 4
- 235000010357 aspartame Nutrition 0.000 claims description 4
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- 239000007788 liquid Substances 0.000 claims description 3
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 15
- 239000003814 drug Substances 0.000 abstract description 6
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- 239000000126 substance Substances 0.000 abstract description 4
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- 230000003712 anti-aging effect Effects 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 abstract description 3
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- 208000024827 Alzheimer disease Diseases 0.000 abstract description 2
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- 239000000470 constituent Substances 0.000 abstract 1
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- 230000004060 metabolic process Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 14
- 239000000945 filler Substances 0.000 description 9
- 239000000314 lubricant Substances 0.000 description 9
- 239000000047 product Substances 0.000 description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
- 235000020985 whole grains Nutrition 0.000 description 8
- UIIMBOGNXHQVGW-UHFFFAOYSA-N sodium;hydron;carbonate Chemical compound [Na+].OC(O)=O UIIMBOGNXHQVGW-UHFFFAOYSA-N 0.000 description 7
- 239000003513 alkali Substances 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 239000002202 Polyethylene glycol Substances 0.000 description 5
- 238000007908 dry granulation Methods 0.000 description 5
- 238000011835 investigation Methods 0.000 description 5
- 210000003734 kidney Anatomy 0.000 description 5
- 229920001223 polyethylene glycol Polymers 0.000 description 5
- 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 description 4
- 239000004375 Dextrin Substances 0.000 description 4
- 229920001353 Dextrin Polymers 0.000 description 4
- 229930195725 Mannitol Natural products 0.000 description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 4
- RCEAADKTGXTDOA-UHFFFAOYSA-N OS(O)(=O)=O.CCCCCCCCCCCC[Na] Chemical compound OS(O)(=O)=O.CCCCCCCCCCCC[Na] RCEAADKTGXTDOA-UHFFFAOYSA-N 0.000 description 4
- -1 benzyl carbinol glycoside Chemical class 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
- 229910052681 coesite Inorganic materials 0.000 description 4
- 229910052906 cristobalite Inorganic materials 0.000 description 4
- 235000019425 dextrin Nutrition 0.000 description 4
- 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 description 4
- 229930182470 glycoside Natural products 0.000 description 4
- 235000019359 magnesium stearate Nutrition 0.000 description 4
- 239000000594 mannitol Substances 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 239000008108 microcrystalline cellulose Substances 0.000 description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 229910052682 stishovite Inorganic materials 0.000 description 4
- 229910052905 tridymite Inorganic materials 0.000 description 4
- 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 description 3
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 210000004556 brain Anatomy 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000000706 filtrate Substances 0.000 description 3
- 238000007493 shaping process Methods 0.000 description 3
- 241000208340 Araliaceae Species 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 102100030703 Interleukin-22 Human genes 0.000 description 2
- FEWJPZIEWOKRBE-XIXRPRMCSA-N Mesotartaric acid Chemical compound OC(=O)[C@@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-XIXRPRMCSA-N 0.000 description 2
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 2
- 235000003140 Panax quinquefolius Nutrition 0.000 description 2
- 102000019197 Superoxide Dismutase Human genes 0.000 description 2
- 108010012715 Superoxide dismutase Proteins 0.000 description 2
- 230000032683 aging Effects 0.000 description 2
- 235000013339 cereals Nutrition 0.000 description 2
- 239000006071 cream Substances 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 235000008434 ginseng Nutrition 0.000 description 2
- 241000411851 herbal medicine Species 0.000 description 2
- 108010074109 interleukin-22 Proteins 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 229940100688 oral solution Drugs 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000001256 tonic effect Effects 0.000 description 2
- 208000014644 Brain disease Diseases 0.000 description 1
- 241000336291 Cistanche deserticola Species 0.000 description 1
- 241000336316 Cistanche tubulosa Species 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 241000372132 Hydrometridae Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010021928 Infertility female Diseases 0.000 description 1
- 206010027514 Metrorrhagia Diseases 0.000 description 1
- 240000007594 Oryza sativa Species 0.000 description 1
- 235000007164 Oryza sativa Nutrition 0.000 description 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 1
- 210000001744 T-lymphocyte Anatomy 0.000 description 1
- 201000004810 Vascular dementia Diseases 0.000 description 1
- 230000009102 absorption Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 238000000540 analysis of variance Methods 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- 230000003005 anti-senility effect Effects 0.000 description 1
- 230000006907 apoptotic process Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 125000005586 carbonic acid group Chemical group 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
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- 230000002708 enhancing effect Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 238000009313 farming Methods 0.000 description 1
- 210000003608 fece Anatomy 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 238000003304 gavage Methods 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 150000002338 glycosides Chemical class 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000007365 immunoregulation Effects 0.000 description 1
- 201000001881 impotence Diseases 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 210000003127 knee Anatomy 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 210000002540 macrophage Anatomy 0.000 description 1
- 239000002398 materia medica Substances 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 210000003061 neural cell Anatomy 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 230000001151 other effect Effects 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 235000019353 potassium silicate Nutrition 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 1
- 230000002787 reinforcement Effects 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 229930182490 saponin Natural products 0.000 description 1
- 150000007949 saponins Chemical class 0.000 description 1
- 230000036299 sexual function Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 description 1
- 235000014347 soups Nutrition 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
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- 210000001541 thymus gland Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a kind of Chinese medicine preparations of Herba Cistanches, and effervescent tablet is made using active constituent in cistanche extracts as raw material, by a certain proportion of bulk pharmaceutical chemicals and pharmaceutically acceptable carrier or auxiliary material in it.Drug of the present invention has significant adjusting immune function, anti-aging, protects liver, enhance memory, prevent senile dementia, boost metabolism.
Description
Technical field：
The present invention relates to a kind of health foods enhanced human immunity, and in particular to cistanche extracts and its effervesce
Piece.
Background technology：
Herba Cistanches are Chinese tradition parts of generic medicinal plants,《Chinese Pharmacopoeia》Version is recorded within 2010, is orobanchaceae plant cistanche
Cistanche deserticola Y.C.Ma's and Cistanche tubulosa Cistanche tubulosa (Schenk) wi ght is dry
The dry fleshy stem with scale leaf.Main product is in the Inner Mongol in China, one band of Xinjiang, Gansu and Ningxia, because growth is in desert, and has
There is fabulous medical value, is known as the good reputation of " desert ginseng ".The fleshy stem also known as Goblin, Jin Sun, desert of Herba Cistanches dry zone squama
Rong, big rue.First recorded in《Legendary god of farming's book on Chinese herbal medicine》, it is classified as top grade, it is classic thereafter《Bencao Jingshu》,《Collected statements on the herbal foundation》,《Japan hanako materia medica》
Deng how on the books.Li Shizhen (1518-1593 A.D.) is said：" this object is mended without high, therefore is had calmly ".Herba Cistanches are sweet in flavor, salty, warm-natured, tonifying kidney and strengthening yang,
Color macrobiosis and other effects is pleased in Tianjing Busuiye medicinal, enriching the blood to restore normal menstruation, is cured mainly under impotence in male, female sterility, band, metrorrhagia, waist and knee crymodynia, blood
Withered constipation etc..Having more than 2,000 years usage history in China, occurrence rate holds pride of place in successive dynasties reinforcement prescriptions of traditional Chinese medicine, and
It is only second to ginseng in anti-senility class prescription and accounts for second.
Chemical composition contained by Herba Cistanches includes：It is benzyl carbinol glycoside, iridoids, lignanoids, polysaccharide, alkaloid, micro-
A plurality of types of chemical compositions such as secondary element.Research reports that its main active benzyl carbinol glycoside just has more than 20 kinds of chemical combination
Object, iridoids are several there are about ten.
Pharmacological research shows that Herba Cistanches can adjust nervous system, anti-aging and antioxidation, be improved memory, exempt from
Many-sided medicines such as epidemic disease adjustment effect, anti-midbrain neural cells apoptosis, ischemic myocardial protection, improvement sexual function, liver protection, defecating feces excretion
Reason activity is widely used in clinic.It is super that Glycosides of Cistanche gavage can significantly improve the subacute aging mouse caused by D- galactolipins
The activity of superoxide dismutase (SOD) significantly reduces the lipid peroxide contents in brain, liver, shows that stronger antioxygen is turned into
With and anti-aging effects；The delayed allergy irradiated by C0-60 can also be enhanced, increase thymus index, increase T lymphocytes
Increment reaction and the activity for improving interleukin-22 (IL-2).Oral medication can obviously increase the ability of macrophage in mouse blood
And the weight of immune organ, display cistanche glycoside compound, which has, promotes immunoregulation effect.
Herba Cistanches sweet-salty, warm-natured matter moisten more liquid, return kidney, large intestine channel.The effect of having benefiting essence-blood, relaxing bowel is negative and positive
The product of two benefits.Motherland's medicine has accumulated abundant experience in terms for the treatment of brain disorder disease with Herba Cistanches,《The new side of doctor》
《Peaceful holy benevolent prescription》《General Records of Holy Universal Relief》《Bencao Shiyi》《Qianjin Yao Fang》In recorded Cistanchis Bolus, Herba Cistanches rice starched pill, Herba Cistanches dissipate,
Senile dementia, enhancing memory are treated all by the kidney tonifying marrow facilitatings such as Herba Cistanches congee, Herba Cistanches soup, gold lock positive element pellet, brain tonic and intelligence development side
There is fine curative effect.Modern Chinese herbal medicine " desert cistanche total saponin capsules " has obtained Chinese medicines quasi-word number, have kidney tonifying marrow facilitating, brain tonic and intelligence development it
Work(, the light moderate vascular dementia for marrow sea deficiency card.Separately with Herba Cistanches product as main component have " red rue oral solution ",
" Qi rue oral solution ", " four times of balls of desert cistanche ", the aging feature that human body can be significantly improved with electuary made of cistanche extracts etc.,
Restore the energy and muscle power of kidney deficiency person in middle and old age, all there is preferable delaying senility function.But it has not yet to see independent with Herba Cistanches
Medicinal material is effervescent tablet made of raw material.
The present invention using Herba Cistanches as raw material, be made using sodium bicarbonate and organic acid meet water can release great amount of carbon dioxide and
At the tablet of effervesce shape, this dosage form, which has, is disintegrated fast, action rapidly, convenient to take, can improve bioavilability, improve clinic
Curative effect.
Invention content：
The purpose of the invention is to improve the value of exploiting and utilizing of Herba Cistanches medicinal material, effervescent tablet preparation formulation, biology profit are selected
Expenditure is high, safe and effective, quality controllable, convenient to take.
For above-mentioned purpose, technical solution provided by the invention is as follows：
The present invention provides a kind of traditional Chinese medicinal material raw materials for having and adjusting immune function, and the drug is Herba Cistanches, the meat desert
Rong is concentrated and dried by extraction, then by extracting solution, and effervescent tablet is made further according to certain preparation prescription and preparation process.
Following manner can be used in the extraction of Herba Cistanches medicinal material in the present invention：
1, medicinal material water refluxing extraction
Herba Cistanches are taken, for the first time plus 4~14 times of water measures refluxing extraction 2 times.
2, medicinal material ethyl alcohol extracts
Herba Cistanches are taken, it is secondary with 10~95% ethyl alcohol, 4~14 times of amount refluxing extractions.
Following manner can be used in extracting solution concentration, the drying of Herba Cistanches medicinal material in the present invention：Extracting solution is recovered under reduced pressure molten
Agent.It is dried using vacuum drying, spray drying or microwave drying mode.
Preparations shaping technique is in the following ways：
In preparation process, to extract extract powder as raw material, using single factor experiment method, with grain forming, mobility,
Compressibility, hygroscopicity, dissolubility of piece etc. are used as evaluation index, the acid sources such as paratartaric acid, citric acid；It is to Macrogol 6000
No inclusion alkali source；The fillers such as lactose, dextrin, mannitol, microcrystalline cellulose；SiO2, magnesium stearate, talcum powder, polyethylene glycol,
The glidants such as lauryl sodium sulfate and lubricant and dry-pressing granulator roll wheel speed, binder speed, charging rate, pressure
The factors such as power are investigated.By experimental study, determine that invention formulation prescription is：
Herba Cistanches dry extract 10%~30%；Acid source 20%~35%；Filler 15%~30%；Alkali source 15%~
35%；Glidant and lubricant 0.5%~5%.
Specific experiment process is：
1, acid source
Select tartaric acid and citric acid as this product acid source, with dry extract and auxiliary material different proportion mixing, dry granulation,
20-60 mesh whole grains investigate preparation effect with dissolution rate and hydroscopicity.
2, filler
Select lactose, dextrin, mannitol, microcrystalline cellulose as this product filler, with dry extract and auxiliary material different proportion
Mixing, dry granulation, 20-60 mesh whole grains investigate preparation effect with shaping rate, angle of repose, dissolution rate and hydroscopicity,
3, soda acid dosage
Using L9(34) orthogonal experiment is carried out, by testing the optimum amount of preferred effervescent tablet mesotartaric acid, sodium bicarbonate,
Evaluation index is that the disintegration time of effervescent tablet and the comprehensive score for the disintegration time being placed at room temperature for after 30 days determine that sodium bicarbonate is used
Amount.
4, glidant and lubricant
Select SiO2, magnesium stearate, talcum powder, polyethylene glycol, lauryl sodium sulfate is as this product glidant and lubrication
Agent.
5, the usage ratio of each supplementary material
Supplementary material usage ratio is determined according to single factor test and orthogonal test.
Soda acid dosage and auxiliary material proportion experiment process and result are as follows：
5.1 acid sources are investigated
Select tartaric acid and citric acid as this product acid source, with dry extract and auxiliary material different proportion mixing, dry granulation,
20-60 mesh whole grains investigate preparation effect with dissolution rate and hydroscopicity, the results are shown in Table 1.
1 acid source of table investigates result
As can be seen from the above results, two kinds of proportioning dissolution rates are suitable, but the > 1 of hydroscopicity 2.
The investigation of 5.2 fillers
Select lactose, dextrin, mannitol, microcrystalline cellulose as this product filler, with dry extract and auxiliary material different proportion
Mixing, dry granulation, 20-60 mesh whole grains are investigated preparation effect with shaping rate, angle of repose, dissolution rate and hydroscopicity, be the results are shown in Table
2。
The investigation result of 2 filler of table
As can be seen from the above results, the > 4 of granulates ratio of briquetting 3 > 2 > 1；Angle of repose is substantially suitable；Dissolving
The > 2 of > 3 of rate 1 > 4；The > 1 of > 4 of hygroscopicity 3 > 2；The > 4 of > 2 of alkali grain forming rate 3 > 1；
Angle of repose is substantially suitable；The > 2 of > 3 of dissolution rate 1 > 4；The > 1 of > 2 of hygroscopicity 3 > 4.
5.3 determine soda acid dosage with orthogonal test
Using L9(34) orthogonal experiment is carried out, by testing preferred effervescent tablet mesotartaric acid, sodium bicarbonate and polyethylene glycol
Optimum amount, evaluation index are the disintegration time of effervescent tablet and the comprehensive score for the disintegration time being placed at room temperature for after 30 days.As a result
It is shown in Table 3,4.
Comprehensive score (s)=effervesce time (s) × after 0.5+30 days effervesce time (s) × 0.5
3 empirical factor water-glass of table
4 effervescent tablet moulding process L of table9(34) orthogonal experiments
5 the results of analysis of variance of table
| Soruces of variation | Sum of squares of deviations | Degree of freedom | F values | P values |
| A | 1286.222 | 2 | 1.753 | |
| B | 49.556 | 2 | 0.068 | |
| C | 122.889 | 2 | 0.168 | |
| Error | 733.56 | 2 |
It is worth by intuitively analyzing K, best moulding process is A282C2, i.e. tartaric acid dosage 685g, sodium bicarbonate dosage
771g Macrogol 6000 dosages 150g.
5.4 Macrogol 6000s include sodium bicarbonate and do not include the investigation of sodium bicarbonate
It compares after No. 1 Macrogol 6000 melts with sodium bicarbonate mixing, after cooling, crushes；No. 2 sodium bicarbonates with it is poly-
Ethylene glycol 6000 is separately added into, two kinds of alkali sources and dry extract and other auxiliary materials and mixings, dry granulation,
20-60 mesh whole grains investigate preparation effect with hydroscopicity, the results are shown in Table 6.
6 Macrogol 6000 of table includes sodium bicarbonate and does not include the investigation table of sodium bicarbonate
As can be seen from the above results, the > 1 of hygroscopicity 2, and it is serious to foam after No. 2 moisture absorptions, therefore select No. 1 to gather
Ethylene glycol 6000 includes sodium bicarbonate.
The selection of 5.5 glidants and lubricant
Select SiO2, magnesium stearate, talcum powder, polyethylene glycol, lauryl sodium sulfate is as this product glidant and lubrication
Agent tests the preparation effect of No. 2 particles and auxiliary material different proportion, the results are shown in Table 7.
The investigation result of 7 glidant of table and lubricant
As can be seen from the above results, select No. 1 SiO is added2Effect is best.
Specific implementation mode：
With reference to specific embodiment, the present invention will be further described, following each embodiments be merely to illustrate the present invention and
Not limitation of the present invention.
Embodiment 1：
(1) the appropriate 1000g of Herba Cistanches is weighed, fritter is broken into, adds water refluxing extraction twice, adds the water of 8000ml for the first time
Extraction 2 hours, lets cool, and filters；Second of addition 6000ml water, extracts 1 hour, lets cool, filter；Filtrate merges twice, amounts to
12500ml, concentration, reduceds pressure relative density are 1.05 (60 DEG C) concentrates, are spray-dried, obtain medicinal powder 360g, spare；
(2) implement prescription supplementary material ratio in following ratio
(3) take 113g Macrogol 6000s that the sodium bicarbonate of 487g is added, stirs evenly, lets cool solidification after heating melting
Afterwards, it is ground into fine powder, crosses 80 mesh sieve and 180g dried cream powders and 200g lactose mixings, 90% alcohol granulation, with 24 mesh sieves.
80 mesh tartaric acid 460g were taken, and 180g dried cream powders and 200g lactose, citric acid 20g mixings, 90% alcohol granulation,
With 24 mesh sieves.
(4) above-mentioned soda acid particle is mixed, the SiO of 20g is added2, mixing, tabletting, piece weight 0.5g, production 3900 altogether.
Embodiment 2：
(1) Herba Cistanches 1000g is weighed, fritter is broken into, adds the extraction of 70% alcohol reflux twice, adds 70% ethyl alcohol for the first time
8000ml is extracted 2 hours, is let cool, and is filtered；Second of 70% ethyl alcohol 6000ml of addition, extracts 1 hour, lets cool, filter；It filters twice
Liquid merges, and amounts to 12300ml, is concentrated under reduced pressure into relative density 1.30 (60 DEG C), and microwave drying gets dry extract, and crushes, and crosses 80 mesh sieve,
Medicinal powder 380g, it is spare；
(2) implement prescription supplementary material ratio in following ratio
(3) after taking the heating melting of 130g polyethanol 6000, sodium bicarbonate 650g is added, stirs evenly, after letting cool solidification, powder
It is broken into fine powder, crosses 80 mesh sieve and 190g extract powders, 230g lactose, 58g Aspartame mixings, 90% alcohol granulation is sieved with 24 mesh
Whole grain.
80 mesh tartaric acid 575g were taken, and 190g extract powders, 230g lactose, 23g citric acid mixings, 90% alcohol granulation,
With 24 mesh sieves.
Above-mentioned soda acid particle is mixed, SiO is added2, mixing, tabletting 0.5g, amount to be made 3940.
Embodiment 3：
(1) it extracts
The appropriate 1000g of Herba Cistanches is weighed, fritter is broken into, adds the extraction of 50% alcohol reflux twice, adds for the first time
8000ml50% ethyl alcohol extracts 2 hours, lets cool, and filters；Second of 50% ethyl alcohol that 6000ml is added, extracts 1 hour, lets cool,
Filtering；Filtrate, which merges, twice amounts to 12000ml, and concentration is concentrated under reduced pressure into 1.30, and microwave drying gets dry extract, and crushes, and crosses 80 mesh
Sieve obtains medicinal powder 370g, spare；
(2) implement prescription supplementary material ratio in following ratio
(3) after taking the heating melting of 91g Macrogol 6000s, 544g sodium bicarbonates is added, stir evenly, after letting cool solidification,
It is ground into fine powder, crosses 80 mesh sieve and 185g extract powders and 144g lactose mixings, 90% alcohol granulation, with 24 mesh sieves.
80 mesh were taken to sieve tartaric acid 368g, with 185g extract powders and 144g lactose mixings, 90% alcohol granulation is sieved with 24 mesh
Whole grain.
Above-mentioned soda acid particle is mixed, the SiO of 32g is added2, mixing, tabletting, piece weight 0.5g, production 3910 altogether.
Embodiment 4：
Herba Cistanches dry extract 12.5%；Acid source 25%；Filler 20%；Alkali source 28%；Glidant and lubricant 2%.
Acid source is tartaric acid or citric acid；Filler is lactose, dextrin, mannitol or microcrystalline cellulose；Alkali source is carbonic acid
Hydrogen sodium；Glidant and lubricant are SiO2, magnesium stearate, talcum powder, polyethylene glycol or lauryl sodium sulfate.
It takes Herba Cistanches appropriate, is broken into fritter, add 8 times of amount 60-70% ethyl alcohol (or water) refluxing extractions twice, every time 2
Hour, filtration, merging filtrate recycles ethyl alcohol, is condensed into thick paste, is dried to powder.Macrogol 6000 is weighed according to prescription ratio to add
After heat fusing, sodium bicarbonate is added, stirs evenly, after letting cool solidification, be ground into fine powder, crosses 80 mesh sieve and 1/2 above-mentioned extract powder
And lactose, Aspartame mixing mixing, 90% alcohol granulation, with 24 mesh sieves.
80 mesh tartaric acid were taken, with remaining 1/2 extract powder and lactose, citric acid mixing, 90% alcohol granulation is sieved with 24 mesh
Whole grain.
Above-mentioned soda acid particle is mixed, SiO is added2, mixing, tabletting, both.Piece weight：0.5g.
Claims (2)
1. a kind of preparation method of Herba Cistanches effervescent tablet, it is characterised in that including step：
(1) Herba Cistanches 1000g is weighed, fritter is broken into, adds the extraction of 70% alcohol reflux twice, adds 70% ethyl alcohol for the first time
8000ml is extracted 2 hours, is let cool, and is filtered；Second of 70% ethyl alcohol 6000ml of addition, extracts 1 hour, lets cool, filter；It filters twice
Liquid merges, and amounts to 12300ml, is concentrated under reduced pressure into relative density 1.30 at 60 DEG C, and microwave drying gets dry extract, and crushes, and crosses 80 mesh sieve,
Medicinal powder 380g, it is spare；
(2) implement prescription supplementary material ratio in following ratio：
Medicinal powder 16.5%
Tartaric acid 25%
Macrogol 6000+sodium bicarbonate 34%, wherein Macrogol 6000：Sodium bicarbonate=1:5
Lactose 20%
Citric acid 1%
Aspartame 2.5%
Silica 1 %
(3) after taking the heating melting of 130g Macrogol 6000s, sodium bicarbonate 650g is added, stirs evenly, after letting cool solidification, crush
At fine powder, 80 mesh sieve and 190g medicinal powder, 230g lactose, 58g Aspartame mixings, 90% alcohol granulation, with 24 mesh sieves are crossed；
(4) 80 mesh tartaric acid 575g were taken, with 190g medicinal powder, 230g lactose, 23g citric acid mixings, 90% alcohol granulation, with 24
Mesh sieve；
(5) above-mentioned soda acid particle is mixed, silica, mixing, tabletting is added.
2. Herba Cistanches effervescent tablet made from preparation method according to claim 1.
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| CN106473038A (en) * | 2016-09-18 | 2017-03-08 | 天津北洋百川生物技术有限公司 | A kind of Herba Cistanches health-care tablet and preparation method thereof |
| CN107549571A (en) * | 2017-09-06 | 2018-01-09 | 张可池 | A kind of saline cistanche coix seed effervescent tablet and preparation method thereof |
| CN108652004B (en) * | 2018-03-29 | 2022-08-05 | 李昀芊 | Desert cistanche granule |
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