CN104337854A - Naoan tablet preparation method - Google Patents
Naoan tablet preparation method Download PDFInfo
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- CN104337854A CN104337854A CN201310316743.5A CN201310316743A CN104337854A CN 104337854 A CN104337854 A CN 104337854A CN 201310316743 A CN201310316743 A CN 201310316743A CN 104337854 A CN104337854 A CN 104337854A
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- fine powder
- radix ginseng
- filtrate
- brain
- ginseng fine
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- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 239000009999 naoan Substances 0.000 title abstract 3
- 239000000843 powder Substances 0.000 claims abstract description 78
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 claims abstract description 60
- 235000003140 Panax quinquefolius Nutrition 0.000 claims abstract description 60
- 235000008434 ginseng Nutrition 0.000 claims abstract description 60
- 238000000034 method Methods 0.000 claims abstract description 34
- 239000000203 mixture Substances 0.000 claims abstract description 28
- 239000008187 granular material Substances 0.000 claims abstract description 21
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 18
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000007787 solid Substances 0.000 claims abstract description 10
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 9
- 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 abstract description 9
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 9
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 9
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 9
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 9
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 9
- 239000011230 binding agent Substances 0.000 claims abstract description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 73
- 241000208340 Araliaceae Species 0.000 claims description 59
- 210000004556 brain Anatomy 0.000 claims description 57
- 239000000706 filtrate Substances 0.000 claims description 56
- 239000000047 product Substances 0.000 claims description 35
- 241000628997 Flos Species 0.000 claims description 27
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims description 26
- 239000007788 liquid Substances 0.000 claims description 16
- 239000007921 spray Substances 0.000 claims description 16
- 238000007598 dipping method Methods 0.000 claims description 8
- 239000007888 film coating Substances 0.000 claims description 8
- 238000009501 film coating Methods 0.000 claims description 8
- 238000012856 packing Methods 0.000 claims description 8
- 238000004064 recycling Methods 0.000 claims description 8
- 238000010992 reflux Methods 0.000 claims description 8
- 235000012239 silicon dioxide Nutrition 0.000 claims description 8
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 3
- -1 after tabletted Substances 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 3
- 229960003943 hypromellose Drugs 0.000 claims description 3
- 229920000609 methyl cellulose Polymers 0.000 claims description 3
- 239000001923 methylcellulose Substances 0.000 claims description 3
- 235000010981 methylcellulose Nutrition 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 3
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 2
- 108010010803 Gelatin Proteins 0.000 claims description 2
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- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 229920000159 gelatin Polymers 0.000 claims description 2
- 239000008273 gelatin Substances 0.000 claims description 2
- 229940014259 gelatin Drugs 0.000 claims description 2
- 235000019322 gelatine Nutrition 0.000 claims description 2
- 235000011852 gelatine desserts Nutrition 0.000 claims description 2
- 229960004793 sucrose Drugs 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 53
- 239000003814 drug Substances 0.000 abstract description 11
- 239000000284 extract Substances 0.000 abstract description 8
- 239000002245 particle Substances 0.000 abstract description 6
- 241000382455 Angelica sinensis Species 0.000 abstract 1
- 244000020518 Carthamus tinctorius Species 0.000 abstract 1
- 235000003255 Carthamus tinctorius Nutrition 0.000 abstract 1
- 241000244365 Ligusticum sinense Species 0.000 abstract 1
- 244000131316 Panax pseudoginseng Species 0.000 abstract 1
- 238000000889 atomisation Methods 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 238000002156 mixing Methods 0.000 abstract 1
- 238000004806 packaging method and process Methods 0.000 abstract 1
- 238000003825 pressing Methods 0.000 abstract 1
- 238000007670 refining Methods 0.000 abstract 1
- 238000005507 spraying Methods 0.000 abstract 1
- 238000005516 engineering process Methods 0.000 description 16
- 239000003960 organic solvent Substances 0.000 description 11
- 239000002360 explosive Substances 0.000 description 7
- 230000003321 amplification Effects 0.000 description 6
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- 239000008280 blood Substances 0.000 description 5
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- 239000002671 adjuvant Substances 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 206010008118 cerebral infarction Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000036571 hydration Effects 0.000 description 2
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- 238000005457 optimization Methods 0.000 description 2
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- 208000019838 Blood disease Diseases 0.000 description 1
- 201000006474 Brain Ischemia Diseases 0.000 description 1
- 208000018152 Cerebral disease Diseases 0.000 description 1
- 206010008120 Cerebral ischaemia Diseases 0.000 description 1
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010019468 Hemiplegia Diseases 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000008344 brain blood flow Effects 0.000 description 1
- 201000008247 brain infarction Diseases 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 230000003727 cerebral blood flow Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
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- 239000012467 final product Substances 0.000 description 1
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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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/286—Carthamus (distaff thistle)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The present invention discloses a Naoan tablet preparation method, which comprises: spraying a traditional Chinese medicine extract obtained by extracting and refining Ligusticum chuanxiong hort, Angelica sinensis and Carthamus tinctorius through a proper process into a one-step granulator filled with ginseng fine powder, a borneol-ginseng fine powder mixture, silica, microcrystalline cellulose and a binder at a room temperature in the specific shape in an atomization form to granulate and dry to achieve the water content of 1-5%, uniformly mixing the finally obtained particles, talc powder and magnesium stearate, pressing into tablets, coating film coat, and carrying out product packaging to obtain the Naoan tablet finished product, wherein the specific shape is one or a combination comprising more than two shapes selected from 1-180 DEG fan, hollow cone, solid cone and solid square. According to the present invention, the method has characteristics of good safety, high productivity, short production cycle, and stable and controllable product quality during the production process.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation and preparation method thereof, specifically a kind of preparation method of brain peace sheet.
Background technology
Brain peace sheet system, according to Chinese medical theory, succeeds in developing through 30 years of researches and clinical practice.This product selects Radix Ginseng, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami, Borneolum Syntheticum rare medicinal herbs, and adopt science preparation method to refine and form, its gas delicate fragrance, bitter in the mouth, has blood circulation promoting and blood stasis dispelling, the effect of activating qi and collateral.Admittedly de-with Radix Ginseng strongly invigorating primordial QI, multiple arteries and veins in product, invigorating the spleen and replenishing QI, promoting the production of body fluid to quench thirst, Fructus Alpiniae Oxyphyllae of calming the nerves, be aided with Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami blood circulation promoting and blood stasis dispelling, and in addition Borneolum Syntheticum is had one's ideas straightened out refreshment, for the disease of various stagnation of blood stasis.Modern pharmacology research shows; this product has anticoagulant, reduces blood viscosity, prevents thrombosis, prevention of recurrence of stroke; protection cerebral tissue, the infringement that anti-cerebral ischemia is caused, expansion of cerebral vascular, reduction vascular resistance; increase cerebral blood flow, promote the effect of brain blood circulation.Brain peace sheet is applicable to treat hemiplegia, crooked mouth and tongue, stiff tongue and retardation in speech, hemianesthesia, shortness of breath and fatigue, the birth of bicker stream, brothers' swelling, cerebral blood supply insufficiency, and the symptom such as the thick and ischemic brain infarction of prevention blood, also be applicable to cerebral thrombosis acute stage and convalescent period, and effectively can improve the symptom of blood disease of brain, reduce the generation of sequela.Because this product dosage is little, it is strong, evident in efficacy to act on, safety, toxic and side effects are little, be now subject to the extensive favor of vast cardio-cerebral diseases patient.
Brain pacifies sheet with Radix Ginseng, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami extract for raw material, said extracted thing is many containing stickum, granulate as used conventional wet, technique is that raw material adds a large amount of adjuvant, ethanol binding agent is granulated, then adopt hot air drier dry, cause the technique using alcohol granulation in product industrialization production process, therefore production security is poor.Due to the restriction of traditional handicraft, this product odd-numbered day production capacity is lower and content fluctuation is larger.Its main cause is: the Chinese medicine extract viscosity component used in brain peace sheet is more, cause the hydration rate in pelletization of the Chinese medicine extract in material very fast, and then before the non-moistening of other adjuvant, Chinese medicine extract just produces large material agglomerate because excessively absorbing water, and finally causes damp production or production capacity extremely low.So in brain peace sheet production process, the preparation technology that the alcoholic solution of high concentration is granulated will be adopted.In process of production, even if full production line adopts antiknock device, but owing to employing inflammable and explosive high concentration ethanol solution, and then greatly reduce the safety of brain peace sheet production, bring hidden danger to the safety in production of enterprise.Even if but adopt the alcoholic solution preparation technology of high concentration, because binding agent adds uneven, material lumps, particle size distribution is undesirable, causing brain to pacify sheet heavily fluctuates larger in high speed tabletting time slice, and then cause the abnormal increase of finished product content fluctuation, thus cause this product to carry out high speed tabletting, odd-numbered day production capacity is very low.Therefore, the odd-numbered day production capacity of the process for producing of brain peace sheet high concentration ethanol solution cannot meet the demand of people to this medicine, and brings larger risk can to the drug safety of the people.
Summary of the invention
The object of the present invention is to provide and obviously can reduce supplementary product consumption, with short production cycle, production capacity is large, and safety is high, the preparation method that constant product quality is controlled.
The object of the present invention is achieved like this:
(1) Radix Ginseng powder is broken into 200-300 order fine powder, gets part Radix Ginseng fine powder and be jointly ground into 80-100 order fine powder according to 3-5 part Radix Ginseng fine powder and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 100-700g Rhizoma Chuanxiong, 100-700g Radix Angelicae Sinensis adds the alcohol reflux secondary that 8-10 times amount volume by volume concentration is 50-90%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 8-10 times amount soak by water secondary, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 10-100g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.20, to obtain brain peace sheet extractum, for subsequent use;
(7) take 50-200g and remain Radix Ginseng fine powder, 3-50g Borneolum Syntheticum Radix Ginseng fine powder mixture, 90-150g silicon dioxide, 40-90g microcrystalline Cellulose, 10-20g binding agent, put into mixer mix homogeneously and be placed on one-step-granulating method;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, brain is pacified spray pattern that sheet extractum is given shape, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A; Described given shape is fan-shaped, the open circles taper of 1 ~ 180 degree, one or more combination of solid conical or solid squares;
(9) granule A is mixed homogeneously with 1-5g Pulvis Talci, 5-10g magnesium stearate, after tabletted, film coating, carry out the packing of product, obtain brain peace sheet finished product.
The optimization formulation proportioning of product and production technology are:
(1) Radix Ginseng powder is broken into 300 order fine powders, gets part Radix Ginseng fine powder and be jointly ground into 80 order fine powders according to 3-4 part Radix Ginseng fine powder and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 200-500g Rhizoma Chuanxiong, alcohol reflux secondary that 200-500g Radix Angelicae Sinensis adds 10 times amount concentration 80-90%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 10 times amount soak by water secondaries, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 10-80g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.20, to obtain brain peace sheet extractum, for subsequent use;
(7) take 50-180g and remain Radix Ginseng fine powder, 3-20g Borneolum Syntheticum Radix Ginseng fine powder mixture, 90-100g silicon dioxide, 40-80g microcrystalline Cellulose, 10-15g binding agent, put into mixer mix homogeneously and be placed on one-step-granulating method, for subsequent use;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state; clean compressed air is passed into pressurized tank; brain is pacified spray pattern that sheet extractum is given shape; one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C; spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A.Described given shape is fan-shaped, the open circles taper of 40 ~ 180 degree, one or more combination of solid conical or solid squares;
(9) granule A is mixed homogeneously with 1-4g Pulvis Talci, 5-9g magnesium stearate, after tabletted, film coating, carry out the packing of product, obtain brain peace sheet finished product.
Adopt this its feature of optimization of C/C composites explained hereafter to be: when high speed tabletting, sheet is heavy more stable, and tablet weight variation is less, and while guarantee high security, high quality of production, become to produce cycle time more than 45%, production capacity amplification can reach more than 90%.
Described binding agent is one or more mixture of methylcellulose, ethyl cellulose, hypromellose, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, gelatin, Polyethylene Glycol, cane sugar powder, white sugar powder or polyvidone.
The present invention is that the industrialization adopting the production technology of non-organic solvent one-step palletizing to carry out brain peace sheet is completely produced, by effectively controlling the spray shapes of Chinese medicine extract extractum in one-step palletizing process and the size of drop, thus the hydration rate of evading the larger Chinese medicine ingredients of viscosity too fast and material that is that cause lumps the problem that cannot normally produce, and evaded the inflammable and explosive high concentration of the employing safety in production hidden danger brought of alcoholic solution preparation technology completely.In addition, the present invention is by effectively controlling the atomized drop size of Chinese medicine extract extractum and then effectively controlling the particle size distribution of prepared granule, evade the defect of the granule prepared by brain peace sheet high concentration ethanol solution preparation process, finally make brain pacify sheet high production capacity preparation technology to be achieved, finished product content fluctuation also significantly reduces.In addition, owing to adopting one-step palletizing technology, Chinese medical concrete is directly prepared to semi-finished granules, decreases extract dry, extractum is pulverized, batching is prepared and prepares the operations such as soft material, thus significantly reduces the production cycle of product, cost-saving and reduction energy resource consumption.In technique preparation process involved in the present invention, adopt one-step palletizing production line, thus the problem that traditional brain peace sheet production technology supplementary product consumption is comparatively large, poor stability, production capacity are low, the production cycle is long and product content fluctuation is large, quality control is difficult can be solved completely.
Detailed description of the invention
Embodiment 1
(1) Radix Ginseng powder is broken into 300 order fine powders, gets part Radix Ginseng fine powder and be jointly ground into 80 order fine powders according to 3 parts of Radix Ginseng fine powders and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 500g Rhizoma Chuanxiong, alcohol reflux secondary that 500g Radix Angelicae Sinensis adds 10 times amount concentration 90%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 10 times amount soak by water secondaries, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 30g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.10, to obtain brain peace sheet extractum, for subsequent use;
(7) take 135g and remain Radix Ginseng fine powder, 3g Borneolum Syntheticum Radix Ginseng fine powder mixture, 95g silicon dioxide, 75g microcrystalline Cellulose, 15g polyvidone, puts into mixer mix homogeneously and is placed on one-step-granulating method, for subsequent use;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, by adjustment shower nozzle shape, making brain pacify sheet extractum is 65 degree of fan-shaped atomized states, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A;
(9) granule A is mixed homogeneously with 2g Pulvis Talci, 6g magnesium stearate, carry out the packing of product after tabletted, film coating and obtain brain peace sheet finished product.
In this embodiment, in actual production process, not using inflammable and explosive organic solvent, completely avoid because of with an organic solvent to producing the potential safety hazard brought.At use one-step palletizing production line, when carrying out the sheet production of brain peace according to this production technology, the production cycle can shorten 48.13%, and hourly output can reach 2.41 ten thousand, and hourly output amplification reaches 92.80%.
Embodiment 2
(1) Radix Ginseng powder is broken into 300 order fine powders, gets part Radix Ginseng fine powder and be jointly ground into 80 order fine powders according to 4 parts of Radix Ginseng fine powders and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 450g Rhizoma Chuanxiong, alcohol reflux secondary that 450g Radix Angelicae Sinensis adds 10 times amount concentration 90%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 10 times amount soak by water secondaries, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 100g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.10, to obtain brain peace sheet extractum, for subsequent use;
(7) take 135g and remain Radix Ginseng fine powder, 5g Borneolum Syntheticum Radix Ginseng fine powder mixture, 100g silicon dioxide, 80g microcrystalline Cellulose, 10g hypromellose, puts into mixer mix homogeneously and is placed on one-step-granulating method, for subsequent use;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, by adjustment shower nozzle shape, making brain pacify sheet extractum is 73 degree of fan-shaped atomized states, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A;
(9) granule A is mixed homogeneously with 2g Pulvis Talci, 6g magnesium stearate, carry out the packing of product after tabletted, film coating and obtain brain peace sheet finished product.
In this embodiment, in actual production process, not using inflammable and explosive organic solvent, completely avoid because of with an organic solvent to producing the potential safety hazard brought.At use one-step palletizing production line, when carrying out the sheet production of brain peace according to this production technology, the production cycle can shorten 47.48%, and hourly output can reach 2.38 ten thousand, and hourly output amplification reaches 90.40%.
Embodiment 3
(1) Radix Ginseng powder is broken into 200 order fine powders, gets part Radix Ginseng fine powder and be jointly ground into 80 order fine powders according to 5 parts of Radix Ginseng fine powders and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 500g Rhizoma Chuanxiong, alcohol reflux secondary that 200g Radix Angelicae Sinensis adds 10 times amount concentration 80%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 10 times amount soak by water secondaries, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 15g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.10, to obtain brain peace sheet extractum, for subsequent use;
(7) take 110g and remain Radix Ginseng fine powder, 15g Borneolum Syntheticum Radix Ginseng fine powder mixture, 120g silicon dioxide, 85g microcrystalline Cellulose, 11g sodium carboxymethyl cellulose, puts into mixer mix homogeneously and is placed on one-step-granulating method, for subsequent use;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, by adjustment shower nozzle shape, making brain pacify sheet extractum is 61 degree of solid conical spray patterns, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A;
(9) granule A is mixed homogeneously with 5g Pulvis Talci, 10g magnesium stearate, carry out the packing of product after tabletted, film coating and obtain brain peace sheet finished product.
In this embodiment, in actual production process, not using inflammable and explosive organic solvent, completely avoid because of with an organic solvent to producing the potential safety hazard brought.At use one-step palletizing production line, when carrying out the sheet production of brain peace according to this production technology, the production cycle can shorten 47.03%, and hourly output can reach 2.36 ten thousand, and hourly output amplification reaches 88.80%.
Embodiment 4
(1) Radix Ginseng powder is broken into 200 order fine powders, gets part Radix Ginseng fine powder and be jointly ground into 80 order fine powders according to 5 parts of Radix Ginseng fine powders and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 190g Rhizoma Chuanxiong, alcohol reflux secondary that 500g Radix Angelicae Sinensis adds 10 times amount concentration 80%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 10 times amount soak by water secondaries, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 10g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.10, to obtain brain peace sheet extractum, for subsequent use;
(7) take 115g and remain Radix Ginseng fine powder, 18g Borneolum Syntheticum Radix Ginseng fine powder mixture, 135g silicon dioxide, 85g microcrystalline Cellulose, 14g methylcellulose, puts into mixer mix homogeneously and is placed on one-step-granulating method, for subsequent use;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, by adjustment shower nozzle shape, making brain pacify sheet extractum is 60 degree of open circles taper spray patterns, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A;
(9) granule A is mixed homogeneously with 5g Pulvis Talci, 9g magnesium stearate, carry out the packing of product after tabletted, film coating and obtain brain peace sheet finished product.
In this embodiment, in actual production process, not using inflammable and explosive organic solvent, completely avoid because of with an organic solvent to producing the potential safety hazard brought.At use one-step palletizing production line, when carrying out the sheet production of brain peace according to this production technology, the production cycle can shorten 46.81%, and hourly output can reach 2.35 ten thousand, and hourly output amplification reaches 88.00%.
Embodiment 5
(1) Radix Ginseng powder is broken into 200 order fine powders, gets part Radix Ginseng fine powder and be jointly ground into 80 order fine powders according to 5 parts of Radix Ginseng fine powders and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 500g Rhizoma Chuanxiong, alcohol reflux secondary that 400g Radix Angelicae Sinensis adds 10 times amount concentration 80%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 10 times amount soak by water secondaries, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 85g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.10, to obtain brain peace sheet extractum, for subsequent use;
(7) take 150g and remain Radix Ginseng fine powder, 17g Borneolum Syntheticum Radix Ginseng fine powder mixture, 145g silicon dioxide, 85g microcrystalline Cellulose, 20g Polyethylene Glycol, puts into mixer mix homogeneously and is placed on one-step-granulating method, for subsequent use;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, by adjustment shower nozzle shape, making brain pacify sheet extractum is 40 degree of solid squares spray patterns, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A;
(9) granule A is mixed homogeneously with 5g Pulvis Talci, 9g magnesium stearate, carry out the packing of product after tabletted, film coating and obtain brain peace sheet finished product.
In this embodiment, in actual production process, not using inflammable and explosive organic solvent, completely avoid because of with an organic solvent to producing the potential safety hazard brought.At use one-step palletizing production line, when carrying out the sheet production of brain peace according to this production technology, the production cycle can shorten 47.26%, and hourly output can reach 2.37 ten thousand, and hourly output amplification reaches 89.60%.
In addition, when adopting present invention process preparation to produce brain peace sheet, effective Chinese medical concrete spray shapes and droplet size control technology and particle size distribution control technology owing to adopting, make the final product particle obtained with the Particle Phase prepared by former technique than having splendid mobility and compressibility, and then reduce the sheet of product when high speed tabletting and heavily fluctuate, and then ensure that product yield and finished product content, significantly shorten life cycle of the product, and ensure that the effectiveness of medicine and the safety of people's medication.Comparing result is in table 1.
Table 1 brain peace sheet comparing result
Claims (3)
1. a preparation method for brain peace sheet, its feature is as follows:
(1) Radix Ginseng powder is broken into 200-300 order fine powder, gets part Radix Ginseng fine powder, be jointly ground into 80-100 order fine powder according to 3-5 part Radix Ginseng fine powder and 1 part of Borneolum Syntheticum, obtain Borneolum Syntheticum Radix Ginseng fine powder mixture, for subsequent use; Residue Radix Ginseng fine powder, for subsequent use;
(2) take 100-700g Rhizoma Chuanxiong, 100-700g Radix Angelicae Sinensis adds the alcohol reflux secondary that 8-10 times amount volume by volume concentration is 50-90%, filter, merging filtrate also reclaims ethanol in filtrate, obtains concentrated solution A;
(3) Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues are added 8-10 times amount soak by water secondary, filter, merging filtrate, obtains Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid;
(4) take after 10-100g Flos Carthami adds water boil, hot dipping secondary, filter, merging filtrate, obtains Flos Carthami filtrate;
(5) Flos Carthami filtrate and Rhizoma Chuanxiong, Radix Angelicae Sinensis medicinal residues decocting liquid are merged, be concentrated between 80 DEG C of relative density 1.05-1.10, adding ethanol to alcohol content after letting cool is 60%, left at room temperature over night, and filter, filtrate recycling ethanol, obtains concentrated solution B;
(6) merge concentrated solution A and concentrated solution B, to be concentrated under room temperature condition between relative density 1.05-1.20, to obtain brain peace sheet extractum, for subsequent use;
(7) take 50-200g and remain Radix Ginseng fine powder, 3-50g Borneolum Syntheticum Radix Ginseng fine powder mixture, 90-150g silicon dioxide, 40-90g microcrystalline Cellulose, 10-20g binding agent, put into mixer mix homogeneously and be placed on one-step-granulating method;
(8) obtained brain peace sheet extractum is loaded in pressurized tank under room temperature state, clean compressed air is passed into pressurized tank, brain is pacified spray pattern that sheet extractum is given shape, one-step-granulating method inlet temperature be 80-100 DEG C, temperature of charge is 60-70 DEG C, outlet temperature is in the parameter area of 50-60 DEG C, spray into one-step-granulating method carry out granulating and be dried to moisture 1-5%, obtain granule A;
(9) granule A is mixed homogeneously with 1-5g Pulvis Talci, 5-10g magnesium stearate, after tabletted, film coating, carry out the packing of product, obtain brain peace sheet finished product.
2. the preparation method of a kind of brain peace sheet according to claim 1, is characterized in that: described given shape is fan-shaped, the open circles taper of 1 ~ 180 degree, one or more combination of solid conical or solid squares.
3. the preparation method of brain peace sheet according to claim 2, is characterized in that: described binding agent is one or more mixture of methylcellulose, ethyl cellulose, hypromellose, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, gelatin, Polyethylene Glycol, cane sugar powder, white sugar powder or polyvidone.
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