CN1325104C - Method for preparing Chinese medicine concentrated pill for treating women's cimacteric metancholia - Google Patents
Method for preparing Chinese medicine concentrated pill for treating women's cimacteric metancholia Download PDFInfo
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- CN1325104C CN1325104C CNB2005100169129A CN200510016912A CN1325104C CN 1325104 C CN1325104 C CN 1325104C CN B2005100169129 A CNB2005100169129 A CN B2005100169129A CN 200510016912 A CN200510016912 A CN 200510016912A CN 1325104 C CN1325104 C CN 1325104C
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Abstract
The present invention relates to a method for preparing a Chinese medical concentrated pill for treating women climacteric syndrome, which belongs to the technical field of medicines, particularly to a method for preparing a Chinese medical preparation for treating women climacteric syndrome by a Chinese medical modern preparation technology. The present invention comprises that blighted wheat, magnetitum and nacre are pulverized into fine powder or superfine powder; rehmanniae, prepared rhizome of rehmannia, figwort root, tuckahoe, common curculigo rhizome and ophiopogon root are decocted with water twice; the decoction liquids are merged, separated with a membrane and concentrated into clear paste under reduced pressure; Chinese magnolivine fruit, uncaria, water plantain, tree peony bark, tuber fleeceflower stem and prepared fleeceflower root are pulverized and immersed with ethanol for percolation, the percolation liquid is collected and is separated with a membrane, the ethanol is recycled, and the percolation liquid is concentrated into clear paste under reduced pressure; the clear paste is merged; the fine powder or the super fine powder of the three medicines, such as the blighted wheat, is added in the merged paste; the paste is dried under reduced pressure and pulverized into fine powder; a disintegrating agent is added in the fine powder, uniformly mixed, palletized and dried to prepare a concentrated pill or a coating concentrated pill prepared by coating with a film coat. The concentrated pill prepared by the present invention obviously accelerates dispersion speed, increases distribution area of the medicine in the gastrointestinal tracts, enhances biological availability and has the advantages of easy absorption for a human body, fast execution, little dosage and convenient administration for patients.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of preparation method for the treatment of the climacteric syndrome Chinese medicine preparation, international Patent classificating number: A61K35/78.
Background technology
Climacteric syndrome, claim again menopause syndrome, betide the women before and after menopause in 45-55 year mostly.Most of women can occur a series of because of gonadal hormone reduces the hectic fever sweating that causes during this period, vertigo and tinnitus, and the irritated eye that loses, symptoms such as hypertension have had a strong impact on normal work and life.According to statistics, the sickness rate of climacteric syndrome is about 60%, and wherein the obvious person of symptom accounts for 30%, calculates thus, and the whole nation has 3,000 ten thousand women to suffer from tangible climacteric syndrome approximately.At present, the clinical hormone medicine treatment climacteric syndromes that adopt more, curative effect is not good enough, and side effect is big.
The GENGNIANAN ball is a pure Chinese medicinal preparation, determined curative effect, and side effect is little, and the product of using this recipe development has GENGNIANAN PIAN, GENGNIANAN capsule etc., disintegration time is long, onset is slow, dose is big, take shortcomings such as inconvenience but all exist.
Summary of the invention
The objective of the invention is to adopt superfine communication technique, membrane separation technique, the preparation of Chinese medicine rapid release ball and packaging technique, provide a kind of rapid-action, bioavailability is high, dose is little, taking convenience, stay-in-grade a kind of preparation method for the treatment of climacteric syndrome Chinese medicine concentrated pill.
The present invention adopts national drug standards WS
3The prescription of-B-2706-97 GENGNIANAN capsule, its prescription is as follows:
Radix Rehmanniae 35g, Radix Rehmanniae Preparata 35g, Rhizoma Alismatis 35g, Radix Ophiopogonis 35g, Radix Scrophulariae 35g,
Cortex Moutan 23g, Poria 70g, Concha Margaritifera 70g, Rhizoma Curculiginis 70g, Fructus Schisandrae Chinensis 35g,
Magnetitum 70g, Caulis Polygoni Multiflori 70g, Ramulus Uncariae Cum Uncis 70g, Fructus Tritici Levis 70g, Radix Polygoni Multiflori Preparata 35g;
The present invention adopts superfine communication technique, membrane separation technique in the modern Chinese medicine production technology that the above-mentioned raw materials medicine is prepared into concentrated pill, or the coating concentrated pill;
Its preparation method is:
1, get Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder and be broken into fine powder, fineness 100～120 orders, or be ground into superfine powder, and fineness 300～400 orders, standby;
Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder are broken into fine powder, and fineness 100～120 orders can satisfy technological requirement, and for shortening onset time, improving drug effect, the present invention preferably is ground into micropowders with it;
2, get Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis and decoct with water secondary, adding for the first time 6～10 times of water gagings extracted 2～4 hours, adding for the second time 4～8 times of water gagings extracted 1～3 hour, collecting decoction is that 20,000 poly (ether sulfone) film separates pressure 0.2～0.4Mpa with the molecular retention value, membrane flux 2000～4000ml/min, 20～40 ℃ of temperature are separated the clear paste that the back concentrating under reduced pressure becomes relative density 1.20～1.25 (60 ℃), and are standby;
3, get Fructus Schisandrae Chinensis, Ramulus Uncariae Cum Uncis, Rhizoma Alismatis, Cortex Moutan, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata Six-element and be ground into coarse powder, adopt according to the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under the fluid extract item, make solvent with 50～70% ethanol, flooded 12～36 hours, the ethanol consumption is 10～14 times, carry out percolation, collect percolate, with the molecular retention value is that 20,000 poly (ether sulfone) film separates, pressure 0.2～0.4Mpa, membrane flux 2000～4000ml/min, 20～40 ℃ of temperature are separated the clear paste that back recovery ethanol and concentrating under reduced pressure become relative density 1.20～1.25 (60 ℃);
4, above-mentioned clear paste is merged, add the superfine powder of three flavors such as Fructus Tritici Levis, drying under reduced pressure is ground into fine powder, fineness 100～120 orders, the carboxymethyl starch sodium of adding 2～8%, mixing, ethanol pill with 70～80%, dry below 60 ℃, make the 333g concentrated pill, promptly; Or the bag film-coat, make the coating concentrated pill, promptly get the present invention.
Described disintegrating agent can be selected carboxymethyl starch sodium, crospolyvinylpyrrolidone or low-substituted hydroxypropyl cellulose; Can select one or both or full choosing in aforementioned, the preferred carboxymethyl starch sodium of the present invention;
Described concentrated pill diameter is below 8 millimeters, is coated pill or coated pill not, the preferred coated pill of the present invention, and its coating material accounts for 1～5% of ball weight.
Foundation of the present invention
1, prescription foundation
The present invention adopts national drug standards WS
3The prescription of-B-2706-97 GENGNIANAN capsule, Radix Rehmanniae, Radix Polygoni Multiflori Preparata are monarch drug in the side, the characteristics that outstanding our nourishing YIN and clearing away heat, relieving restlessness are calmed the nerves, Radix Rehmanniae clearing away heat and cooling blood wherein, YIN nourishing and the production of body fluid promoting; The Radix Polygoni Multiflori Preparata invigorating the liver and kidney, benefiting essence-blood, the black hair palpus, bone and muscle strengthening, the two share replenishing YIN and removing heat and calms the nerves.Radix Rehmanniae Preparata, Radix Scrophulariae, Magnetitum, Concha Margaritifera, close and be ministerial drug, the Radix Rehmanniae Preparata nourishing YIN and benefiting blood; The then refreshing peace of Radix Scrophulariae removing heat from blood YIN nourishing, hemapodium.Magnetitum, Concha Margaritifera suppressing the hyperactive liver and subsiding YANG, tranquillizing and allaying excitement.Four medicine principal drug assistance nourishing YIN and benefiting blood, removing heat from blood suppressing the hyperactive liver, tranquillizing and allaying excitement.Cortex Moutan, Radix Ophiopogonis, Poria, Rhizoma Alismatis are adjuvant drug, wherein strengthen Cortex Moutan, Radix Ophiopogonis the merit of replenishing YIN and removing heat removing heat from blood; Poria, Rhizoma Alismatis invigorating spleen to remove dampness are in case nourishing too and the spleen being blocked by dampness.Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori heat clearing away suppressing the hyperactive liver, dispelling wind and relieving convulsion, nourishing blood to tranquillize the mind, and the merit of blood nourishing acupuncture-stimulating is arranged, also be adjuvant drug.The Rhizoma Curculiginis kidney-replenishing, bone and muscle strengthening, dispelling cold and dampness is got the two meanings of transferring and using corrigent being arranged of its negative and positive.The sweet energy of Fructus Tritici Levis QI invigorating, cool to heat extraction, and the energy hidroschesis, be our messenger drug.Radix Rehmanniae, Radix Rehmanniae Preparata and usefulness in the side, the Radix Polygoni Multiflori, Caulis Polygoni Multiflori complement each other with 5; Radix Rehmanniae Preparata, Rhizoma Curculiginis coexistence, negative and positive are two transfers, oppose each other and yet also complement each other, be the ingenious part that our prescription is sent medicine; All medicines share, nourishing YIN and clearing away heat, and relieving restlessness is calmed the nerves.
2, adjuvant foundation
The screening of prescription adjuvant is according to " pharmaceutical necessities complete works " nineteen ninety-five front page;
Usage of the present invention and consumption: oral, each 1g, 3 times on the one;
The present invention reaches the requirement of state-promulgated pharmacopoeia after tested;
Use the GENGNIANAN ball of the present invention's preparation, molten diffusing speed is obviously accelerated, and by original tablet 30～60 minutes shorten to 7 minutes, and molten diffusing speed improves 4～8 times, and onset is faster; Because concentrated pill is less, diameter has increased the distribution area of medicine in gastrointestinal tract below 8mm, improved bioavailability, and made things convenient for the patient to take; The present invention adopts superfine communication technique, and the pulverizing medicinal materials of being used as medicine with the crude drug powder in the prescription is become micropowders, and sporoderm-broken rate reaches more than 95%, makes the easier stripping of intracellular effective ingredient, farthest is absorbed by the body, and has improved the curative effect of preparation; The present invention adopts the coating of pill technology that the system concentrated pill is carried out coating, has strengthened stability of formulation, has improved product quality.
The specific embodiment
Embodiment 1:
It is standby to get Radix Rehmanniae 35g, Radix Rehmanniae Preparata 35g, Rhizoma Alismatis 35g, Radix Ophiopogonis 35g, Radix Scrophulariae 35g, Cortex Moutan 23g, Poria 70g, Concha Margaritifera 70g, Rhizoma Curculiginis 70g, Fructus Schisandrae Chinensis 35g, Magnetitum 70g, Caulis Polygoni Multiflori 70g, Ramulus Uncariae Cum Uncis 70g, Fructus Tritici Levis 70g, Radix Polygoni Multiflori Preparata 35g, carboxymethyl starch sodium 20-24g;
Preparation method:
(1) get Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder and be broken into superfine powder, fineness 400 orders, standby;
(2) get Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis and decoct with water secondary, adding for the first time 7 times of water gagings extracted 2 hours, adding for the second time 5 times of water gagings extracted 2 hours, collecting decoction, with the molecular retention value is that 20,000 poly (ether sulfone) film separates pressure 0.30Mpa, membrane flux 3300ml/min, 27 ℃ of temperature are separated the clear paste that the rear filtrate concentrating under reduced pressure becomes relative density 1.21 (60 ℃); Standby;
(3) get Fructus Schisandrae Chinensis, Ramulus Uncariae Cum Uncis, Rhizoma Alismatis, Cortex Moutan, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata Six-element and be ground into coarse powder, make solvent with 60% ethanol, flooded 20 hours, the ethanol consumption is 10 times, carry out percolation, collecting percolate, is that 20,000 poly (ether sulfone) film separates pressure 0.36Mpa with the molecular retention value, membrane flux 3600ml/min, 32 ℃ of temperature are separated the clear paste that back recovery ethanol and concentrating under reduced pressure become relative density 1.22 (60 ℃), and are standby.
(4) with above-mentioned fine powder and thick paste mixing, drying is ground into fine powder, crosses 100 mesh sieves, and is standby.
(5) add the 20-24g carboxymethyl starch sodium, mixing is made wetting agent with 80% ethanol, and pill sieves, and gets concentrated pill between 20～10 orders in dry below 60 ℃, makes the 333g concentrated pill, promptly gets the present invention.
Embodiment 2:
It is standby to get Radix Rehmanniae 35g, Radix Rehmanniae Preparata 35g, Rhizoma Alismatis 35g, Radix Ophiopogonis 35g, Radix Scrophulariae 35g, Cortex Moutan 23g Poria 70g, Concha Margaritifera 70g, Rhizoma Curculiginis 70g, Fructus Schisandrae Chinensis 35g, Magnetitum 70g, Caulis Polygoni Multiflori 70g, Ramulus Uncariae Cum Uncis 70g, Fructus Tritici Levis 70g, Radix Polygoni Multiflori Preparata 35g, carboxymethyl starch sodium 26-30g;
Preparation technology:
Step (1) is identical with the step (1) of embodiment 1;
(2) get Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis and decoct with water secondary, adding for the first time 8 times of water gagings extracted 3 hours, adding for the second time 6 times of water gagings extracted 2 hours, collecting decoction, with the molecular retention value is that 20,000 poly (ether sulfone) film separates pressure 0.28Mpa, membrane flux 2900ml/min, 28 ℃ of temperature are separated the back and are pressed the clear paste that is condensed into relative density 1.22 (60 ℃); Standby;
(3) get Fructus Schisandrae Chinensis, Ramulus Uncariae Cum Uncis, Rhizoma Alismatis, Cortex Moutan, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata Six-element and be ground into coarse powder, make solvent with 65% ethanol, flooded 24 hours, the ethanol consumption is 12 times, carry out percolation, collecting percolate, is that 20,000 poly (ether sulfone) film separates pressure 0.27Mpa with the molecular retention value, membrane flux 2800ml/min, 30 ℃ of temperature are separated the clear paste that back recovery ethanol and concentrating under reduced pressure become relative density 1.20 (60 ℃), and are standby;
(4) with above-mentioned fine powder and thick paste mixing, drying is ground into fine powder, crosses 120 mesh sieves, and is standby;
(5) add the 26-30g carboxymethyl starch sodium, mixing is made wetting agent with 80% ethanol, and pill sieves, and gets concentrated pill between 20～10 orders in dry below 60 ℃, and is standby;
(6) with dried concentrated pill with hydroxypropyl emthylcellulose bag film-coat, make the coating concentrated pill and promptly get the present invention.
Claims (5)
1, a kind of preparation method for the treatment of climacteric syndrome Chinese medicine concentrated pill, its preparation method may further comprise the steps:
1. it is standby to take by weighing Radix Rehmanniae 35g, Radix Rehmanniae Preparata 35g, Rhizoma Alismatis 35g, Radix Ophiopogonis 35g, Radix Scrophulariae 35g, Cortex Moutan 23g, Poria 70g, Concha Margaritifera 70g, Rhizoma Curculiginis 70g, Fructus Schisandrae Chinensis 35g, Magnetitum 70g, Caulis Polygoni Multiflori 70g, Ramulus Uncariae Cum Uncis 70g, Fructus Tritici Levis 70g, Radix Polygoni Multiflori Preparata 35g by prescription;
2. get Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder and be broken into fine powder, fineness 100～120 orders, or be ground into superfine powder, and fineness 300～400 orders, standby;
3. get Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis and decoct with water secondary, adding for the first time 6～10 times of water gagings extracted 2～4 hours, adding for the second time 4～8 times of water gagings extracted 1～3 hour, collecting decoction is that 20,000 poly (ether sulfone) film separates pressure 0.2～0.4Mpa with the molecular retention value, membrane flux 2000～4000ml/min, 20～40 ℃ of temperature are separated the back concentrating under reduced pressure and become 60 ℃ of clear paste of surveying relative density 1.20～1.25, and are standby;
4. Fructus Schisandrae Chinensis, Ramulus Uncariae Cum Uncis, Rhizoma Alismatis, Cortex Moutan, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata Six-element are pulverized, make solvent with 50～70% ethanol, flooded 12～36 hours, the ethanol consumption is 10～14 times, carries out percolation, collect percolate, with the molecular retention value is that 20,000 poly (ether sulfone) film separates pressure 0.2～0.4Mpa, membrane flux 2000～4000ml/min, 20～40 ℃ of temperature are separated back recovery ethanol and concentrating under reduced pressure and are become 60 ℃ of clear paste of surveying relative densities 1.20～1.25;
5. above-mentioned clear paste is merged, add step fine powder or superfine powder 2., drying under reduced pressure is ground into fine powder, fineness 100～120 orders, the disintegrating agent carboxymethyl base Starch Sodium of adding 2～8%, mixing, ethanol pill with 70～80%, dry below 60 ℃, make the 333g concentrated pill, promptly; Or the bag film-coat, make the coating concentrated pill, promptly get the present invention.
2, preparation method according to claim 1 is characterized in that: the present invention is broken into superfine powder with Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder, fineness 300～400 orders.
3, preparation method according to claim 1 is characterized in that: disintegrating agent be in carboxymethyl starch sodium, crospolyvinylpyrrolidone or the low-substituted hydroxypropyl cellulose one or both or all.
4, preparation method according to claim 1 is characterized in that: the diameter of described concentrated pill is below 8mm.
5, preparation method according to claim 1 is characterized in that: described concentrated pill is a coated pill, and its coating material accounts for 1～5% of ball weight.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100169129A CN1325104C (en) | 2005-06-23 | 2005-06-23 | Method for preparing Chinese medicine concentrated pill for treating women's cimacteric metancholia |
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| CNB2005100169129A CN1325104C (en) | 2005-06-23 | 2005-06-23 | Method for preparing Chinese medicine concentrated pill for treating women's cimacteric metancholia |
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| CN1709479A CN1709479A (en) | 2005-12-21 |
| CN1325104C true CN1325104C (en) | 2007-07-11 |
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| CNB2005100169129A Active CN1325104C (en) | 2005-06-23 | 2005-06-23 | Method for preparing Chinese medicine concentrated pill for treating women's cimacteric metancholia |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101843740B (en) * | 2009-11-18 | 2011-07-20 | 北京绿源求证科技发展有限责任公司 | Chinese medicament for treating climacteric syndromes |
| CN116999328A (en) * | 2023-09-19 | 2023-11-07 | 仲景宛西制药股份有限公司 | Alcohol-free preparation method of concentrated pill and related equipment |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1181959A (en) * | 1997-07-09 | 1998-05-20 | 迟经惠 | Yin nourishing bolus for curing women's blood deficiency |
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- 2005-06-23 CN CNB2005100169129A patent/CN1325104C/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1181959A (en) * | 1997-07-09 | 1998-05-20 | 迟经惠 | Yin nourishing bolus for curing women's blood deficiency |
Non-Patent Citations (1)
| Title |
|---|
| 中药成方制剂 63 1997 * |
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Assignee: Beijing Pharmaceutical Co., Ltd. Assignor: Xiu Laigui Contract fulfillment period: 2008.6.28 to 2018.6.27 contract change Contract record no.: 2009110000066 Denomination of invention: Method for preparing Chinese medicine concentrated pill for treating women's cimacteric metancholia Granted publication date: 20070711 License type: Exclusive license Record date: 2009.5.5 |
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