CN101491606B - Micro-pills of cassia twig and Tuckahoe and preparation method thereof - Google Patents
Micro-pills of cassia twig and Tuckahoe and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Guizhi Fuling micro pill with coating. The micro pill comprises a pill core and a film-coat covering the outside of the pill core, wherein the pill core is prepared from five material medicines of Guizhi, Fuling, bark of tree peony root, radix paeoniae rubra and peach kernel according to the weight ratio of 1:1:1:1:1, and the pill core is 1.5 to 2.0mm in diameter; the coating material used in the film-coat adopts alcohol-soluble stomach-diluting film coating pre mixing agent; and the weight of the film coating is 1.8 to 2.2 percent of the weight of the pill core. The Guizhi Fuling micro pill has the efficacies of promoting blood circulation by removing blood stasis, eliminating symptoms and stopping pain and regulating Qi and blood; and the medicine has the advantages of stable quality, large distribution area on the surface of the gastrointestinal tract, little irritation, high biological utilization degree and good curative effect. The invention also discloses a method for preparing the Guizhi Fuling micro pill; and by special process, the prepared micro pill is coated, so that the micro pill has good sterilizing effect and stable forming process, and the prepared medicine has reliable quality.
Description
Technical field
The present invention relates to a kind of cassia twig-tuckahoe micropill and preparation method thereof, belong to technical field of medicine.
Background technology
Ramulus Cinnamomi is the cinnamomic dry twig of Lauraceae magaphanerophytes; Nature and flavor: hot, sweet, warm; Chemical constituent contains volatile oil 0.2～0.9%, and main component is that cinnamic aldehyde accounts for 70～80% in the oil, is the effective ingredient of calmness, analgesia, refrigeration function, also has trans isomer cinnamic acid, coumarin, cupreol, protocatechuic acid, glucoside etc.Effect: diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.Clinical anemofrigid cold, coldness and pain in the epigastrium, cold in blood amenorrhea, arthralgia, phlegm retention, edema, cardiopalmus, the renal mass of being used for.Modern pharmacology facts have proved, it has calmness, analgesia, analgesic, anticonvulsant central nervous system's effect.Cough-relieving, antiinflammatory, antimicrobial effect are arranged, and the influence of pair immune system and digestive system is arranged.
Poria is the dry sclerotia of Polyporaceae fungus Poria; Nature and flavor: sweet, light, flat; Chemical constituent contains pachymose, accounts for 84.2% of polysaccharide, hard alkane 0.68%, and vitamin 2.84% contains pachymic acid, that fatty acid has is sad, undecanoic acid, lauric acid etc.Effect: promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.Clinically be used for that edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, loose stool are had loose bowels, irritability, palpitation with fear insomnia.Pharmacological evaluation proves that pair Immune Effects is arranged, and diuresis, calmness is arranged, to the effect of cardiovascular system, also has effects such as antitumor.
Pellet claims pilule again, be meant the spherical shape entity of the diameter of medicine and adjuvant composition less than 2.5mm, outsourcing extended release coatings or use cured class material of fat such as coatings (being generally film-coat) such as fatty acid, aliphatic alcohol and esters, cured class, can make fast according to different needs, at a slow speed or the micropill of sustained release medicine, generally be filled in the hard capsule, or packed or be pressed into tablet after take.
Micropill is usually by forming for the film-coat of ball core and outer wrapping, the adjuvant that is used for the ball core mainly contains diluent and binding agent etc., the adjuvant that is used for film-coat mainly contains with filmogen, plasticizer etc., also can add a certain amount of porogen, lubricant and surfactant etc. as required sometimes.
Increase, can reduce zest at gastrointestinal tract surface distributed area, improve advantages such as bioavailability though pellet has medicine, not all medicine micropill that all suits to make.Ancient Chinese as " LIUSHEN WAN ", " laryngitis ball ", " antiphlogistic bezoar ball " etc., be limited to the application that prescribed dose is little, treat throat's inflammation medicine, and preparation technology is backward, has shortcomings such as working strength is big, efficient is low for just the Chinese medicine pellet preparation being arranged more.
Along with the development of pharmaceutics in modern times, the application of micropill dosage form in Chinese medicine preparation obtained broad research, to promoting the Chinese medicine preparation level, realizes that the Chinese medicine preparation modernization is also significant.But at different material medicines, the adjuvant that can select when making micropill (comprising its proportioning) and preparation technology etc. also are difference to some extent, and suitable coating material and art for coating etc., all are still the problem that is worth research; Especially to the research of the micropill of compound Chinese medicinal preparation, this not only can have influence on the stability of preparations shaping technology and drug quality, the normal performance of medication characteristics such as herbal mixture monarch in the time of also can having influence on clinical practice.Therefore, can be common in the pellet preparations of all medicines without any a kind of omnipotent accessory formula and/or preparation technology etc. of being referred to as.
Summary of the invention
Main purpose of the present invention provides a kind of cassia twig-tuckahoe micropill, and the medicine that will contain raw materials such as Ramulus Cinnamomi, Poria is made micropill, has the effect of the pain relieving of blood circulation promoting and blood stasis dispelling, Xiao wei, QI and blood regulating; And drug quality is stable, and medicine increases at gastrointestinal tract surface distributed area, zest is little, bioavailability is high, good effect.
Another object of the present invention is the preparation method that discloses a kind of above-mentioned cassia twig-tuckahoe micropill.
The technical solution adopted for the present invention to solve the technical problems is:
A kind of cassia twig-tuckahoe micropill, it is a kind of micropill with coating, comprises the film-coat of ball core and ball core outer wrapping, wherein:
The ball core is 1: 1: 1 by Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, five kinds of crude drug of Semen Persicae with weight ratio: make at 1: 1, the ball core diameter is 1.5mm～2.0mm;
The coating material that film-coat adopts adopts the stomach dissolved film coating pre-mix dose of pure dissolubility; The weight of film-coat layer is 1.8～2.2% of ball core weight.
Because ball core medicine absorbs moisture easily, can effectively improve the hygroscopicity of micropill behind the film coating,, can extend protective period to guarantee drug quality.
Cassia twig-tuckahoe micropill of the present invention can prepare by the method that comprises following key step:
(1), the coarse powder and the sterilizing-drying of preparation Ramulus Cinnamomi, Poria, Cortex Moutan and Radix Paeoniae Rubra:
Get Ramulus Cinnamomi, Poria, Cortex Moutan and the Radix Paeoniae Rubra of described proportioning, be ground into 20～40 purpose coarse powder; By the medical material gross weight: ethanol weight is that 5: 1.8～2.2 to add concentration be ethanol (volumetric concentration, same down) 90% or more, mixes, and airtight placement 1.5～3 hours reaches the sterilization purpose; Put drying in 50～70 ℃ of baking ovens then, control moisture is lower than 5%;
(2), Semen Persicae dry sterilization:
Get the Semen Persicae of described proportioning, clean, use microwave drying sterilization 10～20 minutes;
(3), preparation mixture fine powder:
The Semen Persicae of above-mentioned (2) step behind the microwave drying sterilization joined in Ramulus Cinnamomi, Poria, Cortex Moutan and the Radix Paeoniae Rubra coarse powder behind above-mentioned (1) step oven drying, is ground into 80～100 purpose fine powders, mixing, the mixture fine powder;
Semen Persicae is kind of a subclass medical material, is rich in fatty oil, pulverizes easy adhesion separately; The traditional sterilizing methods of this external is not too suitable, uses modern advanced sterilizing methods Zhao microwave drying sterilization instead, and is satisfactory for result, and weak point consuming time.
(4), preparation ball core:
Get the mixture fine powder that above-mentioned (3) step makes, add water 15ml-20ml by 100g medicated powder (with mixture fine powder total) and calculate amount of water; The 25%-35% of the powder total amount of getting it filled earlier, the water that adds amount of calculation is as binding agent, mixing, molding, in coating pan, roll, successively add the mixture fine powder, make the ball core, sieve with 1.5mm～2.0mm round-hole mesh classification, remove diameter greater than 2.0mm with less than 1.5mm's, with the diameter is the qualified ball core of conduct of 1.5mm～2.0mm, and at 40～60 ℃ of oven drying at low temperatures, control moisture is lower than 9%;
(5), coating:
According to preparation coating solutions such as the operation instructions of film coating pre-mix dose, the ball core behind above-mentioned (4) step oven drying at low temperature placed carry out coating in coating pan or the coating machine, promptly make above-mentioned cassia twig-tuckahoe micropill.
In the prescription of cassia twig-tuckahoe micropill of the present invention, except that Ramulus Cinnamomi and Poria, all the other each raw materials are respectively:
Cortex Moutan, nature and flavor: bitter, hot, be slightly cold, chemical constituent contains multiple phenols, paeonol, paeonoside, the former glycosides of paeonol, peoniflorin, benzoylpaeoniflorin, gallic acid etc.Effect: clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling, clinical maculae caused by violent heat pathogen, Tu Xue Nv blood, the night fever abating at dawn of being used for, falls diseases such as pouncing on the pain of injury at lossless hectic fever due to YIN-deficiency, amenorrhea dysmenorrhea, carbuncle sore tumefacting virus.Facts have proved, the reaction of antiinflammatory, disease-resistant attitude is arranged and, also have resisting pathogenic microbes and the effect of nervus centralis to immune influence to the cardiovascular system effect.
The Radix Paeoniae Alba, nature and flavor: bitter, acid, be slightly cold, chemical constituent contains peoniflorin, paeonol, peonin, lactone glucoside of Radix Paeoniae, benzoic acid, cupreol and gallotannin, also contains volatile oil, fatty oil, protein and triterpenoid compound.Effect: suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Clinically be used for that headache is dizzy, costalgia, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.Pharmacological evaluation proves that the influence of pair immune system, cardiovascular system is arranged, and antiinflammatory, antibiotic, antivirus action are arranged, and analgesia, cooling, spasmolysis is arranged, to blood system and hepatoprotective effect.
Semen Persicae, nature and flavor: bitter, sweet, flat, chemical constituent contains liposome, phospholipid etc., wherein phosphatidylcholine 43.7～44.7%, PHOSPHATIDYL ETHANOLAMINE 35.5～37.4% etc., steroidal and glucosides thereof are arranged, also contain 17 seed amino acids such as aspartic acid, threonine and protein, flavone and glucosides thereof etc.Effect: blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation, clinically be used for amenorrhea, dysmenorrhea, WEIJIA mass in the abdomen, fall Piao's damage, dryness of the intestine constipation.Experimental results show that multiple pharmacological effect, as blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation, diuresis, antitussive, antiinflammatory, antibiotic, the town is logical, anti-allergic effects, have analgesic, protect the liver, antioxidation, antitumaous effect, also have immunomodulating and function in delaying senility.
Ramulus Cinnamomi can promoting the flow of QI-blood by warming the meridian and clots absorbing stagnates in the full side, is to be monarch drug.The key medicine of being of Semen Persicae Yu Xiao wei; The Cortex Moutan blood clots absorbing that can loose, the heat that the stasis of blood of clearing up and discharging is again changed for a long time; Radix Paeoniae energy and blood nourish blood, and share with all blood stasis dispelling medicines, and the merit of nourishing blood and promoting blood circulation is arranged, and are ministerial drug altogether.Poria clearing away phlegm diuretic, the eliminating dampness by diuresis spleen invigorating with the power of Zhu Xiao wei, is adjuvant drug.The natural fibre line of meat blood circulation promoting and blood stasis dispelling ， Xiao wei pain relieving altogether of five medicines, the effect of QI and blood regulating.
Compared with prior art, the invention has the beneficial effects as follows:
Cassia twig-tuckahoe micropill of the present invention, the medicine that will contain raw materials such as Ramulus Cinnamomi, Poria is made micropill, has the effect of the pain relieving of blood circulation promoting and blood stasis dispelling, Xiao wei, QI and blood regulating; And drug quality is stable, and medicine increases at gastrointestinal tract surface distributed area, zest is little, bioavailability is high, good effect.
In addition, in the preparation method of above-mentioned cassia twig-tuckahoe micropill provided by the invention, make behind the micropill coating again by specific preparation technology, sterilization effect is good, and moulding process is stable, and the drug quality that makes is reliable.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.
Embodiment
Present embodiment cassia twig tuckahoe (coating) micropill comprises the film-coat of ball core and ball core outer wrapping, wherein:
The ball core is made by crude drug Ramulus Cinnamomi (1000g), Poria (1000g), Cortex Moutan (1000g), Radix Paeoniae Rubra (1000g), Semen Persicae (1000g), and the ball core diameter is 1.5mm～2.0mm;
The coating material that film-coat adopts adopts the Opadry OY-P film coating pre-mix dose of pure dissolubility; The weight of film-coat layer is about 2% of ball core weight.
Cassia twig-tuckahoe micropill of the present invention can prepare by the method that comprises following key step:
(1), the coarse powder and the sterilizing-drying of preparation Ramulus Cinnamomi, Poria, Cortex Moutan and Radix Paeoniae Rubra:
Get Ramulus Cinnamomi, Poria, Cortex Moutan and the Radix Paeoniae Rubra of described weight, be ground into 20～40 purpose coarse powder; Adding concentration is 95% ethanol 2Kg, mixes, and airtight placement 2 hours reaches the sterilization purpose; Put drying in 60 ℃ of left and right sides baking ovens then, control moisture is lower than 5%;
(2), Semen Persicae dry sterilization:
Get the Semen Persicae of described proportioning, clean, use microwave drying sterilization 15 minutes;
(3), preparation mixture fine powder:
The Semen Persicae of above-mentioned (2) step behind the microwave drying sterilization joined in Ramulus Cinnamomi, Poria, Cortex Moutan and the Radix Paeoniae Rubra coarse powder behind above-mentioned (1) step oven drying, is ground into 80～100 purpose fine powders, mixing, the mixture fine powder; Get fine powder amount 4.78kg, receiving the powder rate is 95.6%;
(4), preparation ball core:
Get a small amount of (1.434kg) water (80L) of the mixture fine powder that makes of above-mentioned (3) step and be the binding agent molding, in coating pan, roll, successively add the mixture fine powder, make the ball core, sieve with 1.5mm～2.0mm round-hole mesh classification, remove diameter greater than 2.0mm with less than 1.5mm, the ball core that with the diameter is 1.5mm～2.0mm is as certified products, dry being lower than under 60 ℃ of conditions, control moisture is lower than 9%;
(5), coating:
Adopt coating material: Opadry OY-P;
Coating equipment: BY300A coating machine, Y21515-BT00-1150M peristaltic pump, compressor, spray gun etc.;
The preparation coating solution: according to the operation instruction of Opadry OY-P film coating pre-mix dose, get OY-P 8g, add 88% ethanol 100ml, dissolving was stirred 30～40 minutes,
The ball core of above-mentioned (4) step behind the oven drying at low temperature placed carry out coating in the coating machine, 30～50 rev/mins of rotating speeds, 40 ℃ of coating temperature are to coating weightening finish 2%, promptly.
Get the micropill of present embodiment coating front and back, put under relative humidity 75.28%, 25 ℃ of temperature, the constant temperature and humidity condition, placed 72 hours, take out, observe outward appearance, measure moisture (toluene method of pressing the Chinese Pharmacopoeia regulation is measured) and dissolve scattered time limit, it is as follows to measure the multiple averaging result:
Coated micropill: 15 minutes outward appearances of moisture 9.96% dissolve scattered time limit are bright and clean, rounding;
Coated micropill not: 12 minutes outward appearances of moisture 12.00% dissolve scattered time limit are bright and clean, rounding.
The hygroscopicity of micropill has a greater degree of improvement behind the coating as can be known by testing, and more helps medicine and preserves.
In the research process, the inventor has also carried out the comparative experimental research investigation to associated process conditions, and method and result are as follows respectively:
1, Semen Persicae is carried out the investigation of microwave drying sterilization time:
Rule of thumb selection time is 5,10,15 minutes, estimates with sterilization effect, and the result is as follows:
Sterilization (the crude drug powder of not sterilizing) in 0 minute: 3000/g of bacterial population
Fungi count, 350/g of yeast count
Escherichia coli does not detect
The demodicid mite that lives does not detect
Sterilization in 5 minutes: 1100/g of bacterial population
Fungi count, 100/g of yeast count
Escherichia coli does not detect
The demodicid mite that lives does not detect
Sterilization in 10 minutes: 200/g of bacterial population
Fungi count, yeast count＜10/g
Escherichia coli does not detect
The demodicid mite that lives does not detect
Sterilization in 15 minutes: bacterial population＜10/g
Fungi count, yeast count＜10/g
Escherichia coli does not detect
The demodicid mite that lives does not detect
Above result shows that Semen Persicae adopts microwave sterilizating more than 10 minutes, and sterilization effect is more satisfactory, and weak point consuming time.
2, the sterilization effect of Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra medicinal material coarse powder is investigated:
Get coarse powder,, estimate result such as following table 1 with sterilization effect comparing before and after the ethanol sterilization with a collection of Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra medical material:
Table 1 ethanol sterilization effect
| Ethanol sterilization 1 | Ethanol sterilization 2 | Ethanol sterilization 3 | The crude drug powder of not sterilizing | |
| Bacterial population (individual/g) | ?300 | ?150 | ?250 | 17×10 3 |
| Fungi count, yeast count (individual/g) | ?＜10 | ?＜10 | ?＜10 | 180 |
| Escherichia coli | ?＜10 | ?＜10 | ?＜10 | ＜10 |
| Demodicid mite lives | Do not detect | Do not detect | Do not detect | Do not detect |
By above-mentioned table 1 result as can be known, adopt the effect of ethanol sterilization better to Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra medicinal material coarse powder.
3, the selection of coating medical material:
Adopt water solublity coating powder and pure dissolubility coating powder to try coating respectively, the results are shown in following table 2:
The different coating materials of table 2 are investigated the result
| Coating powder | Concentration | The coating time | The coating result |
| The alcohol dissolubility | 8% | 3 hours | Be difficult for bonding, any surface finish, rounding. |
| Water solublity | 8% | 4.5 hour | Easily bond, fineness is poor, not rounding |
According to the coating result of the test as can be known: its solvent volatilization of water solublity coating powder is slow, and the coating time is longer, easily bonds, and fineness is poor, so should not select for use; And pure dissolubility coating powder solvent volatilization is fast, and the coating time is shorter relatively, is difficult for bonding, any surface finish, rounding, and coating effect is good.
Claims (1)
1. cassia twig-tuckahoe micropill, it is a kind of micropill with coating, comprises the film-coat of ball core and ball core outer wrapping, wherein:
The ball core is 1: 1: 1 by Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, five kinds of crude drug of Semen Persicae with weight ratio: make at 1: 1, the ball core diameter is 1.5mm～2.0mm;
The coating material that film-coat adopts adopts the stomach dissolved film coating pre-mix dose of pure dissolubility; The weight of film-coat layer is 1.8～2.2% of ball core weight; The preparation method of described cassia twig-tuckahoe micropill comprises following key step:
(1), the coarse powder and the sterilizing-drying of preparation Ramulus Cinnamomi, Poria, Cortex Moutan and Radix Paeoniae Rubra:
Get Ramulus Cinnamomi, Poria, Cortex Moutan and the Radix Paeoniae Rubra of described proportioning, be ground into 20～40 purpose coarse powder; By the medical material gross weight: ethanol weight is that 5: 1.8～2.2 to add volumetric concentrations be ethanol more than 90%, mixes, and airtight placement 1.5～3 hours reaches the sterilization purpose; Put drying in 50～70 ℃ of baking ovens then, control moisture is lower than 5%;
(2), Semen Persicae dry sterilization:
Get the Semen Persicae of described proportioning, clean, use microwave drying sterilization 10～20 minutes;
(3), preparation mixture fine powder:
The Semen Persicae of above-mentioned (2) step behind the microwave drying sterilization joined in Ramulus Cinnamomi, Poria, Cortex Moutan and the Radix Paeoniae Rubra coarse powder behind above-mentioned (1) step oven drying, is ground into 80～100 purpose fine powders, mixing, the mixture fine powder;
(4), preparation ball core:
Get the mixture fine powder that above-mentioned (3) step makes, add water 15ml-20ml by 100g medicated powder and calculate amount of water; The 25%-35% of the powder total amount of getting it filled earlier, the water that adds amount of calculation is as binding agent, mixing, molding is rolled in coating pan, successively add the mixture fine powder, make the ball core, classification is sieved, and is the qualified ball core of conduct of 1.5mm～2.0mm with the diameter, at 40～60 ℃ of oven drying at low temperatures, control moisture is lower than 9%;
(5), coating:
The ball core of above-mentioned (4) step behind the oven drying at low temperature placed in coating pan or the coating machine carry out coating, promptly.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008103067101A CN101491606B (en) | 2008-12-31 | 2008-12-31 | Micro-pills of cassia twig and Tuckahoe and preparation method thereof |
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| CN2008103067101A CN101491606B (en) | 2008-12-31 | 2008-12-31 | Micro-pills of cassia twig and Tuckahoe and preparation method thereof |
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| CN101491606B true CN101491606B (en) | 2011-11-30 |
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| JP6626093B2 (en) | 2014-05-12 | 2019-12-25 | 北京慧宝源企▲業▼管理有限公司 | Pharmaceutical composition and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1615978A (en) * | 2004-09-10 | 2005-05-18 | 张凯 | Cassia twig and poria cocos disperse tablet and its producing method |
| CN1748738A (en) * | 2005-09-17 | 2006-03-22 | 浙江天一堂集团有限公司 | Chinese medicine cinnamon twig and poria dripping pill and its preparing method |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1615978A (en) * | 2004-09-10 | 2005-05-18 | 张凯 | Cassia twig and poria cocos disperse tablet and its producing method |
| CN1748738A (en) * | 2005-09-17 | 2006-03-22 | 浙江天一堂集团有限公司 | Chinese medicine cinnamon twig and poria dripping pill and its preparing method |
Non-Patent Citations (1)
| Title |
|---|
| 国家药品监督管理局.桂枝茯苓丸.《国家药品中药标准（外科妇科分册）》.2002,366. * |
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