CN100586425C - Cinnamon poria capsule and its preparation process - Google Patents
Cinnamon poria capsule and its preparation process Download PDFInfo
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- CN100586425C CN100586425C CN200410100866A CN200410100866A CN100586425C CN 100586425 C CN100586425 C CN 100586425C CN 200410100866 A CN200410100866 A CN 200410100866A CN 200410100866 A CN200410100866 A CN 200410100866A CN 100586425 C CN100586425 C CN 100586425C
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Abstract
The present invention relates to a ramulus cinnarnomi poria pill and soft capsule with new dosage form and the making method. It is composed of the content and capsule material, the content includes:compound active ingredient, diluent and auxiliary suspending agent, their proportion by weight is: one colon one point zero to one point eight colon zero point one to zero point six colon zero point double zeroes one to zero point zero one. The material of the capsule is basically composed of gelatin, plasticizer and water, the proportion of the three materials by weight is: one colon zero point three to zero point four colon zero point seven to one point four.
Description
Technical field
The present invention relates to a kind of Ramulus Cinnamomi Poria pill and capsule novel form cassia twig and poria cocos soft capsule and preparation technology thereof.
Background technology
Ramulus Cinnamomi Poria pill comes from Zhang Zhongjing " Medical Treasures of the Golden Chamber ", is tcm clinical practice tradition commonly used name side.According to modern clinical report, this product also has better curative effect for various disease conditions except that being used for dysmenorrhea that tradition cures mainly, menoxenia, anovulatory dysfunctional uterine hemorrhage, hysteromyoma, lochiorrhea.As ovarian cyst, adnexitis and the enclosed mass of gynecological, cyclomastopathy, menstrual period syndrome etc., the habitual abortion of obstetrics, ectopic pregnancy, infertility etc., the hyperlipemia of cardiovascular system, myocarditis, thrombophlebitis etc., and asthma, thyroid disease, lumbago and skelalgia, prostatitis, climacteric syndrome etc.
The pharmacological research of this product single medical material shows that Ramulus Cinnamomi has the specificity hyperemization to the uterus, and blood capillary is had dilating effect, but and anticoagulant; Also have stronger antianaphylaxis and antibacterial action in addition.Poria can calmness, diuresis, antitumor, antibacterial.Cortex Moutan both can suppress platelet aggregation and anticoagulant, can play inhibitory action and promote blood coagulation plasminogen and plasmin activity again, and stronger antibiotic, antiinflammatory, refrigeration function are arranged.But the Radix Paeoniae Rubra anticoagulant, the expansion peripheral blood vessel reduces Peripheral resistance, also has effects such as spasmolytic, analgesia, antibiotic, antiinflammatory.Semen Persicae has significant inhibition hemagglutinative function.The prescription that five tastes medical material is formed has effects such as blood vessel dilating, anticoagulation, spasmolytic, spasmolytic, analgesia widely.
At present this product has only the watered pill and two kinds of dosage forms of close ball, and they all belong to pill, and pill is taken back molten loosing slowly in gastrointestinal tract, and dose is big, manufacturing technology not at that time, its dissolve scattered time limit is difficult to control, and is subject to microbial contamination, easy bacteria-developing mildews.The preparation manipulation of the watered pill is harder to tackle in addition, and general ball is strict to workman's experience and proficiency level, and its finished product drug content is difficult to control, and close ball consumption is big, and easily the moisture absorption shortcoming such as is difficult to deposit and is difficult to solve.
On the Ramulus Cinnamomi Poria pill basis, the novel form of now having developed has the cassia twig tuckahoe hard capsule, compares with its pill, takes, carries, taste all has preferably and improve.
Summary of the invention
The purpose of this invention is to provide a kind of cassia twig tuckahoe novel form soft capsule and preparation technology thereof.
That soft capsule preparation is used for more is water-insoluble, to photaesthesia, run into damp and hot instability, the volatile medicine of oxidation easily, to strengthen stability of drug, the effect of cover the adverse drug taste in addition in addition, being convenient to take experimental results show that the bioavailability of soft capsule is higher than hard capsule and conventional tablet.Because these characteristics of soft capsule have determined that medicine is hedged off from the outer world in the shell, its face shaping, disintegration time and stability etc., none is the influence of receptaculum material and content component not.
Content of the present invention is made up of compound active composition and diluent, suspending agent, wetting agent, and their weight ratio is 1: 1.0-1.8: 0.1-0.6: 0.001-0.01, the compound active composition is as described below to be made by different process.
Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae of weight such as the compound active composition in the content is, in above five tastes medical material, the Ramulus Cinnamomi main component is a cinnamic aldehyde, volatile during decocting, adopt the pulverizing back directly to mix the method for being used as medicine for keeping its effective ingredient with other medicinal substances extracts, Poria starch is many, and mealiness also selects to pulverize earlier the blended method in back too by force.Get Ramulus Cinnamomi, the Poria pulverize separately becomes fine powder; All the other Radix Paeoniae Rubra, Cortex Moutan, Semen Persicae three flavor medical materials are for reducing dose, so the technology that adopts water to carry.Add suitable quantity of water after three flavor medical materials are merged and decoct repeatedly, collecting decoction filters, and after filtrate concentrates, often press dry dry, drying under reduced pressure or spray drying, with above-mentioned fine powder mixing, is the compound active composition.
For effective component extracting more effectively, also composition is feasible to have adopted after the alcohol extraction of part medical material the prepared compound active that water carries again.Promptly wait Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae five tastes medical material of weight, 1/2nd Poria powders of measuring are broken into fine powder; The residue medical material merge the back with ethanol and water respectively reflux, extract, for several times, merge extractive liquid, filters respectively, filtrate concentrates the back and merges, often press dry dry pulverizing, drying under reduced pressure is pulverized or spray drying after, with above-mentioned fine powder mixing, obtain the compound active composition equally.
In order more effectively to reduce taking dose and the abundant extraction of the composition of remaining valid, also can take whole alcohol extractions to add the technology that water is put forward.Promptly wait Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae of weight, with 60～100% ethanol and water difference reflux, extract, several, merge extractive liquid, filters respectively, filtrate concentrates the back and merges, and constant pressure and dry is pulverized, drying under reduced pressure is pulverized or spray drying is made the compound active composition.
Diluent can be all kinds of vegetable oil, and vegetable oil can be one or more the mixture in Oleum Sesami, Semen Maydis oil, Oleum Arachidis hypogaeae semen, Oleum Glycines, almond oil, peach kernel oil, Oleum Gossypii semen, Oleum Helianthi, olive oil, rapeseed oil, Petiolus Trachycarpi oil, the Oleum Cocois.
For diluent is the vegetable oil of oily substrate, normally used suspending agent can be selected the solid matter that can increase dispersant viscosity for use, is respectively in Carboxymethyl cellulose sodium, hydroxyethyl-cellulose, hyprolose, hydroxypropyl emthylcellulose, methylcellulose, ethyl cellulose, hydroxyethylmethyl-cellulose, carbomer, polyvinyl alcohol, sodium alginate, chitin, chitose, agar, Cera Flava, oily wax mixture, xanthan gum, arabic gum, the casein one or more.They can effectively solve the lamination of content, make the content good fluidity.
Wetting agent is surfactant-based material, be respectively Tweens (polysorbas20,40,60,65,80,85), spans (span 20,80,85), poloxamer 188, they can promote the absorption and raising bioavailability of effective ingredient, can improve the flowability of content, the suspendible better effects if of more single use suspending agent.
No matter be the water solublity content, or oil-soluble content, their capsule material is made up of gelatin, plasticizer and water substantially, three's weight ratio is 1: 0.3-0.4: 0.7-1.4, plasticizer is selected from glycerol, sorbitol, hexanetriol, propylene carbonate, hexanediol, anhydro sorbitol oxolane alcohol ether, diethylene glycol monoethyl ether, 1,3-dimethyl-2-imidazolone or the different sorbate of dimethyl.Effect for preventing that softgel shell from going mouldy is beneficial to long-term storage, also can add antiseptic, and the weight ratio of gelatin and antiseptic is 1: 0.003, and antiseptic can be benzoic acid, sodium benzoate, methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben.
Cassia twig and poria cocos soft capsule can adopt conventional soft capsule preparation technology to make among the present invention, as manual die pressing, rotating mould platen press or dropping preparation method.Usually select the rotation pressing for use, use rotation rolling capsule machine automatically, temperature is controlled at 25～35 ℃, rolling soft capsule.
Cassia twig and poria cocos soft capsule of the present invention has overcome the defective that existing other dosage form exists as novel form, reduced patient's dose, guaranteed making full use of of effective ingredient, disintegration is short, absorb soon in the body, and the detection that meets under the relevant soft capsule item of Chinese Pharmacopoeia requires (specifying).When more what deserves to be explained is water solublity PEG-400 or PEG-600 as dispersant, because of they have water absorption, the water that softgel shell itself is contained often can shift to content rapidly, even can reach more than 20% of total amount, thereby the elasticity of softgel shell is reduced, influence the disintegrate, stability of soft capsule etc., if still select the plant oil diluent for use, then overcome the effect of softgel shell to content, the cost of raw material also can reduce significantly.
Cassia twig and poria cocos soft capsule is the disintegration in simulated gastric fluid (9ml hydrochloric acid adds water to 1000ml, 37 ℃): 0 day is 8.5 minutes; Be 40 minutes after room temperature kept sample 12 months, meet the Chinese Pharmacopoeia requirement.
The specific embodiment
Cassia twig and poria cocos soft capsule is made up of content and capsule material among the present invention.
Content is made up of compound active composition and diluent, suspending agent, wetting agent, Oleum Arachidis hypogaeae semen in the diluent preferably vegetable oil, Oleum Glycines, Semen Maydis oil, Oleum Sesami, suspending agent preferred oil wax mixture, the preferred sorbester p17 of wetting agent, preferred 1: 1.3: 0.3 of their weight ratio: 0.004-0.006.The oil wax mixture is made up of hydrogenated vegetable oil, Cera Flava, Oleum Cocois, and three's ratio is 1: 1: 3.
The capsule material is made up of gelatin, plasticizer and water substantially among the present invention, the plasticizer preferably glycerine, and gelatin, glycerol, water preferred weight ratio are 1: 0.33-0.35: 0.9, the preferred methyl hydroxybenzoate of antiseptic.
The starch of the two flavor medical material Poria that desire is pulverized in the compound active composition is many, and mealiness is well easily pulverized, and the fibroid of Ramulus Cinnamomi medical material is strong, but with general mechanical activation comminution fineness is reached more than 120 orders, to guarantee the stability of suspension, is beneficial to absorption of human body.Because the complexity of active component, content is the suspension state, from the sedimentation formula V=2r of suspension
2(d
1-d
2)/9n, V are the microgranule sedimentation velocity, and r is a particle radius, d
1Be density of particle, d
2Be disperse medium density, n is the viscosity of disperse medium, can know minimizing granularity increase dispersion medium viscosity by inference and can reduce sedimentation velocity effectively, guarantees the stability of suspension, so the thin more easy more mixing of the granularity of dried cream powder.
When the compound active composition by cassia twig tuckahoe fine powder and Radix Paeoniae Rubra, Cortex Moutan, when Semen Persicae three flavor medical material water extracts are formed, we have investigated the extraction process by water of Radix Paeoniae Rubra, Cortex Moutan, Semen Persicae three flavor medical materials, be the influence factor promptly with extraction time, extraction time, amount of water and decoction temperature, with dried cream rate and content of paeoniflorin as investigating index, design L
9(3
4) orthogonal experiment.
Table 1, water are put forward the orthogonal test gauge outfit
Table 2, water are put forward orthogonal design table
Above experimental result is carried out The results of analysis of variance to be seen Table
Table 3 goes out the variance analysis of dried cream rate
*F
0.05(2，2)＝19.00；F
0.01(2，2)＝99.00
The variance analysis of table 4 paeoniflorin content
*F
0.05(2，2)＝19.00；F
0.01(2，2)＝99.00
With the sum of deviation square minimum of factor C in the paeoniflorin content mensuration, selecting it is source of error, and the result shows that the decoction temperature has significant difference to the influence of content, gets experiment A the 4th time according to intuitive analysis
2B
1C
2D
3Promptly decoct twice during 100 ℃ of 10 times of water gagings, concentrating dried cream to relative density is 1.20～1.25 (80 ℃), and spray drying merges with the Poria of pulverizing or meet granularity requirements, Ramulus Cinnamomi, is the compound active composition.
The same orthogonal design that adopts has obtained also that water after the alcohol extraction of part medical material elder generation is carried and optimum extraction process parameter that all water is put forward after the alcohol extraction of medical materials elder generation.
The following examples will be described the present invention in more detail.
The preparation of embodiment one, cassia twig and poria cocos soft capsule
1, preparation compound active composition: take by weighing Ramulus Cinnamomi 398.7g Poria 398.7g Cortex Moutan 398.7g Radix Paeoniae Rubra 398.7g Semen Persicae 398.7g five tastes medical material each three times, get Ramulus Cinnamomi, the Poria pulverize separately becomes fine powder; Its excess-three is distinguished the flavor of and is added 10 times of water gagings decoctions twice, and 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is concentrated into the clear paste that relative density is 1.20 (80 ℃), is spray dried to dried cream powder, mixes with above-mentioned fine powder, gets 2206 and restrains the compound active compositions.
2, preparation content: get Cera Flava 200 grams, Oleum Cocois 600 grams, hydrogenated vegetable oil 200 grams, be heated to 80 ℃ and make fusing, stirring evenly and putting cold-working is suspending agent.
Oleum Glycines 2860 grams, suspending agent 660 grams, sorbester p17 8.8 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly.
3, preparation capsule material: get gelatin 5000 grams, water 4500 grams, be heated to 70 ℃, get glycerol 1750 grams, methyl hydroxybenzoate 15 grams, stir, evacuation 1 hour mixes with above-mentioned gelatin, 70 ℃ of insulation standing over night.
4, compacting soft capsule: with the capsule dish liquid that makes and the content rotation rolling capsule machine automatically of packing into, temperature is controlled at 25～35 ℃ and suppresses the soft capsule that contains active component 220mg.
The preparation of embodiment two, cassia twig and poria cocos soft capsule
1, preparation compound active composition: with embodiment one.
2, preparation content: Semen Maydis oil 2200 grams, Cera Flava 220 grams, sorbester p17 2.2 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly.
3, preparation capsule material: with embodiment one.
4, compacting soft capsule: with embodiment one.
The preparation of embodiment three, cassia twig and poria cocos soft capsule
1, preparation compound active composition: with embodiment one.
2, preparation content: Oleum Arachidis hypogaeae semen 3960 grams, Cera Flava 1320 grams, sorbester p17 23 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly.
3, preparation capsule material: with embodiment one.
4, compacting soft capsule: with embodiment one.
The preparation of embodiment four, cassia twig and poria cocos soft capsule
1, preparation compound active composition: take by weighing Ramulus Cinnamomi 2400g Poria 2400g Cortex Moutan 2400g Radix Paeoniae Alba 2400g Semen Persicae 2400g, 1200g is ground into fine powder with Poria, four Chinese medicine materials such as remaining Poria and Ramulus Cinnamomi are ground into coarse powder, mixing, add 7 times of amount 90% ethanol and 10 times of water gagings respectively reflux, extract, each twice, merge extractive liquid, concentrates the back and merges respectively, with above-mentioned Poria fine powder mixing, make 3000 gram compound active compositions.
2, preparation content: get Cera Flava 200 grams, Oleum Cocois 600 grams, hydrogenated vegetable oil 200 grams, be heated to 80 ℃ and make fusing, stirring evenly and putting cold-working is suspending agent.
Soybean oil 2460 grams, suspending agent 600 grams, sorbester p17 12 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly
3, preparation capsule material: get gelatin 10000 grams, water 9000 grams, be heated to 70 ℃, get glycerol 3500 grams, ethyl hydroxybenzoate 30 grams, stir, evacuation 1 hour mixes with above-mentioned gelatin, 70 ℃ of insulation standing over night.
4, compacting soft capsule: with embodiment one, compacting contains the soft capsule of active component 300mg.
The preparation of embodiment five, cassia twig and poria cocos soft capsule
1, preparation compound active composition: take by weighing Ramulus Cinnamomi 2400g Poria 2400g Cortex Moutan 2400g Radix Paeoniae Alba 2400g Semen Persicae 2400g, five tastes medical material is ground into coarse powder, mixing, add each twice of 90% ethanol and water difference reflux, extract,, the difference merge extractive liquid,, concentrate the back and merge, drying under reduced pressure, pulverize 1860 gram compound active compositions.
2, preparation content: get Cera Flava 200 grams, Oleum Cocois 600 grams, hydrogenated vegetable oil 200 grams, be heated to 80 ℃ and make fusing, stirring evenly and putting cold-working is suspending agent.
Soybean oil 2250 grams, suspending agent 370 grams, sorbester p17 20 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly
3, preparation capsule material: with embodiment four.
4, compacting soft capsule: with embodiment one, compacting contains the soft capsule of active component 190mg.
Claims (10)
1, a kind of cassia twig and poria cocos soft capsule, it is characterized in that it is made up of content and capsule material, wherein content is made up of compound active composition and diluent, suspending agent, wetting agent substantially, their weight ratio is 1: 1.0-1.8: 0.1-0.6: 0.001-0.01, compound active composition are obtained by following any one method respectively:
(1) etc. Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae of weight become fine powder with Ramulus Cinnamomi, Poria pulverize separately, and Radix Paeoniae Rubra, Cortex Moutan, Semen Persicae three flavor medical materials decoct with water after merging, collecting decoction, filter, filtrate is concentrated into clear paste, and dried cream powder is pulverized or be spray dried to drying under reduced pressure;
(2) Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae of weight such as, the Poria powder of 1/2nd amounts is broken into fine powder, after merging, the residue medical material adds 90% ethanol and water difference reflux, extract, each twice, the difference merge extractive liquid,, filter, filtrate concentrates the back and merges, and dried cream powder is pulverized or be spray dried to drying under reduced pressure;
(3) Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae of weight such as, with 60～100% ethanol and water respectively reflux, extract, each twice, merge extractive liquid, filters respectively, filtrate concentrates the back and merges, dried cream powder is pulverized or be spray dried to drying under reduced pressure.
2, according to the described cassia twig and poria cocos soft capsule of claim 1, the weight ratio that it is characterized in that compound active composition and diluent, suspending agent, wetting agent is 1: 1.3: 0.3: 0.004-0.006.
3,, it is characterized in that diluent is one or more the mixture in the Oleum Sesami, Semen Maydis oil, Oleum Arachidis hypogaeae semen, Oleum Glycines, almond oil, peach kernel oil, Oleum Gossypii semen, Oleum Helianthi, olive oil, rapeseed oil, Petiolus Trachycarpi oil, Oleum Cocois of plant oil according to the described cassia twig and poria cocos soft capsule of claim 1.
4,, it is characterized in that suspending agent is one or more mixture in Carboxymethyl cellulose sodium, hydroxyethyl-cellulose, hyprolose, hydroxypropyl emthylcellulose, methylcellulose, ethyl cellulose, hydroxyethylmethyl-cellulose, carbomer, polyvinyl alcohol, sodium alginate, chitin, chitose, agar, Cera Flava, oily wax mixture, xanthan gum, arabic gum, the casein according to the described cassia twig and poria cocos soft capsule of claim 1.
5, according to the described cassia twig and poria cocos soft capsule of claim 1, it is characterized in that wetting agent is surfactant-based material, be respectively polysorbas20, polysorbate40, polysorbate60, polysorbate65, Tween 80, polysorbate85, span 20, sorbester p17, sorbester p37, poloxamer 188.
6, according to the described cassia twig and poria cocos soft capsule of claim 1, it is characterized in that the capsule material is made up of glue, plasticizer and water substantially, three's weight ratio is 1: 0.3-0.4: 0.7-1.4.
7,, it is characterized in that glue is gelatin or arabic gum according to the described cassia twig and poria cocos soft capsule of claim 6.
8, according to the described cassia twig and poria cocos soft capsule of claim 6, it is characterized in that plasticizer is selected from glycerol, sorbitol, hexanetriol, propylene carbonate, hexanediol, anhydro sorbitol, oxolane alcohol ether, diethylene glycol monoethyl ether, 1,3-dimethyl-2-imidazolone or the different sorbate of dimethyl.
9, according to the described cassia twig and poria cocos soft capsule of claim 6, it is characterized in that the preferred gelatin of capsule material, glycerol, water, three's weight ratio is 1: 0.33-0.35: 0.9.
10, according to the described cassia twig and poria cocos soft capsule of claim 6, it is characterized in that also adding in the capsule material antiseptic, the weight ratio of glue and antiseptic is 1: 0.003, and antiseptic is benzoic acid, sodium benzoate, methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben.
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| CN101214352B (en) * | 2007-01-05 | 2010-09-08 | 闫淑丽 | Chinese medicine for treating hyperlipemia |
| DE112014006651T5 (en) | 2014-05-12 | 2017-02-09 | Beijing Hebabiz Management Co., Ltd. | Pharmaceutical composition and its use for controlling the blood lipids and body weight of a human body |
| CN108969577A (en) * | 2018-08-21 | 2018-12-11 | 广州圣芳医药科技有限公司 | It is a kind of to act on the SHENJUE acupoint treatment composition of medicine of inflammation, drug pad pasting and its preparation method and application |
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| 中华人民共和国药典. 药典委员会，549，人民卫生出版社. 2000 * |
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