CN103055248B - Chinese medicinal solid granule composition and preparation thereof - Google Patents
Chinese medicinal solid granule composition and preparation thereof Download PDFInfo
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- CN103055248B CN103055248B CN201210547122.3A CN201210547122A CN103055248B CN 103055248 B CN103055248 B CN 103055248B CN 201210547122 A CN201210547122 A CN 201210547122A CN 103055248 B CN103055248 B CN 103055248B
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Abstract
The invention relates to a Chinese medicinal solid granule composition and a preparation thereof. The Chinese medicinal solid granule composition is obtained by mixing and granulating the following components in percentage by weight: 2 to 10 percent of Chinese medicinal material volatile oil, 10 to 40 percent of one or more of raw medicinal material powder and fermentation mycelium powder, 10 to 40 percent of dry medicinal material extract, and 10 to 75 percent of other preparation accessories; the Chinese medicinal material volatile oil is wrapped by beta-cyclodextrin by adopting a saturated aqueous solution method, and solid-liquid separation is performed on the wrapped inclusion; and the inclusion is mixed, granulated and dried to form the Chinese medicinal solid granule composition. The invention has the advantages that a volatile oil inclusion drying procedure with many defects is removed, the loss of the volatile oil is reduced, the process time is greatly shortened, the retention rate of the volatile oil in the finished product of the Chinese medicinal preparation is improved, and the quality and the effectiveness of the medicament are ensured.
Description
Technical field
The present invention relates to field of traditional Chinese, relate in particular to a kind of Chinese medicine solid particle composition and preparation thereof containing volatile oil.
Background technology
The application of traditional medicine volatile oil has long history, and the effectiveness of many traditional medicine volatile oils is early known to ancients.According to the chemical research of modern Chinese medicine, containing the Chinese crude drug One's name is legion of volatile oil, relate to the Chinese medicine of nearly all effect classification, as Herba Menthae, Radix Bupleuri, Herba Pogostemonis, Rhizoma Curcumae, Rhizoma Chuanxiong, Folium Perillae volatilization wet goods.The nature difference of traditional medicine volatile oil is larger, is liquid at normal temperatures, more volatile, and character is unstable.The high solid preparation of oil content can be selected soft capsule or special hard capsule at present, but complicated process of preparation, product storage life is short, is difficult to adopt containing volatile oil preparation taking dry extract as main.
Prior art scheme: first the volatile oil extracting in medical material is carried out to enclose with beta-schardinger dextrin--water, solid-liquid separation, becomes moisture volatile oil clathrate compound; This moisture volatile oil clathrate compound adopts the method for drying or 50 DEG C of dry 8-12 hour of following Oven Method, powdered or granule; Mix with the former powder of medical material, dry extract etc. again, granulate; After being again dried, further make the solid preparation such as tablet, capsule.
Chinese invention patent application (application number: 200510003035.1 applyings date: 2005-03-28) discloses Chinese medicine preparation of a kind of nourishing qi and blood and preparation method thereof, and it is mainly prepared from by the medical materials such as Radix Angelicae Sinensis, Radix Rehmanniae Preparata, the Radix Paeoniae Alba, Rhizoma Chuanxiong and adjuvant.This patent discloses Radix Angelicae Sinensis, Rhizoma Chuanxiong and has first prepared ethereal oil, adopts beta-cyclodextrin inclusion compound, then mixes with dry extract.Although whether dry after the undeclared employing beta-cyclodextrin inclusion compound of this patent, after enclose, mix with dry extract, Benexate Hydrochloride obviously needs dry, otherwise, after dry extract moisture absorption, cannot effectively mix.
Chinese invention patent application (application number: the 201110121569.X applying date: 2011-05-12) discloses a kind of Chinese medicine preparation for the treatment of flu and preparation method thereof, and described Chinese medicine preparation is made up of 600～900 parts of Fructus Forsythiaes, 600～900 parts of Radix Bupleuri, 300～450 portions of Herba Ephedraes, 200～300 parts of Herba Pogostemonis, 200～300 portions of Cortex Cinnamomis and 200～300 parts of Radix Platycodoniss.Its preparation method is Fructus Forsythiae, Herba Pogostemonis, Cortex Cinnamomi to be extracted respectively to volatile oil make mixture A; Again Fructus Forsythiae is extracted to last medicinal residues and Herba Ephedrae after volatile oil, Radix Bupleuri, the active ingredient of Radix Platycodonis medical material united extraction, the dry powder B that makes of spraying; Then by mixture A and beta-cyclodextrin inclusion compound, make volatile oil pressed powder C; Finally powder B and powder C are mixed and pack in softgel shell and get final product.This patent is also clearly, and volatile oil pressed powder C need to carry out cold drying.
Chinese invention patent application (application number: 201010011610.3 applyings date: 2010-01-06) discloses a kind of series of Chinese and preparation technology and quality control method for the treatment of infantile common cold, and they are to be prepared from by Chinese medicine Folium Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Schizonepetae, Radix Platycodonis, Radix Glycyrrhizae and pharmaceutic adjuvant.This patent Radix Bupleuri volatile oil becomes clathrate with beta-cyclodextrin inclusion compound, add again Radix Platycodonis fine powder and volatile oil clathrate compound then making Chinese medicine clear paste, mix, obtain extraction extractum, add and be selected from a kind of of dextrin, lactose, sucrose or two kinds or three kinds as granulation adjuvant, carry out one-step palletizing, mix, obtain children's and separate sense granule.This patent also clear and definite clathrate in description need to be dried under the condition of 50,60 DEG C.
(application number is Chinese invention patent application: 200410081462.7) disclose a kind of pharmaceutical preparation containing volatile oil and preparation method thereof, it contains volatile oil and can be by pharmaceutic adjuvant curing volatile oil, and wherein pharmaceutic adjuvant is the Polyethylene Glycol of mean molecule quantity more than 2500.In preparation method, the medicine such as content and the utilization rate key quality factors to volatile oil is not evaluated.
The Chinese invention patent application (application number: 200910100513.9 applyings date: 2009-07-09) of applicant's application discloses the pharmaceutical composition for the treatment of prostatitis, prostatic hyperplasia, and this pharmaceutical composition is prepared by the raw material of Chinese medicine that comprises following weight parts proportioning: 60～100 parts of powdered Wuling mycelia in combinations, 20～80 parts of Rhizoma Curcumae, 20～80 parts of Bulbus Fritillariae Thunbergiis, 20～40 parts of Rhizoma Alismatis.This patent Rhizoma Curcumae extracts volatile oil beta-cyclodextrin inclusion compound, prepares volatile oil clathrate compound; The medicinal residues of Rhizoma Curcumae and Bulbus Fritillariae Thunbergii, Rhizoma Alismatis merge, and extract, and extracting liquid filtering, is evaporated to clear paste, then adds ethanol, and hold over night filters, and filtrate decompression is concentrated, the dry medical material dried cream powder that makes; Get above-mentioned WULINGJUN Fen ﹑ medical material dried cream powder, volatile oil clathrate compound, mix, obtain described pharmaceutical composition.The volatile oil clathrate compound that this patent relates to directly mixes with medical material dried cream powder, and it is to be also dried.
In each above-mentioned patent, all there is following shortcoming:
1, the clathrate of making after inclusion essential oil need first be dried to after fine powder or granule, then after mixing with other extracts, granulates or further processing; Inclusion essential oil water content of matter high (40-60%) after dehydration, drying process temperature can not exceed 50 DEG C, need to be for up to 8-12 hours;
2, volatile oil clathrate compound dry run, has part volatile oil to overflow and partial loss, and volatile oil reservation amount reduces, and causes certain contamination, operator's discomfort;
If 3 further processing again, the operations such as granulation, particle drying are made the solid preparation such as tablet, capsule, and the volatile oil in these solid preparations retains and can further reduce, and only has 50% left and right, affects medicine effectiveness and quality.
Summary of the invention
In order to solve above-mentioned technical problem, an object of the present invention is to provide a kind of Chinese medicine solid particle composition, said composition has reduced the loss of volatile oil content, can greatly shorten the process time, improve the retention rate of volatile oil in Chinese medicine preparation finished product, guaranteed drug quality and effectiveness.Another object of the present invention is to provide a kind of solid preparation that adopts above-mentioned Chinese medicine solid particle composition to prepare.
In order to realize first above-mentioned object, the present invention has adopted following technical scheme:
A kind of Chinese medicine solid particle composition, this Chinese medicine solid particle composition is by comprising that following percentage by weight composition mixing granulation obtains:
Chinese crude drug volatile oil 2%～10%
In the former powder of Chinese crude drug and fermentation mycelium powder one or more 10%～40%
Chinese crude drug dry extract 10%～40%
Other pharmaceutical adjuncts 10%～75%;
Described Chinese crude drug volatile oil adopts saturated water solution method and β – cyclodextrin inclusion compound, and Chinese crude drug volatile oil and β – cyclodextrin mass ratio are 1:4～7, the clathrate solid-liquid separation after enclose, and not drying, moisture is 35%～50%; First with the former powder of Chinese crude drug and fermentation mycelium one or more granulate after mixing described clathrate, then are dried and make described Chinese medicine solid particle composition with described Chinese crude drug dry extract, other pharmaceutical adjunct mixing granulations.
As preferably, this above-mentioned Chinese medicine solid particle composition is obtained by following percentage by weight composition mixing granulation:
Chinese crude drug volatile oil 3%～10%
In the former powder of Chinese crude drug and fermentation mycelium powder one or more 15%～35%
Chinese crude drug dry extract 10%～40%
Other pharmaceutical adjuncts 10%～60%.
As further improvement, described Chinese crude drug volatile oil is Yu the clathrate of β – cyclodextrin adopts saturated water solution method preparation, Chinese crude drug volatile oil, β – cyclodextrin, water are than being 1:4～7:15～30, enclose temperature is controlled at 25～50 DEG C, 60～120 revs/min of mixing speeds, 2～5 hours response time.
As preferably, above-mentioned Chinese medicine solid particle composition adopts the preparation of fermentation mycelium powder.
As preferably, above-mentioned Chinese crude drug volatile oil is selected from one or more combinations in Rhizoma Curcumae, Radix Bupleuri, Rhizoma Chuanxiong, Herba Pogostemonis and Folium Perillae volatile oil.
As preferably, the former powder of above-mentioned Chinese crude drug is selected from one or more combinations in Radix Ginseng, Radix Panacis Quinquefolii, Cordyceps and Radix Notoginseng.
As preferably, above-mentioned fermentation mycelium is selected from one or more combinations in ganoderma lucidum powder, fermented Cordyceps powder, powdered Wuling mycelia in combination or Coriolous Dersicolor (Fr.) Quel mycopowder.
As preferably, other above-mentioned pharmaceutical adjuncts are selected from one or more combinations in filler, binding agent, disintegrating agent and lubricant.As preferred again, other above-mentioned pharmaceutical adjuncts are selected from one or more in pregelatinized Starch, microcrystalline Cellulose, calcium hydrogen phosphate, hydroxypropyl cellulose and polyvidone.
In order to realize second above-mentioned object, the present invention has adopted following technical scheme:
A kind of solid preparation of Chinese medicine, said preparation adopts the Chinese medicine solid particle composition described in above-mentioned arbitrary technical scheme to prepare.Solid preparation of Chinese medicine can be tablet, hard capsule or granule, for Tabules, should carry out coating.
The preparation method that the invention also discloses a kind of above-mentioned Chinese medicine solid particle composition, the method comprises the following steps:
1) Chinese crude drug volatile oil carries out enclose with beta-schardinger dextrin--water, and Chinese crude drug volatile oil, Yu β – cyclodextrin mass ratio is 1:4～7, obtains wet Chinese crude drug volatile oil clathrate compound by solid-liquid separation after enclose, and its moisture is 35%～50%;
2) by moisture be the former powder of Chinese crude drug or the granulation of fermentation mycelium oscillating granulator premix of 35%～50% Chinese crude drug volatile oil clathrate compound and recipe quantity;
3) above-mentioned pre-mixed granule, Chinese crude drug dry extract and other adjuvants put to granulator granulation and be dried, obtain granule, dry finishing control moisture 4.0%～9.0%, make described Chinese medicine solid particle composition.
As further improvement, described Chinese crude drug volatile oil clathrate compound adopts saturated water solution method preparation, and volatile oil, β – cyclodextrin, water are than being 1:4～7:15～30, and enclose temperature is controlled at 25～50 DEG C, 60～120 revs/min of mixing speeds, 2～5 hours response time.
As further improvement, the solid-liquid separating method of described Chinese crude drug volatile oil clathrate compound is centrifugal filtration, filter press or decompress filter, the moist material obtaining.
As further improvement, described Chinese crude drug volatile oil clathrate compound and the former powder of Chinese crude drug or fermentation mycelium premix are granulated 1～3 time, stainless steel mesh 10～30 orders.
As further improvement, described step 3) is mixed premix granule with Chinese crude drug dry extract, then adds other adjuvants to mix, and carries out wet granulation or one-step palletizing.
As further improvement, the step of described wet granulation is as follows: in mixer-granulator, add binding agent wet granular processed, and 70～150 revs/min of paddle rotating speeds, 200～800 revs/min of fly cutter rotating speeds, move 10～30 minutes.Wet granular is placed in to boiling drier, 45～85 DEG C of inlet temperature, dry 5～30 minutes, obtain granule, control pellet moisture 4.0%～9.0%.
As further improvement, the step of described one-step palletizing is as follows: control temperature of charge at 50 ± 5 DEG C, dry, moisture Control is 4.0%～9.0%.
The present invention is owing to having adopted above-mentioned technical scheme, and the mixed method of the volatile oil clathrate compound of employing undried and the former powder of medical material, dry extract, makes mixed material meet the needs of Chinese medicine preparation molding.Thereby remove the volatile oil clathrate compound drying process that has many drawbacks, reduced the loss of volatile oil content, greatly shortened the process time, improved the retention rate of volatile oil in Chinese medicine preparation finished product, guaranteed drug quality and effectiveness.
Every comparison that the wet volatile oil clathrate compound of table 1 is directly granulated and volatile oil clathrate compound is granulated after drying
The technique time shorten consuming time that the technique of directly being granulated by the visible wet volatile oil clathrate compound of table 1 is granulated after drying than volatile oil clathrate compound more than 8 times, and volatile oil utilization rate has improved more than 30%, greatly reduce production cost, improved the utilization rate of volatile oil.
Detailed description of the invention
embodiment 1
The weight ratio of the composition of the present embodiment is: Oleum Curcumae 2.5%, powdered Wuling mycelia in combination 36%, Chinese medicine dry extract 32%, other adjuvants 29.5%.
The preparation method that contains the Film coated tablets of Oleum Curcumae, the method comprises the following steps:
1) Rhizoma Curcumae is extracted into volatile oil, other Chinese medicine extraction are made dry extract;
2) inclusion essential oil: get beta-schardinger dextrin-and be mixed with saturated aqueous solution, get 50% the dissolve with ethanol of Oleum Curcumae with weight ratio, add in saturated aqueous solution in the ratio of Oleum Curcumae: beta-schardinger dextrin-=1:6, stirring at room temperature 3 hours, 100 revs/min of mixing speeds, hold over night, removes supernatant, bottom precipitation vacuum filtration, for subsequent use;
3) wet Oleum Curcumae clathrate and powdered Wuling mycelia in combination are placed in to premix granulation on rotary granulator;
4) above granule is mixed and is placed in high efficient mixed granulator with other adjuvants such as Chinese medicine dry extract, calcium hydrogen phosphate, microcrystalline Cellulose, add binding agent, wet method is made soft material;
5) above-mentioned soft material is put in boiling drier, drying time 30min, 60～80 DEG C of inlet temperature;
6) dry granule is added to the lubricant of recipe quantity, mix;
7) by mixed granule tabletting, coating.
embodiment 2
The weight ratio of the composition of the present embodiment is: Rhizoma Chuanxiong oil: 3%, and fermented Cordyceps powder 35%, Chinese medicine dry extract 25%, other adjuvants 37%.
The preparation method that contains the granule of Rhizoma Chuanxiong oil, the method comprises the following steps:
1) Rhizoma Chuanxiong is extracted into volatile oil, and other Chinese medicine extraction are made dry extract;
2) inclusion essential oil: get beta-schardinger dextrin-and be mixed with saturated aqueous solution, get 50% the dissolve with ethanol of Rhizoma Chuanxiong oil with weight ratio, add in saturated aqueous solution in the ratio of Oleum Curcumae: beta-schardinger dextrin-=1:5,25 DEG C are stirred 5 hours, and hold over night, removes supernatant, bottom precipitation decompress filter, for subsequent use;
3) wet Oleum Curcumae clathrate and fermented Cordyceps powder are placed in to premix granulation on oscillating granulator;
4) adjuvants such as above granule and Chinese medicine dry extract, pregelatinized Starch, microcrystalline Cellulose are added in Fluidbedgranulatingdrier; Spray into binding agent, 70 DEG C of inlet temperature, temperature of charge is controlled at 50 ± 5 DEG C, and dry, moisture Control is below 6%;
5) by dry granule subpackage pack, become granule.
embodiment 3
The weight ratio of the composition of the present embodiment is: Folium Perillae volatile oil: 1.5%, and ganoderma lucidum powder: 30%, Chinese medicine dry extract: 30%, other adjuvants 38.5%.
The preparation method that contains the capsule of perilla oil, the method comprises the following steps:
1) Rhizoma Chuanxiong is extracted into volatile oil, and other Chinese medicine extraction are made dry extract;
2) inclusion essential oil: get beta-schardinger dextrin-and be mixed with saturated aqueous solution, get 50% the dissolve with ethanol of Rhizoma Chuanxiong volatile oil with weight ratio, add in saturated aqueous solution in the ratio of Folium Perillae volatile oil: beta-schardinger dextrin-=1:10, stirring at room temperature 1.5 hours, hold over night, take down supernatant, bottom precipitation vacuum filtration, for subsequent use;
3) wet perilla oil clathrate and ganoderma lucidum powder are placed in to premix granulation on oscillating granulator;
4) above granule is mixed homogeneously with filler with Chinese medicine dry extract, other adjuvants, be placed in method rolling pelletizer, make wet granular;
5) above-mentioned granule is put in boiling drier, 65 DEG C of inlet temperature, control temperature of charge at 50 ± 5 DEG C, dry 30min, dry granule control moisture 4.0%～9.0%;
6) dry granule is added to lubricant, mix filled capsules.
Claims (6)
1. a Chinese medicine solid particle composition, is characterized in that this Chinese medicine solid particle composition is by comprising that following percentage by weight composition mixing granulation obtains:
Chinese crude drug volatile oil 2%～10%
In the former powder of Chinese crude drug and fermentation mycelium powder one or more 10%～40%
Chinese crude drug dry extract 10%～40%
Other pharmaceutical adjuncts 10%～75%;
Described Chinese crude drug volatile oil adopts saturated water solution method and β – cyclodextrin inclusion compound, and Chinese crude drug volatile oil and β – cyclodextrin mass ratio are 1:4～7, the clathrate solid-liquid separation after enclose, and not drying, moisture is 35%～50%; First with the former powder of Chinese crude drug and fermentation mycelium one or more granulate after mixing described clathrate, then are dried and make described Chinese medicine solid particle composition with described Chinese crude drug dry extract, other pharmaceutical adjunct mixing granulations; Described Chinese crude drug volatile oil is selected from one or more combinations in Rhizoma Curcumae volatile oil, Radix Bupleuri volatile oil, Rhizoma Chuanxiong volatile oil, Herba Agastaches Rugosae volatile oil and Folium Perillae volatile oil; The former powder of Chinese crude drug is selected from one or more combinations in Radix Ginseng, Radix Panacis Quinquefolii, Cordyceps and Radix Notoginseng; Fermentation mycelium is selected from one or more combinations in ganoderma lucidum powder, fermented Cordyceps powder, powdered Wuling mycelia in combination or Coriolous Dersicolor (Fr.) Quel mycopowder.
2. a kind of Chinese medicine solid particle composition according to claim 1, is characterized in that this Chinese medicine solid particle composition is obtained by following percentage by weight composition mixing granulation:
Chinese crude drug volatile oil 3%～10%
In the former powder of Chinese crude drug and fermentation mycelium powder one or more 15%～35%
Chinese crude drug dry extract 10%～40%
Other pharmaceutical adjuncts 10%～60%.
3. a kind of Chinese medicine solid particle composition according to claim 1 and 2, it is characterized in that: Chinese crude drug volatile oil is Yu the clathrate of β – cyclodextrin adopts saturated water solution method preparation, Chinese crude drug volatile oil, β – cyclodextrin, water are than being 1:4～7:15～30, enclose temperature is controlled at 25～50 DEG C, 60～120 revs/min of mixing speeds, 2～5 hours response time.
4. a kind of Chinese medicine solid particle composition according to claim 1, is characterized in that: other pharmaceutical adjuncts are selected from one or more combinations in filler, binding agent, disintegrating agent and lubricant.
5. a kind of Chinese medicine solid particle composition according to claim 1, is characterized in that: other pharmaceutical adjuncts are selected from one or more in pregelatinized Starch, microcrystalline Cellulose, calcium hydrogen phosphate, hydroxypropyl cellulose and polyvidone.
6. a solid preparation of Chinese medicine, is characterized in that: said preparation adopts the Chinese medicine solid particle composition described in claim 1 ~ 5 any one claim to prepare.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1520871A (en) * | 2003-02-12 | 2004-08-18 | 毛友昌 | Effervescence granulas for treating gynecologic inflammations and preparing process thereof |
| CN1839998A (en) * | 2005-03-28 | 2006-10-04 | 贵州益佰制药股份有限公司 | Chinese medicinal preparation for replenishing qi and blood and preparation method thereof |
| CN101032589A (en) * | 2006-03-10 | 2007-09-12 | 北京星昊嘉宇医药科技有限公司 | Gynaecological inflammation-treating medicine and its preparation |
| CN101596303A (en) * | 2009-07-09 | 2009-12-09 | 浙江佐力药业股份有限公司 | Pharmaceutical composition of treatment prostatitis, prostatic hyperplasia and preparation method thereof and preparation |
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- 2012-12-17 CN CN201210547122.3A patent/CN103055248B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1520871A (en) * | 2003-02-12 | 2004-08-18 | 毛友昌 | Effervescence granulas for treating gynecologic inflammations and preparing process thereof |
| CN1839998A (en) * | 2005-03-28 | 2006-10-04 | 贵州益佰制药股份有限公司 | Chinese medicinal preparation for replenishing qi and blood and preparation method thereof |
| CN101032589A (en) * | 2006-03-10 | 2007-09-12 | 北京星昊嘉宇医药科技有限公司 | Gynaecological inflammation-treating medicine and its preparation |
| CN101596303A (en) * | 2009-07-09 | 2009-12-09 | 浙江佐力药业股份有限公司 | Pharmaceutical composition of treatment prostatitis, prostatic hyperplasia and preparation method thereof and preparation |
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