CN1704072A - Heat clearing Chinese proprietary capsule(tablet) of 'Ganlu Xiaodu' for treating cold and its preparation process - Google Patents
Heat clearing Chinese proprietary capsule(tablet) of 'Ganlu Xiaodu' for treating cold and its preparation process Download PDFInfo
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Abstract
The invention discloses a heat clearing Chinese proprietary capsule (tablet) of 'Ganlu Xiaodu' for treating cold and its preparation process, which comprises eleven kinds of Chinese medicinal herbs including baikal skullcap root, talcum powder, grassleaved sweetflag rhizome and belamcanda rhizome. The preparing process comprises making extract by prescription contents, mixing 100 parts of extract with 2-5 parts of silicon dioxide to prepare capsule, or mixing 100 parts of extract with 0.2-0.5 part of magnesium stearate to obtain tablets, and the content of the active ingredient of baicalin in the extract in no less than 9.0%.
Description
Technical field
The invention belongs to field of traditional Chinese, relate to a kind of Chinese patent medicine nectar disinfection capsule capsule (sheet) and preparation technology thereof who treats cold reducing-fever, more precisely, is to improve dosage form and preparation technology thereof on the basis of former dosage form manna disinfecting pills.
Background technology
Ancient times, the Chinese patent medicine of treatment flu mostly was pill or powder, but because of summer easy mould evil idea rotten, and large usage quantity is taken inconvenience.How changed some ancient prescriptions or classic prescriptions into tablet, capsule or electuary modern age.For example the manna disinfecting pills is old classical side, its dosage form is the watered pill, (seeing the 9th 54 pages of Drug Standard of Ministry of Public Health of the Peoples Republic of Chinas for details) is mainly used in the treatment cold reducing-fever, has significant curative effect through the proof of clinical practice for many years, the no obvious toxic-side effects of safety, but owing to be subjected to the limitation of dosage form and dose, the market share is little always, can not satisfy vast cold, fever patient's demand far away.
At present, mainly there is following problem (1) in the manna disinfecting pills. and the molten diffusing time, length was general needs 50 minutes, causes the oral absorption onset slow, has reduced bioavailability, is unfavorable for the drug effect performance; (2). taking dose is bigger, and each about 86～129 balls of dose (being equivalent to crude drug amount 6～9 grams) cause the inconvenience of taking medicine to patient especially old people; (3). because the preparation process of manna disinfecting pills is that prescription medical material is ground into direct general ball molding behind the powder, thereby medicament contg is lower, and does not have quality standard at present and control, and it is up to standard or the like that health examination is difficult for.The manna disinfecting pills all is further improved at aspects such as dissolubility, dissolution rate, bioavailability and active constituent content controls in a word.
Therefore, at the problem of above existence, utilizing the Chinese medicinal formulae of state-of-the-art technology with determined curative effect, be developed to the manna sterilization novel form that meets clinical needs, is the important topic of Chinese medicine research work.
Summary of the invention
One object of the present invention is to overcome above-mentioned shortcoming with not enough, and the Chinese patent medicine nectar disinfection capsule capsule (sheet) of the treatment cold reducing-fever that a kind of taking dose is little, dissolution velocity is fast, bioavailability is high is provided.
Another object of the present invention provides a kind of preparation technology of easy and simple to handle, quality controllable nectar disinfection capsule capsule (sheet).For achieving the above object, the technical solution adopted in the present invention is:
A kind of Chinese patent medicine nectar disinfection capsule capsule (sheet) for the treatment of cold reducing-fever, it is that raw material is made by Radix Scutellariae 20g, Pulvis Talci 30g, Rhizoma Acori Graminei 12g, Rhizoma Belamcandae 8g, Herba Artemisiae Scopariae 22g, Fructus Amomi Rotundus 8g, Herba Menthae 8g, Caulis Clematidis Armandii 10g, Fructus Forsythiae 8g, Bulbus Fritillariae Cirrhosae 10g, Herba Pogostemonis 8g 11 flavor Chinese medicines by the refining extract that extracts of recipe quantity, it is characterized in that, with 100 parts of extract extractum and 5-30 part starch mixing, add 2-5 part silicon dioxide, be mixed and made into capsule; Or with 100 parts of extract extractum, mix with 10-50 part starch, 5-30 part dehydrated alcohol, granulate, add 0.2-0.5 part magnesium stearate subsequently, make tablet.Wherein, extract is to adopt alcohol extraction or water is carried or alcohol-water mixed extraction is made.The effective ingredient baicalin content is not less than 9.0% in the extract.
A kind of Chinese patent medicine nectar disinfection capsule capsule (sheet) preparation technology who treats cold reducing-fever comprises the steps:
1) medical material is handled: take by weighing the 1000g medical material by above-mentioned recipe quantity, respectively extract twice with 85-95% second alcohol and water, use the 6000-8000ml ethanol extraction at every turn, each 1 hour.Alcohol extract is evaporated to dried, adds water and be suspension, extract volatile oil, after the enrichment, suspension is evaporated to extractum.Water extraction is meant the each 8000-10000ml of using water extraction, each 0.5-2 hour.Then the water extract is concentrated into relative density 1.05-1.15, the concentrated solution ethanol precipitation removal of impurity makes to contain alcohol and reach 70%～80%.Leave standstill, supernatant concentration becomes extractum, mixes with the ethanol extraction concentrated extract, and wherein the effective ingredient baicalin content is not less than 9.0% in the extract.
(2). drying: blended extraction extractum is added 5-50 part starch mixing, and (A) vacuum drying: mixed extract is put the drying baker vacuum drying, 70～75 ℃ of temperature, vacuum 0.08～0.09Mpa, dry thing is pulverized; (B) spray drying: condition is medicinal liquid density 1.05-1.15 (80 ℃), and feed liquor speed 8-15ml/min, gets dry extract by inlet temperature 110-170 ℃;
(3). make preparation: tablet is according to extracting 100 parts of dry things and 5-30 part dehydrated alcohol mixing granulation, and sprays into the volatile oil of enrichment, mixing, subsequently with magnesium stearate with 100: the ratio of 0.2-0.5 adds, mix homogeneously, tabletting, every contains the 0.3-0.4 gram and extracts dry thing; Capsule is 100 according to extracting dry thing and silica weight portion rate: the ratio of 2-5 adds, and sprays into the volatile oil of enrichment, and is encapsulated behind the mix homogeneously, and every contains the 0.3-0.4 gram and extracts dry thing.
Because the present invention has adopted technique scheme, therefore compare with existing manna disinfecting pills technology, have following advantage:
1. dosage form advanced person: capsule (sheet) agent is easy to accept than ancient watered pill, is fit to more ill crowd.
2. dissolubility is good: this product capsule, sheet, dissolve scattered time limit were respectively 10 minutes, 30 minutes, and in the time of in vivo, dissolubility is good, absorbed fast.Shorten onset time, can bring into play curative effect rapidly in vivo.
3. active constituent content is high and controlled: in the former watered pill dosage form of manna disinfecting pills, no quality standard, novel form capsule, tablet, determined quality standard, make this product quality controlled, and measure effective ingredient baicalin content in this prescription, and the content in the new Drug Capsule (sheet) is 9.14%, watered pill dosage form is 2.85%.Novel form content is higher than 3.2 times of former dosage forms.
4. taking dose is little: each 3 of this product dose (being equivalent to crude drug in whole 6 grams), each 3 grams of former watered pill, (be 86 balls, be equivalent to crude drug in whole 6 grams).The reduction of taking dose is taken to the patient and to be brought convenience, and the colony of suitable all ages and classes section takes.
Further set forth good effect of the present invention below by experiment disintegration, stability experiment:
Experiment disintegration:
1. material: nectar disinfection capsule capsule lot number 031229 (nectar disinfection capsule capsule, seminar's preparation)
Manna sterilization sheet lot number 031229 (manna sterilization sheet, seminar's preparation)
Manna disinfecting pills lot number 030503 (Fuzhou Jinxiang Chinese Medicine Pharmaceutical Co., Ltd.)
2. method: check its disintegration according to Chinese Pharmacopoeia version appendix in 2000 XIIA item following disintegration of inspection method, using instrument is disintegration instrument ZB-1C intelligence disintegration tester (University Of Tianjin's manufacturing).
3. result: former manna disinfecting pills disintegration is 50 minutes, and the nectar disinfection capsule capsule is 9 minutes, and manna sterilization sheet is 30 minutes.
4. conclusion: nectar disinfection capsule capsule (sheet) disintegration only is 9 minutes (30 minutes), is 1/5 (3/5) of former manna disinfecting pills disintegration, shows that nectar disinfection capsule capsule (sheet) is molten rapidly in vivo to loose, and onset time is short, can bring into play curative effect rapidly.
Stability test:
1. material: instrument is high performance liquid chromatograph HP-1100, and it is YWG-C18 that disintegration tester ZB-1C type intelligence collapses the instrument chromatographic column, 4.6mm * 250mm.Reagent is that to be analytical pure (Concord, Tianjin chemical reagent work) reference substance be baicalin (purchasing in Nat'l Pharmaceutical ﹠ Biological Products Control Institute) for methanol, ethanol, water, phosphoric acid etc.
2. method: according to nectar disinfection capsule capsule, the contained effective ingredient of tablet is that baicalin is one of effective ingredient wherein,, formulates with baicalin as component target control technology stable in order to make process stabilizing.Its method is to adopt high performance liquid chromatography, is reference substance with the baicalin, and methanol-phosphoric acid-water is mobile phase, is that the 280nm place measures baicalin content in the nectar disinfection capsule capsule (sheet) detecting wavelength, and adopts disintegration tester to measure disintegration.
3. result:
Nectar disinfection capsule capsule, sheet and manna disinfecting pills stability test result
4. conclusion: above-mentioned experiment shows that at the aspects such as content of outward appearance, disintegration and effective ingredient baicalin, nectar disinfection capsule capsule (sheet) is all stable than the manna disinfecting pills.
In sum, the present invention has good prospects for application at the aspects such as dissolubility, dissolution rate and bioavailability that improve medicine, is the treatment cold reducing-fever, realizes a new Chinese medicine of modernization of Chinese medicine development, quality controllable stabilization formulations.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only means never that for indicative it limits the scope of the invention by any way.
Embodiment 1: the preparation of nectar disinfection capsule capsule, tablet
1. write out a prescription: be made up of Radix Scutellariae 20g, Pulvis Talci 30g, Rhizoma Acori Graminei 12g, Rhizoma Belamcandae 8g, Herba Artemisiae Scopariae 22g, Fructus Amomi Rotundus 8g, Herba Menthae 8g, Caulis Clematidis Armandii 10g, Fructus Forsythiae 8g, Bulbus Fritillariae Cirrhosae 10g, Herba Pogostemonis 8g 11 flavor Chinese medicines, gross weight is totally 144 grams.
2. method for making:
1) medical material is handled: take by weighing the 1000g medical material by recipe quantity, with each reflux, extract, of 85% second alcohol and water 2 times, during with 85% ethanol extraction, each 8000ml extracted 1 hour, and each 10000ml extraction is 0.5 hour during with water extraction, and is concentrated respectively.Alcohol extract is evaporated to dried, adds water and is suspension, extracts volatile oil, and after the enrichment, suspension is evaporated to extractum.It is 1.05 that the water extract is evaporated to relative density, adds 95% ethanol, makes to contain alcohol in the solution and reach 70%, stirs, and leaves standstill, and inclining supernatant, is evaporated to extractum, mixes with alcohol-extracted extract, and paste-forming rate is 13.5%.Wherein the effective ingredient baicalin content is 9.0% in the extract.
2) drying: (1) vacuum drying will extract 100 parts of extractum, and (film-making adds 20 parts of starch to add the starch mixing; The glue capsule adds 8 parts of starch), put vacuum drying in the drying baker then, temperature is 80 ℃, vacuum 0.09Mpa gets dry thing; (2) spray drying will be extracted medicinal liquid (relative density is 1.10 (80 ℃)) with feed liquor speed 10ml/min, inlet temperature will be carried out spray drying for 130 ℃, dry thing;
3) preparation of preparation: (1) adds 5 parts of mixed pelletizations of ethanol for 100 parts with dry extract, and sprays into the volatile oil mixing of enrichment, adds 0.5 part of magnesium stearate again, mix homogeneously, tabletting, film coating again.(2) dry extract is added 2 parts of mixings of silicon dioxide for 100 parts, and spray into the volatile oil of enrichment, fill capsule.
This capsule specification is every 0.30 gram, on inspection, the capsule 's content good fluidity of making, weight differential complies with relevant regulations.Instructions of taking: oral, usual amounts be one time 3,2 times on the one.
This tablet specification is every 0.30 gram, on inspection, makes tablet, and hardness, weight differential all comply with relevant regulations.Instructions of taking: oral, usual amounts be one time 3,2 times on the one.
This technology shows that through pilot scale research prescription is formed rationally, and process stabilizing can be operated, and is quality controllable, easily row.
Embodiment 2: the preparation of nectar disinfection capsule capsule, tablet
1. write out a prescription: with embodiment 1.
2. method for making:
1) medical material is handled: take by weighing the 1000g medical material by recipe quantity, with each reflux, extract, of 90% second alcohol and water 2 times, during with 90% ethanol extraction, each 7000ml extracted 1 hour, and each 9000ml extraction is 1 hour during with water extraction, and is concentrated respectively.Alcohol extract is evaporated to dried, adds water and is suspension, extracts volatile oil, and after the enrichment, suspension is evaporated to extractum.It is 1.10 that the water extract is evaporated to relative density, adds 95% ethanol, makes to contain alcohol in the solution and reach 75%, stirs, and leaves standstill, and inclining supernatant, is evaporated to extractum, mixes with alcohol-extracted extract, and paste-forming rate is 12.5%.Wherein the effective ingredient baicalin content is 9.14% in the extract.
2) drying: (1) vacuum drying will extract 100 parts of extractum, and (wherein film-making adds 40 parts of starch to add the starch mixing; The glue capsule adds 12 parts of starch), put vacuum drying in the drying baker then, temperature is 80 ℃, vacuum 0.09Mpa gets dry thing; (2) spray drying will be extracted medicinal liquid (relative density is 1.10 (80 ℃)) with feed liquor speed 10ml/min, inlet temperature will be carried out spray drying for 130 ℃, dry thing;
3) preparation of preparation: (1) adds 15 parts of mixed pelletizations of ethanol for 100 parts with dry extract, and sprays into the volatile oil mixing of enrichment, adds 0.3 part of magnesium stearate subsequently, mix homogeneously, tabletting, film coating again.(2) dry extract is added 3 parts of mixings of silicon dioxide, fill capsule for 100 parts.
This capsule specification is every 0.35 gram, on inspection, the capsule 's content good fluidity of making, weight differential complies with relevant regulations.Instructions of taking: oral, usual amounts be one time 3,2 times on the one.
This tablet specification is every 0.35 gram, on inspection, makes tablet, and hardness, weight differential all comply with relevant regulations.Wherein, instructions of taking: oral, usual amounts be one time 3,2 times on the one.
This technology shows that through pilot scale research prescription is formed rationally, and process stabilizing can be operated, and is quality controllable, easily row.
Embodiment 3: the preparation of nectar disinfection capsule capsule, tablet
1. write out a prescription: with embodiment 1.
2. method for making:
1) medical material is handled: take by weighing the 1000g medical material by recipe quantity, with each reflux, extract, of 95% second alcohol and water 2 times, during with 95% ethanol extraction, each 6000ml extracted 1 hour, and each 8000ml extraction is 2 hours during with water extraction, and is concentrated respectively.Alcohol extract is evaporated to dried, adds water and is suspension, extracts volatile oil, and after the enrichment, suspension is evaporated to extractum.It is 1.15 that the water extract is evaporated to relative density, adds 95% ethanol, makes to contain alcohol in the solution and reach 80%, stirs, and leaves standstill, and inclining supernatant, is evaporated to extractum, mixes with alcohol-extracted extract, and paste-forming rate is 12.0%.Wherein the effective ingredient baicalin content is 9.18% in the extract.
2) drying: (1) vacuum drying will extract 100 parts of extractum, and (film-making adds 50 parts of starch to add the starch mixing; The glue capsule adds 20 parts of starch), put vacuum drying in the drying baker then, temperature is 80 ℃, vacuum 0.09Mpa gets dry thing; (2) spray drying will be extracted medicinal liquid (relative density is 1.05 (80 ℃)) with feed liquor speed 10ml/min, inlet temperature will be carried out spray drying for 130 ℃, dry thing;
3) preparation of preparation: (1) adds 30 parts of mixed pelletizations of ethanol with 100 parts of dry extracts, and the volatile oil that sprays into enrichment is mixed, and adds 0.4 part of magnesium stearate, mix homogeneously, tabletting, film coating again.(2) dry extract is added 4 parts of mixings of silicon dioxide, fill capsule for 100 parts.
This capsule specification is every 0.40 gram, on inspection, the capsule 's content good fluidity of making, weight differential complies with relevant regulations.Instructions of taking: oral, usual amounts be one time 3,2 times on the one.
This tablet specification is every 0.40 gram, on inspection, makes tablet, and hardness, weight differential all comply with relevant regulations.Instructions of taking: oral, usual amounts be one time 3,2 times on the one.
This technology shows that through pilot scale research prescription is formed rationally, and process stabilizing can be operated, and is quality controllable, easily row.
Although the present invention has done detailed description in conjunction with its special embodiment, clearly concerning the skilled people in present technique field, still can make various changes and improvements, can not depart from spirit of the present invention and protection domain.
Claims (5)
1. Chinese patent medicine nectar disinfection capsule capsule (sheet) for the treatment of cold reducing-fever, it is raw material with Radix Scutellariae, Pulvis Talci, Rhizoma Acori Graminei, Rhizoma Belamcandae, Herba Artemisiae Scopariae, Fructus Amomi Rotundus, Herba Menthae, Caulis Clematidis Armandii, Fructus Forsythiae, Bulbus Fritillariae Cirrhosae, Herba Pogostemonis 11 flavor Chinese medicines by the refining extract that extracts of recipe quantity, it is characterized in that, make capsule by following materials of weight proportions:
100 parts of extracts
Starch 5-30 part
Silicon dioxide 2-5 part;
Make tablet by following materials of weight proportions:
100 parts of extracts
Starch 10-50 part
Dehydrated alcohol 5-30 part
Magnesium stearate 0.2-0.5 part;
Wherein, the effective ingredient baicalin content is not less than 9.0% in the described extract.
2. a kind of Chinese patent medicine nectar disinfection capsule capsule (sheet) for the treatment of cold reducing-fever according to claim 1, it is characterized in that: described extract is to adopt alcohol extraction or water is carried or alcohol-water mixed extraction is made, and wherein the effective ingredient baicalin content is not less than 9.0% in the extract.
3. a preparation technology who treats the Chinese patent medicine nectar disinfection capsule capsule (sheet) of cold reducing-fever comprises the steps:
(1). medical material is handled: take by weighing the 1000g medical material by recipe quantity, with 85-95% ethanol and water difference reflux, extract, twice, alcohol extract is evaporated to dried, adds water and is suspension, extracts volatile oil, and after the enrichment, suspension is evaporated to extractum; The water extract is concentrated into relative density 1.05-1.15, uses ethanol precipitation impurity, leaves standstill, and inclining supernatant, is concentrated into extractum, mixes with the ethanol extraction concentrated extract, and wherein the effective ingredient baicalin content is not less than 9.0% in the extract;
(2). drying: blended extraction extractum is added 5-50 part starch mixing, and (A) vacuum drying: mixed extract is put the drying baker vacuum drying, 70～75 ℃ of temperature, vacuum 0.08～0.09Mpa, dry thing is pulverized; (B) spray drying: condition is medicinal liquid density 1.05-1.15 (80 ℃), and feed liquor speed 8-15ml/min, gets dry extract by inlet temperature 110-170 ℃;
(3). make preparation: tablet is according to extracting 100 parts of dry things and 5-30 part dehydrated alcohol mixing granulation, spray into the volatile oil mixing of enrichment subsequently, and with magnesium stearate with 100: the ratio of 0.2-0.5 adds, mix homogeneously, tabletting, every contains the 0.3-0.4 gram and extracts dry thing; Capsule is 100 according to extracting dry thing and silica weight portion rate: the ratio of 2-5 adds, and sprays into the volatile oil of enrichment, and is encapsulated behind the mix homogeneously, and every contains the 0.3-0.4 gram and extracts dry thing.
4. preparation technology according to claim 3 is characterized in that: use the ethanol precipitation removal of impurity in the described medical material treatment step, be meant that the ethanol consumption reaches 70-80% for making solution contain alcohol.
5. preparation technology according to claim 3 is characterized in that: described respectively the extraction with the second alcohol and water is meant each usefulness 6000～8000ml ethanol extraction 1 hour for twice; At every turn with 8000～10000ml water extraction 0.5-2 hour.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100194658A CN100446804C (en) | 2004-06-02 | 2004-06-02 | Heat clearing Chinese proprietary capsule(tablet) of 'Ganlu Xiaodu' for treating cold and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100194658A CN100446804C (en) | 2004-06-02 | 2004-06-02 | Heat clearing Chinese proprietary capsule(tablet) of 'Ganlu Xiaodu' for treating cold and its preparation process |
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| CNA2007103020469A Division CN101199813A (en) | 2004-06-02 | 2004-06-02 | Chinese patent drug nectar disinfection capsule for treating cold reducing-fever and preparing process thereof |
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| CN1704072A true CN1704072A (en) | 2005-12-07 |
| CN100446804C CN100446804C (en) | 2008-12-31 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102847045A (en) * | 2012-09-13 | 2013-01-02 | 李承平 | Subprostrate sophora diuresis promoting and turbid removing tablet combination |
| CN103933454A (en) * | 2014-04-14 | 2014-07-23 | 青岛市市立医院 | Traditional Chinese medicine for treating saprodontia caused by noxious dampness fumigation and preparation method thereof |
| CN104998178A (en) * | 2015-07-06 | 2015-10-28 | 安庆市孝柱食品科技有限公司 | Walnut oil for expelling wind and removing cold |
| CN112791164A (en) * | 2020-12-09 | 2021-05-14 | 新疆医科大学第四附属医院 | Traditional Chinese medicine preparation for treating respiratory system infectious diseases |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1208082C (en) * | 2003-04-18 | 2005-06-29 | 云南植物药业有限公司 | Yunan red drug tablet , its preparation method and use |
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2004
- 2004-06-02 CN CNB2004100194658A patent/CN100446804C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102847045A (en) * | 2012-09-13 | 2013-01-02 | 李承平 | Subprostrate sophora diuresis promoting and turbid removing tablet combination |
| CN103933454A (en) * | 2014-04-14 | 2014-07-23 | 青岛市市立医院 | Traditional Chinese medicine for treating saprodontia caused by noxious dampness fumigation and preparation method thereof |
| CN104998178A (en) * | 2015-07-06 | 2015-10-28 | 安庆市孝柱食品科技有限公司 | Walnut oil for expelling wind and removing cold |
| CN112791164A (en) * | 2020-12-09 | 2021-05-14 | 新疆医科大学第四附属医院 | Traditional Chinese medicine preparation for treating respiratory system infectious diseases |
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