CN105395514A - Zhonghua ganling capsule and preparation method thereof - Google Patents
Zhonghua ganling capsule and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Zhonghua ganling capsule and a preparation method thereof. The Zhonghua ganling capsule is characterized by being prepared from the following medicinal materials by weight: 222g of pogostemon cablin, 111g of pomegranate bark, 60g of radix bupleuri (processed with vinegar), 300g of mangnolia officinalis (processed with ginger), 40g of pseudo-ginseng, 333g of radix angelica sinensis, 111g of rhizoma chuanxiong, 200g of turtle shell (processed with vinegar), 180g of radix curcumae, 333g of pericarpium citri reticulatae viride (processed with vinegar), and 270g of immature bitter orange (stir-fried with bran). The preparation method comprises the following steps: extracting by adopting a carbon dioxide supercritical extraction method, carrying out drying under reduced pressure, grinding by adopting a high-energy nanometer impact mill to obtain dry nanometer paste, and adding functional auxiliary materials into the dry nanometer paste, thus preparing the Zhonghua ganling capsule. The Zhonghua ganling capsule and the preparation method have the advantages that the disintegration time is obviously shortened, the curative effect of the Zhonghua ganling capsule is obviously superior to that of the commercially available Zhonghua ganling capsule, and positive effects are achieved.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Chinese liver curing capsule and preparation method thereof.
Background technology
China's liver curing capsule the liver soothing and the spleen invigorating, regulating QI to relieve pain, blood blood stasis dispelling in living, hard masses softening and resolving.For the resistance of stagnation of QI due to depression of the liver blood, gather and do not disappear, two side of body distending pains, anorexia and loose stool, tongue has cold speckle, the unable person of deep and hesitant pulse.Commercially available Chinese liver curing capsule is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides Chinese liver curing capsule that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 19 ~ 40Mpa, extraction temperature 15 ~ 43 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 35 ~ 60 DEG C, disengaging time 2.6 ~ 3.4 hours, carbon dioxide flow 24 ~ 36L per hour, obtains extracting solution; Get extracting solution 61 ~ 75 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Chinese liver curing capsule 1700.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Herba Pogostemonis: China's coastal port one ministerial standard.This product is that labiate extensively stores fragrant Pogostemoncablin(Blanco) dry aerial parts of Benth..Tap when branch and leaf are luxuriant, Exposure to Sunlight is vexed for night, repeatedly to dry.
Pericarpium Granati: China's coastal port one ministerial standard.This product is the dry peel of Punicaceae plant Punica granatum L. PunicagranatumL..Autumn collects peel after fruit maturation, dries.
Radix Bupleuri: China's coastal port one ministerial standard.This product is the dry root of umbelliferae bupleurum BupleurumchinenseDC. or Radix Bupeuri Scorzonerfolii. BupleurumscocrzonerifoliumWilld..Different by character, practise title " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii " respectively.Spring, Qiu Erji excavate, removing stem and leaf and silt, dry.
Cortex Magnoliae Officinalis: China's coastal port one ministerial standard.This product is the dry dried bark of Magnoliacea plant Cortex Magnoliae Officinalis MignoliaofficinalisRehd.etWils. or magnolia officinalis rehd.et wils.var.biloba rehd.et wils. MignoliaofficinalisRehd.etWils.var.bilobaRehdetWils., root bark and branch skin.The 4-6 month strips, root bark and branch skin Directly Dried in Shadow; In skin put in boiling water micro-boil after, dark and damp place of banking up, when " diaphoresis " is to inner surface purpling brown or sepia, steams soft, takes out, is rolled into tubular, dry.
Radix Notoginseng: China's coastal port one ministerial standard.This product is the dry root and rhizome of panax araliaceae plant Punaxnotoginseng (Burk.) F.H.Chen.Autumn excavates before the flowers are in blossom, cleans, and separately main root, a root and rhizome, dry.Supporting root is practised and is claimed " rib ", and rhizome is practised and claimed " clip ".
Radix Angelicae Sinensis: China's coastal port one ministerial standard.This product is umbelliferae angelica Angelicasinensis(Oliv.) dry root of Diels.Autumn end excavates, and removing fibrous root and silt, after moisture slightly evaporates, be bundled into wisp, upper canopy, with pyrotechnics slowly smoke-dried beancurd.
Rhizoma Chuanxiong: China's coastal port one ministerial standard.This product is the dry rhizome of samphire Rhizoma Chuanxiong LigusticumchuanriongHort..The joint dish that summer works as on stem is significantly outstanding, and excavates during purplish, and removing silt, shines post-drying, then remove fibrous root.
Carapax Trionycis: China's coastal port one ministerial standard.This product is the carapace of Trionychidae animal Trionyx sinensis Wiegmann TrionyxsinensisWiegmann.The whole year all can catch, and is many, kills after seizure with autumn, season in winter two, puts in boiling water and scalds when can peel off to the sclerderm on carapace, takes out, strips carapace, remove residual meat, dry.
Radix Curcumae: China's coastal port one ministerial standard.This product is the dried root of zingiberaceous plant RADIX CURCUMAE CurcumawenyujinY.H.ChenetC.Ling, Rhizoma Curcumae Longae CurcumalongaL., Guangxi zedoary CurcumakwaugsienisS.G.LeeetC.F.Liang or Rhizoma Curcumae Curcumapha-eocaulisVal..The above two practise title " RADIX CURCUMAE " and " Radix Curcuma " respectively, and all the other are practised by character difference and claim " osmanthus Radix Curcumae " or " green filament Radix Curcumae ".Winter, stem and leaf was excavated after withering, and removing silt and radicula, steam or boil to the saturating heart, dry.
Pericarpium Citri Reticulatae Viride: China's coastal port one ministerial standard.This product is the dry young fruit of rutaceae orange CitrusreticulataBlanco and variety thereof or the peel of immature fruit.Collecting the young fruit from falling the 5-6 month, drying, practise and claim " FTUCTUS CITRI IMMATURI "; Gather the 7-8 month green fruit, on peel, vertical profile becomes pintongs to base portion, eliminates flesh lobe, dries, and practises and claims " Sihuaqingpi ".
Fructus Aurantii Immaturus: China's coastal port one ministerial standard.This product is the dry young fruit of rutaceae Citrus aurantium Linn. CitrusaurantiumL. and variety or Fructus Citri sinensis CitrussinensisOsbeck.Collect the fruit from falling the 5-6 month, removing impurity, be two halves from middle part crosscut, dry or cold drying, smaller directly dries or cold drying.
Mannitol: Chinese Pharmacopoeia version two ministerial standard in 2010.
Microcrystalline Cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Crospolyvinylpyrrolidone: Chinese Pharmacopoeia version two ministerial standard in 2010.
Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Carboxymethyl starch sodium: Chinese Pharmacopoeia version two ministerial standard in 2010.
Magnesium stearate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above Chinese liver curing capsule all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression ", " vinegar system ", " processed with Rhizoma Zingiberis Recens " etc. all defer to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Four detailed description of the invention
Specific embodiments of the invention 1
Get Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19Mpa, extraction temperature 15 DEG C, separator pressure 11Mpa, separator temperature 35 DEG C, disengaging time 2.6 hours, carbon dioxide flow 24L per hour, obtains extracting solution; Get extracting solution 61 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45g, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 35g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional carboxymethyl starch sodium 7g, magnesium stearate 1g, granulate, incapsulates, obtained Chinese liver curing capsule 1700.
Specific embodiments of the invention 2
Get Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 43 DEG C, separator pressure 19Mpa, separator temperature 60 DEG C, disengaging time 3.4 hours, carbon dioxide flow 36L per hour, obtains extracting solution; Get extracting solution 75 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 55g, crospolyvinylpyrrolidone 55g, cross-linking sodium carboxymethyl cellulose 45g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, granulate, incapsulates, obtained Chinese liver curing capsule 1700.
Specific embodiments of the invention 3
Get Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 29 DEG C, separator pressure 15Mpa, separator temperature 48 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 68 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 175g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, incapsulates, obtained Chinese liver curing capsule 1700.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Chinese liver curing capsule.Actual effect of the present invention is investigated below with the Chinese liver curing capsule that embodiment 3 is obtained:
(1) embodiment 3 Chinese liver curing capsule and contrast disintegration of commercially available Chinese liver curing capsule
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 Chinese liver curing capsule and commercially available Chinese liver curing capsule contrast table disintegration
The above results shows, Chinese liver curing capsule prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available Chinese liver curing capsule.
(2) embodiment 3 Chinese liver curing capsule and the resistance of commercially available Chinese liver curing capsule treatment stagnation of QI due to depression of the liver blood, gather and do not disappear, two side of body distending pains, anorexia and loose stool, tongue has cold speckle, the unable clinical observation on the therapeutic effect of deep and hesitant pulse
1 case scenario
Statistics outpatient service and inpatient, observe the resistance of stagnation of QI due to depression of the liver blood altogether, gather and do not disappear, two side of body distending pains, anorexia and loose stool, and tongue has cold speckle, unable case 128 example of deep and hesitant pulse, 45 years old mean age.Patient is divided into two groups, test group takes the Chinese liver curing capsule of embodiment 3, and matched group takes commercially available Chinese liver curing capsule.
2 efficacy assessment standards
According to new Chinese medicine treatment guideline of clinical investigations tcm syndrome curative effect determinate standard:
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 Chinese liver curing capsule and commercially available Chinese liver curing capsule clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, Chinese liver curing capsule prepared by the present invention, in the resistance for the treatment of stagnation of QI due to depression of the liver blood, gathers and do not disappear, two side of body distending pains, anorexia and loose stool, tongue has cold speckle, when deep and hesitant pulse is unable, evident in efficacy higher than commercially available Chinese liver curing capsule, p < 0.05.
Claims (3)
1. treatment stagnation of QI due to depression of the liver blood resistance, gather and do not disappear, two side of body distending pains, anorexia and loose stool, tongue has cold speckle, the Chinese medicine that deep and hesitant pulse is unable, it is characterized in that getting Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 19 ~ 40Mpa, extraction temperature 15 ~ 43 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 35 ~ 60 DEG C, disengaging time 2.6 ~ 3.4 hours, carbon dioxide flow 24 ~ 36L per hour, obtain extracting solution, get extracting solution 61 ~ 75 DEG C of drying under reduced pressure, get dry extract, get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm, get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Chinese liver curing capsule.
2. the preparation method of Chinese medicine according to claim 1, it is characterized in that getting Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 19 ~ 40Mpa, extraction temperature 15 ~ 43 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 35 ~ 60 DEG C, disengaging time 2.6 ~ 3.4 hours, carbon dioxide flow 24 ~ 36L per hour, obtain extracting solution, get extracting solution 61 ~ 75 DEG C of drying under reduced pressure, get dry extract, get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm, get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Chinese liver curing capsule.
3. the preparation method of Chinese medicine according to claim 1, gets Herba Pogostemonis 222g, Pericarpium Granati 111g, Radix Bupleuri (vinegar system) 60g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 300g, Radix Notoginseng 40g, Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 111g, Carapax Trionycis (vinegar system) 200g, Radix Curcumae 180g, Pericarpium Citri Reticulatae Viride (vinegar system) 333g, Fructus Aurantii Immaturus (parched with bran) 270g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 29 DEG C, separator pressure 15Mpa, separator temperature 48 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 68 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 175g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, incapsulates, obtained Chinese liver curing capsule.
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CN201510879031.3A CN105395514A (en) | 2015-12-05 | 2015-12-05 | Zhonghua ganling capsule and preparation method thereof |
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EP3400932A1 (en) * | 2017-05-08 | 2018-11-14 | mcePharma s. r. o. | Mixture of stabilised biologically available curcumin for orodispersible formulations, formulations of biologically available curcumin, and an orodispersible tablet with biologically available curcumin, and its application |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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EP3400932A1 (en) * | 2017-05-08 | 2018-11-14 | mcePharma s. r. o. | Mixture of stabilised biologically available curcumin for orodispersible formulations, formulations of biologically available curcumin, and an orodispersible tablet with biologically available curcumin, and its application |
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