CN102343021B - New process method for preparing Guifudihuang capsule - Google Patents
New process method for preparing Guifudihuang capsule Download PDFInfo
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- CN102343021B CN102343021B CN201010242822.2A CN201010242822A CN102343021B CN 102343021 B CN102343021 B CN 102343021B CN 201010242822 A CN201010242822 A CN 201010242822A CN 102343021 B CN102343021 B CN 102343021B
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Abstract
The invention relates to a new process method for preparing Guifudihuang capsule. The Guifudihuang capsule comprises 1-2 parts of cassia bark, 1-2 parts of prepared common monkshood daughter root (prepared), 8-16 parts of prepared rehmannia root, 4-8 parts of wine-prepared fructus corni, 3-6 parts of tree peony root-bark, 4-8 parts of common yam rhizome, 3-6 parts of tuckahoe and 3-6 parts of oriental waterplantain tuber. The process method provided by the present invention has the following advantages that: according to main active ingredients and physical and chemical properties of various drugs, different solvents for the drugs are adopted to carry out extraction; a D101 macroporous adsorption resin column is adopted to carry out separation, purification and impurity removing, such that the taking amount of the capsule is substantially reduced, wherein the taking amount of the capsule provided by the present invention is reduced by 85% than the taking amount of the capsule prepared through the existing process method; animal experiments show that: the capsule provided by the present invention provides a significant treatment effect for kidney yang deficiency syndrome; long-term toxicity tests show that: the clinical application of the capsule provided by the present invention is safe, the quality control standard of the capsule provided by the present invention is substantially improved compared to the taking amount of the capsule prepared through the existing process.
Description
Technical field:
The invention belongs to a kind of Traditional Chinese medicine historical preparation, particularly a kind of new process of preparing osmanthus attached glutinous rehmannia capsule.
Background technology:
GUIFU DIHUANG WAN comes from the JINGUI SHENQI WAN of the holy Zhang Zhongjing of doctor, be the ancestral side of the kidney invigorating, side is made up of 3～6 parts of 1～2 part of Cortex Cinnamomis, 1～2 part of Radix Aconiti Lateralis Preparata (system), 8～16 parts of Radix Rehmanniae Preparata, 4～8 parts of wine Fructus Corni, 3～6 parts of Cortex Moutans, 4～8 parts of Rhizoma Dioscoreaes, 3～6 parts, Poria, Rhizoma Alismatis.There is effect of warming and recuperating the kidney-YANG.For insufficiency of kidney-YANG, Yao Xi Acid is cold, limbs edema, and dysuria or anti-many, phlegm retention is breathed with cough, and quenches one's thirst.The party is come out nearly bimillennium, due to determined curative effect, for a long time with not waning.
Kidney qi yang deficiency is people's the natural law, and with advancing age, kidney qi yang deficiency increases the weight of day by day, and particularly after person in middle and old age, the syndrome of kidney qi yang deficiency becomes clear day by day.Therefore Japanese is to the first-elected JINGUI SHENQI WAN of advocating of Chinese prescription preparation (Japanese is called eight taste balls).Japanese thinks that people crosses 40 and just should take eight taste balls, can prevent the generation of a lot of Senile disease, as cataract, prostatic hyperplasia, diabetes and cardiovascular and cerebrovascular disease etc.Also there is significant curative effect for senile cataract, prostatic hyperplasia.The theory of " preventive treatment of disease is upper doctor " of Here it is classical Chinese medicine.So-called preventive treatment of disease, is exactly prevention of diseae, and disease is preapred for an unfavorable turn of events.The best prescribed preparation of this classical theory that osmanthus attached glutinous rehmannia capsule " is above cured preventive treatment of disease " just.The speed of Chinese aging, scale can be rated as the whole world first.According to authority's prediction, within 2050, Aged in China population will reach 3.3 hundred million, account for nearly 1/4th of national population.Therefore the medicine preventing and treat Senile disease has huge market, and the first-elected GUIFU DIHUANG WAN class of these medicines.Osmanthus attached glutinous rehmannia capsule prepared by former method, each serving 7, day takes 2 times, and old people is beyond affordability, dysphagia on the one hand, and too many capsule floats on and in stomach, causes sensation of fullness on the one hand.Therefore, reducing dose is the inevitable course.The present invention adopt just advanced pharmaceutical technology make its dose reduced 85%, one time 1,2 times on the one, successfully overcome many defects of osmanthus attached glutinous rehmannia capsule prepared by former side, can create fabulous economic results in society.
Summary of the invention:
The present invention is according to the effective elements of the medicine and physicochemical property thereof in eight tastes of composition osmanthus attached glutinous rehmannia capsule, design and completed the experimentation of the process that osmanthus attached glutinous rehmannia capsule is new, successfully make dose significantly decline, and the content's index of its main effective ingredient is not less than osmanthus attached glutinous rehmannia capsule prepared by former method, and having increased thin layer chromatography and differentiate the method for all the other medical materials, overall end product quality standard is significantly improved.Zoopery shows, for improving Kidney-Yang Deficiency Syndrome, standby 7 effects of osmanthus attached glutinous rehmannia capsule of 1 of osmanthus attached glutinous rehmannia capsule prepared by the present invention and former legal system quite or higher.Show 7 uses of osmanthus attached glutinous rehmannia capsule that 1 of the prepared osmanthus attached glutinous rehmannia capsule of the present invention can replace former method to prepare completely.
The present invention has adopted the extraction process that is different from former method, and the post isolation technics purification remove impurity of application D101 macroporous adsorbent resin, had both reduced dose, again greatly the reservation of degree effective ingredient.
3～6 parts of Cortex Moutan coarse powder, add 6～12 times of water gagings, soak 2～5 hours, carry out steam distillation, distillation speed is controlled at the distillate that steams 3 times of crude drug amounts in 1～3 hour, adds therein 1mol/ LHCl or NaCl to make crystallization, places, crystallization paeonol, filter, with cold water washing, low temperature (40～50 DEG C) is dry, for subsequent use, its Cortex Moutan medicinal residues are for subsequent use;
4～8 parts of coarse yam powder, 3～6 parts of Poria coarse powder, add 4～6 times of water gaging reflux, extract, 2～4 times, and each 0.5～1.5 hour, extracting solution filtered, and decompression (below 70 DEG C, 0.09MPa) is concentrated, to thick paste, for subsequent use;
4～8 parts of wine Fructus Corni coarse powder, add 4～6 times of amount 70% ethanol, reflux, extract, 2～4 times, and each 0.5～1.5 hour, extracting solution filtered, and decompression (below 70 DEG C, 0.09MPa) is reclaimed ethanol extremely without alcohol taste, and for subsequent use, its wine Fructus Corni medicinal residues are for subsequent use;
1～2 part of Cortex Cinnamomi coarse powder, 1～2 part of Radix Aconiti Lateralis Preparata (system) coarse powder, add 4～6 times of amount 95% alcohol reflux 2～4 times, extracts 1～2 hour at every turn, extracting solution filters, decompression (below 70 DEG C, 0.09MPa) is reclaimed ethanol to most, and condensed cream is for subsequent use; Its Cortex Cinnamomi, Radix Aconiti Lateralis Preparata medicinal residues are for subsequent use;
8～16 parts of Radix Rehmanniae Preparata coarse powder, 3～6 parts of Rhizoma Alismatis coarse powder, with Cortex Moutan medicinal residues, wine Fructus Corni medicinal residues, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata medicinal residues, add 5～8 times of water gagings and be total to hot reflux extraction 3 times, each 0.5～2 hour, extracting solution filters, merge with wine Fructus Corni alcohol extraction concentrated solution, adopt D101 macroporous adsorptive resins to carry out the remove impurity of post separating-purifying.
The technical parameter that D101 macroporous adsorptive resins post separates is as follows:
Macroporous adsorbent resin volume and above-mentioned except Rhizoma Dioscoreae, Radix Aconiti Lateralis Preparata Six-element medicament extracting solution volume ratio be 1: 3～4;
Before macroporous adsorbent resin upper prop, carry out according to a conventional method pretreatment;
Adsorption rate be 1BV resin/hour;
Absorption finishes the distilled water of 2 times of amount resin volumes of rear use and gets pillar express developed, and effluent is abandoned it;
With 70% ethanol desorbings of 3 times of amount resin volumes, desorption rate be 0.8BV resin/hour.
Stripping liquid reduces pressure (below 70 DEG C, 0.09MPa) reclaim ethanol, continue to be concentrated into thick paste, add above-mentioned Rhizoma Dioscoreae, Poria water extraction condensed cream and Cortex Cinnamomi, Radix Aconiti Lateralis Preparata alcohol extraction condensed cream, continue to be evaporated to thick paste, proceed to vacuum drying oven, below 70 DEG C, 0.09MPa vacuum drying is to dry, add paeonol and appropriate amount of auxiliary materials to be pulverized and mixed evenly, make heavy every of capsule once take 1 for 0.35g, within 1st, take 2 times.These adjuvants comprise one or several in micropowder silica gel, microcrystalline Cellulose, hyprolose.
There is strict quality control standard with the prepared osmanthus attached glutinous rehmannia capsule of the present invention:
Adopt high effective liquid chromatography for measuring the main effective ingredient of this product, wherein every capsules containing wine Fructus Corni with loganin (C
17h
26o
10) meter, being not less than 2.24mg, every capsules contains Cortex Moutan with paeonol (C
9h
10o
3) meter is not less than 4.20mg;
The medical materials such as the wine Fructus Corni in side, Radix Rehmanniae Preparata, Rhizoma Alismatis, Cortex Cinnamomi that adopted thin layer chromatography qualitative identification, wherein differentiate wine Fructus Corni taking oleanolic acid as reference substance, differentiate Radix Rehmanniae Preparata taking catalpol as reference substance; Differentiate Rhizoma Alismatis taking Alisol B monoacetate as reference substance; Differentiate Cortex Cinnamomi taking cinnamic aldehyde as reference substance.Because contain toxic component aconitine in Radix Aconiti Lateralis Preparata, therefore adopt thin layer chromatography to carry out the inspection of aconitine limit taking aconitine as reference substance, specify that every capsules is containing aconitine (C
34h
47nO
11) must not exceed 28ppm, to ensure to use the safety of this product.
Because using the remove impurity of macroporous adsorptive resins post separating-purifying, therefore must detect the residual organic solvent of possibility in finished product, adopt headspace GC to detect the organic residues such as normal hexane, benzene,toluene,xylene, styrene, divinylbenzene, and determined that the limit of residue must not exceed respectively normal hexane 10ppm, benzene 2ppm, toluene 10ppm, dimethylbenzene 20ppm, styrene 10ppm, divinylbenzene 60ppm.
Zooperal result shows the effect of enhancing human body immunity function to be better than GUIFU DIHUANG WAN, and the osmanthus attached glutinous rehmannia capsule standby with former legal system is suitable; There is obvious carbohydrate metabolism, and be better than GUIFU DIHUANG WAN and former method osmanthus attached glutinous rehmannia capsule; Can obviously improve the syndrome of kidney-yang deficiency model, suitable with the effect of former method osmanthus attached glutinous rehmannia capsule with GUIFU DIHUANG WAN.For this product treatment syndrome of deficiency of kidney-YANG provides zoopery foundation.Rat oral gavage six months continuously, except high dose group body weight slightly declines, with matched group there was no significant difference, and outside convalescent period recovery is normal, diet, drinking-water, body weight, form, hematology, blood biochemical, organ index and the internal organs pathological anatomy of other dosage group all do not occur abnormal, shows that this product is safe.
Embodiment: make 1000 capsules,
Prescription:
Cortex Cinnamomi 155.54g Radix Aconiti Lateralis Preparata (system) 155.54g Radix Rehmanniae Preparata 1244.39g wine Fructus Corni 622.16g
Cortex Moutan 466.62g Rhizoma Dioscoreae 622.16g Poria 466.62g Rhizoma Alismatis 466.62g
Operation:
Get coarse powder Cortex Moutan 466.62g and add 4666.2ml water, soak 3 hours, steam distillation was collected distillate 1400ml in 2.5～3 hours, in distillate, add 70gNaCl, refrigerator (cold preservation) is placed and is spent the night, and separates out white crystals, filters, with cold water washing, 45 DEG C following dry, for subsequent use, and the another device of Cortex Moutan medicinal residues is collected for subsequent use;
Get add water 5450ml reflux, extract, 3 times of coarse powder Rhizoma Dioscoreae 622.16g, Poria 466.62g, each 0.5 hour, extracting solution filtered, and decompression (below 70 DEG C, 0.09MPa) is concentrated into thick paste (D
60 °=1.20～1.24) for subsequent use;
Get coarse powder wine Fructus Corni 622.16g, add 70% ethanol 3110ml, reflux, extract, 2 times, each 1 hour, extracting solution filtered, and decompression (below 70 DEG C, 0.09MPa) is reclaimed ethanol to without alcohol taste, for subsequent use, and the another device of wine Fructus Corni medicinal residues is collected for subsequent use;
Get coarse powder Cortex Cinnamomi 155.54g Radix Aconiti Lateralis Preparata (system) 155.54g, add 95% ethanol 1560ml, reflux, extract, 2 times, each 1.5 hours, extracting solution filtered, and decompression is (below 70 DEG C, 0.09MPa) reclaim ethanol to most, condensed cream is for subsequent use, and Cortex Cinnamomi, the another device of Radix Aconiti Lateralis Preparata medicinal residues are collected for subsequent use;
Cortex Moutan medicinal residues, wine Fructus Corni medicinal residues, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata medicinal residues are merged, add coarse powder Radix Rehmanniae Preparata 1244.39g, Rhizoma Alismatis 466.62g, 18.7L adds water, reflux, extract, 3 times, each 1 hour, extracting solution filtered, and filtrate and wine Fructus Corni alcohol extraction concentrated solution merge, about 49L, with the separation of D101 macroporous adsorptive resins post.
D101 macroporous adsorbent resin volume is 14L, adsorption rate is 1BV resin/h (is about 14L/h), and absorption is finished, and gets detached dowel express developed with 28L distilled water, then use 70% ethanol 42L desorbing, desorption rate is 0.8BV resin/h (being 11.2L/h left and right).Stripping liquid decompression (below 70 DEG C, 0.09MPa) is concentrated into thick, adds above-mentioned Rhizoma Dioscoreae, Poria water extraction condensed cream, wine Fructus Corni alcohol extraction concentrated solution, continues to be evaporated to thick paste (D
60 °=1.25 left and right), proceed to vacuum drying oven, be dried to dry in 0.09MPa below 70 DEG C, adding above-mentioned paeonol crystallization and appropriate micropowder silica gel to make output is 1000, is pulverized and mixed evenly, incapsulates, the heavy 0.35g of every capsules, each serving 1, takes 2 times every day.
Claims (5)
1. a process of preparing osmanthus attached glutinous rehmannia capsule, is characterized in that:
Osmanthus attached glutinous rehmannia capsule is made up of following traditional Chinese medicines:
4～8 parts of 8～16 parts of wine Fructus Corni of 1～2 part of Radix Rehmanniae Preparata of 1～2 part of Radix Aconiti Lateralis Preparata of Cortex Cinnamomi
3～6 parts of 3～6 portions of Rhizoma Alismatis of 4～8 parts of Poria of 3～6 portions of Rhizoma Dioscoreaes of Cortex Moutan;
First each taste medicine of prescription is extracted, the process of its extraction is as follows:
Get 3～6 parts of Cortex Moutan coarse powder, 6～12 times of amounts that add water, soaked after 2～5 hours, carry out steam distillation, distillation speed is the distillate that steamed 3 times of amount crude drugs in 1～3 hour, adds 1mol/LHCl or NaCl to make crystallization in distillate, places, separate out paeonol crystallization, filter, with cold water washing, cold drying, for subsequent use, its medicinal residues are for subsequent use;
Get 4～8 parts of coarse yam powder, 3～6 parts of Poria coarse powder, add 4～6 times of water gaging reflux, extract, 2～4 times, extract 0.5～1.5 hour at every turn, extracting solution filters, and below 70 DEG C, under the condition of 0.09MPa, is evaporated to thick paste, for subsequent use;
Get 4～8 parts of wine Fructus Corni coarse powder, add 4～6 times of amount 70% alcohol reflux 2～4 times, extract 0.5～1.5 hour at every turn, extracting solution filters, and below 70 DEG C, under the condition of 0.09MPa, decompression recycling ethanol is extremely without alcohol taste, and for subsequent use, its medicinal residues are for subsequent use; Get 1～2 part of Cortex Cinnamomi coarse powder, 1～2 part of Radix Aconiti Lateralis Preparata coarse powder, add 4～6 times of amount 95% alcohol reflux 2～4 times, extract 1～2 hour at every turn, extracting solution filters, and below 70 DEG C, under the condition of 0.09MPa, decompression recycling ethanol is to most, condensed cream is for subsequent use, and medicinal residues are for subsequent use;
Get Cortex Moutan medicinal residues, wine Fructus Corni medicinal residues, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata medicinal residues, add 8～16 parts of Radix Rehmanniae Preparata coarse powder, 3～6 parts of Rhizoma Alismatis coarse powder, add 5～8 times of water gagings hot extraction 3 times altogether, each 0.5～2 hour, extracting solution filters, merge with wine Fructus Corni alcohol extraction concentrated solution, adopt D101 macroporous adsorptive resins to carry out post separation;
Through high effective liquid chromatography for measuring, every capsules contains wine Fructus Corni with loganin (C
17h
26o
10) meter, being not less than 2.24mg, every capsules contains Cortex Moutan with paeonol (C
9h
10o
3) meter is not less than 4.20mg.
2. the process of preparing osmanthus attached glutinous rehmannia capsule according to claim 1, is characterized in that: the technological parameter that adopts D101 macroporous adsorptive resins to separate is as follows:
Macroporous adsorbent resin and above-mentioned except Rhizoma Dioscoreae, Poria Six-element medicament extracting solution volume ratio be 1: 3～4;
Adsorption rate is 1BV resin/h;
The distilled water that absorption finishes 2 times of amount resin volumes of rear use rushes post fast, and effluent is abandoned it;
With 70% ethanol desorbing of 3 times of amount resin volumes, desorption rate is 0.8BV resin/h;
The stripping liquid obtaining is below 70 DEG C, decompression recycling ethanol under the condition of 0.09MPa, continue to be concentrated into thick paste, add Rhizoma Dioscoreae, Poria water extraction condensed cream and Cortex Cinnamomi, Radix Aconiti Lateralis Preparata alcohol extraction condensed cream, continue concentrating under reduced pressure, proceed to vacuum drying oven, below 70 DEG C, 0.09MPa vacuum drying, to dry, adds paeonol and appropriate amount of auxiliary materials co-grinding; In incapsulating, make every heavy 0.35g of capsule, once take 1, within 1st, take 2 times, these adjuvants comprise one or several in micropowder silica gel, microcrystalline Cellulose, hyprolose.
3. the process of preparing osmanthus attached glutinous rehmannia capsule according to claim 1, is characterized in that: made capsule adopts the following medical material of thin layer chromatography qualitative identification, differentiates wine Fructus Corni taking oleanolic acid as reference substance; Differentiate Radix Rehmanniae Preparata taking catalpol as reference substance; Differentiate Rhizoma Alismatis taking Alisol B monoacetate as reference substance; Differentiate Cortex Cinnamomi taking cinnamic aldehyde as reference substance.
4. the process of preparing osmanthus attached glutinous rehmannia capsule according to claim 1, is characterized in that: made capsule, taking aconitine as reference substance, adopts thin layer chromatography to carry out the inspection of aconitine limit, aconitine limit, and every capsules is containing aconitine (C
34h
47nO
11) must not cross 28ppm.
5. the process of preparing osmanthus attached glutinous rehmannia capsule according to claim 1, it is characterized in that: adopt gas chromatography to detect the following organic solvent residual quantity that may exist in made capsule, must not cross normal hexane 10ppm, benzene 2ppm, toluene 10ppm, dimethylbenzene 20ppm, styrene 10ppm, divinylbenzene 60ppm.
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| CN102872295A (en) * | 2011-07-14 | 2013-01-16 | 天津丹溪国药研究所 | New process for preparing cinnamon, Radix aconiti lateralis preparata and rehmannia root preparation |
| CN103239486B (en) * | 2012-04-23 | 2014-09-10 | 成都百裕科技制药有限公司 | Residue determination method of ginkgo lactone composition for treating cardiovascular and cerebrovascular diseases |
| CN108272945A (en) * | 2018-04-19 | 2018-07-13 | 河南新纯源生物科技有限公司 | A kind of kidney-supplementing liver-boosting oral solution |
| CN115105560B (en) * | 2021-03-18 | 2024-03-01 | 河北百善药业有限公司 | Large-size Guifu rehmannia tablets and preparation method thereof |
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| CN1775262A (en) * | 2005-11-18 | 2006-05-24 | 北京阜康仁生物制药科技有限公司 | Guifu-Dihuang preparation and preparing method |
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| CN1775262A (en) * | 2005-11-18 | 2006-05-24 | 北京阜康仁生物制药科技有限公司 | Guifu-Dihuang preparation and preparing method |
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