CN102343021A - New process method for preparing Guifudihuang capsule - Google Patents
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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 Chinese traditional patent formulation preparation, the capsular new process of particularly a kind of preparation osmanthus attached glutinous rehmannia.
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, the side is made up of for 3～6 parts 1～2 part of Cortex Cinnamomi, 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 in Poria, Rhizoma Alismatis.Effect with warming and recuperating the kidney-YANG.Be used for the insufficiency of the kidney yang, the acid of waist knee is cold, the limbs edema, and difficult urination or anti-many, phlegm and retained fluid is breathed with cough, and quenches one's thirst.This side is come out nearly bimillennium, because 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 the syndrome of kidney qi yang deficiency becomes clear day by day after the person in middle and old age.So the Japanese is to the first-elected JINGUI SHENQI WAN of advocating of Chinese prescription preparation (Japanese is called eight flavor balls).The Japanese thinks that the people crosses 40 and just should take eight flavor balls, can prevent the generation of a lot of Senile disease, like cataract, prostatic hyperplasia, diabetes and cardiovascular and cerebrovascular disease etc.For senile cataract, prostatic hyperplasia significant curative effect is arranged also.The theory of " preventive treatment of disease is last doctor " of Here it is classical Chinese medicine.So-called preventive treatment of disease is exactly the prevention of diseae, and disease is preapred for an unfavorable turn of events.The osmanthus attached glutinous rehmannia capsule is the best prescribed preparation of " on cure preventive treatment of disease " this classical theory just.Speed, the scale of China's aging can be rated as the whole world first.According to authority's prediction, Chinese aging population will reach 3.3 hundred million in 2050, account for nearly 1/4th of national population.Therefore the medicine of prevention and treatment Senile disease has the huge market, and the first-elected GUIFU DIHUANG WAN class of these medicines.The osmanthus attached glutinous rehmannia capsule of former method preparation is obeyed 7 at every turn, day clothes 2 times, and the old people is beyond affordability, the one side dysphagia, too many capsule floats on and causes sensation of fullness in the stomach 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 the capsular many defectives of osmanthus attached glutinous rehmannia that former side prepares, can create fabulous economic results in society.
Summary of the invention:
The present invention is according to forming capsular eight flavor Effective Components of Chinese Herb and the physicochemical properties thereof of osmanthus attached glutinous rehmannia; Design has also been accomplished the experimentation of the new process of osmanthus attached glutinous rehmannia capsule; Dose is descended significantly; And the content's index of its main effective ingredient is not less than the osmanthus attached glutinous rehmannia capsule of former method preparation; And having increased the method that thin layer chromatography is differentiated all the other medical materials, overall end product quality standard is significantly improved.Zoopery shows, for improving the insufficiency of kidney-YANG syndrome, 17 effect of osmanthus attached glutinous rehmannia capsule that prepare with former method of the osmanthus attached glutinous rehmannia capsule of the present invention's preparation quite or higher.Show that 1 of the prepared osmanthus attached glutinous rehmannia capsule of the present invention can replace 7 uses of osmanthus attached glutinous rehmannia capsule of former method preparation fully.
The present invention has adopted the extraction process that is different from former method, uses the post isolation technics purification remove impurity of D101 macroporous adsorbent resin, has 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 1mol/ LHCl or NaCl therein and makes crystallization, places; Separate out the crystallization paeonol; Filter, use cold water washing, low temperature (40～50 ℃) drying; Subsequent use, its Cortex Moutan medicinal residues are 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 ℃, 0.09MPa) concentrate, to thick paste, 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 (below 70 ℃, 0.09MPa) reclaim ethanol to there not being the alcohol flavor, subsequent use, its wine Fructus Corni medicinal residues are subsequent use in decompression;
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, extract 1～2 hour at every turn, and extracting solution filters, and (below 70 ℃, 0.09MPa) reclaim ethanol extremely to the greatest extent, condensed cream is subsequent use in decompression; Its Cortex Cinnamomi, Radix Aconiti Lateralis Preparata medicinal residues are 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 the D101 macroporous adsorptive resins to carry out post and separate the purification remove impurity.
The isolating technical parameter of D101 macroporous adsorptive resins post is following:
The macroporous adsorbent resin volume and above-mentioned except that Rhizoma Dioscoreae, Radix Aconiti Lateralis Preparata Six-element medicament extracting solution volume ratio be 1: 3～4;
Carry out pretreatment by conventional method before the macroporous adsorbent resin upper prop;
Adsorption rate be the 1BV resin/hour;
Absorption finishes the back and gets pillar express developed with the distilled water of 2 times of amount resin volumes, and effluent is abandoned it;
With 70% alcohol desorptions of 3 times of amount resin volumes, desorption rate be the 0.8BV resin/hour.
The stripping liquid decompression is (below 70 ℃; 0.09MPa) reclaim ethanol, continue to be concentrated into thick paste, add above-mentioned Rhizoma Dioscoreae, Poria water and carry condensed cream and Cortex Cinnamomi, Radix Aconiti Lateralis Preparata alcohol extraction condensed cream; Continue to be evaporated to thick paste; Change vacuum drying oven over to, below 70 ℃, the 0.09MPa vacuum drying is to doing; Add paeonol and appropriate amount of auxiliary materials and pulverize mix homogeneously; Make heavy every of capsule once obey 1, took 2 times in 1st for 0.35g.These adjuvants comprise a kind of in micropowder silica gel, microcrystalline Cellulose, the hyprolose or several.
With the prepared osmanthus attached glutinous rehmannia capsule of the present invention strict quality control standard is arranged:
The main effective ingredient of these article that adopted high effective liquid chromatography for measuring, wherein every capsules contains the 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 the side, Radix Rehmanniae Preparata, Rhizoma Alismatis, Cortex Cinnamomi that adopted the thin layer chromatography qualitative identification wherein are that reference substance is differentiated the wine Fructus Corni with the oleanolic acid, are that reference substance is differentiated Radix Rehmanniae Preparata with the catalpol; With 23-alisol acetyl B is that reference substance is differentiated Rhizoma Alismatis; With the cinnamic aldehyde is that reference substance is differentiated Cortex Cinnamomi.Because contain the toxic component aconitine in the Radix Aconiti Lateralis Preparata, with the aconitine inspection that reference substance has carried out aconitine limit so adopt thin layer chromatography, stipulate that every capsules contains aconitine (C
34H
47NO
11) must not surpass 28ppm, to guarantee to use the safety of these article.
Because of using the macroporous adsorptive resins post to separate the purification remove impurity; So must detect the residual organic solvent of possibility in the finished product; Adopt the headspace sampling gas chromatography to detect organic residues such as normal hexane, benzene,toluene,xylene, styrene, divinylbenzene, and confirmed that the limit of residue distinguish must not above normal hexane 10ppm, benzene 2ppm, toluene 10ppm, xylene 20ppm, styrene 10ppm, divinylbenzene 60ppm.
Zooperal result shows that the effect to the enhancing human body immunity function is better than GUIFU DIHUANG WAN, and is suitable with the osmanthus attached glutinous rehmannia capsule of former method preparation; Have tangible carbohydrate metabolism, and be better than GUIFU DIHUANG WAN and former method osmanthus attached glutinous rehmannia capsule; Can obviously improve the syndrome of insufficiency of kidney-YANG model, suitable with GUIFU DIHUANG WAN with the effect of former method osmanthus attached glutinous rehmannia capsule.For these article treatment syndrome of deficiency of kidney-YANG provides the zoopery foundation.Rat oral gavage is six months continuously; Removing the high dose group body weight slightly descends; With the matched group there was no significant difference; And outside the convalescent period recovery is normal; The diet of other dose groups, drinking-water, body weight, form, hematology, blood biochemical, organ index and internal organs pathological anatomy all do not occur unusual, show that these article are safe.
Embodiment: process 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; Soaked 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; Use cold water washing; Dry, subsequent use below 45 ℃, Cortex Moutan medicinal residues device are in addition collected subsequent use;
Get coarse powder Rhizoma Dioscoreae 622.16g, Poria 466.62g adds water 5450ml reflux, extract, 3 times, each 0.5 hour, extracting solution filtered, decompression (below 70 ℃, 0.09MPa) is concentrated into thick paste (D
60 °=1.20～1.24) 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 (below 70 ℃, 0.09MPa) reclaim ethanol to there not being the alcohol flavor, subsequent use, wine Fructus Corni medicinal residues device are in addition collected subsequent use in decompression;
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 (below 70 ℃, 0.09MPa) reclaim ethanol to most, condensed cream is subsequent use, and Cortex Cinnamomi, Radix Aconiti Lateralis Preparata medicinal residues device are in addition collected subsequent use in decompression;
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; Add water 18.7L; Reflux, extract, 3 times; Each 1 hour, extracting solution filtered, and filtrating merges with wine Fructus Corni alcohol extraction concentrated solution; About 49L separates with D101 macroporous adsorptive resins post.
D101 macroporous adsorbent resin volume is 14L, and adsorption rate is 1BV resin/h (being about 14L/h), and absorption is finished, and gets detached dowel express developed with the 28L distilled water, uses 70% ethanol 42L desorbing then, and desorption rate is 0.8BV resin/h (being about 11.2L/h).Stripping liquid decompression (below 70 ℃, 0.09MPa) is concentrated into thickly, adds above-mentioned Rhizoma Dioscoreae, Poria water is carried condensed cream, wine Fructus Corni alcohol extraction concentrated solution, continued to be evaporated to thick paste (D
60 °About=1.25), change vacuum drying oven over to, be dried to dried in 0.09MPa below 70 ℃; Adding above-mentioned paeonol crystallization and an amount of micropowder silica gel, to make output be 1000, pulverizes mix homogeneously, incapsulates; The heavy 0.35g of every capsules obeys 1 at every turn, obeys every day 2 times.
Claims (8)
1. one kind prepares the capsular new process of osmanthus attached glutinous rehmannia; It is characterized in that: this new process is different from the capsular method for preparing of former osmanthus attached glutinous rehmannia (Chinese Pharmacopoeia version in 2010 fully; The 981st page), the osmanthus attached glutinous rehmannia capsule of the more former method preparation of the osmanthus attached glutinous rehmannia capsule oral amount of new method preparation has reduced 85%.
2. new process according to claim 1 is characterized in that: the 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 (system)
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
3. new process according to claim 1 is characterized in that: at first the medicine of respectively distinguishing the flavor of to prescription extracts, and the process of its extraction is following:
Get 3～6 parts of Cortex Moutan coarse powder, add 6～12 times of amounts of water, soak after 2～5 hours; Carry out steam distillation; Distillation speed is for steaming the distillate of 3 times of amount crude drugs in 1～3 hour, adding 1mol/L HCl or NaCl make crystallization in the distillate, place; Separate out the paeonol crystallization; Filter, use cold water washing, cold drying; Subsequent use, its medicinal residues are 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, extracted 0.5～1.5 hour at every turn, extracting solution filters, and decompression (below 70 ℃, 0.09MPa) be concentrated into thick paste, subsequent use;
Get 4～8 parts of wine Fructus Corni coarse powder, add 4～6 times of amount 70% alcohol reflux 2～4 times, extracted 0.5～1.5 hour at every turn, extracting solution filters, and (below 70 ℃, 0.09MPa) reclaim ethanol to there not being the alcohol flavor, subsequent use, its medicinal residues are subsequent use in decompression;
Get 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, extracted 1～2 hour at every turn, extracting solution filters, and (below 70 ℃, 0.09MPa) reclaim ethanol extremely to the greatest extent, condensed cream is subsequent use, and medicinal residues are subsequent use in decompression;
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 the hot altogether extraction of 5～8 times of water gagings 3 times; Each 0.5～2 hour; Extracting solution filters; Merge with wine Fructus Corni alcohol extraction concentrated solution, adopt the D101 macroporous adsorptive resins to carry out post and separate.
4. new process according to claim 1 is characterized in that: the described extracting solution of claim 3 adopts the D101 macroporous adsorptive resins to separate, and its technological parameter is following:
Macroporous adsorbent resin and said extracted liquid volume ratio are 1: 3～4;
Adsorption rate is 1BV resin/h;
Fast towards post, effluent is abandoned it with 2 times of distilled water of measuring the resin volumes in absorption end back;
With 70% alcohol desorption of 3 times of amount resin volumes, desorption rate is 0.8BV resin/h;
The stripping liquid decompression that obtains is (below 70 ℃; 0.09MPa) recovery ethanol; Continue to be concentrated into thick paste; Add Rhizoma Dioscoreae, Poria water and carry condensed cream and Cortex Cinnamomi, Radix Aconiti Lateralis Preparata alcohol extraction condensed cream; Continue concentrating under reduced pressure, change vacuum drying oven over to, below 70 ℃; 0.09MPa vacuum drying to doing, adds paeonol and appropriate amount of auxiliary materials and mixes pulverizing.In incapsulating, make every heavy 0.35g of capsule, once obey 1, took 2 times in 1st.These adjuvants comprise a kind of in micropowder silica gel, microcrystalline Cellulose, the hyprolose or several.
5. new process according to claim 1 is characterized in that: its main effective ingredient of prepared capsule all adopts high effective liquid chromatography for measuring, and wherein every contains the wine Fructus Corni with loganin (C
17H
26O
10) meter, be not less than 2.24mg, every contains Cortex Moutan with paeonol (C
9H
10O
3) meter is not less than 4.20mg.
6. new process according to claim 1 is characterized in that: made capsule adopts the following medical material of thin layer chromatography qualitative identification, is that reference substance is differentiated the wine Fructus Corni with the oleanolic acid; With the catalpol is that reference substance is differentiated Radix Rehmanniae Preparata; With 23-alisol acetyl B is that reference substance is differentiated Rhizoma Alismatis; With the cinnamic aldehyde is that reference substance is differentiated Cortex Cinnamomi.
7. new process according to claim 1 is characterized in that: made capsule is reference substance with the aconitine, adopts thin layer chromatography to carry out the inspection of aconitine limit, aconitine limit, and every capsules contains aconitine (C
34H
47NO
11) must not cross 28ppm.
8. new process according to claim 1, made capsule is characterized in that: adopt gas chromatography to detect the following organic solvent residual quantity that possibly exist and must not cross normal hexane 10ppm, benzene 2ppm, toluene 10ppm, xylene 20ppm, styrene 10ppm, divinylbenzene 60ppm.
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|---|---|---|---|
| CN201010242822.2A CN102343021B (en) | 2010-08-02 | 2010-08-02 | New process method for preparing Guifudihuang capsule |
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| CN201010242822.2A CN102343021B (en) | 2010-08-02 | 2010-08-02 | New process method for preparing Guifudihuang capsule |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN103239486A (en) * | 2012-04-23 | 2013-08-14 | 成都百裕科技制药有限公司 | Ginkgo lactone composition for treating cardiovascular and cerebrovascular diseases, and residue determination method |
| 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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2010
- 2010-08-02 CN CN201010242822.2A patent/CN102343021B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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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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| 孙玲等: "桂附地黄丸中乌头碱限量检查方法研究", 《齐鲁药事》, vol. 23, no. 5, 31 December 2004 (2004-12-31), pages 27 - 28 * |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN103239486A (en) * | 2012-04-23 | 2013-08-14 | 成都百裕科技制药有限公司 | Ginkgo lactone composition for treating cardiovascular and cerebrovascular diseases, and residue determination method |
| 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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| CN102343021B (en) | 2014-12-10 |
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