CN101450169A - Preparation method of spine date seed decoction - Google Patents
Preparation method of spine date seed decoction Download PDFInfo
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Abstract
The invention discloses a preparation method of spine date seed decoction belonging to the traditional Chinese medicine technology field. The preparation method in the invention comprises: water extracting according to the 'obeying ancient' thought and centrifuging and filtering combining with modern technology, and a best matched preparation process parameter and applicable auxiliary materials to thetraditional Chinese medicine preparation are summarized out. The invention not only furthest reserves the traditional medicine experiences, but also can adapt to the rapid paces of modern society by the preparation forms such as powder, pill, granule, tablet and capsule.
Description
[technical field]
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of spine date seed decoction and preparation method thereof.
[background technology]
Suanzaoren decoction is called " Ziziphi Spinosae soup " the earliest, sees Eastern Han Dynasty's Zhang Zhongjing and shows " Medical Treasures of the Golden Chamber " book.Arrived the Qing Dynasty, just in its " Principle and Prohibition for Medical profession ", renamed as " suanzaoren decoction " by the Yu Jia speech.We are one of representative prescriptions of Cure for insomnia, and the Chinese traditional treatment insomnia is had important significance for theories and clinical value.
Suanzaoren decoction cures mainly insomnia, palpitation and night sweat, the vertigo, dry mouth and throat, thready and stringy pulse, deficiency dysphoric insomnia, the suanzaoren decoction master it.The traditional Chinese medical science is thought, the reason that causes insomnia is a lot, has because of the person of disturbing, disorder of stomach-QI person or the like in disarmony between the heart and kidney person, deficiency of liver-blood person, deficiency of both the heart and spleen person, expectorant are turbid, and not all insomnia can be treated with suanzaoren decoction, must determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, the just effect that can obtain.
Record in " Medical Treasures of the Golden Chamber ": " consumptive disease with restlessness insomnia, suanzaoren decoction master it ".That is to say that we are that treatment is because of fidgets due to deficiency institute induced insomnia.Theory of Chinese medical science is thought, " heart storing spirit ", " liver storing soul ", insomnia is the closest with conscience two dirty relations." liver storing blood ", blood deficiency is given birth to interior-heat, disturbance of deficiency-heat inside the body, blood deficiency can not nourish heart in addition, and then the state of mind is not peaceful, so vexed insomnia.
Therefore, the insomnia that suanzaoren decoction cures mainly belongs to deficiency of liver-blood, disturbance of deficiency-heat inside the body, and blood failing to tonify the heart and causing, the insomniac is often with symptoms such as palpitation and night sweat, the vertigo, dry mouth and throat, thready and stringy pulse.Modern many plus-minus with we is used for the treatment of diseases such as neurasthenia, premature beat, climacteric syndrome, anxiety neurosis.
Semen Ziziphi Spinosae is flat in the side, sweet in the mouth, acid, energy replenishing blood and nourishing liver, beneficial heart and tranquilizing mind, arresting sweating; Rhizoma Chuanxiong, warm in nature, acrid in the mouth can be invigorated blood circulation and can circulation of qi promoting, can transfer blood soothing the liver; The Rhizoma Anemarrhenae, cold in nature, bitter in the mouth, matter profit, energy resolving heat and reducing pathogenic fire, YIN nourishing relieving restlessness; Poria, property is flat, and is sweet light tasteless, the energy mind tranquilizing and the heart calming; The Radix Glycyrrhizae heat clearing away, coordinating the actions of various ingredients in a prescription.All medicines match, nourishing YIN and benefiting blood, and resolving heat and reducing pathogenic fire transfers blood soothing the liver, the relieving restlessness of calming the nerves, with the treatment deficiency of liver-blood, disturbance of deficiency-heat inside the body revolves on the liver-yang and causes disease such as deficiency dysphoric insomnia.Modern pharmacological research shows that Semen Ziziphi Spinosae has significant calmness, syngignoscism; Poria, Rhizoma Chuanxiong have tangible sedation, can resist the excitation of caffeine.
Suanzaoren decoction not only provides effective prescription for the insomnia that the treatment deficiency of liver-blood causes, and has started the Therapeutic Principle of " nourish blood and transfer the liver tranquillization method " treatment deficiency of liver-blood insomnia, to having a far reaching influence later age.The prescription of many Cure for insomnias all produces on this basis., " book of Nanyang for Life Saving " middle Ziziphi Spinosae soup diffusing as the Ziziphi Spinosae in the Ziziphi Spinosae soup in the Tang Dynasty Sun Simiao " prescriptions worth thousand gold ", the medium and small Ziziphi Spinosae soup of Wang Tao " medical secrets of official ", the Song dynasty Holy Benevolent Prescriptions, they all are effective prescriptions of Cure for insomnia.
In recent decades, the production of Chinese herbal medicine has realized mechanization and semi-mechanization to a certain degree.Chinese medicine often is considered to that active constituent content is low, impurity is many, quality is unstable, so medication is based upon on the empirical basis more, can not integrate with modern medicine.For addressing this problem, Chinese medicine must be walked the road of extraction and purification.The extraction of Chinese medicine comprises many unit operationss such as leaching, clarification, filtration and evaporation.
[summary of the invention]
The preparation method that the purpose of this invention is to provide a kind of new spine date seed decoction.Basis of the present invention prescription derives from Chinese medicine preparation.
Chinese medicine preparation of the present invention, its prescription consists of: Semen Ziziphi Spinosae 15 weight portions, Poria 5 weight portions, Rhizoma Chuanxiong, each 3 weight portion of the Rhizoma Anemarrhenae, Radix Glycyrrhizae 1 weight portion, its preparation method is: medical material is decocted with water 2-4 time, each 0.5-3 hour, merge decocting liquid, filter the back concentrate fluid extract, add behind the adjuvant with behind the fluidized bed granulation useful in preparing drug formulations.
The proportion of above-mentioned fluid extract is 1.15-1.30, preferred 1.20-1.30.
Above-mentioned decocting liquid can carry out centrifugation earlier, gets clarifying decocting liquid, and centrifugal rotation speed is 1500-20000 rev/min, and preferred 1500-10000 rev/min, more preferably 2000-8000 rev/min, most preferably 3000-5000 rev/min.
Above-mentioned decocting liquid can adopt the method for membrane filtration to filter.
Above-mentioned membrane filtration comprises one of filter method of employing ultrafiltration and nanofiltration or ultrafiltration and nanofiltration is used in combination.
Above-mentioned ultrafilter membrane is selected from cellulose diacetate film, three cellulose acetate membrane, cyanoethyl cellulose film, polysulfone membrane, sulfonated polysulfone membrane, poly (ether sulfone) film, sulfonated polyether sulfone film, polysulfonamides film, phenolphthalein side group polyarylsulfone (PAS) film, polyvinylidene fluoride film, polyacrylonitrile film, polyimide film, cellulose membrane, methyl methacrylate-acrylonitrile copolymer film, polyacrylonitrile-cellulose diacetate blend film, the dynamic ultrafilter membrane that forms, one of and the Modified Membrane of above-mentioned film, its molecular retention amount is below the 6000-10000.
The filter membrane aperture of above-mentioned ultrafiltration is: the 0.22-0.45 micron.
The membrane ultrafiltration device that above-mentioned ultrafiltration is adopted can be commercial doughnut or plate ultrafilter membrane separator.
Above-mentioned NF membrane molecular retention amount is 500-2000, preferred 500-1000, more preferably 700-1000.
The process of above-mentioned membrane filtration preferably with the process ultrafiltration earlier of decocting liquid, is carried out nanofiltration again.
Above-mentioned adjuvant is selected from microcrystalline Cellulose, powdery cellulose, mannitol, starch, lactose, gelatin, methylcellulose, dextrin, pregelatinized Starch, micropowder silica gel, hydroxypropyl methylcellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, Polyethylene Glycol, xylitol, lactose, glucose, glycine, mannitol, tartaric acid, silicon dioxide, one or more in calcium stearate and the magnesium stearate.
The said medicine preparation comprises granule, tablet, capsule, powder, drop pill.
The at present used extracting technique of Chinese medicine compound recipes that adopt certain density ethanol extraction Chinese medicine more, help reclaiming solvent like this and reduce impurity, but the method that adopts alcohol extraction has deviated from the experience accumulation of the treatment disease of Chinese medicine since 3000, has ignored for the purpose that can arrive " quality controllable " comparatively simply under the guiding theory of " modernization of Chinese medicine " " effectiveness " even " safety ".
In sum, the hysteresis of Chinese medicine extraction separating technology development becomes the bottleneck of traditional Chinese medicine development and existence, must be optimized, reform and strengthen original technology.The reinforcement technique of chemical separating and mass transfer will provide strong assurance for this reason, and realization Chinese medicine subject intersects with Chemical Engineering, will help realizing the modernization of Chinese medicine production equipment.With the Chinese medicine extraction separation process that induces one of notion, the theory of Chemical Engineering.Utilize available research achievements,,, technological process, production equipment, operating condition are done modernization overlay and careful groping, provided feasible scheme from basic influence factor's research staff in conjunction with the concrete condition that Chinese medicine is produced.
In order to return the marrow of traditional medicine treatment disease, the present invention proposes the guiding theory according to " abiding by Gu " with Chinese medicine preparation classics side, use the water extraction medicine, concentrated, granulating process in conjunction with modern have summed up the preparation process parameter and the suitable adjuvant that mate the most with Chinese medicine preparation.Kept the experience accumulation of traditional medicine to greatest extent, and it is allegro as dosage forms such as tablet, capsule, granule, powder, drop pills to adapt to modern society.
Guaranteed the stable content of jujuboside A among the present invention, for the standardization production of preparation is laid a good foundation.By realization of the present invention, can be under the prerequisite that the effective ingredient in the Chinese medicine preparation is extracted to greatest extent, reducing in the extract macromolecular substances such as impurity such as tannin, polyphenol, resin, protein, phlegmatic temperament and solid particle effectively removes, keep the active ingredient in the Chinese medicine preparation of the present invention, for the preparation of oral drug preparation is provided convenience.
[specific embodiment]
Following embodiment further describes the present invention, but described embodiment only is used to illustrate the present invention rather than restriction the present invention.Following examples Chinese crude drug unit of feeding intake is gram, and according to Semen Ziziphi Spinosae 150g, Poria 50g, Rhizoma Chuanxiong, each 30g of the Rhizoma Anemarrhenae, Radix Glycyrrhizae 10g feeds intake.
Embodiment 1
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times with water extraction, each 2 hours, amount of water was 12 times of medical material, merge the water extract, filter decompression and solvent recovery, get fluid extract (proportion is 1.15-1.18), add adjuvant boiling granulating in fluid bed, promptly get granular preparation of the present invention.
Embodiment 2
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times with water extraction, each 2 hours, amount of water was 8 times of medical material, merge the water extract, filter, decompression and solvent recovery gets fluid extract (proportion is 1.15-1.21), add adjuvant boiling granulating in fluid bed, encapsulated, promptly obtain capsule preparations of the present invention.
Embodiment 3
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times with water extraction, each 2 hours, amount of water was 10 times of medical material, merged the water extract, filter, decompression and solvent recovery gets fluid extract (proportion is 1.16-1.23), adds adjuvant boiling granulating in fluid bed, add the adjuvant tabletting, promptly obtain tablet of the present invention.
Embodiment 4
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times with water extraction, each 3 hours, amount of water was 10 times of medical material, merge the water extract, filter, decompression and solvent recovery gets fluid extract (proportion is 1.20-1.26), add adjuvant boiling granulating in fluid bed, add vegetable oil substrate, pill promptly obtains drop pill of the present invention.
Embodiment 5
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times with water extraction, each 2.5 hours, amount of water was 10 times of medical material, merge the water extract, filter, decompression and solvent recovery gets fluid extract (proportion is 1.19-1.25), add adjuvant boiling granulating in fluid bed, add 800 gram vegetable oil, mix homogeneously promptly obtains soft capsule of the present invention with being pressed into soft capsule after the colloid mill grinding.
Embodiment 6
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times with water extraction, each 1.5 hours, amount of water was 10 times of medical material, merge the water extract, filter, decompression and solvent recovery gets fluid extract (proportion is 1.20-1.24), add adjuvant boiling granulating in fluid bed, pulverize, promptly obtain powder of the present invention.
Embodiment 7
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times with water extraction, each 2 hours, amount of water was 6 times of medical material, merged the water extract, filtered, and filtrate is 8000 three cellulose acetate membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.It is to handle in 500 the rolling nanofiltration device that ultrafiltration gained filtrate is selected molecular cut off for use through system, wherein the nanofiltration amount of water can be controlled in about 0.85 times of former ultrafiltrate, get fluid extract (proportion is 1.18-1.25), add adjuvant boiling granulating in fluid bed, promptly get granular preparation of the present invention.
Embodiment 8
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times with water extraction, each 2 hours, amount of water was 8 times of medical material, merged the water extract, filtered, and filtrate is 6000 cyanoethyl cellulose membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.It is to handle in 500 the rolling nanofiltration device that ultrafiltration gained filtrate is selected molecular cut off for use through system, wherein the nanofiltration amount of water can be controlled in about 0.8 times of former ultrafiltrate, get fluid extract (proportion is 1.25-1.35), add adjuvant boiling granulating in fluid bed, encapsulated, promptly obtain capsule preparations of the present invention.
Embodiment 9
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times with water extraction, each 2 hours, amount of water was 6 times of medical material, merged the water extract, filtered, and filtrate is 10000 polysulfone membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.It is to handle in 500 the rolling nanofiltration device that ultrafiltration gained filtrate is selected molecular cut off for use through system, wherein the nanofiltration amount of water can be controlled in about 0.75 times of former ultrafiltrate, get fluid extract (proportion is 1.28-1.30), add adjuvant boiling granulating in fluid bed, add the adjuvant tabletting, promptly obtain tablet of the present invention.
Embodiment 10
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times with water extraction, each 3 hours, amount of water was 10 times of medical material, merged the water extract, filtered, and filtrate is 6000 SPSF membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.It is to handle in 1000 the rolling nanofiltration device that ultrafiltration gained filtrate is selected molecular cut off for use through system, wherein the nanofiltration amount of water can be controlled in about 0.7 times of former ultrafiltrate, get fluid extract (proportion is 1.20-1.28), add adjuvant boiling granulating in fluid bed, add vegetable oil substrate, pill promptly obtains drop pill of the present invention.
Embodiment 11
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times with water extraction, each 2.5 hours, amount of water was 10 times of medical material, merged the water extract, filtered, and filtrate is 8000 poly (ether sulfone) film ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.It is to handle in 2000 the rolling nanofiltration device that ultrafiltration gained filtrate is selected molecular cut off for use through system, wherein the nanofiltration amount of water can be controlled in about 0.75 times of former ultrafiltrate, get fluid extract (proportion is 1.21-1.29), add adjuvant boiling granulating in fluid bed, add 200 gram vegetable oil, mix homogeneously promptly obtains soft capsule of the present invention with being pressed into soft capsule after the colloid mill grinding.
Embodiment 12
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times with water extraction, each 1.5 hours, amount of water was 10 times of medical material, merged the water extract, filtered, and filtrate is 6000 sulfonated polyether sulfone membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.It is to handle in 500 the rolling nanofiltration device that ultrafiltration gained filtrate is selected molecular cut off for use through system, wherein the nanofiltration amount of water can be controlled in about 0.65 times of former ultrafiltrate, get fluid extract (proportion is 1.27-1.30), add adjuvant boiling granulating in fluid bed, pulverize, promptly obtain powder of the present invention.
Embodiment 13
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times each 2 hours with water extraction, amount of water is 8 times of medical material, merges the water extract, centrifugal (rotating speed is 2000 rev/mins), filter, filtrate is 6000 three cellulose acetate membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.Ultrafiltration gained filtrate decompression reclaims solvent, gets fluid extract (proportion is 1.20-1.25), adds adjuvant boiling granulating in fluid bed, promptly gets granular preparation of the present invention.
Embodiment 14
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times each 2 hours with water extraction, amount of water is 8 times of medical material, merges the water extract, centrifugal (rotating speed is 2500 rev/mins), filter, filtrate is 8000 cyanoethyl cellulose membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.Ultrafiltration gained filtrate decompression reclaims solvent, gets fluid extract (proportion is 1.21-1.24), adds adjuvant boiling granulating in fluid bed, and is encapsulated, promptly obtains capsule preparations of the present invention.
Embodiment 15
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times each 2 hours with water extraction, amount of water is 8 times of medical material, merges the water extract, centrifugal (rotating speed is 5000 rev/mins), filter, filtrate is 6000 polysulfone membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.Ultrafiltration gained filtrate decompression reclaims solvent, gets fluid extract (proportion is 1.26-1.30), adds adjuvant boiling granulating in fluid bed, adds the adjuvant tabletting, promptly obtains tablet of the present invention.
Embodiment 16
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times each 3 hours with water extraction, amount of water is 8 times of medical material, merges the water extract, centrifugal (rotating speed is 3000 rev/mins), filter, filtrate is 6000 SPSF membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.Ultrafiltration gained filtrate decompression reclaims solvent, gets fluid extract (proportion is 1.24-1.29), adds adjuvant boiling granulating in fluid bed, adds vegetable oil substrate, and pill promptly obtains drop pill of the present invention.
Embodiment 17
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 2 times each 2.5 hours with water extraction, amount of water is 8 times of medical material, merges the water extract, centrifugal (rotating speed is 8000 rev/mins), filter, filtrate is 6000 poly (ether sulfone) film ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.Ultrafiltration gained filtrate decompression recovery solvent gets fluid extract (proportion is 1.21-1.29), adds adjuvant boiling granulating in fluid bed, adds 200 gram vegetable oil, and mix homogeneously promptly obtains soft capsule of the present invention with being pressed into soft capsule after the colloid mill grinding.
Embodiment 18
Take by weighing the pulverizing medicinal materials of recipe quantity, decoct 3 times each 1.5 hours with water extraction, amount of water is 8 times of medical material, merges the water extract, centrifugal (rotating speed is 10000 rev/mins), filter, filtrate is 6000 sulfonated polyether sulfone membrane ultrafiltration with molecular cut off, filter type employing cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1 MPa, and low 0.5 kPa of the liquid outlet pressure ratio inlet pressure of ultrafiltration progressively boosts during ultrafiltration.In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1 MPa.Ultrafiltration gained filtrate decompression reclaims solvent, gets fluid extract (proportion is 1.24-1.30), adds adjuvant boiling granulating in fluid bed, pulverizes, and promptly obtains powder of the present invention.
Determining of the amount of experimental example 1-dry extract of the present invention
Embodiment 1-18 fluid extract with among the present invention does not add adjuvant, and directly lyophilization obtains dry extract, data such as following table 1:
The data of the amount of table 1 dry extract of the present invention
By realization of the present invention, can be under the prerequisite that the effective ingredient in the Chinese medicine preparation of the present invention is extracted to greatest extent, reducing in the extract macromolecular substances such as impurity such as tannin, polyphenol, resin, protein, phlegmatic temperament and solid particle effectively removes, the active ingredient that keeps medicine is for the preparation of oral drug preparation is provided convenience.
Experimental example 2-carries out the liquid phase analysis research of Chinese medicine preparation with high performance liquid chromatograph
One, materials and methods
(1), experimental drug
The standard substance jujuboside A that this research is used is available from Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
(2), instrument and equipment and experiment condition
1. instrument and equipment
Liquid phase pump: Applied Biosystems (ABI) 400 * 2
Injection valve: Rheodyne Type 7125 (10 μ L loop)
The automatic gradient controller of mobile phase controller: ABI
Detector: DAD detector
2. analysis condition
Pre-column: μ-Bondapak TMC18 (Millipore, Milford, MA, USA)
Chromatographic column: Cosmosil 5C18-MS, 5 μ m, 25cm * 4.6mm (Nacalai Tesque, Kyoto, Japan)
Mobile phase: methanol-water (66:34)
Flow velocity: 1.0 ml/min
Detect wavelength: 203nm
Experimental example 3-preparation index substance of the present invention assay
With embodiment 1-18 fluid extract, do not add adjuvant, directly lyophilization obtains dry extract according to above test condition detection level, and gained jujuboside A content is as follows:
The effective ingredient peoniflorin is investigated in table 1 sample
Conclusion: guaranteed the stable content of jujuboside A among the present invention, for the standardization production of preparation is laid a good foundation.By realization of the present invention, can be under the prerequisite that the effective ingredient in the Chinese medicine preparation is extracted to greatest extent, reducing in the extract macromolecular substances such as impurity such as tannin, polyphenol, resin, protein, phlegmatic temperament and solid particle effectively removes, keep the active ingredient in the Chinese medicine preparation of the present invention, for the preparation of oral drug preparation is provided convenience.
Claims (9)
1. the preparation method of a spine date seed decoction, its prescription consists of: Semen Ziziphi Spinosae 15 weight portions, Poria 5 weight portions, Rhizoma Chuanxiong, each 3 weight portion of the Rhizoma Anemarrhenae, Radix Glycyrrhizae 1 weight portion, it is characterized in that medical material is decocted with water 2-4 time, each 0.5-3 hour, merge decocting liquid, filter the back concentrate fluid extract, add behind the adjuvant with behind the fluidized bed granulation useful in preparing drug formulations.
2. preparation method according to claim 2, the proportion that it is characterized in that described fluid extract is 1.15-1.30.
3. preparation method according to claim 3, the proportion that it is characterized in that described fluid extract is 1.20-1.30.
4.. preparation method according to claim 3 is characterized in that described decocting liquid can carry out centrifugation earlier, gets clarifying decocting liquid, centrifugal rotation speed is 1500-20000 rev/min.
5. according to the arbitrary described preparation method of claim 1-4, it is characterized in that described decocting liquid can adopt the method for membrane filtration to filter.
6. preparation method according to claim 5 is characterized in that described membrane filtration comprises ultrafiltration and nanofiltration.
7. preparation method according to claim 6, the process that it is characterized in that described membrane filtration is carried out nanofiltration again for the process ultrafiltration earlier of decocting liquid.
8. according to the arbitrary described preparation method of claim 1-7, it is characterized in that described adjuvant is selected from microcrystalline Cellulose, powdery cellulose, mannitol, starch, lactose, gelatin, methylcellulose, dextrin, pregelatinized Starch, micropowder silica gel, hydroxypropyl methylcellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, Polyethylene Glycol, xylitol, lactose, glucose, glycine, mannitol, tartaric acid, silicon dioxide, one or more in calcium stearate and the magnesium stearate.
9. according to the arbitrary described preparation method of claim 1-7, it is characterized in that described pharmaceutical preparation comprises granule, tablet, capsule, powder, drop pill.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926865A (en) * | 2010-09-11 | 2010-12-29 | 天津医科大学 | Spina date seed depression-resolving and nerve-soothing composition and preparation method thereof |
| CN102488826A (en) * | 2011-12-14 | 2012-06-13 | 哈药集团中药二厂 | Method for preparing freeze-dried oral preparation of spina date seed decoction |
| CN102772629A (en) * | 2012-07-24 | 2012-11-14 | 李承平 | Tablet for soothing nerves and relieving restlessness |
| CN102895482A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of sour jujube decoction |
| CN105477286A (en) * | 2015-12-16 | 2016-04-13 | 齐鲁工业大学 | Traditional Chinese medicinal decoction for treating insomnia |
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2007
- 2007-12-07 CN CNA2007101955433A patent/CN101450169A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926865A (en) * | 2010-09-11 | 2010-12-29 | 天津医科大学 | Spina date seed depression-resolving and nerve-soothing composition and preparation method thereof |
| CN101926865B (en) * | 2010-09-11 | 2012-01-25 | 天津医科大学 | Spina date seed depression-resolving and nerve-soothing composition and preparation method thereof |
| CN102895482A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of sour jujube decoction |
| CN102488826A (en) * | 2011-12-14 | 2012-06-13 | 哈药集团中药二厂 | Method for preparing freeze-dried oral preparation of spina date seed decoction |
| CN102488826B (en) * | 2011-12-14 | 2013-07-03 | 哈药集团中药二厂 | Method for preparing freeze-dried oral preparation of spina date seed decoction |
| CN102772629A (en) * | 2012-07-24 | 2012-11-14 | 李承平 | Tablet for soothing nerves and relieving restlessness |
| CN105477286A (en) * | 2015-12-16 | 2016-04-13 | 齐鲁工业大学 | Traditional Chinese medicinal decoction for treating insomnia |
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