CN103230434A - Manufacturing process of leonurus - Google Patents
Manufacturing process of leonurus Download PDFInfo
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- CN103230434A CN103230434A CN2013101364547A CN201310136454A CN103230434A CN 103230434 A CN103230434 A CN 103230434A CN 2013101364547 A CN2013101364547 A CN 2013101364547A CN 201310136454 A CN201310136454 A CN 201310136454A CN 103230434 A CN103230434 A CN 103230434A
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Abstract
The invention discloses a manufacturing process of leonurus. The process comprises the following steps of: selecting leonurus, washing and cutting and then draining off till the water content is 78-82%; placing the drained leonurus in a tray, wherein the weight in each tray is 2-4kg/m<2> and thickness is 2-3cm; gradually cooling for 2.5-3.2 hours and freezing at -30 to -37 DEG C; vacuumizing till the absolute pressure of the system is 70-100Pa, starting heating to 60-70 DEG C, and drying for 15-18 hours; and maintaining the temperature at 30-40 DEG C, and discharging till the water content is below 3%. The leonurus decoction piece obtained by the manufacturing process disclosed by the invention not only has the essential characteristics of fresh medicines to store the drug properties of fresh traditional Chinese medicines for a long time and ensure the effect, but also is convenient to store and convey and suitable for industrial production and clinical use. The effective components are further effectively prevented from being decomposed in the storage process, and the leonurus decoction piece has good use value and wide market prospect.
Description
Technical field
The invention belongs to the Chinese medicine technical field of producing, relate in particular to a kind of processing technique of Herba Leonuri.
Background technology
Herba Leonuri is the fresh or dry aerial parts of labiate Herba Leonuri (Leonurus JaponicusHoutt.).Bright product seedling in spring phase to first summer flower is tapped in earlier stage; Dry product stem and leaf in summer is luxuriant, and Hua Weikai or tap when just opening dries or cutting is dried.
Pharmacopoeia of the People's Republic of China version in 2010, record in an one, the medical material of Herba Leonuri is divided into fresh Herba Leonuri and two product of dried Herba Leonuri are advised.
Fresh Herba Leonuri: seedling phase acaulescence, basal leaf center of circle shape, edge 5～9 shallow splitting, every sliver has 2～3 cognates.Flower stem in early stage is square column type, top multi-branched, the recessed one-tenth longitudinal furrow in four sides, long 30～60 centimetres, 0.2～0.5 centimetre of diameter; The surface is dark green; Matter is fresh and tender, and there is marrow at the section middle part.Leaf has handle alternately to life; Blade is dark green, and matter is fresh and tender, and that rubs has juice; Bottom stem leaf palmate 3 is split, upper leaf pinniform drastic crack or shallowly be cleaved into 3, the full edge of sliver or tool minority sawtooth.Feeble QI, mildly bitter flavor.
Dried Herba Leonuri: stem surface celadon or yellow green; Body is light, and matter is tough, and there is marrow at the section middle part.The blade celadon, many shrinkages, fragmentation easily come off.Wheel umbrella inflorescence axil is given birth to Xiao Hua lavender, calyx tubular, corolla two lips.Cutting person is about 2cm.
The Herba Leonuri beginning is stated from Shennong's Herbal " Fructus Leonuri " bar, classifies as top grade.Have another name called Herba Leonuri Chinese mugwort, Herba Leonuri, HERBA LEONURI, Herba Linderniae Crustaceae etc.Bitter in the mouth, suffering, cold nature is returned liver, pericardium, urinary bladder channel, has the merit of promoting blood flow to regulate menstruation, inducing diuresis to remove edema, heat-clearing and toxic substances removing, is used for menoxenia, dysmenorrhea amenorrhea, lochiorrhea, edema oliguria, sore swollen toxin.Be described as " blood man panacea ", " multiparity good medicine " by ancient Chinese medicine doctor, be the key medicine for the treatment of gynaecopathia.
Main chemical compositions contains alkaloids, Diterpenes, sterol, flavonoid, organic acid, volatile oil, various trace elements and fatty acid etc. in the Herba Leonuri.Pharmacological research proves that it has effects such as regulating menstruation, hemostasis, protection myocardial ischemia reperfusion injury, antiplatelet aggregation, reduction blood viscosity; Be commonly used to treat diseases such as hemorrhage, coronary heart disease post-abortion, myocardial ischemia, high sticky blood, dysmenorrhea clinically.
Clinical commonly used be Herba Leonuri medical material (decoction pieces) and motherwort formulation, its quality control is index with the total alkaloids.Modern pharmacology studies show that Herba Leonuri has biologic activity widely, can treat multiple disease, has broad application prospects.Vast researcher has been obtained many achievements to its research, but its pharmacodynamics material base is not clear.
Herba Leonuri divides fresh Herba Leonuri and dried Herba Leonuri two product rule as the Chinese crude drug (prepared slices of Chinese crude drugs) of a record of Pharmacopoeia of the People's Republic of China version in 2010.
The Herba Leonuri using fresh herb has long history and unique effect clinically, is one of characteristic of medical drugs in the motherland, and fresh Herba Leonuri has special curative effect, and dried medical material can not replace.But because fresh Herba Leonuri is very inconvenient at aspects such as storage, plantation, processing, transportations, traditional preservation technique of bright medical material falls behind, and uses clinically to be subjected to a lot of condition restriction, has restricted the extensive use of bright medical material.Fresh Herba Leonuri is very rare in the pharmacy at present.As a kind of medicine, its drug action to human body at first is the material base that contains with it on the one hand, and namely active component is directly related.Materials such as volatile aromatic class, protein and the enzyme that fresh Herba Leonuri contains, polypeptide class, vitamins are all extremely unstable to heat, and it is then destroyed to show as chance heat, and this point has obtained fully proving of modern science experiment at present.On the other hand, from the Chinese medicine property theory, the fresh Herba Leonuri property of medicine belongs to cold and cool property, and traditional heat drying mode makes the hot fragrant that hot (sun) helps of himself, and nature will be dispersed and ageusia in ascension, makes original drug effect impaired, even completely loses.
The drying of dried Herba Leonuri comprises two processes in actual production, first: and the drying of carrying out after fresh plant is gathered from the soil, namely fresh plant becomes dry medical material; Second: with cutting into prepared slices of Chinese crude drugs drying again according to concocted specification behind the water infiltration, namely Chinese crude drug becomes the dry traditional Chinese medicine decoction pieces to dry medical material again.The prepared slices of Chinese crude drugs are as a special sort in the medicine, because multiformity and the complexity of its composition, performance, probability and degree that qualitative variability takes place in storage process are relatively large, drying is an extremely important step, it is a key factor that influences its quality, because appropriate drying not only is conducive to storage and the storage of medical material, more be conducive to give full play to its curative effect, prevent from reducing medicine usefulness.
The drying means that dried Herba Leonuri is traditional, usually the plant of gathering is removed impurity and the branch and leaf that rot after dry or cutting stores after drying or circulates; Soft according to the concocted specification profit again after the decoction pieces processing factory, cutting, packing and storing or circulation behind the after drying.And soft in the profit of dry in the sun and the process of preparing course of processing, cutting, in the drying, the active ingredient meeting of Herba Leonuri is run off in a large number or is destroyed again, thereby has greatly reduced its drug effect and active component.According to statistics, 1 year its alkaloids content of the Herba Leonuri raw material of traditional drying placement will be fallen more than 50%.Simultaneously, the influence of factor such as the prepared slices of Chinese crude drugs also are subject to transport, store in a warehouse, preservation further reduces its active ingredient.
In addition, by Herba Leonuri medical material or the decoction pieces of traditional diamond-making technique drying, its water content almost reaches 13%, very easily goes mouldy, damages by worms, and is difficult for storing and utilizing.The content of moisture also can produce different influences to effectiveness, safety and the stability of medical material.Relevant research points out, reasonably moisture in the storage custody of medical material, can prevent infested, go mouldy, avoid that effective ingredient decomposes, enzymolysis is rotten etc.Thereby, keep the suitable moisture of medical material not only to be conducive to store, can also keep the drug effect of Chinese crude drug.The dry run of Chinese crude drug, decoction pieces is actually the process that dynamic change takes place for moisture, heat, effective ingredient three, influences each other between the three, mutual restriction, reaches a relative balance state then.Find out optimum combination, make moisture, heat, effective ingredient three reach optimum balance state and drying effect.
Given this, traditional preservation technique can not be extensive use of by the bright medicine of restriction of objective condition on the one hand, need seek the drying mode that modern drying process obtains the most approaching bright product; The dried medical material that obtains of traditional drying process is in water content and keep aspect bright pharmaceutically active ingredient or the active component very big with bright medicine difference on the other hand, seek fresh Chinese medicine preservation technique, break away from the season limit of its clinical use, the effective ingredient or the active component that at utmost keep medicine are the problems of needing solution at present badly.
Summary of the invention
The invention provides a kind of processing technique of Chinese medicine Herba Leonuri, this process using is carried out reasonable configuration to operating time, temperature, pressure and other parameters, find out optimum combination, make moisture, heat, effective ingredient three reach optimum balance state and drying effect, thereby make the drug effect of Herba Leonuri and active component obtain maximum reservation, and the water content that makes dry medical material is significantly less than the water content of traditional Herba Leonuri medical material, effectively stops the degraded of effective ingredient in the storage process.The Herba Leonuri decoction pieces that utilizes processing technique of the present invention to obtain, the basic feature that had both had bright medicine, the property feature of the bright Chinese medicine of energy long preservation guarantees drug effect, be convenient to storage again, transport and be suitable for suitability for industrialized production and clinical use, have good use value and vast market prospect.
The present invention takes following technical scheme: a kind of processing technique of Chinese medicine Herba Leonuri, comprise that Herba Leonuri cleans, washing, cutting, drain, freezing, dry, dry, packing storage for the second time for the first time, concrete steps are as described below:
1) cleans: the fresh or dry aerial parts of tapping labiate Herba Leonuri (Leonurus JaponicusHoutt.) in earlier stage to first summer flower in the seedling phase in spring; Or summer stem and leaf luxuriant, Hua Weikai or the fresh or dry aerial parts of tapping labiate Herba Leonuri (Leonurus JaponicusHoutt.) when just opening; The branch and leaf of removing impurity and rotting;
2) washing: adopt the circulating water rinsing, the foreign material such as earth on flush away Herba Leonuri surface;
3) cutting: clean by process of preparing Chinese medicine requirement cutting;
4) drain: Herba Leonuri is drained to water content 78%～82%;
5) freezing: the Herba Leonuri that drains is contained dish, and Sheng dish weight is 2～4kg/m
2, thickness is 2～3cm, carries out freezing at-33 ℃～-37 ℃ after lowering the temperature gradually 2.8～3.2 hours;
Because the particularity of Chinese medicine Herba Leonuri, contain materials such as alkaloids, Diterpenes, sterol, flavonoid, organic acid, volatile oil, various trace elements and fatty acid, it needs dry " moisture " to be actually the liquid of a complexity, its freezing process also is the process of a complexity, similar to solution, the temperature that really all condenses into solid, i.e. an eutectic point are also arranged.Because lyophilization is carried out under vacuum state, could under vacuum, carry out the drying first time after having only the fresh Herba Leonuri freeze all, otherwise when having partially liq to exist, under subsequent evacuation state, not only can evaporate rapidly, cause the concentrated volume-diminished that causes freeze-drying prods of liquid; And the gas that is dissolved in the water can come up rapidly under vacuum, causes the appearance that resembles liquid boiling, causes the freeze-drying prods bubbling.For this reason, the parameter setting of the solidification point in this stage and freeze-off time is very important and crucial.
6) for the first time dry: the system absolute pressure of being evacuated to is 70～100Pa, beginning heat temperature raising to 60 ℃～70 ℃, dry 15～18 hours;
At this step drying stage, material need absorb heat (every gram ice is sublimed into the heat that steam absorbs 2.8 Kilojoule approximately fully), if medicine is not heated or shortage of heat, then when distilling, can absorb the heat of medicine itself and the temperature of medicine is reduced at moisture, cause the vapour pressure of medicine to reduce, so cause the reduction of rate of sublimation, the time of whole drying will prolong, and productivity ratio descends; If to medicine heating too much, the rate of sublimation of medicine no doubt can improve, but after having offset the heat that the medicine distillation absorbs, unnecessary heat can make the temperature rising of freezing medicine itself, influence the effective ingredient of medical material.If temperature is too high, effective ingredient is with destroyed.Therefore, choose reasonable parameter by this step and solve foregoing problems.
7) dry for the second time: as to keep temperature of charge at 30 ℃～40 ℃, make water content reach back discharging below 3%.Dried Herba Leonuri is packaged in the constant temperature dehumidification workshop to carry out, in order to avoid the material suction is made moist.Shady and cool airtight storage.
The Herba Leonuri decoction pieces that utilizes processing technique of the present invention to obtain, the basic feature that had both had bright medicine, the property feature of the bright Chinese medicine of energy long preservation, guarantee drug effect, be convenient to store, transport and be suitable for suitability for industrialized production and clinical use again, can also effectively stop the degraded of effective ingredient in the storage process, have good use value and vast market prospect.
Through the Herba Leonuri of the present invention processing, can preserve the active ingredient of former medicine and the performance of going back crude drug in whole to greatest extent, the Herba Leonuri after the processing is no matter on profile or volume, and is all very nearly the same with fresh medical material.After testing, the Herba Leonuri of technology of the present invention is measured greater than 15.0% with reference to the hot dipping under the water-soluble extractives algoscopy item, and the moisture inspection is measured less than 5.0% with reference to pharmacopeia appendix VI H first method.Measure with reference to high performance liquid chromatography (pharmacopeia appendix VI D), press dry product and calculate, the content of main component stachydrine hydrochloride (C7H13NO2.HCL) is 1.0～3.0 times of traditional drying technology; The content of hydrochloric acid leonurine (C14H21O5N3.HCL) is 1.0～2.0 times of traditional drying technology.
The processing method of Chinese medicine is pharmaceutically occupied very consequence in motherland, and the quality of Chinese medicine processing method directly influences the effect of disease treatment.Through the Chinese medicine Herba Leonuri of the present invention processing, can keep drug effect and active component thereof, effectively stop the degraded of effective ingredient in the storage process; Save natural resources of Chinese medicinal materials, promote the modernization of Chinese medicine, opened up new road for the development of traditional Chinese medicine.
The processing technique of Chinese medicine Herba Leonuri of the present invention is carried out reasonable configuration to operating time, temperature, pressure and other parameters, find out optimum combination, make moisture, heat, effective ingredient three reach optimum balance state and drying effect, thereby make protein in the Herba Leonuri, microorganism and so on degeneration can not take place or lose biologos; The loss of volatile oil composition is very little; The medical material volume is almost constant, has kept original structure, the shrinkage phenomenon can not take place; Medical material is loose porous, is spongy, adds that dissolving almost recovers original character rapidly and fully immediately behind the water; Can get rid of the moisture more than 95%.Can make Herba Leonuri drug effect and active component obtain maximum reservation in a word, water content is significantly less than traditional Herba Leonuri medical material, and effective ingredient very easily is dissolved in clinical use.
The specific embodiment
Below the embodiment of the invention is elaborated.
Embodiment 1
Choose the fresh or dry aerial parts that extremely first summer flower of seedling phase in spring is tapped labiate Herba Leonuri (Leonurus JaponicusHoutt.) in earlier stage; Or summer stem and leaf luxuriant, Hua Weikai or the fresh or dry aerial parts of tapping labiate Herba Leonuri (Leonurus JaponicusHoutt.) when just opening; The branch and leaf of removing impurity and rotting; Adopt the circulating water rinsing, the earth on flush away Herba Leonuri surface also drains cutting; Carry out sabot to water content about 80% with Herba Leonuri is predrying, sabot weight is 2kg/m
2, thickness is 2cm, carries out freezing at-35 ℃ after lowering the temperature gradually 2.5 hours; Being evacuated to system's absolute pressure then is 75Pa, beginning heat temperature raising to 60 ℃, dry 15 hours; Keep temperature of charge at 35 ℃ again, make water content reach back discharging below 3%.Pack shady and cool airtight preservation in the constant temperature dehumidification workshop.
Embodiment 2
Choose the fresh or dry aerial parts that extremely first summer flower of seedling phase in spring is tapped labiate Herba Leonuri (Leonurus JaponicusHoutt.) in earlier stage; Or summer stem and leaf luxuriant, Hua Weikai or the fresh or dry aerial parts of tapping labiate Herba Leonuri (Leonurus JaponicusHoutt.) when just opening; The branch and leaf of removing impurity and rotting; Adopt the circulating water rinsing, the earth on flush away Herba Leonuri surface also drains cutting; Carry out sabot to water content about 80% with Herba Leonuri is predrying, sabot weight is 4kg/m
2, thickness is 3cm, carries out freezing at-30 ℃ after lowering the temperature gradually 3 hours; Being evacuated to system's absolute pressure then is 80Pa, beginning heat temperature raising to 70 ℃, dry 18 hours; Keep temperature of charge at 40 ℃ again, make water content reach back discharging below 3%.Pack shady and cool airtight preservation in the constant temperature dehumidification workshop.
Herba Leonuri is after drying made the prepared slices of Chinese crude drugs by the mode of embodiment 1, can single brews with the boiled water about 60 degree to do the medicine drink, also can form compound compatibility with other prepared slices of Chinese crude drugs.
Embodiment 3
Choose the fresh or dry aerial parts that extremely first summer flower of seedling phase in spring is tapped labiate Herba Leonuri (Leonurus JaponicusHoutt.) in earlier stage; Or summer stem and leaf luxuriant, Hua Weikai or the fresh or dry aerial parts of tapping labiate Herba Leonuri (Leonurus JaponicusHoutt.) when just opening; The branch and leaf of removing impurity and rotting; Adopt the circulating water rinsing, the earth on flush away Herba Leonuri surface also drains cutting; Carry out sabot to water content about 80% with Herba Leonuri is predrying, sabot weight is 3kg/m
2, thickness is 2.5cm, carries out freezing at-35 ℃ after lowering the temperature gradually 3 hours; Being evacuated to system's absolute pressure then is 90Pa, beginning heat temperature raising to 65 ℃, dry 18 hours; Keep temperature of charge at 40 ℃ again, make water content reach back discharging below 3%.Pack shady and cool airtight preservation in the constant temperature dehumidification workshop.
Above-described embodiment can adopt Shenyang JDF-0.2 type drying machine processing Chinese medicine Herba Leonuri, also can adopt other machine to operate.
Bai Kang pharmaceutcal corporation, Ltd institute of materia medica, Zhejiang is detected the Herba Leonuri effective ingredient that the present invention's processing makes by high performance liquid chromatography according to 2010 editions one one of the Pharmacopoeia of the People's Republic of China.
Stachydrine hydrochloride is measured according to high performance liquid chromatography (appendix VI D).
Chromatographic condition and system suitability test are filler with the propyl amides bonded silica gel; With acetonitrile O.2% glacial acetic acid solution (80:20) be mobile phase; Detect with evaporative light scattering detector.Number of theoretical plate calculates by the stachydrine hydrochloride peak should be not less than 6000.
It is an amount of that the stachydrine hydrochloride reference substance is got in the preparation of reference substance solution, accurate claims surely, adds 70% ethanol and make every 1ml and contain O.57mg solution, namely.
The about 1g of this product powder (crossing sieve No. three) is got in the preparation of need testing solution, and accurate the title decides, and puts in the tool plug conical flask, and the accurate 70% ethanol 25ml that adds claims to decide weight, reflux 2 hours is put coldly, claims to decide weight again, supplies the weight that subtracts mistake with 70% ethanol, shake up, filter, get subsequent filtrate, namely.
Algoscopy is accurate reference substance solution 5 μ l, the lO μ l of drawing respectively, and need testing solution 10～20 μ 1 inject chromatograph of liquid, measures, and calculates with external standard two-point method logarithmic equation, namely.
The hydrochloric acid leonurine is measured according to high performance liquid chromatography (appendix VI B).
Chromatographic condition and system suitability test are filler with the octadecylsilane chemically bonded silica; With acetonitrile O.4% the O.1% phosphoric acid solution (24:76) of perfluorooctane sulfonate be mobile phase; The detection wavelength is 277nm.Number of theoretical plate calculates by hydrochloric acid leonurine peak should be not less than 6000.
It is an amount of that hydrochloric acid leonurine reference substance is got in the preparation of reference substance solution, and accurate the title decides, and adds 70% ethanol and makes the solution that every 1m1 contains 30 μ g, namely.
Algoscopy precision is respectively drawn each 10 μ l of need testing solution under reference substance solution and stachydrine hydrochloride [assay] item, and the injection chromatograph of liquid is measured, namely.
From testing result as can be known, the Herba Leonuri that processing technique of the present invention makes, the content of its main component stachydrine hydrochloride (C7H13NO2.HCL) is about 1.0%; The content of hydrochloric acid leonurine (C14H21O5N3.HCL) is about 0.08%.
Freezing dry process carries out Herba Leonuri under cold environmental conditions, it has suppressed the heat-sensitive materials biology effectively, variation chemistry or physics, the active substance and the color and luster that have fully kept Herba Leonuri, it is the optimal way of dry Herba Leonuri, vacuum has been avoided oxidation, low temperature has guaranteed the alkaloids in the Herba Leonuri, Diterpenes, sterol, flavonoid, organic acid, volatile oil, main component such as various trace elements and fatty acid is not destroyed, overcome and caused effective ingredient and active ingredient loss serious in traditional processing, caused drug effect to reduce, the defective of product variable color.Therefore, the Herba Leonuri of the present invention's processing both can be used as the fresh Herba Leonuri decoction pieces and had used, because this technology is a breakthrough of the modern antistaling process of Chinese medicine; Can be used as dried Herba Leonuri decoction pieces and use, the content height of its effective ingredient and active component, taking dose is little, and curative effect is more definite; And effectively stop the degraded of effective ingredient in the storage process, have a extensive future.
Claims (4)
1. the processing technique of a Herba Leonuri, it carries out as follows: after cleaning Herba Leonuri, wash, cutting, it is drained to water content 78%～82% then; The Herba Leonuri that drains is contained dish, and Sheng dish weight is 2～4kg/m
2, thickness is 2～3cm, carries out freezing after lowering the temperature gradually 2.5～3.2 hours under-30 ℃～-37 ℃ temperature; The system absolute pressure of being evacuated to is 70～100Pa, beginning heat temperature raising to 60 ℃～70 ℃, dry 15～18 hours; Maintain the temperature at 30 ℃～40 ℃, make water content reach back discharging below 3%.
2. the processing technique of Herba Leonuri as claimed in claim 1, it is characterized in that: Herba Leonuri is selected from: the fresh or dry aerial parts that seedling phase in spring to first summer flower is tapped the labiate Herba Leonuri in earlier stage; Or summer stem and leaf luxuriant, Hua Weikai or the fresh or dry aerial parts of tapping the labiate Herba Leonuri when just opening.
3. the processing technique of Herba Leonuri as claimed in claim 1 is characterized in that: the rinsing of described washing employing circulating water, the foreign material on flush away Herba Leonuri surface.
4. as the processing technique of each described Herba Leonuri of claim 1-3, it is characterized in that: the Herba Leonuri after the discharging is packed in the constant temperature dehumidification workshop.
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| CN106771012A (en) * | 2016-05-21 | 2017-05-31 | 广州今典精方药业有限公司 | The quality standard and manufacturing process of the motherwort qualitative, quantitative prepared slices of Chinese crude drugs |
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| CN108853006A (en) * | 2018-08-15 | 2018-11-23 | 康美保宁（四川）制药有限公司 | A kind of preparation method of motherwort thick paste and the preparation method of Herba Leonuri granule |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104798769A (en) * | 2015-03-30 | 2015-07-29 | 西华大学 | Fresh-keeping method or storage method of fresh motherwort |
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