CN102119992B - Pharmaceutical preparation prepared from fresh motherwort and fresh aloe and preparation method thereof - Google Patents
Pharmaceutical preparation prepared from fresh motherwort and fresh aloe and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical preparation prepared from fresh motherwort and fresh aloe and a preparation method thereof. The pharmaceutical preparation is characterized by being prepared from the following raw medicines in parts by weight: 12-40 parts of fresh motherwort and 3-270 parts of fresh aloe. The pharmaceutical preparation disclosed by the invention has the functions of promoting blood circulation to activate collaterals and dispelling toxins to beautify the face, and has an effect on improving dysmenorrhea, amenorrhea, uterine bleeding, dizziness due to deficiency of blood, palpitation and intestine dryness constipation.
Description
Technical field
The present invention relates to a kind of pharmaceutical formulation that is used for promoting blood circulation to restore menstrual flow, eliminating toxin and beautifying the skin and preparation method thereof, belong to technical field of traditional Chinese medicine pharmacy.
Background technology
Herba Leonuri records in Chinese Pharmacopoeia, is labiate.Bitter in the mouth, suffering are slightly cold.Return liver, pericardium, urinary bladder channel.Complex chemical composition mainly contains alkaloid, flavone, fatty acid, diterpene, volatile oil, polypeptide class, trace element etc.According to bibliographical information, Herba Leonuri has multiple pharmacological effect, mainly show to the excited of animal isolated uterine and uterus on the throne with to the cardiovascular and cerebrovascular vessel effect, and to aspects such as lymph and blood system and anti-aging effects.Bright article are tender with the matter that flower is gathered early stage, contain the total alkaloids height leaf more.The amount of each position stachydrine hydrochloride all is higher than the amount of each position stachydrine hydrochloride in the dried Herba Leonuri of summer in the spring fresh Herba Leonuri; Aloe (Aloe) is the Liliaceae herbaceos perennial; Its medicinal existing long history; Can trace back to the earliest in " paper leather "-" Ye Bilusibabilusi " book of finding in the Egypt Pyramids of Giza before 4000, Aloe was mainly as cathartic, hypnotic and bitters at that time.Pharmacopoeia of the People's Republic of China version record in 2010 Aloe bitter in the mouth, cold, return liver, stomach, large intestine channel, be used for constipation with heat retention, infantile convulsion is twitched, infantile malnutrition; External treatment tinea skin ulcer.
So far, the chemical analysis in the Aloe is known to have kind more than 160 approximately, and wherein active ingredient reaches more than 72 kinds, and along with the extensive application of modern analytical technique, the new chemical analysis of Aloe is also among constantly finding.Main component has vitamin, aminoacid, amino sugar, saccharide, metal ion, nonmetallic ion, steroid, anthraquinone analog compound, enzyme (polypeptide), organic acid etc.; Modern pharmacological research shows; Its mainly contain rush down down, trauma care, improve cardiovascular, raise immunity, antibacterial, immunity and regeneration, antitumor, detoxifcation, defying age, analgesia, calmness, healing inflammation, antioxidation, protect the liver, resisting fatigue etc.; Each section such as that medical scope relates to is inside and outside, woman, youngster, skin, face, aloetic peculiar effect has caused scientific circles, particularly the extensive attention of medical circle; Especially with the U.S. western developed country of representative; Dropped into great amount of manpower and material resources, financial resources research and development application Aloe, the development utilization is remarkable, and economic benefit is huge; Its achievement in research not only is used for medical treatment, beauty treatment, health care of food, but also is applied in the fields such as dyestuff, metallurgy, weaving, pesticide, herding.
The product that is development of raw materials with bright article Herba Leonuri of single and the bright article Aloe of single has a lot, like aquatic foods article Herba Leonuri capsule, aloe capsule etc.The report that two delicious article is not share.
Summary of the invention
The objective of the invention is to: a kind of bright article Herba Leonuri and aloetic pharmaceutical formulation of bright article and preparation method thereof are provided.The present invention is that feed purification forms with aquatic foods article Herba Leonuri with bright article reed, has the effect of promoting blood circulation to restore menstrual flow, eliminating toxin and beautifying the skin.Dysmenorrhea, amenorrhea, metrorrhagia, dizziness due to deficiency of blood, cardiopalmus, dryness of the intestine constipation there is the improvement effect.
Technical scheme of the present invention: a kind of bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article is characterized in that: according to listed as parts by weight, it is that crude drug is processed for 3～270 parts with bright article Aloe for 12～40 parts with aquatic foods article Herba Leonuri.
Aforementioned bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article, preferred version is: according to listed as parts by weight, it is with 12 parts of aquatic foods article Herba Leonuris, 4 parts of aquatic foods article Aloes are processed for crude drug.
Aforementioned bright article Herba Leonuri is tablet or capsule with the aloetic pharmaceutical formulation of bright article.
The method for preparing of aforementioned bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article is: claim bright article Herba Leonuri and bright article Aloe in proportion, and cutting, extracting juice is squeezed the juice in making beating; The skin slag adds the suitable quantity of water mixing squeezes the juice, and 2～3 times repeatedly, the skin slag is subsequent use after centrifugal, merges juice, and vacuum decompression concentrates; Drying, pulverize medicated powder 1., the skin slag use earlier 75% ethanol ultrasonic extraction, filtration, filtering residue is subsequent use; The vacuum decompression of will filtrating reclaims ethanol, medicinal liquid A article, vacuum decompression is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, filters, and filtrating is B article, and vacuum decompression is concentrated, drying, pulverize medicated powder 3., with medicated powder 1., 2. mixing is processed preparation again as the preparation semi-finished product.
The capsule preparation method thereof of aforementioned bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article is to take by weighing bright article Herba Leonuri and bright article Aloe, cutting, making beating in proportion; Squeeze the juice, extracting juice, skin slag add the suitable quantity of water mixing and squeeze the juice; 2～3 times repeatedly, the centrifugal back of skin slag is subsequent use, merges juice; Filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, handles 30 minutes with the ultrasonic echography of frequency 40kHz, filters, and filtering residue is subsequent use, and the vacuum decompression of will filtrate reclaims ethanol, gets medicinal liquid, and vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended powder compaction is become hardness, the suitable thin slice of thickness, pulverize the back again and cross 20 mesh sieve granulate, incapsulate, get capsule; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate incapsulates, capsule.
The method for preparing tablet thereof of aforementioned bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article is to take by weighing bright article Herba Leonuri and bright article Aloe, cutting, making beating in proportion; Squeeze the juice, extracting juice, skin slag add the suitable quantity of water mixing and squeeze the juice; 2～3 times repeatedly, the skin slag is centrifugal, merges juice; Filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and filtering residue is subsequent use, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended powder compaction is become hardness, the suitable thin slice of thickness; Pulverize the back again and cross 20 mesh sieve granulate; Add tabletting behind microcrystalline Cellulose and the silicon dioxide, must contain mass fraction and be the tablet of the silicon dioxide of 3% microcrystalline Cellulose and 2%, or coating becomes Film coated tablets again; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate adds microcrystalline Cellulose and silicon dioxide tabletting, must contain mass fraction and be the tablet of the silicon dioxide of 3% microcrystalline Cellulose and 2%.
Side of the present invention separates: Herba Leonuri promoting blood flow to regulate menstruation, heat-clearing and toxic substances removing; Aloe relieving constipation by purgation, purging liver-fire, parasite killing are treated infantile malnutrition, two delicious article share, and the traditional Chinese medical science " accent ", " separating ", " leading to " three kinds of methods are organically combined together, have started the new way of tcm health preserving, toxin expelling.
Compare with prior art; The present invention is on bright article Herba Leonuri of single and the aloetic basis of the bright article of single; According to theory of Chinese medical science and modern pharmacological research achievement and pharmaceutical technology through testing, contrast, conclude, screen, sum up the novel composing prescription proportioning of acquisition repeatedly; Technology for extracting effective component, the method for preparing of various preparations.Inventor of the present invention in comprehensive study the parameters in the preparation process to the medicine Effect on Performance, again through experimental study many times, draw the best of breed of parameters, make preparation of the present invention reach optimal effectiveness.
Through clinical 180 examples, effective 178 examples, DeGrain 1 example, invalid 1 example, effective percentage 98.9%.Model case: the Wang, woman 19 years old, the student, pachylosis has a small amount of blackhead on the face, habitual constipation with dysmenorrhea, is taken these article after 1 day, transference cure after 7 days is taken in the alleviation of constipation doing well,improving, dysmenorrhea continuously, take 15 days continuously after, skin improves.
Chen, woman 35 years old, dysmenorrhea, amenorrhea were taken these article after 1 day, and transference cure after 2 days is taken in dysmenorrhea alleviation, takes continuously that skin improves after 7 days.
The applicant carries out a series of experiments, and can confirm that method for preparing provided by the invention is effectively controlled, and the quality of the pharmaceutical preparations is stable, meets " Chinese pharmacopoeia requirement.
One, Study on extraction:
Get bright article Herba Leonuri, bright article Aloe (for medicinal Aloe vulgaris), require fresh, do not have and rot, reject the scab position, with the surperficial dirt of clear water flush away, the cleaning of reuse pure water; Drain, get 6.0 kilograms of bright article Herba Leonuris, 2.0 kilograms of bright article Aloes, cutting; Making beating is squeezed the juice, and extracting juice, skin slag add the suitable quantity of water mixing and squeeze the juice; 2～3 times repeatedly, skin slag centrifugal (subsequent use) merges juice, filters (subsequent use).
Chinese herbal medicine extraction method of active ingredients at present commonly used adopts soak at room temperature, Suo Shi extractions, reflux etc. mostly, and is because these methods extraction times is all longer, too high as if temperature; Many compositions such as vitamin, aminoacid etc. can be unstable, therefore in practical application, have great limitation, and the ultrasonic extraction that the present invention uses can make by the chemical constituent structure of lixiviate and character and can not change; Specific actions such as the judder that ultrasonic wave energy produces, high acceleration, intensive cavitation effect, stirring; Destroy cell, solvent is penetrated in its cell, so that make Aloe and be dissolved in the solvent; Simultaneously; Release, diffusion and the dissolving of intracellular matter strengthened in the vibration effect that ultrasound wave produces, and this shattering process is a physical process, can keep bright article Herba Leonuri and the aloetic active ingredient of bright article as much as possible.
Therefore the skin slag is used ethanol ultrasonic extraction earlier, to concentration of ethanol and consumption, supersound extraction time, the supersound extraction frequency is investigated, and is testing index with barbaloin and stachydrine hydrochloride.
(1) ethanol ultrasonic extraction of skin slag
1, detection method:
1.1 the mensuration of barbaloin: after getting the ethanol liquid filtering with microporous membrane of supersound extraction, according to " under an Aloe assay of Chinese pharmacopoeia version in 2005 item, direct injected is measured;
1.2 the mensuration of stachydrine hydrochloride: get the ethanol liquid of supersound extraction, filter, precision is measured 50ml, and evaporate to dryness, residue add water 20ml makes dissolving; Extract 3 times with the ethyl acetate jolting, each 25ml discards acetic acid ethyl fluid, and water liquid evaporate to dryness, residue add ethanol 10mL makes dissolving; Be added on neutral alumina-activated-charcoal column (3: 1) post (ethanol wet method upper prop, aluminium oxide in the elder generation is gone up active carbon again for 100～200 orders, internal diameter 1.5cm); Use ethanol elution, collect eluent 100mL, evaporate to dryness, residue add the 0.05mol/L phosphoric acid solution makes dissolving, is transferred in the 10mL measuring bottle; Add the 0.05mol/L phosphoric acid solution to scale, shake up, filter, get subsequent filtrate, as need testing solution.It is an amount of that other gets the stachydrine hydrochloride reference substance, and accurate the title decides, and adds water and processes the solution that every 1mL contains 0.5mg; As reference substance solution; Accurate reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, is the general post of color of filler at the cationite with sulfonic acid group bonded silica gel (SCX); With 0.05mol/L potassium dihydrogen phosphate-triethylamine (100: 0.1) (regulating pH value to 2.3 with phosphoric acid) is mobile phase, flow velocity: 1.0mL/min; Column temperature: 30 ℃; Detect wavelength: 192nm, number of theoretical plate must not calculate with basin acid stachydrine peak and is less than 1500.
2, the selection of supersound extraction concentration of ethanol:
Precision takes by weighing skin slag 30g; Use 30 times of amounts of 60%, 65%, 70%, 75%, 80%, 95% ethanol respectively; Supersound extraction 30 minutes (ultrasonic power 300W, frequency 40kHz), its result (barbaloin of the following stated and stachydrine hydrochloride content are all measured according to the said determination method) sees the following form 1:
Table 1 supersound extraction different ethanol concentration is to the influence of barbaloin and stachydrine hydrochloride
| Concentration of alcohol | 60％ | 65％ | 75％ | 80％ | 95％ |
| Barbaloin (ug/ml) | 7.18 | 7.35 | 7.48 | 7.51 | 7.53 |
| Stachydrine hydrochloride (ug/ml) | 12.30 | 12.52 | 12.85 | 12.88 | 12.97 |
Result from table 1 can find out, 75% and the ethanol extraction result of above concentration similar, from the consideration that saves production cost, the ethanol extraction with 75% is good.
3, the selection of supersound extraction amount of ethanol:
Precision takes by weighing skin slag 30g, with 10 times of amounts of ethanol of 75% concentration, 12 times of amounts, 15 times of amounts, 20 times of amounts, 30 times of amounts, and supersound extraction 30 minutes (ultrasonic power 300W, frequency 40kHz), its result sees the following form 2:
The different amount of ethanol of table 2 supersound extraction are to the influence of barbaloin and stachydrine hydrochloride
| Amount of ethanol | 10 times of amounts | 12 times of amounts | 15 times of amounts | 20 times of amounts | 30 times of amounts |
| Barbaloin (ug/ml) | 7.06 | 7.13 | 7.45 | 7.47 | 7.48 |
| Stachydrine hydrochloride (ug/ml) | 12.27 | 12.51 | 12.80 | 12.82 | 12.85 |
Result from table 2 can find out that with 75% ethanol extraction, it is similar that 15 times of amounts and above consumption extract the result, and from the consideration that saves production cost, 15 times of amounts of the ethanol with 75% are extracted as good.
4, the selection of supersound extraction time:
Precision takes by weighing skin slag 30g, adds 75% ethanol of 15 times of amounts, supersound extraction 15 minutes, 25 minutes, 30 minutes, 40 minutes, 60 minutes (ultrasonic power 300W, frequency 40kHz) respectively, and its result sees the following form 3:
Table 3 supersound extraction different time is to the influence of barbaloin and stachydrine hydrochloride
| Amount of ethanol | 15 minutes | 25 minutes | 30 minutes | 40 minutes | 60 minutes |
| Barbaloin (ug/ml) | 7.38 | 7.42 | 7.48 | 7.49 | 7.51 |
| Stachydrine hydrochloride (ug/ml) | 12.53 | 12.77 | 12.85 | 12.87 | 12.92 |
Result from table 3 can find out, with 75% ethanol, measures supersound extraction 30 minutes for 15 times, and barbaloin and Determination of Contents of Hydrochloric Stachydrine are increasing hardly, considers from energy savings, and 15 times of amounts of the ethanol with 75% supersound extraction 30 minutes was good.
5, the selection of supersound extraction frequency:
Precision takes by weighing skin slag 30g, adds 75% ethanol of 15 times of amounts, respectively at supersonic frequency 40kHz, 50kHz, 60kHz, and supersound process 30 minutes, its result sees the following form 4:
The different supersound extraction frequencies of table 4 supersound extraction are to the influence of barbaloin and stachydrine hydrochloride
| Amount of ethanol | 40kHz | 50kHz | 60kHz |
| Barbaloin (ug/ml) | 7.48 | 7.51 | 7.50 |
| Stachydrine hydrochloride (ug/ml) | 12.85 | 12.88 | 12.94 |
Result from table 4 can find out; With 75% ethanol, 15 times of amounts were handled 30 minutes under supersonic frequency 40kHz, and barbaloin and Determination of Contents of Hydrochloric Stachydrine are increasing hardly; Consider that from energy savings it is good that 15 times of amounts of the ethanol with 75% are extracted 30 minutes under supersonic frequency 40kHz.
(2) extraction of the skin dregs water-soluble composition after the supersound extraction:
Skin slag reuse decocting after the supersound extraction boils, the water consumption and the decoction number of times that decoct investigated, and with the paste-forming rate index; Take by weighing skin slag 100g; Behind the extracting in water, filter, filtrating is concentrated into 100mL; Measure 20mL and put and carry out moisture determination in the moisture determination instrument, calculate the dried cream rate of extract according to the moisture content value.
1, decoct the selection of water consumption:
Take by weighing the skin slag 100g after the supersound extraction, experimentize by following parallel laboratory test table 5, behind the skin slag extracting in water, filter, filtrating is concentrated into 100mL, measures 20mL and puts and carry out moisture determination in the moisture determination instrument, calculates the dried cream rate of extract according to the moisture content value.
Table 5 extraction process by water parallel laboratory test table and result
Result from table 5 can find out that the consumption that the skin pulp water is carried solvent in the technology has certain influence to dried cream rate, but after the solvent consumption is brought up to a certain degree this; Increase the solvent consumption again the result is not had obvious influence; Consider the big practical situation of producing, select No. 4 experimental programs as the ultrasonic extraction process by water of skin slag afterwards, promptly the skin slag reuse water extraction after the supersound extraction is 2 times; Measured 2.0 hours for 8 times respectively, measured 1.0 hours for 6 times.Extracting liquid filtering, merging filtrate, vacuum decompression below 50 ℃ concentrates, is dried to medicated powder.
Two, drying process research:
For making thermal sensitivity ingredient stability in bright article Herba Leonuri and the bright article Aloe; Selected 75% ethanol ultrasonic extraction thing baking temperature to its juice and skin slag is unsuitable too high; Through consulting documents and materials; Can lyophilization, any/multiple mixing in the vacuum decompression drying, spray drying, microwave drying uses, and considers in conjunction with the existing big production equipment of company, selects for use the vacuum decompression drying to experimentize.
Three, extraction process confirmatory experiment:
Precision takes by weighing skin slag 100g, adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and (the skin slag is subsequent use) vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression concentrates, dry; The skin slag is decocte with water twice again, measures 2.0 hours for 8 times respectively, measured 1.0 hours for 6 times, and extracting liquid filtering, merging filtrate, vacuum decompression below 50 ℃ concentrates, is dried to medicated powder; Do 3 experiments with above-mentioned method, be used for investigating its stability.Detection method under sampling is shone 1.1,1.2 is measured.The result sees table 6.
Table 6: skin slag extraction process study on the stability and result thereof
Can know that by last table this extraction process is stablized feasible.
Four, Study on Forming
(1) bright article Herba Leonuri aloe capsule Study on Forming
Get bright article Herba Leonuri, bright article Aloe (for medicinal Aloe vulgaris), require fresh, do not have and rot, reject the scab position, with the surperficial dirt of clear water flush away, the cleaning of reuse pure water drains; Get 12.0 kilograms of bright article Herba Leonuris, 4.0 kilograms of bright article Aloes, cutting, making beating is squeezed the juice; Extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, and 2～3 times repeatedly, the skin slag is centrifugal; Merge juice, filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 2.; The skin slag is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended floury texture is loose, and density is less, and is mobile poor, and it is directly not encapsulated not suit, so be made as behind the granule it encapsulated.
1, method of granulating
Dry granulation: blended powder compaction is become hardness, the suitable thin slice of thickness, pulverize the back again and cross 20 mesh sieve granulate, promptly get.
2, wet granulation.
2.1 granulate with the screening of binding agent:
With blended powder, respectively water, 50% ethanol, 70% ethanol, 75% ethanol, 80% ethanol, 95% ethanol, 95% ethanol, 8% starch slurry are granulated, and drying under reduced pressure is investigated particulate flowability and bulk density.
2.2 method:
(1) mobility of particle investigates that to get granule an amount of, makes it flow down and be cone shape through a funnel, surveys its angle of repose;
(2) it is an amount of to take by weighing granule, places the 250ml graduated cylinder respectively, falls for several times with certain altitude, makes degree of tightness suitable, reads the shared volume of granule, calculates bulk density.And see table 7 with the dry granulation comparative result:
Table 7 uses different binding agents to granulate and the mobility of particle and the bulk density of dry granulation are investigated the result
All below 42 °, have good flowability particulate angle of repose, considers that with mobile granule with dry granulation and 75% ethanol wet granulation is good from production cost.Confirm that according to experimental result bright article Herba Leonuri aloe capsule technology is:
Get bright article Herba Leonuri, bright article Aloe (for medicinal Aloe vulgaris), require fresh, do not have and rot, reject the scab position, with the surperficial dirt of clear water flush away, the cleaning of reuse pure water drains subsequent use.Take by weighing the bright article Herba Leonuri of optimal proportion amount, bright article Aloe, cutting, making beating is squeezed the juice, extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, 2～3 times repeatedly, the skin slag is centrifugal, merges juice, filtration, vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 2.; The skin slag is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended powder compaction is become hardness, the suitable thin slice of thickness, pulverize the back again and cross 20 mesh sieve granulate, incapsulate, promptly get; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate incapsulates, and promptly gets.
(2) bright article Herba Leonuri Chinese aloe tablet Study on Forming
Get the granule of above-mentioned bright article Herba Leonuri aloe capsule, direct compression is though particulate flowability is better; The slice, thin piece hardness that extrudes is also enough, but outward appearance is not bright and clean, considers to add adjuvant and solves; Add with 3% microcrystalline Cellulose, silicon dioxide, calcium hydrogen phosphate, pregelatinized Starch respectively through preliminary experiment; The result is better with the outward appearance of microcrystalline Cellulose, silicon dioxide, and outward appearance and disintegration serving as to investigate index, disintegration is by " VIIA of Chinese pharmacopoeia version in 2005 checks that the tablet inspection requirements carries out disintegration; Its consumption is investigated, and the result sees the following form 8:
Table 8 adjuvant adds the different amounts result:
Result from above-mentioned table 8 can find out that to add the microcrystalline Cellulose of grain amount 3%, it is good that 2% silicon dioxide comes tabletting.Bright article Herba Leonuri Chinese aloe tablet moulding process is confirmed as:
Get bright article Herba Leonuri, bright article Aloe (for medicinal Aloe vulgaris), require fresh, do not have and rot, reject the scab position, with the surperficial dirt of clear water flush away, the cleaning of reuse pure water drains subsequent use.Take by weighing the bright article Herba Leonuri of optimal proportion amount, bright article Aloe, cutting, making beating is squeezed the juice, extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, 2～3 times repeatedly, the skin slag is centrifugal, merges juice, filtration, vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 2.; The skin slag is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended powder compaction is become hardness, the suitable thin slice of thickness, pulverize the back again and cross 20 mesh sieve granulate, add the microcrystalline Cellulose of grain amount 3%, 2% silicon dioxide tabletting promptly get, or coating becomes Film coated tablets; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate adds the microcrystalline Cellulose of grain amount 3%, 2% silicon dioxide tabletting promptly get, or coating becomes Film coated tablets.
The moulding process confirmatory experiment.
According to preferred method for distilling and moulding process:
Get bright article Herba Leonuri 125kg, bright article Aloe 65kg (for medicinal Aloe vulgaris), require fresh, do not have and rot, reject the scab position, with the surperficial dirt of clear water flush away, the cleaning of reuse pure water drains subsequent use.Take by weighing bright article Herba Leonuri 120kg, bright article Aloe 40kg, cutting, making beating is squeezed the juice, extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, 2～3 times repeatedly, the skin slag is centrifugal, merges juice, filtration, vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 2.; The skin slag is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.
1, the powder compaction that will mix 1/4 amount becomes the suitable thin slice of hardness, thickness, pulverizes the back again and crosses 20 mesh sieve granulate, incapsulates, and processes 2500, and the 0.38g/ grain promptly gets.Dose: each 2～3,2～3 times on the 1st.
2, maybe will mix 1/4 the amount powder with 75% ethanol wet granulation, drying under reduced pressure, granulate incapsulates, and processes 2500, the 0.38g/ grain promptly gets.Dose: each 2～3,2～3 times on the 1st.
3, the powder compaction that will mix 1/4 amount becomes the suitable thin slice of hardness, thickness, pulverizes the back again and crosses 20 mesh sieve granulate, adds the microcrystalline Cellulose of grain amount 3%, and 2% silicon dioxide tabletting is processed 2500, and the 0.40g/ sheet promptly gets, or coating becomes Film coated tablets.Dose: each 2～3,2～3 times on the 1st.
4, with the mixed-powder of remainder with 75% ethanol wet granulation, drying under reduced pressure, granulate adds the microcrystalline Cellulose of grain amount 3%, 2% silicon dioxide tabletting is processed 2500, the 0.40g/ sheet promptly gets, or coating becomes Film coated tablets.Dose: each 2～3,2～3 times on the 1st.
Repeat above-mentioned three experiments, the sample of preparing all meets " corresponding prescription under Chinese pharmacopoeia granule of version in 2005 and the tablet item.
Prescription among the present invention and method add suitable adjuvant and correctives and also can be made into granule and liquid preparation.
The specific embodiment
A kind of bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article is characterized in that: according to listed as parts by weight, it is that crude drug is processed for 3～270 parts with bright article Aloe for 12～40 parts with aquatic foods article Herba Leonuri.
Preferred version is with 12 parts of aquatic foods article Herba Leonuris, and 4 parts of bright article Aloes are processed for crude drug.
Described pharmaceutical formulation is tablet or capsule.
Concrete method for preparing is, claims bright article Herba Leonuri and bright article Aloe in proportion, and cutting, pulls an oar, and squeezes the juice; Extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, and 2～3 times repeatedly, the skin slag is subsequent use after centrifugal, merges juice; Vacuum decompression concentrates, drying, pulverize medicated powder 1., the skin slag use earlier 75% ethanol ultrasonic extraction, filtration; Filtering residue is subsequent use, and the vacuum decompression of will filtrating reclaims ethanol, medicinal liquid A article, vacuum decompression is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, filters, and filtrating is B article, and vacuum decompression is concentrated, drying, pulverize medicated powder 3., with medicated powder 1., 2. mixing is processed preparation again as the preparation semi-finished product.
Wherein the method for preparing of capsule is: take by weighing bright article Herba Leonuri and bright article Aloe in proportion, and cutting, making beating is squeezed the juice; Extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, and 2～3 times repeatedly, the centrifugal back of skin slag is subsequent use; Merge juice, filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, handles 30 minutes with the ultrasonic echography of frequency 40kHz, filters, and filtering residue is subsequent use, and the vacuum decompression of will filtrate reclaims ethanol, gets medicinal liquid, and vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended powder compaction is become hardness, the suitable thin slice of thickness, pulverize the back again and cross 20 mesh sieve granulate, incapsulate, get capsule; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate incapsulates, capsule.
Wherein the method for preparing of tablet is: take by weighing bright article Herba Leonuri and bright article Aloe in proportion, and cutting, making beating is squeezed the juice; Extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, and 2～3 times repeatedly, the skin slag is centrifugal; Merge juice, filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, and supersound process 30 minutes (supersonic frequency 40kHz) filters, and filtering residue is subsequent use, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 1., 2. mix homogeneously is subsequent use.Blended powder compaction is become hardness, the suitable thin slice of thickness; Pulverize the back again and cross 20 mesh sieve granulate; Add tabletting behind microcrystalline Cellulose and the silicon dioxide, must contain mass fraction and be the tablet of the silicon dioxide of 3% microcrystalline Cellulose and 2%, or coating becomes Film coated tablets again; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate adds microcrystalline Cellulose and silicon dioxide tabletting, must contain mass fraction and be the tablet of the silicon dioxide of 3% microcrystalline Cellulose and 2%.
The present invention be the inventor according to theory of Chinese medical science and experience, bright article Herba Leonuri and bright article Aloe two prescriptions of distinguishing the flavor of organically combine the traditional Chinese medical science " accent ", " separating ", " leading to " three kinds of methods together, have started the new way of tcm health preserving, toxin expelling.Effect with promoting blood circulation to restore menstrual flow, eliminating toxin and beautifying the skin.Dysmenorrhea, amenorrhea, metrorrhagia, dizziness due to deficiency of blood, cardiopalmus, dryness of the intestine constipation there is the improvement effect.Clinical 180 examples, effective 178 examples, DeGrain 1 example, invalid 1 example, effective percentage 98.9%.
Claims (6)
1. bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article, it is characterized in that: according to listed as parts by weight, it is that crude drug is processed for 3～270 parts with 12～40 parts of aquatic foods article Herba Leonuris and aquatic foods article Aloe.
2. according to said bright article Herba Leonuri of claim 1 and the aloetic pharmaceutical formulation of bright article, it is characterized in that: according to listed as parts by weight, it is with 12 parts of aquatic foods article Herba Leonuris, and 4 parts of aquatic foods article Aloes are processed for crude drug.
3. according to claim 1 or 2 said bright article Herba Leonuris and the aloetic pharmaceutical formulation of bright article, it is characterized in that: described pharmaceutical formulation is tablet or capsule.
4. like the method for preparing of each said bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article in the claim 1～3, it is characterized in that: claim bright article Herba Leonuri and bright article Aloe in proportion, and cutting, making beating; Squeeze the juice, extracting juice, skin slag add the suitable quantity of water mixing squeezes the juice, 2～3 times repeatedly; The skin slag is subsequent use after centrifugal, merges juice, and vacuum decompression concentrates, drying; Pulverize medicated powder 1., the skin slag use earlier 75% ethanol ultrasonic extraction, filtration, filtering residue is subsequent use; The vacuum decompression of will filtrating reclaims ethanol, medicinal liquid A article, vacuum decompression is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, filters, and filtrating is B article, and vacuum decompression is concentrated, drying, pulverize medicated powder 3., with medicated powder 3. 1., 2. mixing is processed preparation again as the preparation semi-finished product with medicated powder.
5. the method for preparing of bright article Herba Leonuri and the aloetic pharmaceutical formulation of bright article described in claim 4 is characterized in that: take by weighing bright article Herba Leonuri and bright article Aloe, cutting, making beating in proportion; Squeeze the juice, extracting juice, skin slag add the suitable quantity of water mixing and squeeze the juice; 2～3 times repeatedly, the centrifugal back of skin slag is subsequent use, merges juice; Filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, handles 30 minutes with the ultrasonic echography of frequency 40kHz, filters, and filtering residue is subsequent use, and the vacuum decompression of will filtrate reclaims ethanol, gets medicinal liquid, and vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 3. with medicated powder 1., 2. mix homogeneously is subsequent use; Blended powder compaction is become hardness, the suitable thin slice of thickness, pulverize the back again and cross 20 mesh sieve granulate, incapsulate, get capsule; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate incapsulates, capsule.
6. according to the method for preparing of said bright article Herba Leonuri of claim 4 and the aloetic pharmaceutical formulation of bright article, it is characterized in that: take by weighing bright article Herba Leonuri and bright article Aloe, cutting, making beating in proportion; Squeeze the juice, extracting juice, skin slag add the suitable quantity of water mixing and squeeze the juice; 2～3 times repeatedly, the skin slag is centrifugal, merges juice; Filter, vacuum decompression below 50 ℃ concentrates, dry, pulverize medicated powder 1.; The skin slag adds 75% ethanol of 15 times of amounts, handles 30 minutes with the ultrasonic echography of frequency 40kHz, filters, and filtering residue is subsequent use, and vacuum decompression reclaims ethanol, medicinal liquid, vacuum decompression below 50 ℃ is concentrated, dry, pulverize medicated powder 2.; Filtering residue is decocte with water twice again, and respectively 8 times of amounts are 2.0 hours, 6 times of amounts 1.0 hours, extracting liquid filtering, merging filtrate, vacuum decompression concentrate, dry, pulverize medicated powder 3., with medicated powder 3. with medicated powder 1., 2. mix homogeneously is subsequent use; Blended powder compaction is become hardness, the suitable thin slice of thickness; Pulverize the back again and cross 20 mesh sieve granulate; Add tabletting behind microcrystalline Cellulose and the silicon dioxide, must contain mass fraction and be the tablet of the silicon dioxide of 3% microcrystalline Cellulose and 2%, or coating becomes Film coated tablets again; Or with blended powder with 75% ethanol wet granulation, drying under reduced pressure, granulate adds microcrystalline Cellulose and silicon dioxide tabletting, must contain mass fraction and be the tablet of the silicon dioxide of 3% microcrystalline Cellulose and 2%.
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| CN104688961A (en) * | 2015-03-21 | 2015-06-10 | 石哲文 | Capsule for treating dysmenorrheal and preparation method thereof |
| CN105232607A (en) * | 2015-11-14 | 2016-01-13 | 芜湖天成普阳中药科技有限公司 | Cactus freshly-squeezed spray dried granule decoction piece and preparation process thereof |
| CN105193883A (en) * | 2015-11-14 | 2015-12-30 | 芜湖天成普阳中药科技有限公司 | Freshly squeezed spray drying parslane herb granular decoction pieces and preparation process thereof |
| CN105213445A (en) * | 2015-11-14 | 2016-01-06 | 芜湖天成普阳中药科技有限公司 | A kind of Herba Portulacae fresh squeezing vacuum drying powder decoction pieces and preparation technology thereof |
| CN105213444A (en) * | 2015-11-14 | 2016-01-06 | 芜湖天成普阳中药科技有限公司 | A kind of Herba Portulacae fresh squeezing spray-dried powders decoction pieces and preparation technology thereof |
| CN105213450A (en) * | 2015-11-14 | 2016-01-06 | 芜湖天成普阳中药科技有限公司 | A kind of Herba Taraxaci fresh squeezing spray-dried powders decoction pieces and preparation technology thereof |
| CN105362309A (en) * | 2015-11-14 | 2016-03-02 | 芜湖天成普阳中药科技有限公司 | Herba Portulacae freshly-squeezed freeze-dried powder decoction pieces and preparation process thereof |
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| CN1448127A (en) * | 2002-04-03 | 2003-10-15 | 王杰 | Aloe beauty salt and its preparing process |
| CN1284592C (en) * | 2004-02-25 | 2006-11-15 | 香港理工大学 | Chinese materia medica preparation for nourishing face and preparation method |
| CN101843813A (en) * | 2009-03-23 | 2010-09-29 | 周蕙英 | Chinese herbal medicine quick-acting nursing liquid with functions of dispelling scars and fading pigments |
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Application publication date: 20110713 Assignee: Guizhou Bailing Group Zhengxin Pharmaceutical Co., Ltd. Assignor: Guizhou Bailing Group Pharmacy Co., Ltd. Contract record no.: 2013330000023 Denomination of invention: Pharmaceutical preparation prepared from fresh motherwort and fresh aloe and preparation method thereof Granted publication date: 20120509 License type: Exclusive License Record date: 20130304 |
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