CN105168960A - Preparation method and application of non-decocting preparation of fresh Dendrobium officinale - Google Patents
Preparation method and application of non-decocting preparation of fresh Dendrobium officinale Download PDFInfo
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Abstract
The invention provides a preparation method and an application of a non-decocting preparation of a fresh Dendrobium officinale and belongs to the technical field of traditional Chinese medicine preparation. According to the preparation method of the non-decocting preparation of the fresh Dendrobium officinale, firstly, a special high-speed breaking and centrifuging device is adopted to break the Dendrobium officinale material at a high speed, a flow-state crude medicine is obtained and subjected to ultrasonic-wave processing, dissolution of effective ingredients is further enhanced, then the processed crude medicine is filtered, a filtrate is concentrated, dried and ground, and a finished product is obtained. The preparation method is simple to control, green and environment-friendly, the processing steps have synergistic interaction, so that the preparation method has higher universality, the extraction efficiency is high, active ingredients are protected effectively, and the availability of the finished product of the Dendrobium officinale material is improved better.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to preparation method and application thereof that fresh Herba Dendrobii exempts from fried dose.
Background technology
Chinese medicine is Chinese nation's crystallization of wisdom, for ensureing that people ' s health has made tremendous contribution.The traditional dosage form of Chinese medicine has pill, powder, unguentum, medicated wine etc., but the deficiencies such as conventional dosage forms majority exists, and taking dose is large, dosage form thick, appearance poor, along with the raising of social development and people's economic level, these deficiencies have seriously constrained the paces of Chinese medicine development, introduce high-tech, utilizing new technique to improve the quality of Chinese medicine, is one of important channel of innovation of Chinese medicinal dosage form.
Herba Dendrobii: be orchid Herba Dendrobii.March in November to next year gathers, removing impurity, and cut off part fibrous root, limit heating edge is twisted into spiral type or spring-like, dries, and practises and claims " Herba Dendrobii ".Compendium of Material Medica highlights Herba Dendrobii " reinforcing YIN-essence benefit essence, takes thick the intestines and stomach for a long time, make light of one's life by commiting suicide and prolong life " effect.Experimentation proves that Herba Dendrobii contains abundant water soluble polysaccharide.This polysaccharide has the effect that Promote immunity systemic lymphoid cell produces migration inhibitory factor; Promote the effect of splenocyte increment conversion.And phagocytic percentage and the phagocytic index of normal mouse and cyclophosphamide suppression Turnover of Mouse Peritoneal Macrophages can be significantly improved.Dendrobium polysaccharide not only can improve the immunologic function of body, but also has antineoplastic biological activity, by improving the immunologic function of body, reaches the object of Tumor suppression growth.In addition Herba Dendrobii also has good effect as the Chinese medicine preparation of attenuation synergistic after radiation and chemotherapy clinically.
At present, extraction to effective ingredient in Herba Dendrobii, Herba Dendrobii are comprised in disease treatment as compatibility medical material etc. to the Land use systems of Herba Dendrobii.Wherein, mainly concentrate on the extraction to water soluble polysaccharide to the extraction of Herba Dendrobii effective ingredient, the unification of extract component makes Chinese medicine lose original compound recipe characteristic, limits its application in prescription drug.Next, drinking mostly still based on decoction of formula Chinese medicine.Although in the place of conditions permit, the deposit such as Partial Hospitals, outpatient service has compound decoction finished product, only need heat namely drinkable, but, the curative effect of each secondary compound decoction finished product is fixed, can not dissolve according to the various state of an illness, motility is poor, stores compound decoction finished product simultaneously, existence takes up room, the problem such as waste energy, and compound decoction finished product is in deposit process, and drug effect also can be faded.Moreover Herba Dendrobii extract and other Chinese crude drug are prepared into compound preparation, and because formula is fixed, curative effect is determined, its range of application receives certain restriction.Therefore, finding efficacy stability, storing the preparation method of simple, that motility is strong dendrobium officinale preparation is the task of top priority.
Summary of the invention
Technical problem to be solved by this invention is, for the deficiencies in the prior art, provides a kind of efficacy stability, effectively extracts and protects the fresh Herba Dendrobii of effective ingredient to exempt from the preparation method of fried dose.
For solving the problems of the technologies described above, the technical solution adopted in the present invention is: fresh Herba Dendrobii exempts from the preparation method of fried dose, comprises the following steps:
1) the fresh Herba Dendrobii of gathering is removed root, peduncle peel off sheath, clean with clear water, drain, add in the broken centrifugal device of specialized high-speed and process, obtain fluidised form medical material;
2) collect the fluidised form medical material that step 1) obtains, add the water of its volume 3 ~ 5 times, at 20 ~ 25 DEG C, adopt ultrasonic Treatment;
3) by step 2) once filter through the fluidised form medical material of ultrasonic Treatment, obtain filtrate I and filtering residue I; In described filtering residue I, add the water of its volume 1 ~ 2 times, fully stir 20 ~ 30 minutes, carry out secondary filter, obtain filtrate II and filtering residue II;
4) in described filtering residue II, add the alcoholic solution that volume fraction is 30 ~ 50%, controlling filtering residue II with the w/v of ethanol is 1:5 ~ 7mg/mL, reflux, extract, 2 ~ 3 times, each 1.5 ~ 2 hours, merges backflow; After backflow is mixed with filtrate I, filtrate II, add in concentrator and concentrate, then dry, pulverize, obtain fresh Herba Dendrobii and exempt from fried dose.
Preferably, the broken centrifugal device of described specialized high-speed, comprise container containing, centrifuge container, broken cutting mechanism, controlling organization, motor and scraping mechanism, described motor is connected with controlling organization, described container containing is arranged on the outside of centrifuge container, described broken cutting mechanism is arranged in centrifuge container, and drive with motor and be connected, the blade that described broken cutting mechanism comprises rotating shaft and is connected with described rotating shaft, described blade is around described shaft circumference Heterogeneous Permutation, the inwall of described centrifuge container arranges the catch to described centrifuge container bottom angled, the wall of described centrifuge container arranges the filter opening communicated with described container containing, described filter opening flare structure, large mouth is towards the inside of described centrifuge container, the top of described centrifuge container arranges charging aperture, the bottom of described container containing arranges discharging opening, between described container containing and centrifuge container, scraping mechanism is set.
Preferably, step 2) described in the process conditions of ultrasonic Treatment be: supersonic frequency 25 ~ 40kHz, power 250 ~ 400W, time 8 ~ 15min, number of repetition is 2 ~ 3 times.
Preferably, employing vacuum filtration is once filtered described in step 3).
Preferably, concentrated described in step 4) is that filtrate is carried out vacuum-concentrcted, and when being concentrated into 60 ~ 80 DEG C, relative density is the mastic of 1.05 ~ 1.13.
Preferably, dry for described mastic is carried out vacuum lyophilization described in step 4).
Preferably, micronizing described in step 4) is, through super micron mill, dried mastic is ground into the fine powder that particle diameter is 10 ~ 75 μm.
Preferably, the present invention also comprises and exempts from fried dose to the fresh Herba Dendrobii of gained and carry out sterilizing, packaging.
Present invention also offers the fresh Herba Dendrobii of above-mentioned preparation method gained to exempt from fried dose and preparing the application in compound preparation, fresh Herba Dendrobii being exempted from fried dose directly adds in described compound preparation, make pharmaceutically acceptable dosage form, comprise liquid preparation, granule, tablet, capsule, injection, powder, unguentum, pill.
Preferably, present invention also offers the fresh Herba Dendrobii of above-mentioned preparation method gained and exempt from the fried dose of application in compound preparation, fresh Herba Dendrobii is exempted from fried dose and directly adds in described compound preparation, make Chinese medicine compound liquid preparation or granule.
Compared with prior art, its beneficial effect is in the present invention:
First the present invention adopts the broken centrifugal device of specialized high-speed to carry out high-speed breakage to Herba Dendrobii, by the cutting of broken cutting mechanism, effect of impact between material, between material and chamber wall, make the cell wall rupture of Chinese crude drug cell, intracellular effective ingredient flows out, and is then thrown away by fluidised form medical material by centrifugal, collides again with container containing, then converge, discharging; Then ultrasonic Treatment is carried out to the fluidised form medical material of discharging, strengthens further the stripping of effective ingredient, then filter, filtrate is concentrated, dry, then pulverize, sterilizing, packaging, gets product.Whole process control of the present invention is simple, environmental protection, each processing step Synergistic; make preparation method universality of the present invention stronger; extraction efficiency is higher, and active component obtains available protecting, improves the availability of Herba Dendrobii material finished product preferably.
Figure of description
Fig. 1: the structural representation of the broken centrifugal device of a kind of specialized high-speed of the present invention;
Fig. 2: the structural representation of blade in Fig. 1 of the present invention.
Detailed description of the invention
In order to understand the present invention better, set forth content of the present invention below in conjunction with embodiment is clear further, but protection content of the present invention is not only confined to the following examples.In the following description, a large amount of concrete details is given to provide more thorough understanding of the invention.But, it will be apparent to one skilled in the art that the present invention can be implemented without the need to these details one or more.In other example, in order to avoid obscuring with the present invention, technical characteristics more well known in the art are not described.
Herba Dendrobii has another name called Herba hedyotis costatae, is the orchid family Dendrobium herbaceos perennial, is China's tradition rare Chinese medicine; Sweet in the mouth, cold nature; Enter stomach, kidney channel, have effect of reinforcing stomach reg fluid, nourishing YIN and clearing away heat, for calentura Tianjin wound, xerostomia excessive thirst, deficiency of stomach-Yin, lack of appetite is retched, and deficiency-heat is not moved back after being ill, hyperactivity of fire caused by deficiency of YIN, hectic fever due to YIN-deficiency consumptive fever, poor vision, and muscles and bones flaccidity is soft.Modern study shows, Herba Dendrobii is mainly containing effective ingredient such as dendrobium polysaccharide, alkaloid, aminoacid, trace element and luxuriant and rich with fragrance compounds, there is defying age, antitumor, reduction blood glucose, improve the effects such as immunologic function, to diseases such as malignant tumor, gastroenteropathy, diabetes, cataract, arthritis, thromboangiitis obliterans and chronic pharyngitiss, there is good curative effect.
The invention provides the preparation method that fresh Herba Dendrobii exempts from fried dose, comprise the following steps:
1) the fresh Herba Dendrobii of gathering is removed root, peduncle peel off sheath, clean with clear water, drain, add in the broken centrifugal device of specialized high-speed and process, obtain fluidised form medical material;
2) collect the fluidised form medical material that step 1) obtains, add the water of its volume 3 ~ 5 times, at 20 ~ 25 DEG C, adopt ultrasonic Treatment;
3) by step 2) once filter through the fluidised form medical material of ultrasonic Treatment, obtain filtrate I and filtering residue I; In described filtering residue I, add the water of its volume 1 ~ 2 times, fully stir 20 ~ 30 minutes, carry out secondary filter, obtain filtrate II and filtering residue II;
4) in described filtering residue II, add the alcoholic solution that volume fraction is 30 ~ 50%, controlling filtering residue II with the w/v of ethanol is 1:5 ~ 7mg/mL, reflux, extract, 2 ~ 3 times, each 1.5 ~ 2 hours, merges backflow; After being mixed with filtrate I, filtrate II by backflow, add in concentrator and concentrate, then dry, pulverize, what obtain fresh Herba Dendrobii exempts from fried dose.
Of the present invention exempt from fried dose be preferably powder, also the powder obtained can be dissolved in any solvent of medically acceptable, be prepared into liquid preparation; Or be combined with medically acceptable adjuvant, be prepared into granule, pill or capsule.
In step 1), consult Fig. 1, the broken centrifugal device of specialized high-speed, comprise container containing 1, centrifuge container 2, broken cutting mechanism, controlling organization, motor 3 and scraping mechanism, motor 3 is connected with controlling organization, container containing 1 is arranged on the outside of centrifuge container 2, broken cutting mechanism is arranged in centrifuge container 2, and drive with motor 3 and be connected, the blade 5 that broken cutting mechanism comprises rotating shaft 4 and is connected with rotating shaft 4, blade 5 is 4 circumference Heterogeneous Permutations around the shaft, the inwall of centrifuge container 2 arranges the catch 6 to centrifuge container 2 bottom angled, the wall of centrifuge container 2 arranges the filter opening 7 communicated with container containing 1, filter opening 7 flare structure, large mouth is towards the inside of centrifuge container 2, the top of centrifuge container 2 arranges charging aperture 8, the bottom of container containing 1 arranges discharging opening 9, between container containing 1 and centrifuge container 2, scraping mechanism is set.
In the broken centrifugal device of above-mentioned specialized high-speed, motor 3 adopts high-speed electric expreess locomotive.Filter opening 7 is tubaeform, and large mouth (one end that namely diameter is large) is towards the inside of centrifuge container 2, and osculum (one end that namely diameter is little) is towards container containing 1, and the diameter of osculum is 0.1 ~ 1 millimeter.Wherein, the blade 5 that broken cutting mechanism comprises rotating shaft 4 and is connected with rotating shaft 4, described blade 5 is 4 circumference Heterogeneous Permutations around the shaft.Wherein, rotating shaft 4 exceeds the bottom of centrifuge container, and one end of blade 5 is located in rotating shaft 4, and blade 5 is around rotating shaft Heterogeneous Permutation between two.As shown in Figure 2, blade 5 is flat, and symmetrical, both sides are arc, and with sharp-pointed sawtooth 11 on arcuate structure.As shown in Figure 1, scraping mechanism comprises scraper plate 10-1,10-2, horizontal plate 10-3, telescopic scraping arm 10-4, bracing frame 10-5, motor 10-6 and switch, scraper plate comprises scraper plate I 10-1 coincide with the inwall of container containing 1 and scraper plate II 10-2 coincide with the outer wall of centrifuge container 2, described scraper plate I is connected by horizontal plate 10-3 with the upper end of scraper plate II, horizontal plate is connected with telescopic scraping arm 10-4, telescopic scraping arm is multiple, is all electrically connected successively with motor 10-6, switch by bracing frame 10-5.
During use, fresh Herba Dendrobii after draining is dropped in centrifuge container by the charging aperture 8 at centrifuge container 2 top, close charging aperture 8, open motor 3, rotating shaft high-speed rotation, blade cuts Herba Dendrobii repeatedly, broken cut after Herba Dendrobii particle diameter be centrifuged power when being less than or equal to the filter footpath of filter opening and throw away, enter in container containing, converge a certain amount of after, by discharging opening 9 flow out enter in collecting mechanism.Treat that Herba Dendrobii in centrifuge container 2 is broken and cut end, disable motor 3.Open motor 10-6, scraping plate mechanism is started working, the outer wall of inwall and centrifuge container 2 that scraper plate 10-1,10-2 against container containing 1 moves up and down, and is scraped by the fluidised form Herba Dendrobii on the outer wall of the inwall of container containing 1 and centrifuge container 2, is flowed out by discharging opening 9.
In step 2) in, the process conditions of described ultrasonic Treatment are: supersonic frequency 25 ~ 40kHz, power 250 ~ 400W, time 8 ~ 15min, and number of repetition is 2 ~ 3 times.Accelerate breaking of cell wall further by ultrasonic Treatment, strengthen the release of intracellular organic matter, diffusion and dissolving.
In step 3), described once filtration adopts vacuum filtration, is this area routine techniques.
Concentrated described in step 4) is that filtrate is carried out vacuum-concentrcted, and when being concentrated into 60 ~ 80 DEG C, relative density is the mastic of 1.05 ~ 1.13.This process can be carried out in vacuum-concentrcted equipment, and vacuum-concentrcted can reduce the boiling point of material, increases the temperature difference of steam and storeroom, and improve concentrated speed, thermal loss is few, concentrates at low ambient temperatures, can prevent the loss of heat-sensitive materials.
Dry for described mastic is carried out vacuum lyophilization described in step 4).Concrete, mastic is put into vacuum freeze drier, close hermatic door, open vacuum pump switch and freeze dryer switch, be evacuated to 5kPa ~ 12kPa, start refrigeration simultaneously, in 4 hours, the condenser temperature of vacuum freeze drier is down to-20 DEG C ~-40 DEG C, 1 ~ 3 hour retention time, by heating system, mastic is slowly heated, in 8 ~ 20 hours, mastic is warming up to 0 ~ 12 DEG C, makes mastic dry.
Described in step 4), micronizing is, through super micron mill, dried mastic is ground into the fine powder that particle diameter is 10 ~ 75 μm.Preferred pulverization conditions is: temperature-30 ~-10 DEG C, time 5 ~ 30min, through micronizing, material is under the effects such as impact, collision, shearing, grinding, dispersion, overcome solid interior cohesiveness and make material broken, the dissolution of effective ingredient increases further, and take assimilation effect better, availability is higher.
In addition, the present invention also comprises and exempts from fried dose to the fresh Herba Dendrobii of gained and carry out sterilizing, packaging.The present invention there is no particular determination to sterilizing, and can be sterilizing methods well known to those skilled in the art, the present invention preferably adopts low temperature sterilization.
Present invention also offers the fresh Herba Dendrobii of above-mentioned preparation method gained and exempt from the fried dose of application comprised in the compound preparation of Herba Dendrobii in preparation, fresh Herba Dendrobii being exempted from fried dose directly adds in described compound preparation, make any pharmaceutically acceptable dosage form, as liquid preparation, granule, tablet, capsule, injection, powder, unguentum or pill.
Below by specific embodiment, those skilled in the art can be implemented.
Embodiment 1
The preparation method of fresh Herba Dendrobii free decoction preparation, carry out according to the following steps:
1) the fresh Herba Dendrobii of gathering is removed root, peduncle peel off sheath, clean with clear water, drain, add in the broken centrifugal device of specialized high-speed and process, obtain fluidised form medical material; Wherein, the broken centrifugal device of specialized high-speed is recorded in this article in detail, repeats no more;
2) collect the fluidised form medical material that step 1) obtains, add the water of its volume 3 times, at 20 ~ 25 DEG C, adopt ultrasonic Treatment, supersonic frequency 25kHz, power 300W, time 8min, number of repetition is 3 times;
3) by step 2) carry out vacuum filtration through the fluidised form medical material of ultrasonic Treatment, obtain filtrate I and filtering residue I; In described filtering residue I, add the water of its volume 1 times, fully stir 25 minutes, carry out secondary filter, obtain filtrate II and filtering residue II;
4) in gained filtering residue II, add the alcoholic solution that volume fraction is 30%, controlling filtering residue II with the w/v of ethanol is 1:6mg/mL, reflux, extract, 2 times, each 2 hours, merges backflow; After backflow is mixed with filtrate I, filtrate II, add in concentrator and carry out vacuum-concentrcted, when being concentrated into 60 DEG C, relative density is the mastic of 1.05, then vacuum lyophilization is carried out to gained mastic, dried mastic is ground into the fine powder that particle diameter is 10 ~ 75 μm, and what obtain fresh Herba Dendrobii exempts from fried dose.
The fresh Herba Dendrobii of gained exempt from fried dose through sterilizing, packaging, get product.
Embodiment 2
The preparation method of fresh Herba Dendrobii free decoction preparation, carry out according to the following steps:
1) the fresh Herba Dendrobii of gathering is removed root, peduncle peel off sheath, clean with clear water, drain, add in the broken centrifugal device of specialized high-speed and process, obtain fluidised form medical material; Wherein, the broken centrifugal device of specialized high-speed is recorded in this article in detail, repeats no more;
2) collect the fluidised form medical material that step 1) obtains, add the water of its volume 4 times, at 20 ~ 25 DEG C, adopt ultrasonic Treatment, supersonic frequency 40kHz, power 2500W, time 15min, number of repetition is 2 times;
3) by step 2) carry out vacuum filtration through the fluidised form medical material of ultrasonic Treatment, obtain filtrate I and filtering residue I; In described filtering residue I, add the water of its volume 2 times, fully stir 20 minutes, carry out secondary filter, obtain filtrate II and filtering residue II;
4) in gained filtering residue II, add the alcoholic solution that volume fraction is 50%, controlling filtering residue II with the w/v of ethanol is 1:5mg/mL, reflux, extract, 3 times, each 1.8 hours, merges backflow; After backflow is mixed with filtrate I, filtrate II, add in concentrator and carry out vacuum-concentrcted, when being concentrated into 80 DEG C, relative density is the mastic of 1.13, then vacuum lyophilization is carried out to gained mastic, dried mastic is ground into the fine powder that particle diameter is 10 ~ 75 μm, and what obtain fresh Herba Dendrobii exempts from fried dose.
The fresh Herba Dendrobii of gained exempt from fried dose through sterilizing, packaging, get product.
Embodiment 3
The preparation method of fresh Herba Dendrobii free decoction preparation, carry out according to the following steps:
1) the fresh Herba Dendrobii of gathering is removed root, peduncle peel off sheath, clean with clear water, drain, add in the broken centrifugal device of specialized high-speed and process, obtain fluidised form medical material; Wherein, the broken centrifugal device of specialized high-speed is recorded in this article in detail, repeats no more;
2) collect the fluidised form medical material that step 1) obtains, add the water of its volume 5 times, at 20 ~ 25 DEG C, adopt ultrasonic Treatment, supersonic frequency 35kHz, power 400W, time 12min, number of repetition is 3 times;
3) by step 2) carry out vacuum filtration through the fluidised form medical material of ultrasonic Treatment, obtain filtrate I and filtering residue I; In described filtering residue I, add the water of its volume 1.5 times, fully stir 30 minutes, carry out secondary filter, obtain filtrate II and filtering residue II;
4) in gained filtering residue II, add the alcoholic solution that volume fraction is 40%, controlling filtering residue II with the w/v of ethanol is 1:7mg/mL, reflux, extract, 2 times, each 1.5 hours, merges backflow; After backflow is mixed with filtrate I, filtrate II, add in concentrator and carry out vacuum-concentrcted, when being concentrated into 70 DEG C, relative density is the mastic of 1.10, then vacuum lyophilization is carried out to gained mastic, dried mastic is ground into the fine powder that particle diameter is 10 ~ 75 μm, and what obtain fresh Herba Dendrobii exempts from fried dose.
The fresh Herba Dendrobii of gained exempt from fried dose through sterilizing, packaging, get product.
Below by experiment embodiment, beneficial effect of the present invention is described.
Drug efficacy study
For a kind of oral capsule for the treatment of gastric cancer
Existing Chinese medicine formula: Thallus Laminariae (Thallus Eckloniae) 8 grams, fine and soft 25 grams of dance, phellin uspini 20 grams, Herba Selaginellae Doederleinii 17 grams, Radix Asteris 15 grams, Herba Dendrobii 22 grams, hop 17 grams, 12 grams, Flos Sophorae, Semen Hyoscyami 12 grams.
Existing method: a) Thallus Laminariae (Thallus Eckloniae) of above-mentioned parts by weight is ground into 300 object fine powders, for subsequent use;
B) dance of described parts by weight young pilose antler, phellin uspini, Herba Selaginellae Doederleinii, Radix Asteris, Herba Dendrobii, hop, Flos Sophorae, Semen Hyoscyami are ground into 30 object powder, after mix homogeneously, by solid-liquid ratio 1:8, add 85% ethanol, reflux, extract, 3 times, each 2 hours, merges backflow; Be condensed into the extractum that relative density is 1.20 ~ 1.35 (38 DEG C);
C) by the extractum in step b) and the fine powder in step a), mix homogeneously, dry, pulverize, and incapsulates, and is designated as capsule I.
The inventive method: a) Thallus Laminariae (Thallus Eckloniae) of above-mentioned parts by weight is ground into 300 object fine powders, for subsequent use;
B) dance of above-mentioned parts by weight young pilose antler, phellin uspini, Herba Selaginellae Doederleinii, Radix Asteris, hop, Flos Sophorae, Semen Hyoscyami are ground into 30 object powder, after mix homogeneously, by solid-liquid ratio 1:8, add 85% ethanol, reflux, extract, 3 times, each 2 hours, merges backflow; Be condensed into the extractum that relative density is 1.20 ~ 1.35 (38 DEG C);
C) Herba Dendrobii of above-mentioned parts by weight is prepared into Herba Dendrobii according to the method for the embodiment of the present invention 1 and exempts from fried dose;
D) by the extractum in step b), the fine powder in step a) and step c) in Herba Dendrobii exempt from fried dose, mix homogeneously, dry, pulverize, incapsulate, be designated as capsule II.
Lanqin oral solutions:
Tracing observation clinical case 100 example, man 56 example, female 44 example; 42 ~ 75 years old age.All cases are all diagnosed as gastric cancer through pathology, stadium III b ~ IV phase.Previously do not accept chemotherapy, have at least 1 can measure focus.Estimate life cycle >=5 months.Two groups of physical data compare no difference of science of statistics, P>0.05, have comparability.
Therapeutic Method: above-mentioned case is divided into 2 groups at random, is respectively matched group and experimental group, often organizes 50 examples.Matched group, oral capsule I, every day three times, one time four.Experimental group, oral capsule II, every day three times, one time four.Continuous treatment 1 month is 1 course for the treatment of, treats 4 courses for the treatment of altogether, observes clinical efficacy.
Evaluation index: by performance and the calibration standard rating of acute and subacute toxicity after WHO solid tumor short term effect grade scale and treatment, be divided into CR: all entity focuses all disappear, i.e. complete incidence graph; PR: focus major diameter summation reduces the scope >=and 30%, i.e. partial rcsponse; SD: focus major diameter summation reduces but too late PR to some extent, or focus newly increases but too late PD, and namely focus is stablized; PD: focus major diameter summation increases scope >=20%, or occurs new focus, i.e. progression of disease.Calculate effective percentage (RR) with CR+PR, confirmation need be checked at interval after 4 weeks.
Clinical efficacy statistical result sees the following form shown in 1:
Table 1 liang group Clinical efficacy comparison
| Group | Number of cases | SD | PD | Effective percentage |
| Matched group | 50 | 16 | 6 | 28 |
| Experimental group | 50 | 14 | 5 | 31 |
Found out by table 1; experimental group is better than matched group, adopts method of the present invention not only not reduce drug effect, and better efficacy; this also illustrates that fresh Herba Dendrobii prepared according to the methods of the invention is exempted from fried dose of its drug effect and maintained better, and active component obtains protection preferably and extracts.
Above-mentioned clinical research can obviously be found out, the fresh Herba Dendrobii prepared by the present invention is exempted from fried dose and can be applied to and prepare compound preparation, namely can be prepared into the capsule comprising Herba Dendrobii, record in detail in this article; Same, according to record of the present invention, also can be prepared into the pill, tablet, injection, powder, unguentum, the granule that comprise Herba Dendrobii, not enumerate in this application, can prepare under the enlightenment of the application; And evident in efficacy, be obviously better than conventional directly decoction gained Chinese medicine preparation.
Claims (8)
1. fresh Herba Dendrobii exempts from the preparation method of fried dose, it is characterized in that, comprises the following steps:
1) the fresh Herba Dendrobii of gathering is removed root, peduncle peel off sheath, clean with clear water, drain, add in the broken centrifugal device of specialized high-speed and process, obtain fluidised form medical material;
2) collect the fluidised form medical material that step 1) obtains, add the water of its volume 3 ~ 5 times, at 20 ~ 25 DEG C, adopt ultrasonic Treatment;
3) by step 2) once filter through the fluidised form medical material of ultrasonic Treatment, obtain filtrate I and filtering residue I; In described filtering residue I, add the water of its volume 1 ~ 2 times, fully stir 20 ~ 30 minutes, carry out secondary filter, obtain filtrate II and filtering residue II;
4) in described filtering residue II, add the alcoholic solution that volume fraction is 30 ~ 50%, controlling filtering residue II with the w/v of ethanol is 1:5 ~ 7mg/mL, reflux, extract, 2 ~ 3 times, each 1.5 ~ 2 hours, merges backflow; After backflow is mixed with filtrate I, filtrate II, add in concentrator and concentrate, then dry, pulverize, obtain fresh Herba Dendrobii and exempt from fried dose.
2. fresh Herba Dendrobii as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: the broken centrifugal device of described specialized high-speed, comprise container containing, centrifuge container, broken cutting mechanism, controlling organization, motor and scraping mechanism, described motor is connected with controlling organization, described container containing is arranged on the outside of centrifuge container, described broken cutting mechanism is arranged in centrifuge container, and drive with motor and be connected, the blade that described broken cutting mechanism comprises rotating shaft and is connected with described rotating shaft, described blade is around described shaft circumference Heterogeneous Permutation, the inwall of described centrifuge container arranges the catch to described centrifuge container bottom angled, the wall of described centrifuge container arranges the filter opening communicated with described container containing, described filter opening flare structure, large mouth is towards the inside of described centrifuge container, the top of described centrifuge container arranges charging aperture, the bottom of described container containing arranges discharging opening, between described container containing and centrifuge container, scraping mechanism is set.
3. fresh Herba Dendrobii as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: step 2) described in the process conditions of ultrasonic Treatment be: supersonic frequency 25 ~ 40kHz, power 250 ~ 400W, time 8 ~ 15min, number of repetition is 2 ~ 3 times.
4. fresh Herba Dendrobii as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: once filter described in step 3) and adopt vacuum filtration.
5. fresh Herba Dendrobii as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: concentrated described in step 4) is that filtrate is carried out vacuum-concentrcted, and when being concentrated into 60 ~ 80 DEG C, relative density is the mastic of 1.05 ~ 1.13.
6. fresh Herba Dendrobii as claimed in claim 5 exempts from the preparation method of fried dose, it is characterized in that: dry for described mastic is carried out vacuum lyophilization described in step 4).
7. fresh Herba Dendrobii as claimed in claim 6 exempts from the preparation method of fried dose, it is characterized in that: micronizing described in step 4) is, through super micron mill, dried mastic is ground into the fine powder that particle diameter is 10 ~ 75 μm.
8. fresh Herba Dendrobii prepared by the preparation method as described in any one of claim 1 ~ 7 exempts from the application of fried dose, it is characterized in that: fresh Herba Dendrobii is exempted from fried dose and directly adds in compound preparation, make pharmaceutically acceptable dosage form, comprise liquid preparation, granule, tablet, capsule, injection, powder, unguentum, pill.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510635108.2A CN105168960A (en) | 2015-09-30 | 2015-09-30 | Preparation method and application of non-decocting preparation of fresh Dendrobium officinale |
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Application publication date: 20151223 |