CN105434511A - Hemsleya chinensis decoction piece and preparation method and use thereof - Google Patents

Hemsleya chinensis decoction piece and preparation method and use thereof Download PDF

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CN105434511A
CN105434511A CN201410411862.3A CN201410411862A CN105434511A CN 105434511 A CN105434511 A CN 105434511A CN 201410411862 A CN201410411862 A CN 201410411862A CN 105434511 A CN105434511 A CN 105434511A
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radix
hemsleyae macrospermae
radix hemsleyae
macrospermae
glycyrrhizae
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CN105434511B (en
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孙继林
胡昌江
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Chengdu auxiliary Biology Technology Co., Ltd.
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CHENGDU MAIDESHEN MEDICINE TECHNOLOGY Co Ltd
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Abstract

The present invention provides a hemsleya chinensis-containing drug or health product composition which is a preparation prepared from the following raw materials by weight: 100 parts of hemsleya chinensis and 5-35 parts of licorice. The present invention also provides a hemsleya chinensis decoction piece prepared from 100 parts of hemsleya chinensis and 5-35 parts of licorice as raw materials. The present invention also provides a preparation method and use of the hemsleya chinensis decoction piece. The hemsleya chinensis decoction piece is processed with licorice juice to ease bitter taste and eliminate mild toxicity, makes full use of the sweet mild-natured licorice, and has the effects of clearing away heat and toxic materials, relaxing spasm and relieving pain to achieve the processing purpose of taste modification and detoxification, bitter tastes of various ratios can be tasted by mouth, anti-inflammatory analgesic and acute toxicity experiments are used for investigation of influence of processing with the licorice juice on synergistic hemsleya chinensis detoxification, Curcurbitacin IIa is taken as an index for observation of the licorice juice content before and after the processing, experiments show that after the hemsleya chinensis is processed with the licorice juice, the drug property can be eased, toxicity can be reduced, the taste can be modified, and the bitter taste of the hemsleya chinensis can be reduced.

Description

A kind of Radix Hemsleyae Macrospermae decoction pieces and its production and use
Technical field
The present invention relates to Radix Hemsleyae Macrospermae decoction pieces.
Background technology
Radix Hemsleyae Macrospermae is the dried root of Cucurbitaceae Genus Hemsleya plant dolichocarpel hemsleya root, high eyebrow Radix Hemsleyae Macrospermae or huge colored Radix Hemsleyae Macrospermae.Nature and flavor are bitter, cold.Slightly poisonous.There is heat-clearing and toxic substances removing, effect of anti-inflammatory analgetic.Be usually used in stomachache, Peptic Ulcers, upper respiratory tract infection, bronchitis, pneumonia, bacillary dysentery, enteritis, urinary system infection, septicemia and other multi-infections.
At present for the effective ingredient of extract in Radix Hemsleyae Macrospermae or Radix Hemsleyae Macrospermae be prepared into preparation report more, as application number: 200810044933.5, denomination of invention: a kind of compound hemsleyadin preparation, the present invention relates to a kind of compound Chinese medicinal preparation, is specially a kind of compound hemsleyadin preparation.A kind of compound hemsleyadin preparation, be made up of hemsleyadin, glycyrrhizic acid, Radix Arnebiae (Radix Lithospermi) glycosides, its formula is hemsleyadin 2.5 milligrams, glycyrrhizic acid 1.25 milligrams, Radix Arnebiae (Radix Lithospermi) glycosides 1.25 milligrams.Preparation formulation is effervescent tablet or suppository.Invention formulation is the administration of external cavity, and effect affected part is direct, and composition stimulates little to body, the course for the treatment of section, curative effect is fast, life-time service pathogen-free domestic drug resistance situation occurs, has specially good effect to the disease such as gynecology colpitis, cervical erosion.Application number: 03159059.4, denomination of invention: a kind of medicine for the treatment of gastroenteropathy, the invention discloses a kind of medicine for the treatment of gastroenteropathy, it selects mainly to comprise the Chinese medicines such as Radix Hemsleyae Macrospermae, Rhizoma Paridis, Fructus Evodiae, the Radix Aucklandiae, Rhizoma Corydalis, Pseudobulbus Bletillae (Rhizoma Bletillae), Endoconcha Sepiae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Codonopsis, the Radix Astragali and Radix Glycyrrhizae to combine, make each efficacy of drugs produce synergism, thus effectively treat gastroenteropathy.It can be prepared to the conventional dosage form for oral administration of any one.The present invention has effect of the effect such as obvious Antiulcer activity, stronger spasmolytic and analgesia, significantly antiinflammatory and certain tonneau stool, the very good and safe without toxic side effect to curative effects such as digestive tract ulcer, gastritis and enteritis.
Summary of the invention
Technical scheme of the present invention there is provided Radix Hemsleyae Macrospermae decoction pieces, and another technical scheme of the present invention there is provided the Preparation Method And The Use of this Radix Hemsleyae Macrospermae decoction pieces.
The invention provides a kind of medicine or Halth-care composition, it is the preparation be prepared from by the raw material of following weight proportioning:
Radix Hemsleyae Macrospermae 100 parts, Radix Glycyrrhizae 5-35 part.
Further preferably, it is the preparation be prepared from by the raw material of following weight proportioning:
Radix Hemsleyae Macrospermae 100 parts, 25 parts, Radix Glycyrrhizae.
Wherein, described Radix Hemsleyae Macrospermae derives from the dried root of Cucurbitaceae Genus Hemsleya plant dolichocarpel hemsleya root HemsleyadolichocarpaW.J.Chang, high eyebrow Radix Hemsleyae Macrospermae HemsleyaomeiensisL.T.ShenetW.J.Chang or huge colored Radix Hemsleyae Macrospermae HemsleyagiganthaW.J.Chang.Pharmaceutical composition of the present invention is by the protogenic medicinal powder of Radix Hemsleyae Macrospermae, Radix Glycyrrhizae, or water or extractive with organic solvent are active component, adds pharmaceutically or preparation that on food, acceptable adjuvant or adjuvant composition are prepared from.
Wherein, described preparation is oral liquid, tablet, capsule, pill, granule, medicinal tea.
Present invention also offers a kind of Radix Hemsleyae Macrospermae decoction pieces, it concocts with raw material Radix Hemsleyae Macrospermae and Radix Glycyrrhizae to form, and wherein the weight proportion of Radix Hemsleyae Macrospermae, Radix Glycyrrhizae is:
Radix Hemsleyae Macrospermae 100 parts, Radix Glycyrrhizae 5-35 part.
Further preferably, the weight proportion of described Radix Hemsleyae Macrospermae Radix Glycyrrhizae is:
Radix Hemsleyae Macrospermae 100 parts, 25 parts, Radix Glycyrrhizae.
Present invention also offers a kind of method preparing described Radix Hemsleyae Macrospermae decoction pieces, it comprises the steps:
A, extracting liquorice, decoct with water and remove slag;
B, add Radix Hemsleyae Macrospermae, moistening 1.5-3h, treat that Sucus Glycyrrhizae exhausts, 35-60 DEG C of oven dry.
Present invention also offers this Radix Hemsleyae Macrospermae decoction pieces and prepare the purposes in anti-inflammatory drug.
Present invention also offers this Radix Hemsleyae Macrospermae decoction pieces and prepare the purposes in analgesic.
Radix Hemsleyae Macrospermae decoction pieces of the present invention is concocted by Sucus Glycyrrhizae, to alleviate bitterness, dispel mild toxicity, make full use of Radix Glycyrrhizae sweet in the mouth, property is put down, there is the effect of heat-clearing and toxic substances removing, relieving spasm to stop pain, reach the process of preparing Chinese medicine object of taste masking, removing toxic substances, taste different proportion solution bitterness with mouth simultaneously, investigate the impact of the Sucus Glycyrrhizae process of preparing Chinese medicine on Radix Hemsleyae Macrospermae removing toxic substances potentiation with anti-inflammatory and antalgic and acute toxicity testing, and with hemsleyadin first for the content before and after the process of preparing Chinese medicine of index observing Sucus Glycyrrhizae, experiment proves that Radix Hemsleyae Macrospermae can relax the property of medicine after Sucus Glycyrrhizae system, reduce toxicity, all right taste masking, alleviates the bitterness of Radix Hemsleyae Macrospermae simultaneously.
Accompanying drawing explanation
Fig. 1 hemsleyadin first reference substance collection of illustrative plates
Fig. 2 raw product HPLC collection of illustrative plates
Fig. 3 goods HPLC collection of illustrative plates
Detailed description of the invention
The preparation of embodiment 1 Radix Hemsleyae Macrospermae processed product of the present invention
Extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
The preparation of embodiment 2 Radix Hemsleyae Macrospermae capsule of the present invention
Extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry; Beat powder, cross No. six sieves, medicated powder loads 1# capsule shells, and every dress 0.3g, packaging, to obtain final product.
The preparation of embodiment 3 medicinal granule of the present invention
Extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
Get Radix Hemsleyae Macrospermae decoction pieces processed, add 25 times of water gagings, decoct 3 times, each 1 hour, merge medicinal liquid, filter, after 60 DEG C of concentrating under reduced pressure, constant pressure and dry, gained extract powder adds appropriate dextrin (ratio is 1:0.67), mixing, adds appropriate 75% ethanol adjustment humidity, makes the soft material of " hands is pinched agglomerating, flicking and namely fallen apart ", with fashion of extrusion by 14 mesh sieves, make uniform granule, dry, granulate, packaging, to obtain final product.
The preparation of embodiment 4 medicinal tablet of the present invention
Extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
Get Radix Hemsleyae Macrospermae decoction pieces processed, add 25 times of water gagings, decoct 3 times, each 1 hour, merge medicinal liquid, filter, after 60 DEG C of concentrating under reduced pressure, constant pressure and dry, gained extract powder adds appropriate lactose as filler, and 50% ethanol is wetting agent, tabletting, and sugar coating, to obtain final product.
The preparation of embodiment 5 Radix Hemsleyae Macrospermae teabag of the present invention
Get Radix Hemsleyae Macrospermae 100g, Radix Glycyrrhizae 25g, mixing, beats powder, sieves, and pack, is prepared into teabag.
Embodiment 6 Radix Hemsleyae Macrospermae processed product of the present invention prescription screening test
1. different proportion Radix Glycyrrhizae is to Radix Hemsleyae Macrospermae bitterness influence research
This experiment on the research of the impact of Radix Hemsleyae Macrospermae bitterness, determines the optimum amount of Sucus Glycyrrhizae by the consumption of Radix Glycyrrhizae.
Concocting method 1 extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 5kg.
Concocting method 2 extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 10kg.
Concocting method 3 extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 25kg.
Concocting method 4 extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and remove slag, and adds clean Radix Hemsleyae Macrospermae, and moistening 2h treats that Sucus Glycyrrhizae exhausts, 40 DEG C of oven dry.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 35kg.
Result: per os is tasted, concocting method 1 taste is extremely bitter, concocting method 2 bitter in the mouth, and concocting method 3 is lightly seasoned, and concocting method 4 taste is micro-sweet.Therefore, select Radix Glycyrrhizae (using the Radix Hemsleyae Macrospermae) extracting juice of 25% as the consumption concocting Radix Hemsleyae Macrospermae.(Radix Glycyrrhizae of 25% and the clean Radix Hemsleyae Macrospermae of every 100kg, use Radix Glycyrrhizae 25kg.Sucus Glycyrrhizae 25kg is prepared with Radix Glycyrrhizae 25kg.)
Table 1 Sucus Glycyrrhizae consumption is for the impact of Radix Hemsleyae Macrospermae taste
2 concoct front and back hemsleyadin first changes of contents
Radix Hemsleyae Macrospermae is mainly containing hemsleyadin first and a small amount of hemsleyadin second and saponin constituent, and modern pharmacological research shows, hemsleyadin has the multiple pharmacologically actives such as antitumor, antiviral, antibacterial, protection stomach.Existing germ experiment illustrates that hemsleyadin first can suppress the synthesis of the cell wall of staphylococcus aureus, and antibacterial action is obvious.Meanwhile, intravenous injection hemsleyadin first 40mg (lumbar injection) has slight antipyretic effect to the heating that rabbit injection TAB first polyvalent vaccine causes.Therefore, this experimental selection hemsleyadin first concocts the index components of front and back changes of contents as Radix Hemsleyae Macrospermae.
2.1 instruments and reagent
Japan ShimadzuLC-20AT high-efficient liquid phase system (DAD detector SPD-M20A230V), BP211D electronic analytical balance (sensibility reciprocal 0.00001g, Sartorius company of Germany), KQ-300E ultrasonic cleaner (Kunshan Ultrasonic Instruments Co., Ltd.); BP-61 electronic balance (sensibility reciprocal 0.0001g, German Sartorius company).
2.2 experiment and result
2.2.1 chromatographic condition
Chromatographic column: ThermoBDSHYPERSILC18 post (4.6mm × 250mm, 5 μm), mobile phase: acetonitrile-water (28:72), sample size: 10 μ L; Flow velocity: 1mL/min; Column temperature: 25 DEG C; Determined wavelength: 212nm.
2.2.2 reference substance solution preparation
It is appropriate that precision takes hemsleyadin first reference substance, and put in 10mL volumetric flask, dissolve with methanol is also settled to scale.
2.2.3 need testing solution preparation
The Radix Glycyrrhizae of accurately weighed 1g25% is concocted Radix Hemsleyae Macrospermae sample and puts in tool plug conical flask, and precision adds methanol 40mL, close plug, weighed weight, supersound process (power 250W, frequency 40kHz), lets cool, weighed weight again, supply the weight of less loss with methanol, shake up, with 0.45 μm of filtering with microporous membrane, filtrate is need testing solution, for subsequent use.
2.2.4 Precision Experiment
Precision Experiment, with same concentration standard substance continuous 6 times, record hemsleyadin first peak area.
Table 2 hemsleyadin first Precision Experiment result
Result: hemsleyadin first peak area RSD is 1.66%, illustrates that instrument precision is good.
2.2.5 stability experiment
Sample stability is tested, and measures at different time points sample introduction with the solution after sample extraction, and the peak area of record hemsleyadin first, to assess the stability of sample.
Table 3 stability experiment result
Result: hemsleyadin first peak area RSD is 1.10%, has good stability within interpret sample 12h after extraction.
2.2.6 repeated experiment
Get same sample parallel extraction 6 parts, inject Instrumental Analysis, record hemsleyadin first peak area.
Table 4 hemsleyadin first Precision Experiment result
Result: hemsleyadin first RSD is 2.09%, the reproduction of interpret sample extracting method is linearly good.
2.2.7 average recovery
Application of sample recovery test is the accuracy investigating sample determination result, reduce by half and weigh 6 parts, the sample of known content, add a certain amount of reference substance, participate in leaching process, extracting solution injection liquid chromatography record experimental data, calculates the ratio that the actual amount recorded deducts the amount that the amount in known sample adds with reference substance again.
Table 5 hemsleyadin first application of sample recovery experiment result
Result: obtaining hemsleyadin first average recovery according to formula is that 96.51% ~ 101.70% the data obtained accuracy is higher.
2.2.8 sample hemsleyadin first assay (see Fig. 1-Fig. 3) before and after concocting
Table 6 raw product hemsleyadin first content results
Table 7 goods hemsleyadin first content results
The content of raw product hemsleyadin first is 0.1639% ~ 0.1727%, and goods hemsleyadin content is 0.1526% ~ 0.1649%, and result shows that the content of Radix Hemsleyae Macrospermae hemsleyadin first after Sucus Glycyrrhizae system decreases.
Beneficial effect of the present invention is proved below by way of concrete pharmacodynamics test.
Test example 1 medicine antiinflammatory experiment of the present invention
1 laboratory animal
Cleaning grade kunming mice, weight 18 ~ 22g, reaching large animal experimental center by Sichuan provides.Laboratory animal production licence number: SCXK (river) 2013-24.
2 experiment reagents
Raw product: get Radix Hemsleyae Macrospermae sample, add 10 times of water gagings, extract 2 times, each 30min, filter, filtrate is concentrated into containing Radix Hemsleyae Macrospermae 0.2g/ml and 0.1g/ml, is respectively high dose group and low dose group, stand-by.
Processed product: extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and removes slag, and adds clean Radix Hemsleyae Macrospermae, fries to micro-dry, take out, dry with slow fire.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 25kg.
Get above-mentioned processed product, add 10 times of water gagings, extract 2 times, each 30min, filter, filtrate is concentrated into containing to containing Radix Hemsleyae Macrospermae 0.2g/ml and 0.1g/ml, is respectively high dose group and low dose group, stand-by.
Aspirin suspension: powder beaten by aspirin (Shijiazhuang Kang Li pharmaceutcal corporation, Ltd, lot number 120923), crosses 100 mesh sieves, is mixed with distilled water the suspension that concentration is 0.025g/mL, for subsequent use.
3 experimental techniques and result
The impact of 3.1 xylol induced mice auricle edemas
Kunming mice gets male 60, be divided at random: normal saline group, aspirin group (0.5g/kg), raw product high dose group (4g/kg) of Radix Hemsleyae Macrospermae, raw product low dose group ((2g/kg) of Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae processs product high dose group (4g/kg), Radix Hemsleyae Macrospermae processs product low dose group ((2g/kg) dosage group, often organize 10, each treated animal is with relative medicine 0.2ml/10g gavage, once a day, continuous 3d, after last gavage 2h, scorching in auris dextra auricle tow sides uniform application 0.15ml caused by dimethylbenzene xylene, put to death after 45min, cut left and right two ears, with card punch two auricle same position punching samplings about mice of diameter 9mm, weigh in time, calculate according to formula below:
Swelling and suppression ratio (%): suppression ratio=(normal saline group swelling-administration group swelling)/normal saline group swelling × 100%
Swelling=auris dextra sheet weight-auricle weight
Table 8 Radix Hemsleyae Macrospermae concocts the impact of front and back xylol induced mice auricle inflammation
Note: compare * P<0.05 with blank group, * * P<0.01; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, #p<0.05, ##p<0.01.
Result shows, compares with blank group, and Radix Hemsleyae Macrospermae concocts the mice auricle swelling of front and back caused by xylol all certain inhibitory action (P<0.01).Compare with the raw product of same dosage Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae is processed the inhibitory action of product high dose group to mice auricle swelling and is had significant difference (P<0.05), low dose group no difference of science of statistics, but the therapeutic effect that result display Radix Hemsleyae Macrospermae processs product low dosage is better.
3.2 cause the impact of rat paw edema to Ovum Gallus domesticus album
Kunming mice, male, 60, be divided at random: normal saline group, aspirin group (0.5g/kg), raw product high dose group (4g/kg) of Radix Hemsleyae Macrospermae, raw product low dose group ((2g/kg) of Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae processs product high dose group (4g/kg), Radix Hemsleyae Macrospermae processs product low dose group ((2g/kg) dosage group, often organize 10, each treated animal is with relative medicine 0.2ml/10g gavage, once a day, continuous 3d, after last gavage 0.5 ~ 1h in the middle part of rat paw the clear 0.1ml of subcutaneous injection 10% Fresh Egg, respectively at injection rear 1, 2, 3, 4h said method measures its right back sufficient volume, calculate pedal swelling rate, the difference condition of comparative control group and administration group, the results are shown in Table
Pedal swelling rate (%)=(after swelling each time point foot volume-original sufficient volume)/original sufficient volume × 100%
Table 9 Radix Hemsleyae Macrospermae concocts front and back cause rat paw edema impact on Ovum Gallus domesticus album
Note: compare * P<0.05 with blank group, * * P<0.01; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, #p<0.05, ##p<0.01.
Result shows, compares with blank group, and Radix Hemsleyae Macrospermae all has certain inhibitory action (P<0.05 ~ 0.01) to the rat paw edema degree caused by Ovum Gallus domesticus album before and after concocting in 1 ~ 4h, and analgesic effect strengthens along with time lengthening; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae processs product, and to the inhibitory action of rat paw edema, there were significant differences (P<0.05 ~ 0.01), and the product effect of processing is stronger, and rapid-action, long action time.
Test example 2 medicine analgesic experiment of the present invention
1 laboratory animal
Cleaning grade kunming mice, weight 18 ~ 22g, reaching large animal experimental center by Sichuan provides.Laboratory animal production licence number: SCXK (river) 2013-24.
2 experiment reagents
Raw product: get Radix Hemsleyae Macrospermae sample, add 10 times of water gagings, extract 2 times, each 30min, filter, filtrate is concentrated into containing Radix Hemsleyae Macrospermae 0.2g/ml and 0.1g/ml, is respectively high dose group and low dose group, stand-by.
Processed product: extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and removes slag, and adds clean Radix Hemsleyae Macrospermae, fries to micro-dry, take out, dry with slow fire.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 25kg.
Get above-mentioned processed product, add 10 times of water gagings, extract 2 times, each 30min, filter, filtrate is concentrated into containing Radix Hemsleyae Macrospermae 0.2g/ml and 0.1g/ml, is respectively high dose group and low dose group, stand-by.
Aspirin suspension: powder beaten by aspirin (Shijiazhuang Kang Li pharmaceutcal corporation, Ltd, lot number 120923), crosses 100 mesh sieves, is mixed with distilled water the suspension that concentration is 0.025g/mL, for subsequent use.
2.1 hot plate method
Screen qualified mice: mice is from being placed on hot plate to occurring licking the pain value valve of metapedes required time (second) as this Mus.Allly lick the metapedes time and be less than 5s or be greater than 30s or leaper abandons it.
Mice 60, female, raw product high dose group (4g/kg) of Radix Hemsleyae Macrospermae, the raw product low dose group of Radix Hemsleyae Macrospermae ((2g/kg), Radix Hemsleyae Macrospermae process product high dose group (4g/kg), Radix Hemsleyae Macrospermae processs product low dose group ((2g/kg) dosage group, matched group (normal saline), positive controls aspirin 0.5g/kg, first measure the pain threshold twice of every mice before administration, the meansigma methods of getting twice is pain threshold before administration.Each group of gastric infusion, gavage volume is (10ml/kg).Successive administration 3d, last mice is according to dosage after gastric infusion 30min, mice is put into hot plate dolorimeter, hot plate temperature is (55 ± 0.5) DEG C, dropping into hot plate to the time occurring licking metapedes from mice is the pain threshold of this Mus, survey once (60s is still reactionless, in 60s) every 30min (4 times), obtain average pain threshold and add up.
Average pain threshold × 100% before threshold of pain increase rate=(after medication the front average pain threshold of average pain threshold-medication)/medication
Table 10 Radix Hemsleyae Macrospermae concocts the impact of front and back on thermostimulation induced mice pain
Note: compare * P<0.05 with blank group, * * P<0.01; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, #p<0.05, ##p<0.01.
Result shows, compares with blank group, and except 30min, Radix Hemsleyae Macrospermae has certain inhibitory action (P<0.05 ~ 0.01) to the mice pain that thermostimulation causes before and after concocting; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, after 30min, Radix Hemsleyae Macrospermae processs the analgesic effect significance enhancing of product, and persistent.
2.2 writhing method
Mice 120, male and female half and half, raw product high dose group (4g/kg) of normal saline group, aspirin group (0.5g/kg), Radix Hemsleyae Macrospermae, the raw product low dose group of Radix Hemsleyae Macrospermae ((2g/kg), Radix Hemsleyae Macrospermae process product high dose group (4g/kg), Radix Hemsleyae Macrospermae processs product low dose group ((2g/kg) dosage group, often organize 10, each group of gastric infusion, every day 1 time, continuous 3d, 1h after last administration, each Mus lumbar injection 0.6% acetic acid 0.1mL/10g, record, to the number of animals and the writhing number of times that occur writhing response in 15min after acetic acid, calculates analgesia rate.
Analgesia writhing rate=(matched group writhing response number of times-administration group writhing response number of times)/matched group writhing response Mus number × 100%
Table 11 Radix Hemsleyae Macrospermae concocts the impact that front and back Dichlorodiphenyl Acetate causes mouse writhing reaction
Note: compare * P<0.05 with blank group, * * P<0.01; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, #p<0.05, ##p<0.01.
Result shows, compares with blank group, and the raw product of positive drug group, Radix Hemsleyae Macrospermae are high, process product high dose group Dichlorodiphenyl Acetate causes mouse writhing and all have certain analgesic activity (P<0.05 ~ 0.01), illustrates that Radix Hemsleyae Macrospermae has certain analgesic activity; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae is processed the analgesic activity of product to mice and is had significant difference, illustrates that Radix Hemsleyae Macrospermae processs the analgesic activity of product to mice stronger.
Test example 3 concocts front and back Radix Hemsleyae Macrospermae acute toxicity test research
1 laboratory animal
Cleaning grade kunming mice, male and female half and half, weight 18 ~ 22g, reaching large animal experimental center by Sichuan provides.Laboratory animal production licence number: SCXK (river) 2013-24.
2 experiment reagents
Processed product: extracting liquorice sheet or fragment, add suitable quantity of water, decocts soup and removes slag, and adds clean Radix Hemsleyae Macrospermae, fries to micro-dry, take out, dry with slow fire.
The clean Radix Hemsleyae Macrospermae of every 100kg, uses Radix Glycyrrhizae 25kg.
Prepared by medicinal liquid:
Get Radix Hemsleyae Macrospermae sample, add 10 times of water gagings, extract 2 times, each 30min, filter, filtrate is concentrated into containing Radix Hemsleyae Macrospermae 2g/ml stand-by.
With reference to classical acute toxicity (oral median lethal dose(LD 50) LD 50, maximum tolerated dose MTD, maximum dosage-feeding MLD) test method, carry out Radix Hemsleyae Macrospermae toxicity comparative study before and after the process of preparing Chinese medicine.
3 experimental techniques and result
3.1 different component sample Mouse Acute Toxicity trial tests
Get fasting 12h mice before test, be divided into 3 groups at random by body weight and sex: the raw product group of Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae process product group and blank according to group, often organize 6.Medicine group presses 40gkg -1administration, the isopyknic normal saline of blank group gavage, carries out LD 50the mensuration of value.Be difficult to measure LD 50value, by 40gkg -1mouse Weight 1 day repeatedly gastric infusion carries out the mensuration of MTD and MLD value.
Preliminary result shows: the raw product group of Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae process product group and the blank restriction being subject to administration volume and concentration according to group, are difficult to measure LD 50value, toxic performance and death after mouse stomach, therefore carry out the mensuration of MTD value.Formal test is carried out according to trial test result.
3.2 acute toxicity MTD formal tests
Get above-mentioned mice 60, be divided into the raw product group of Radix Hemsleyae Macrospermae at random by body weight and sex, Radix Hemsleyae Macrospermae processs product group and blank group of shining often organizes 20.After before mouse test, water 12h is can't help in fasting, administration group presses 20gkg -1mouse Weight gastric infusion 1 time, dosage in calculating 1, the isopyknic water of water matched group gavage, carries out acute toxicity test observation.
To the behavioral activity of observation post administration mice, the mental status, by hair, ingest, drink water, breathe, feces situation and nose, eye, oral cavity is with or without situations such as abnormal secretion thing, death and body weight change.Continuous Observation 14 days, observes its acute toxic symptoms spectrum, record accumulation death toll and Mouse Weight change.Dead animal performs an autopsy on sb. at once, the change of its main organs of perusal (heart, brain, liver,spleen,kidney, lung), finds that diseased organ then carries out Pathomorphologic inspection.
Table 12 is concocted front and back Radix Hemsleyae Macrospermae acute toxicity MTD and is reported situations
Continuous Observation 14d, result shows, compares with control group mice, and it is all normal that Radix Hemsleyae Macrospermae processs the diet of product group test mice, hair color, activity and defecation.Eye, nose, oral cavity no abnormality seen secretions, occur without ill symptoms; Radix Hemsleyae Macrospermae raw product group test mice extremity are movable and diet drinking-water is normal, but occur that hair color is not magnificent, and feces becomes the phenomenon of scattered paste shape, and occurs that mouse is dead, and finding through dissecting, is not that gavage causes.
Front and back Radix Hemsleyae Macrospermae acute toxicity MTD body weight growth pattern concocted by table 13
Note: compare * P<0.05 with blank group, * * P<0.01; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, #p<0.05, ##p<0.01.
Result shows, compares with blank group, after gavage 7d the raw product of Radix Hemsleyae Macrospermae, process product group Mouse Weight rate of increase and decline (P<0.05) all to some extent, illustrate that Radix Hemsleyae Macrospermae has a certain impact to Mouse Weight growth; Compare with waiting raw product of dosage Radix Hemsleyae Macrospermae, Radix Hemsleyae Macrospermae processs the impact of product on Mouse Weight rate of increase relatively low (P<0.05).
Dissect the main organs such as each group of the experiment mice heart, lung, liver, kidney, stomach, spleen, perusal is showed no abnormality.
Found that: give birth to product to mouse stomach Radix Hemsleyae Macrospermae and process product through MTD experiment investigation, Radix Hemsleyae Macrospermae raw product group MTD value is 20.0gkg -1d -1water is equivalent to 133 times of clinical 60kg people's per kilogram of body weight consumption per day respectively and has certain toxicity, after the raw product of mouse stomach Radix Hemsleyae Macrospermae, main acute signs of toxicity has the not magnificent Radix Hemsleyae Macrospermae of diarrhoea, hair color to process product group mouse diet, hair color, activity and defecation all normally, and its MTD value is greater than 20.0gkg -1d -1, illustrate that Radix Hemsleyae Macrospermae MTD after concocting becomes large, toxicity reduces.
Discuss
This experiment by 5%, 15%, 25%, 35% Radix Glycyrrhizae on the impact of Radix Hemsleyae Macrospermae bitterness, final select the Radix Glycyrrhizae of 25% as the best materials concocted.Antiinflammatory and analgesic experimental result show, the raw product of Radix Hemsleyae Macrospermae, the product of processing have certain antiinflammatory and analgesic activity, and simultaneously after Sucus Glycyrrhizae is processed, its antiinflammatory and analgesic activity strengthen.Acute toxicity testing result shows, but there was no significant difference between the two.Radix Hemsleyae Macrospermae raw product group MTD value is 20.0gkg -1d -1, but after Sucus Glycyrrhizae is processed, its MTD value is greater than 20.0gkg -1d -1, illustrate that Radix Hemsleyae Macrospermae MTD after concocting becomes large, toxicity reduces.

Claims (10)

1., containing medicine or the Halth-care composition of Radix Hemsleyae Macrospermae, it is characterized in that: it is the preparation be prepared from by the raw material of following weight proportioning:
Radix Hemsleyae Macrospermae 100 parts, Radix Glycyrrhizae 5-35 part.
2. compositions according to claim 1, is characterized in that: it is the preparation be prepared from by the raw material of following weight proportioning:
Radix Hemsleyae Macrospermae 100 parts, 25 parts, Radix Glycyrrhizae.
3. compositions according to claim 1 and 2, is characterized in that: described Radix Hemsleyae Macrospermae derives from the dried root of Cucurbitaceae Genus Hemsleya plant dolichocarpel hemsleya root HemsleyadolichocarpaW.J.Chang, high eyebrow Radix Hemsleyae Macrospermae HemsleyaomeiensisL.T.ShenetW.J.Chang or huge colored Radix Hemsleyae Macrospermae HemsleyagiganthaW.J.Chang.
4. compositions according to claim 1 and 2, is characterized in that: it is by the protogenic medicinal powder of Radix Hemsleyae Macrospermae, Radix Glycyrrhizae, or water or extractive with organic solvent are active component, adds pharmaceutically or preparation that on food, acceptable adjuvant or adjuvant composition are prepared from.
5. compositions according to claim 4, is characterized in that: described preparation is oral liquid, tablet, capsule, pill, granule, medicinal tea.
6. a Radix Hemsleyae Macrospermae decoction pieces, it concocts with raw material Radix Hemsleyae Macrospermae and Radix Glycyrrhizae to form, and wherein the weight proportion of Radix Hemsleyae Macrospermae, Radix Glycyrrhizae is:
Radix Hemsleyae Macrospermae 100 parts, Radix Glycyrrhizae 5-35 part.
7. Radix Hemsleyae Macrospermae decoction pieces according to claim 6, is characterized in that: the weight proportion of described Radix Hemsleyae Macrospermae Radix Glycyrrhizae is:
Radix Hemsleyae Macrospermae 100 parts, 25 parts, Radix Glycyrrhizae.
8. prepare a method for the Radix Hemsleyae Macrospermae decoction pieces described in claim 6 or 7, it comprises the steps:
A, extracting liquorice, decoct with water and remove slag, and prepares Sucus Glycyrrhizae;
B, add Radix Hemsleyae Macrospermae, moistening, treat that Sucus Glycyrrhizae exhausts, dry.
9. the purposes in anti-inflammatory drug prepared by the Radix Hemsleyae Macrospermae decoction pieces described in claim 6 or 7.
10. the purposes in analgesic prepared by the Radix Hemsleyae Macrospermae decoction pieces described in claim 6 or 7.
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CN108072707A (en) * 2016-11-16 2018-05-25 四川辅正药业股份有限公司 Measure the HPLC methods of Hemsleyadin first content in Radix Glycyrrhizae hymsleya amabilis
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CN109298121A (en) * 2017-07-24 2019-02-01 四川辅正药业股份有限公司 The HPLC method of Cucurbitacin in Xuedan and dihydrocucurbitacin F content is measured simultaneously
CN108478622A (en) * 2018-04-16 2018-09-04 成都辅正生物科技有限公司 A kind of composition and its preparation method and application of anti-treating dental ulcer
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