CN1293903C - Fant calming powder injection and its preparation method - Google Patents

Fant calming powder injection and its preparation method Download PDF

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CN1293903C
CN1293903C CN 200510059784 CN200510059784A CN1293903C CN 1293903 C CN1293903 C CN 1293903C CN 200510059784 CN200510059784 CN 200510059784 CN 200510059784 A CN200510059784 A CN 200510059784A CN 1293903 C CN1293903 C CN 1293903C
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bottle
extract
add
ethanol
semen armeniacae
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CN1686373A (en
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张海峰
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Abstract

The present invention discloses a powder injection for relieving asthma and a preparation method thereof. The present invention is characterized in that the powder injection is prepared by the combination of effective parts which are extracted and purified from the traditional Chinese medicine of ephedrae, datura flower, bitter apricot kernel and forsythia fruit and medicine supplementary material; the content of ephedra total alkaloid which is measured by ephedrine in the powder injection of the present invention is from 1.0 mg/bottle to 1.6 mg/bottle, the content of datura flower total alkaloid which is measured by scopolamine is from 0.08 mg/bottle to 0.2 mg/bottle, the content of amygdalin is from 2.1 mg/bottle to 3.6 mg/bottle, and the content of forsythin is from 0.13 mg/bottle to 0.30 mg/bottle. Pharmacological experiment results show that the powder injection of the present invention has good pharmacological action.

Description

A kind of ZHICHUANGLING injectable powder and preparation method thereof
Affiliated technical field
The invention belongs to field of traditional Chinese medicine pharmacy, be specifically related to a kind of ZHICHUANGLING injectable powder and preparation method thereof.
Technical background
The Chinese medicine ZHICHUANLING ZHUSHEYE is prepared into by Chinese medicine Herba Ephedrae, Flos Daturae, Semen Armeniacae Amarum, Fructus Forsythiae, has the effect of sending down the abnormal ascending QI lung qi, lung qi dispersing Dingchuan, cures mainly various bronchial asthmas and chronic tracheitis, and is evident in efficacy.The Herba Ephedrae beginning is stated from Shennong's Herbal, classify middle product as, the successive dynasties book on Chinese herbal medicine all records, dry herb stem for Ephedraceae plant plait Herba Ephedrae epheday intermedia or ephedra equisetina, tool is delivered effects such as cold expelling, depressed lung-energy dispersing, inducing diuresis to remove edema, is used for anemofrigid cold, uncomfortable in chestly breathes with cough, disease such as edema due to wind pathogen edema, bronchial asthma; Flos Daturae is the dried floral of Solanaceae annual herb plant datura metel or Mao Tuoluo, aboundresources, and medicinal have datura metel, datura innoxia, Europe Flos Daturae, stingless Flos Daturae, datura, a polyphyll Flos Daturae, the property suffering, temperature, poisonous.GUIXIN, lung, spleen channel has relieving cough and asthma, narcotic analgesic, the effect of endogenous wind stopping antispasmodic, and the alkaloid in the chemical constituent of Flos Daturae contains scopolamine 80%, and surplus is atropine and hyoscyamine etc.; Fructus Forsythiae is the dry fruit of Oleaceae forsythia Fructus Forsythiae, and the property hardship is slightly cold, return lung, the heart, gallbladder meridian, effect with heat-clearing and toxic substances removing, dispersing swelling and dissipating binds cures mainly diseases such as warm, erysipelas, macule, sore swollen toxin, scrofula, mainly contains chemical constituents such as phillyrin in the Fructus Forsythiae; Semen Armeniacae Amarum is the seed of rosaceous plant Fructus Pruni, warm in nature, bitter in the mouth, slightly poisonous, has the sending down the abnormal ascending QI relieving cough and asthma, the effect of loosening bowel to relieve constipation, be mainly used in cough and asthma, the fullness in the chest abundant expectoration, blood deficiency Tianjin is withered, diseases such as dryness of the intestine constipation, main chemical compositions contains amygdaloside, emulsin, amygdalase, prunase etc., amygdaloside belongs to aromatic series cyanogen glycosides, structural formula benzene hydroxyl second cyanogen-β-D-glucose-6-β-D-glucoside, its hydrolysis under glucosidase such as emulsin and prunase generates prunasin and Semen Armeniacae Amarum cyanogen, latter's instability, meet heat and easily decompose generation benzaldehyde and hydrocyanic acid, hydrocyanic acid has severe toxicity, and mechanism of poisoning mainly is that the cytochrome oxidase ferric iron in hydrocyanic acid and the cell mitochondrial reacts, the activity of inhibitory enzyme and cause the histiocyte respiration inhibition, cause death, therefore, it is with Semen Armeniacae Amarum " back down " that tradition is extracted amygdalate method, its objective is with boiling water enzyme-deactivating in the Semen Armeniacae Amarum, thereby amygdaloside can't be degraded, alleviate its toxicity;
The Pharmacopoeia of the People's Republic of China (version was one one in 2005) has been put down in writing the preparation method of ZHICHUANLING ZHUSHEYE: behind the common water extraction of four flavor Chinese medicines, twice ethanol precipitation remove impurity is prepared into injection, its preparation method is very not sufficient to reduce amygdalate toxicity, therefore, can cause the ZHICHUANLING ZHUSHEYE untoward reaction to increase.
Consult document and patent, do not find that with Herba Ephedrae, Flos Daturae, Semen Armeniacae Amarum, Fructus Forsythiae be the injectable powder of feedstock production.
Summary of the invention
For these reasons, we are through the experiment of systematic science, with Herba Ephedrae, Flos Daturae, the common water extraction of Fructus Forsythiae, ethanol precipitation twice, ultrafiltration obtains extract, with Semen Armeniacae Amarum with 100 ℃ of steam steaming and decoctings after supersound extraction while hot, definite lives enzyme fire in the Semen Armeniacae Amarum, obtain extract behind the extracting solution precipitate with ethanol, the said extracted thing is mixed with into injectable powder with pharmaceutic adjuvant, controlling injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.0-1.6mg/ bottle, Flos Daturae total alkaloids is the 0.08-0.2mg/ bottle in (scopolamine), amygdaloside is the 2.1-3.6mg/ bottle, phillyrin 0.13-0.30mg/ bottle, pharmacological evaluation shows that ZHICHUANGLING injectable powder of the present invention has better pharmacological action than commercially available ZHICHUANLING ZHUSHEYE.
The present invention is achieved through the following technical solutions.
One. process recipes
(1) crude drug of the present invention consists of:
Herba Ephedrae 6-10 weight portion, Flos Daturae 3-5 weight portion, Semen Armeniacae Amarum 7-12 weight portion, Fructus Forsythiae 8-20 weight portion.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae is soaked, and extracts each 2-4 hour 3-5 time, merge extractive liquid, filters, and relative density was 1.20-1.30 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 40%-60% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.25-1.35 when being concentrated to 50 ℃, add ethanol, make solution contain the alcohol amount, leave standstill, get supernatant for 70%-90%, reclaim ethanol to most, add water, relative density is 1.05-1.10 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 10-20 minute, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 2-4 time, each 30 minutes, merge extractive liquid,, relative density is 1.30-1.35 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 60%-80%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 20-40 weight portion, Semen Armeniacae Amarum extract 4-7 weight portion, pharmaceutic adjuvant 53-76 weight portion;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains the ZHICHUANGLING injectable powder.
Two. the check and analysis experiment
1. the check and analysis of Herba Ephedrae total alkaloids
Experimental technique: precision takes by weighing injectable powder 500mg of the present invention, put in the separatory funnel, add 1mol/L sodium hydroxide solution 0.5ml, with chloroform extraction 4 times (10,10,5,5ml), combined chloroform liquid, put in the tool plug conical flask cold water 10ml that precision adds sulphuric acid volumetric solution (0.01mol/L) 10ml and newly boiled, shake well, add 1~2 of alizarine S indicator solution,, and titration results proofreaied and correct with blank assay to pale red with sodium hydroxide volumetric solution (0.02mol/L) titration, promptly.The sulphuric acid volumetric solution (0.01mol/L) of every 1ml is equivalent to the ephedrine of 3.305mg.The experiment with computing result sees Table 1:
2. Flos Daturae total alkaloids check and analysis
The preparation of reference substance solution: precision takes by weighing scopolamine hydrobromide reference substance 15mg, puts in the 10ml measuring bottle, adds methanol and is diluted to scale, shakes up, and promptly gets (containing hydrobromic acid scopolamine 1.5mg among every 1ml).The preparation of need testing solution: precision takes by weighing injectable powder 500mg of the present invention, put in the separatory funnel, add ammonia solution and regulate pH value to 9, with chloroform extraction 3 times (25,20,20ml), combined chloroform liquid is put and is reclaimed chloroform in the tepidarium to doing, and residue adds dissolve with methanol and moves in the 2ml measuring bottle, add methanol and be diluted to scale, promptly.
Algoscopy: according to the thin layer chromatography test, precision is measured reference substance solution and each 50 μ l of need testing solution, put respectively on same-silica GF254 lamellae, make into strips, with ethyl acetate-methanol-strong ammonia solution (17: 2: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect, scrape respectively and get test sample and the corresponding locational streak of reference substance, put in the separatory funnel, scrape the silica GF254 got on the same chromatoplate with test sample streak homalographic simultaneously as blank.Respectively add bromocresol green solution (get bromocresol green 50mg and Potassium Hydrogen Phthalate 1.021g, add 0.2mol/L hydrochloric acid solution 1.6ml and make dissolving back thin up become 100ml, filter in case of necessity) 4ml, shake up, the accurate respectively chloroform 10ml that adds, jolting is left standstill and was made layering in 1 hour after extracting, divide and get chloroform solution, according to the spectrophotography test, measure trap at the 415nm place, calculate, result and 0.6921 is multiplied each other, promptly get the amount that contains scopolamine (C17H21NO4) in the test sample.Result of calculation sees Table 1:
3. the check and analysis of amygdaloside
Experimental technique: precision takes by weighing injectable powder 1.0 grams of the present invention, put in the kjeldahl flask, add water 150ml, close immediately plug, put in 37 ℃ of water-baths and be incubated 2 hours, connect condensing tube, water flowing steam distillation, distillate imports in the absorption liquid of water 10ml and ammonia solution 2ml, and receiving flask is put in the ice bath and is cooled off, when reaching 60ml, distillate stops distillation, add potassium iodide test solution 2ml in the distillate, with slowly titration of silver nitrate titration liquid (0.1mol/1), the yellow-white muddiness of showing to solution does not disappear, every 1ml silver nitrate titration liquid (0.1mol/1) is equivalent to 91.48 amygdalosides, and result of calculation sees Table 1:
4. the check and analysis of phillyrin
High performance liquid chromatography is carried out check and analysis
Experimental technique: the detection method according to the Pharmacopoeia of the People's Republic of China (version was an one in 2005,118 pages) Fructus Forsythiae is carried out check and analysis, and experimental result sees Table 1:
Table 1 ZHICHUANGLING injectable powder assay
Group Herba Ephedrae total alkaloids (in ephedrine) mg/ bottle Flos Daturae total alkaloids is in (scopolamine) mg/ bottle Amygdaloside mg/ bottle Phillyrin mg/ bottle
1 2 1.28 1.20 0.14 0.14 2.43 2.37 0.27 0.21
Average 3 1.31 1.26 0.16 0.15 2.34 2.38 0.25 0.24
Conclusion: show that by above check and analysis experiment technology of the present invention has practical significance.
Three. pharmacology embodiment
Embodiment 1
Influence to guinea pig asthmatic model
Laboratory animal: Cavia porcellus 150-200g, male and female dual-purpose.
Experiment medicine: commercially available ZHICHUANLING ZHUSHEYE (pharmaceutical factory in the Soviet Union of Jiangsu)
ZHICHUANGLING injectable powder of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental technique: Cavia porcellus is inserted in the lucite case of 20 * 20 * 150cm, and ultrasonic atomizatio sprays into 2% acetylcholine and 0.2% histamine phosphate mixed liquor screens for 15 seconds, and it draws to breathe heavily and surpasses 120 seconds persons incubation period and will not select for use.Next day, the Cavia porcellus random packet is through lumbar injection ZHICHUANGLING ejection preparation, dosage is 30mg crude drug/kg, matched group gives normal saline, waits the appearance inequality, measures and draw and breathe heavily incubation period (promptly beginning to asthma attack, dyspnea, up to time that tic falls down to the ground from spraying) after the administration in 1 hour.
Experimental result sees Table 2:
Table 2 ZHICHUANGLING ejection preparation is to the influence of guinea pig asthmatic model
Group The number of animals mouth Draw and breathe heavily second incubation period
The commercially available ZHICHUANLING ZHUSHEYE of normal saline group ZHICHUANGLING injectable powder of the present invention 10 9 10 61.1±14.0 117.6±39.1 ** 176.3±75.9 ***
Annotate: compare with the normal saline group *P<0.01, compare with positive controls [ *] P<0.05
Embodiment 2
Influence to the contraction of guinea-pig isolated tracheal smooth muscle bar
Laboratory animal: Cavia porcellus 150-200g, male and female dual-purpose.
Experiment medicine: commercially available ZHICHUANLING ZHUSHEYE (pharmaceutical factory in the Soviet Union of Jiangsu)
ZHICHUANGLING injectable powder of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental technique: the preparation isolated helical strips of guinea, place to fill in oxygenation Ke-Heng Shi liquid isolated organ mensuration bath (37 ℃), load 2.0 gram balances, (final concentration is respectively 2.5 * 10 to inject acetylcholine or histamine respectively -7With 5 * 10 -7G/ml), record maximum collapse height adds given the test agent on this basis respectively, and record shrinks height after the balance.Experimental result sees Table 3:
The influence that table 3 ZHICHUANGLING ejection preparation shrinks the guinea-pig isolated tracheal smooth muscle bar
Group Acetylcholine shrinks height mm Acetylcholine suppression ratio % Histamine shrinks height mm Histamine suppression ratio %
The commercially available ZHICHUANLING ZHUSHEYE of normal saline group ZHICHUANGLING injectable powder of the present invention 57.3±10.6 20.0±5.2 ** 8.2±2.3 ** 65.1 85.7 94.2±10.2 79.0±8.9 * 44.3±15.2 ** 16.1 52.9
Annotate: compare with the normal saline group *P<0.01, *P<0.05
Embodiment 3
To the volumetrical influence of guinea-pig isolated trachea
Laboratory animal: Cavia porcellus 150-200g, male and female dual-purpose.
Experiment medicine: commercially available ZHICHUANLING ZHUSHEYE (pharmaceutical factory in the Soviet Union of Jiangsu)
ZHICHUANGLING injectable powder of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental technique: get the stripped complete trachea specimen of Cavia porcellus preparation, place the bath of the oxygenation Ke-Heng Shi liquid of constant temperature (37 ℃), observe and connect liquid level in the 0.1ml capillary tube, after injecting acetylcholine, trachea shrinks, and liquid level is raised, and given the test agent and normal saline reinject, 5 minutes liquid level is poor after the record administration, and experimental result sees 4:
Table 4 ZHICHUANGLING ejection preparation is to the volumetrical influence of guinea-pig isolated trachea
Group End liquid level difference mm falls
The commercially available ZHICHUANLING ZHUSHEYE of normal saline group ZHICHUANGLING injectable powder of the present invention 0.5±0.4 3.0±0.6 ** 4.5±0.8 ***
Annotate: compare with the normal saline group *P<0.01, compare with positive controls [ *] P<0.05
Embodiment 4
Influence to the Cavia porcellus lung airway perfusion that exsomatizes
Laboratory animal: Cavia porcellus 150-200g, male and female dual-purpose.
Experiment medicine: commercially available ZHICHUANLING ZHUSHEYE (pharmaceutical factory in the Soviet Union of Jiangsu)
ZHICHUANGLING injectable powder of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental technique: Cavia porcellus hits dizzy, and the carotid artery blood-letting separates trachea and takes out in the lump together with cardiopulmonary, contains oxygen locke solution influent stream with 37 ℃, is about 10ml/min by perfusion bottle altitude mixture control perfusion flow, treat that perfusion is fixed after, give acetylcholine (3 * 10 -7), perfusion flow obviously reduces, and respectively with going into given the test agent, observes the variation of perfusion flow again, and experimental result sees Table 5:
Table 5 ZHICHUANGLING ejection preparation is to the influence of the Cavia porcellus lung airway perfusion that exsomatizes
Group Perfusion flow ml/min
The commercially available ZHICHUANLING ZHUSHEYE of normal saline group acetylcholine matched group ZHICHUANGLING injectable powder of the present invention 9.5±2.3 ** 4.9±2.1 8.1±1.5 ** 10.2±1.0 **
Annotate: compare with the normal saline group *P<0.01
Conclusion: show that by pharmacological evaluation ZHICHUANGLING injectable powder of the present invention has better pharmacological action than commercially available ZHICHUANLING ZHUSHEYE.
Four. preparation embodiment
Embodiment 1
(1) crude drug of the present invention consists of:
Herba Ephedrae 60 grams, Flos Daturae 30 grams, Semen Armeniacae Amarum 70 grams, Fructus Forsythiae 80 grams.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae and soak, extract each 2 hours 3 times, merge extractive liquid, filters, and relative density was 1.20 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 40% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.25 when being concentrated to 50 ℃, add ethanol, making solution contain the alcohol amount is 70%, leaves standstill, and gets supernatant, reclaim ethanol to most, add water, relative density is 1.05 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 10 minutes, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 2 times, each 30 minutes, merge extractive liquid,, relative density is 1.30 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 60%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 20 grams, Semen Armeniacae Amarum extract 4 gram weight parts, pharmaceutic adjuvant lactose 76 grams;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains 1000 bottles of ZHICHUANGLING injectable powder.[injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.0mg/ bottle, and Flos Daturae total alkaloids is the 0.08mg/ bottle in (scopolamine), and amygdaloside is the 2.1mg/ bottle, phillyrin 0.13mg/ bottle.】
Embodiment 2
(1) crude drug of the present invention consists of:
Herba Ephedrae 100 grams, Flos Daturae 50 grams, Semen Armeniacae Amarum 120 grams, Fructus Forsythiae 200 grams.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae and soak, extract each 4 hours 5 times, merge extractive liquid, filters, and relative density was 1.30 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 60% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.35 when being concentrated to 50 ℃, add ethanol, making solution contain the alcohol amount is 90%, leaves standstill, and gets supernatant, reclaim ethanol to most, add water, relative density is 1.10 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 20 minutes, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 4 times, each 30 minutes, merge extractive liquid,, relative density is 1.35 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 80%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 40 grams, Semen Armeniacae Amarum extract 7 grams, pharmaceutic adjuvant sucrose 53 grams;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains 1000 bottles of ZHICHUANGLING injectable powder.[injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.6mg/ bottle, and Flos Daturae total alkaloids is the 0.2mg/ bottle in (scopolamine), and amygdaloside is the 3.6mg/ bottle, phillyrin 0.30mg/ bottle.】
Embodiment 3
(1) crude drug of the present invention consists of:
Herba Ephedrae 80 grams, Flos Daturae 40 grams, Semen Armeniacae Amarum 100 grams, Fructus Forsythiae 120 grams.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae and soak, extract each 3 hours 4 times, merge extractive liquid, filters, and relative density was 1.25 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 50% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.22 when being concentrated to 50 ℃, add ethanol, making solution contain the alcohol amount is 80%, leaves standstill, and gets supernatant, reclaim ethanol to most, add water, relative density is 1.08 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 15 minutes, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 3 times, each 30 minutes, merge extractive liquid,, relative density is 1.32 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 70%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 30 grams, Semen Armeniacae Amarum extract 6 grams, pharmaceutic adjuvant mannitol 64 grams;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains 1000 bottles of ZHICHUANGLING injectable powder.[injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.3mg/ bottle, and Flos Daturae total alkaloids is the 0.15mg/ bottle in (scopolamine), and amygdaloside is the 3.0mg/ bottle, phillyrin 0.20mg/ bottle.】
Embodiment 4
(1) crude drug of the present invention consists of:
Herba Ephedrae 70 grams, Flos Daturae 35 grams, Semen Armeniacae Amarum 80 grams, Fructus Forsythiae 100 grams.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae and soak, extract each 2.5 hours 3 times, merge extractive liquid, filters, and relative density was 1.22 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 45% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.22 when being concentrated to 50 ℃, add ethanol, making solution contain the alcohol amount is 75%, leaves standstill, and gets supernatant, reclaim ethanol to most, add water, relative density is 1.06 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 12 minutes, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 2 times, each 30 minutes, merge extractive liquid,, relative density is 1.31 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 65%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 25 grams, Semen Armeniacae Amarum extract 5 grams, pharmaceutic adjuvant mannitol, lactose 70 grams;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains 1000 bottles of ZHICHUANGLING injectable powder.[injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.1mg/ bottle, and Flos Daturae total alkaloids is the 0.11mg/ bottle in (scopolamine), and amygdaloside is the 2.9mg/ bottle, phillyrin 0.17mg/ bottle.】
Embodiment 5
(1) crude drug of the present invention consists of:
Herba Ephedrae 90 grams, Flos Daturae 45 grams, Semen Armeniacae Amarum 110 grams, Fructus Forsythiae 180 grams.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae and soak, extract each 3.5 hours 5 times, merge extractive liquid, filters, and relative density was 1.28 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 55% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.32 when being concentrated to 50 ℃, add ethanol, making solution contain the alcohol amount is 85%, leaves standstill, and gets supernatant, reclaim ethanol to most, add water, relative density is 1.09 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 18 minutes, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 4 times, each 30 minutes, merge extractive liquid,, relative density is 1.34 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 75%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 35 grams, Semen Armeniacae Amarum extract 6 grams, pharmaceutic adjuvant mannitol, sucrose 59 grams;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains 1000 bottles of ZHICHUANGLING injectable powder.[injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.5mg/ bottle, and Flos Daturae total alkaloids is the 0.17mg/ bottle in (scopolamine), and amygdaloside is the 3.4mg/ bottle, phillyrin 0.27mg/ bottle.】
Embodiment 6
(1) crude drug of the present invention consists of:
Herba Ephedrae 80 grams, Flos Daturae 40 grams, Semen Armeniacae Amarum 100 grams, Fructus Forsythiae 120 grams.
(2) get Herba Ephedrae, Flos Daturae, Fructus Forsythiae and soak, extract each 3 hours 4 times, merge extractive liquid, filters, and relative density was 1.25 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 50% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.30 when being concentrated to 50 ℃, add ethanol, making solution contain the alcohol amount is 80%, leaves standstill, and gets supernatant, reclaim ethanol to most, add water, relative density is 1.08 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(3) get Semen Armeniacae Amarum, steamed 15 minutes, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 3 times, each 30 minutes, merge extractive liquid,, relative density is 1.32 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 70%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(4) preparation prescription of the present invention is: Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 308 grams, Semen Armeniacae Amarum extract 61 grams, pharmaceutic adjuvant mannitol 631 grams;
(5) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains 1000 bottles of ZHICHUANGLING injectable powder.[injectable powder epheday intermedia total alkaloids of the present invention (in ephedrine) is the 1.3mg/ bottle, and Flos Daturae total alkaloids is the 0.15mg/ bottle in (scopolamine), and amygdaloside is the 3.0mg/ bottle, phillyrin 0.20mg/ bottle.】

Claims (2)

1. a ZHICHUANGLING injectable powder is characterized in that it is to be prepared from by following crude drug: Herba Ephedrae 6-10 weight portion, Flos Daturae 3-5 weight portion, Semen Armeniacae Amarum 7-12 weight portion, Fructus Forsythiae 8-20 weight portion; Preparation is prepared from by Herba Ephedrae, Flos Daturae, Fructus Forsythiae extract 20-40 weight portion, Semen Armeniacae Amarum extract 4-7 weight portion, pharmaceutic adjuvant 53-76 weight portion, wherein be with supersound extraction while hot after 100 ℃ of steam steaming and decoctings with Semen Armeniacae Amarum extract, obtain behind the extracting solution precipitate with ethanol, preparation epheday intermedia total alkaloids is counted the 1.0-1.6mg/ bottle with ephedrine, Flos Daturae total alkaloids is counted the 0.08-0.2mg/ bottle with scopolamine, amygdaloside is the 2.1-3.6mg/ bottle, phillyrin 0.13-0.30mg/ bottle.
2. ZHICHUANGLING injectable powder according to claim 1, its preparation method is:
(1) gets Herba Ephedrae, Flos Daturae, Fructus Forsythiae is soaked, and extracts each 2-4 hour 3-5 time, merge extractive liquid, filters, and relative density was 1.20-1.30 when filtrate was concentrated to 50 ℃, add ethanol, make that ethanol content is 40%-60% in the solution, leave standstill, get supernatant, reclaim ethanol to most, relative density is 1.25-1.35 when being concentrated to 50 ℃, add ethanol, make solution contain the alcohol amount, leave standstill, get supernatant for 70%-90%, reclaim ethanol to most, add water, relative density is 1.05-1.10 when regulating 20 ℃, is 5000 hollow fiber column ultrafilter with molecular cut off, keep permeate, concentrate, drying obtains extract;
(2) get Semen Armeniacae Amarum, steamed 10-20 minute, Semen Armeniacae Amarum is added in the supersound extraction jar while hot with 100 ℃ of steam, extract 2-4 time, each 30 minutes, merge extractive liquid,, relative density is 1.30-1.35 when being concentrated to 50 ℃, add ethanol, making the concentration of alcohol of solution is 60%-80%, leaves standstill, filter, filtrate concentrates, and drying obtains extract;
(3) get the said extracted thing, add the dissolving of injection water fully, add pharmaceutic adjuvant, filter, sterilization, drying obtains the ZHICHUANGLING injectable powder.
CN 200510059784 2005-04-01 2005-04-01 Fant calming powder injection and its preparation method Expired - Fee Related CN1293903C (en)

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CN114344380A (en) * 2016-03-01 2022-04-15 神威药业集团有限公司 Asthma-relieving aerosol inhalation solution preparation and preparation method thereof
CN106236925B (en) * 2016-09-28 2018-11-02 江苏苏中药业集团股份有限公司 A kind of Chinese medicine inhalation aerosol and the preparation method and application thereof for treating asthma
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