CN1864713A - Spray for treating influenza and preparation method thereof - Google Patents

Spray for treating influenza and preparation method thereof Download PDF

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Publication number
CN1864713A
CN1864713A CN 200510016786 CN200510016786A CN1864713A CN 1864713 A CN1864713 A CN 1864713A CN 200510016786 CN200510016786 CN 200510016786 CN 200510016786 A CN200510016786 A CN 200510016786A CN 1864713 A CN1864713 A CN 1864713A
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radix
spray
influenza
virus
preparation
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CN 200510016786
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CN100406034C (en
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刘东升
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Abstract

The invention provides a Chinese medicinal herbal preparation for preventing and treating upper respiratory tract infection, which is prepared from licorice root, astragalus root, asaryl, frankincense, root of red rooted saliva, Chinese angelica root, radix paeoniae rubrathe, safflower and atractylodes rhizome by predetermined weight ratio proportions.

Description

Spray for treating influenza and preparation method thereof
Technical field
The invention belongs to the Chinese medicine technical field, relate to Chinese medicine preparation of preventing and treating upper respiratory tract infection such as influenza and preparation method thereof.
Background technology
Annual winter-spring season all is the multiple phase of upper respiratory tract infection disease, the common cold that causes comprising virus and bacteria, pharyngolaryngitis, influenza etc., especially influenza is bigger to social influence, can cause the popular of disease, makes people's physical and mental health be subjected to great threat.Except that with the influenza vaccines prevention, do not have other means of prevention now, particularly directly the spray agent of the Chinese herbal medicine purification of dissipation upper respiratory tract influenza virus is more rare.
Summary of the invention
The invention provides a kind of Chinese medicine composition of effectively preventing and treating upper respiratory tract infection such as influenza, and the preparation and the quality detecting method of said composition are provided.According to pharmacology of Chinese materia medica and the immunologic theory of Chinese medicine, the consumption of drug component has carried out a large amount of experimental summaries and has drawn each component and in following ranges curative effect is preferably arranged:
Radix Glycyrrhizae 0.5-2.5 part, Radix Astragali 0.5-3.0 part, Herba Asari 0.25-1.0 part, Olibanum 0.5-1.75 part, Radix Salviae Miltiorrhizae 0.5-2.5 part, Radix Angelicae Sinensis 0.5-2.0 part, Radix Paeoniae Rubra 0.2-0.5 part, Flos Carthami 0.2-1.0 part, Rhizoma Atractylodis 0.25-1.75 part.
Be preferably: 1.5 parts in Radix Glycyrrhizae, 0.5 part of the Radix Astragali, 0.5 part of Herba Asari, 1.0 parts of Olibanums, 0.5 part of Radix Salviae Miltiorrhizae, 0.5 part of Radix Angelicae Sinensis, 0.2 part of Radix Paeoniae Rubra, 0.5 part on Flos Carthami, 0.5 part of Rhizoma Atractylodis
The spray preparation method is made up of following:
1. the tcm and herbal slice of respectively distinguishing the flavor of need reach 2000 editions one ministerial standards of Chinese Pharmacopoeia.
2. take by weighing the prepared slices of Chinese crude drugs by prescription and add 10 times of water boil 3-4 hours, go sediment to receive supernatant.
3. add ethanol according to quantity, the ethanol ultimate density is 70%, then decontamination.
4. receipts supernatant, reduction vaporization removes ethanol.
5. with different aperture fibers film clarification degerming, add the liquor strength that sterile distilled water is made into requirement, bottling is distributed into spray or oral liquid
Resisiting influenza virus is renderd a service and sterility test
1. use Embryo Gallus domesticus EID 50Method detects the effectiveness that this batch goods kill influenza virus (first 1 type, B-mode), the viral index reached 10 of going out 6EID 50More than be qualified, do not reach requirement and discard.
2. carry out sterility test by the conventional sampling observation of biological product sample, sterility test should be qualified.After the above binomial passed examination, goods can carry out the branch packing.
Chinese medicine preparation of the present invention all has extremely strong killing action, 40% medical herbs concentration can suppress viral index up to 10 to influenza virus (first 1 type, B-mode) 6EID 50More than, simultaneously the upper respiratory tract antibacterial also there is inhibitory action.When common cold initial stage such as nasal obstruction, rhinorrhea and laryngopharynx swelling and pain, be that respirovirus and malignant bacteria are in the upper respiratory tract local infection propagation phase.Be sprayed at the part with this product, can kill partial virus and antibacterial very soon, make it can not continue propagation and spread, also controlled virus and propagated to other healthy people, patient symptom also disappears simultaneously, reaches recovery from illness very soon, plays the dual function of curing the disease with diseases prevention.Still unmatchful influenza virus has the Chinese medicine preparation of killing action so by force both at home and abroad at present.The present invention provides a kind of new medicine preparation for upper respiratory tract infection such as control influenzas, and is easy to use, reliable for effect, without any side effects.
Specific embodiments
To the beneficial effect of the present invention by the further elaboration of following test medicine of the present invention, these tests comprise drug effect, pharmacology, toxicity inspection and the clinical observation on the therapeutic effect of medicine of the present invention (hereinafter to be referred as clear pestilence spirit) below in conjunction with embodiment.
The preparation of [embodiment] clear pestilence spirit spray
1. it is standby to take by weighing decoction pieces such as Radix Glycyrrhizae 15 grams, the Radix Astragali 5 grams, Herba Asari 5 grams, Olibanum 10 grams, Radix Salviae Miltiorrhizae 5 grams, Radix Angelicae Sinensis 5 grams, Radix Paeoniae Rubra 2 grams, Rhizoma Atractylodis 5 grams.
2. place extraction pot to add 10 times of water gagings, decoct three hour time, remove slag and get supernatant, add ethanol to 70%, decontamination carries out purification, goes precipitation to receive supernatant again, and reduction vaporization removes ethanol, get medicinal liquid after the plain film clarification of 0.45u aperture fibers, heat sterilization promptly gets the clear medicinal liquid.Add sterile distilled water and be made into 40% medicinal liquid, medicinal liquid is brown yellow transparent liquid, in the aseptic subpackaged spray bottle, and every bottle of 10-20ml.
3. do antivirus test before the packing and measure biological activity, the resisiting influenza virus index reached is less than requiring, and medicinal liquid is discarded.
The test of [test example 1] clear pestilence spirit spray resisiting influenza virus
1. test material
1) medicine of the present invention " clear pestilence spirit spray " three batches (04-1,04-2,04-3), liquor strength is 40% (crude drug W/V)
2) Influenza A1 virus strain A1/NEW CALEDONIA-Nat'l Pharmaceutical ﹠ Biological Products Control Institute provides
3) Influenza B virus strain B/SHANG DONG-Nat'l Pharmaceutical ﹠ Biological Products Control Institute provides
4) instar chicken embryo-Changchun Biological Products Institute on the 11st provides
5) 1% Sanguis Gallus domesticus ball suspension
2. test method
1) with the medicinal liquid is diluent, dilute first 1 type and Influenza B virus respectively by 10 times of serial dilutions, be medicinal liquid and viral mixed liquor, put room temperature 40 minutes, routinely mixed liquor is seeded in the chick embryo allantoic cavity then, hatched three for 37 ℃, put 4 ℃ of cold embryos again, get every embryo urine next day and 1% Sanguis Gallus domesticus ball suspension is done blood agglutination test, blood clotting positive person proof has virus multiplication, feminine gender promptly prove virus killed virus-free seedlings by medicinal liquid.Do simple virus control simultaneously, calculate inactivation of viruses amount (inactivation of viruses amount EID 50=simple virus control EID 50-medicinal liquid adds viral mixed liquor EID 50But, be the EID of 0.2ml medicinal liquid inactivation of viruses 50Number)
2) by 2 times of serial dilutions clear pestilence spirit spray is diluted to the medicinal liquid of variable concentrations, with 200 EID 50First 1 type virus is mixed, and room temperature effect 40 minutes is carried out hemagglutination test as stated above and surveyed its deactivation to virus, calculates the EC of clear pestilence spirit spray medicinal liquid then 50(medium effective concentration) and EC 90(90% valid density).
3. result of the test
1) clear pestilence spirit spray does not have any toxic action to Embryo Gallus domesticus.The results are shown in Table 1.
The clear pestilence spirit of table 1 spray is to the toxic action of Embryo Gallus domesticus
The medicinal liquid lot number The inoculated into chick embryo number Every embryo inoculum concentration Hatch work in 3 days and deposit the embryo number Conclusion
04-1 04-2 04-3 5 5 5 0.2ml 0.2ml 0.2ml 5 5 5 Nontoxic nontoxic
2) clear pestilence spirit spray medicinal liquid is to the deactivation of Influenza A1 virus, and strain is A1/NEWCALEDONIA, to the deactivation of Influenza A1 virus all 10 6EID 50More than.Deactivation the results are shown in Table 2.
The clear pestilence spirit of table 2 spray medicinal liquid is to the deactivation of Influenza A1 virus
The medicinal liquid lot number Every dilution factor inoculation embryo number Inoculate back 3 days urine blood clotting number positive Remaining virus quantity (EID 50 /0.2ml) Inactivation of viruses amount (EID 50)
10 -1 10 -2 10 -3 10 -4 10 -5 10 -6 10 -7 10 -8
04-1 4 0/4 0/4 0/4 - - - - - ＜10 1 ＞10 6.75
04-2 4 0/4 0/4 0/4 - - - - - ＜10 1 ＞10 6.75
04-3 4 0/4 0/4 0/4 - - - - - ＜10 1 ＞10 6.75
The Influenza A1 virus contrast 4 - - - - 4/4 4/4 1/4 0/4 10 7.75
The ※ denominator is each inoculation embryo number, and molecule is a urine blood clotting number positive, and "-" representative is not done.
3) clear pestilence spirit spray medicinal liquid is to the deactivation of Influenza B virus, and strain is B/SHANG DONG, to the deactivation of Influenza B virus all 10 5.5EID 50More than.Deactivation the results are shown in Table 3.
The clear pestilence spirit of table 3 spray medicinal liquid is to the deactivation of Influenza B virus
The medicinal liquid lot number Every dilution factor inoculation embryo number Inoculate back 3 days urine blood clotting number positive Remaining virus quantity (EID 50 /0.2ml) Inactivation of viruses amount (EID 50)
10 -1 10 -2 10 -3 10 -4 10 -5 10 -6 10 -7 10 -8
04-1 4 0/4 0/4 0/4 - - - - - ＜10 1 ＞＝10 5.75
04-2 4 0/4 0/4 0/4 - - - - - ＜10 1 ＞10 5.5
04-3 4 0/4 0/4 0/4 - - - - - ＜10 1 ＞10 5.75
The Influenza B virus contrast 4 - - - - 4/4 4/4 1/4 0/4 10 6.75
The ※ denominator is each inoculation embryo number, and molecule is a urine blood clotting number positive, and "-" representative is not done.
4) the clear pestilence spirit spray medicinal liquid of variable concentrations is surveyed deactivation to 200 Influenza A1 viruses, calculates EC 50(medium effective concentration) is 37.1mg/ml.EC 90(90% valid density) is 77.7mg/ml.The results are shown in Table 4.
The clear pestilence spirit of table 4 spray medicinal liquid is measured EC 50And EC 90Dosage (resisting influenza virus A 1 type)
The medicinal liquid lot number Drug level (mg/ml) Blood clotting number positive behind the different pharmaceutical mass action EC 50 mg/ml EC 90 mg/ml Average EC 50 mg/ml Average EC 90 mg/ml
Former times 1/2 1/4 1/8 1/16 1/32
04-1 400 0/4 0/4 0/4 0/4 1/4 3/4 34.6 75.0 37.1 77.7
04-2 400 0/4 0/4 0/4 0/4 1/4 2/4 33.8 70.6
04-3 400 0/4 0/4 0/4 0/4 2/4 3/4 43.0 87.5
The test of [test example 2] clear pestilence spirit spray antibacterium
1. test material
1) (04-3) liquor strength is 40% (crude drug W/V) to clear three batches of sprays of pestilence spirit for 04-1,04-2.
2) bloodthirsty property hemophilus influenza, staphylococcus aureus, A type Streptococcus hemolyticus etc., strain provides by Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
3) be suitable for the culture medium of different strain, provide for oneself.
4) plate.
5) stainless steel tube, internal diameter are 6.0mm, high 10mm.
6) ampicillin, North China Pharmaceutical Factory's product.
2. test method
1) preparation of bacteria suspension: get 24 hours cultures such as bloodthirsty property hemophilus influenza, staphylococcus aureus, A type Streptococcus hemolyticus, be suspended in the normal saline standby.
2) preparation of two dish: cut-off directly is the plate of 90mm, add the 20ml appropriate media, evenly be laid at the bottom of the dish, other gets an amount of culture medium heating and melting, adds an amount of bacterium liquid after being cooled to 50 ℃, shake up, every dish adds 5ml, evenly spreads out cloth as the bacterium layer, after cooling, equidistantly laying stainless steel tube (internal diameter 6.0mm, high 10mm) in every dish, to cover plate lid standby.
3) add medicinal liquid 150ul to be checked in each stainless steel tube, the steel pipe that only adds the 150ul normal saline fills negative control, and the ampicillin 150ul that adds variable concentrations fills positive control, will test plate and put 37 ℃ of cultivations after 24 hours, result of determination antibacterial ring occurs and promptly has been considered as bacteriostasis.
3. result of the test: clear pestilence spirit spray medicinal liquid has all showed bacteriostasis to bloodthirsty property hemophilus influenza, staphylococcus aureus, A type Streptococcus hemolyticus.Above-mentioned three kinds of antibacterials are the common pathogenic bacterium of upper respiratory tract, and especially bloodthirsty property hemophilus influenza is the main pathogens of epidemic encephalitis, and antibacterial ring can reach more than the 10mm, the results are shown in Table.
Table
The medicinal liquid lot number Liquor strength Inhibition zone diameter (meansigma methodss of three plates)
Bloodthirsty property hemophilus influenza Staphylococcus aureus A type Streptococcus hemolyticus
04-1 04-2 04-3 40％ 40％ 40％ 12 11 11.5 11 11.5 11 14 15 14.5
Ampicillin (positive control) 15ug 30ug 26 26 28 27.5
Normal saline (negative control) - - -
The no antibacterial ring of ※ "-" representative occurs.
The resisiting influenza virus test in the mice body of [test example 3] clear pestilence spirit spray
Infect white mice so that Mus lung influenza virus FM1 strain (Chinese Center for Disease Control (CDC) virus institute provided) to be provided,, observed the calculating mortality rate then 14 days with oral 4 days of the clever spray of clear pestilence.Do positive control with injection of interferon, its result shows that the mortality rate of this product is lower than interferon (interferon is one of antiviral drugs of generally acknowledging), that is to say that the effect of this product resisiting influenza virus is better than interferon.
The toxicological effect of [test example 4] clear pestilence spirit spray
This product to mice also avirulence, is done acute toxicity test with mice to Embryo Gallus domesticus avirulence (the results are shown in test example 1), and intravenously administrable is equivalent to 0.5g crude drug/kg, does not have toxicity.Oral administration is equivalent to the maximal dose of 200g crude drug/kg and does not see toxicity yet.More than one week, upper respiratory tract mucosas such as oral cavity, nasal mucosa not show are swollen to 4 successive administrations of rat administration every day, and are consistent with blank through the pathology detection, do not have any histopathology and change.
[clinical trial example 1] clear pestilence spirit spray is observed upper respiratory tract infection patient's therapeutic effect.
20 men and women patient that catches a cold, age 6-71 year, to bottleneck throat, nasal cavity spray medicine, every day 3-4 time, more than each 3-5 sprayed, after general 2 days, transference cures such as patient's nasal obstruction, rhinorrhea, laryngopharynx swelling and pain were fully recovered after 2-3 days with this product.
The effect observation of [clinical trial example 2] clear pestilence spirit spray treatment oral ulcer.
10 men and women's oral ulcer, gingival swelling and pain patient are stained with this product with cotton rod and smear affected part, every day 3-4 time, recovery from illness after 2 days.

Claims (3)

1. spray for treating influenza and preparation method thereof is characterized in that mainly being made up of following bulk drugs:
Radix Glycyrrhizae 0.5-2.5 part, Radix Astragali 0.5-3.0 part, Herba Asari 0.25-1.0 part, Olibanum 0.5-1.75 part, Radix Salviae Miltiorrhizae 0.5-2.5 part, Radix Angelicae Sinensis 0.5-2.0 part, Radix Paeoniae Rubra 0.2-0.5 part, Flos Carthami 0.2-1.0 part, Rhizoma Atractylodis 0.25-1.75 part.
2. medicine according to claim 1 is characterized in that the preferred amounts of described crude drug is: 1.5 parts in Radix Glycyrrhizae, 0.5 part of the Radix Astragali, 0.5 part of Herba Asari, 1.0 parts of Olibanums, 0.5 part of Radix Salviae Miltiorrhizae, 0.5 part of Radix Angelicae Sinensis, 0.2 part of Radix Paeoniae Rubra, 0.5 part on Flos Carthami, 0.5 part of Rhizoma Atractylodis.
3. according to the preparation method of right 1 described medicine, it is characterized in that comprising the following steps:
1) tcm and herbal slice of respectively distinguishing the flavor of need reach 2000 editions one ministerial standards of Chinese Pharmacopoeia;
2) take by weighing the prepared slices of Chinese crude drugs by prescription and add 10 times of water boil 3-4 hours, go sediment to receive supernatant;
3) add ethanol according to quantity, the ethanol ultimate density is 70%, roguing then;
4) receive supernatant, reduction vaporization removes ethanol;
5) with different aperture fibers film clarification degerming, add the liquor strength that sterile distilled water is made into requirement, be distributed into spray or oral liquid.
CNB2005100167867A 2005-05-16 2005-05-16 Spray for treating influenza and preparation method thereof Expired - Fee Related CN100406034C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102578288A (en) * 2012-02-29 2012-07-18 万勤劳 Healthcare bean curd sheet containing Chinese herbal medicine and production technology of healthcare bean curd sheet
CN102670712A (en) * 2012-06-04 2012-09-19 黄芸 Traditional Chinese medicine oral liquid for curing emphysema and preparation method thereof
CN104306453A (en) * 2014-11-04 2015-01-28 哈尔滨市海江科技开发有限公司 Traditional Chinese medicine composition for treating upper respiratory tract infection

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1166389C (en) * 2002-01-05 2004-09-15 谢华 Inhalation 'Shangfengjing' and its preparing process
CN1380098A (en) * 2002-05-20 2002-11-20 张勇飞 Anti-infection compound preparation and its preparation method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102578288A (en) * 2012-02-29 2012-07-18 万勤劳 Healthcare bean curd sheet containing Chinese herbal medicine and production technology of healthcare bean curd sheet
CN102670712A (en) * 2012-06-04 2012-09-19 黄芸 Traditional Chinese medicine oral liquid for curing emphysema and preparation method thereof
CN104306453A (en) * 2014-11-04 2015-01-28 哈尔滨市海江科技开发有限公司 Traditional Chinese medicine composition for treating upper respiratory tract infection

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