CN1159053C - Compoiste bear gall spray for treating rhinocleisis and its preparing process - Google Patents
Compoiste bear gall spray for treating rhinocleisis and its preparing process Download PDFInfo
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- CN1159053C CN1159053C CNB021137102A CN02113710A CN1159053C CN 1159053 C CN1159053 C CN 1159053C CN B021137102 A CNB021137102 A CN B021137102A CN 02113710 A CN02113710 A CN 02113710A CN 1159053 C CN1159053 C CN 1159053C
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- ethanol
- purified water
- radix angelicae
- tween
- angelicae dahuricae
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Abstract
The present invention relates to a compound bear gall spraying agent for treating rhinocleisis, which is composed of the following raw materials with the proportioning by weight: 3.0 to 5.0kg of fructus xanthil, 6.0 to 8.0kg of angelica dahurica, 0.8 to 1.2kg of bear gall powder, 2.8 to 3.2kg of natrii sulfas exsiccatus, 1.3 to 1.7kg of white vitriol (calcining), 0.15kg of borneol, 0.15kg of mentha camphor, 60kg of alcohol with the concentration of 95%, 0.3kg of sorbic acid, 1.5L of Tween 80, 1.2kg of sodium cyclamate, and 150L of purifying water. The prescription and the dosage form design of the present invention are reasonable, and the spraying agent directly acts on target organs without absorption of gastrointestinal tracts. The spraying agent can be safely used, and has the functions of obvious inflammation resistance, immunological function adjustment, bacterium resistance, analgesia and irritability resistance. The present invention relates to the spraying agent for treating rhinocleisis, which belongs to the traditional Chinese medicine; the spraying agent also has the advantages of unique dosage form, convenient use, accurate dosage, simple, convenient and controllable production process and reliable product quality.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine for the treatment of acute and chronic rhinitis, be specifically related to a kind of spray for the treatment of acute and chronic rhinitis, the invention still further relates to the preparation method of this medicine.
Background technology
As everyone knows, acute and chronic rhinitis is common frequently-occurring disease.Tradition nose therapy, as blow, inhale, jerk, plug, point, news, drip, smoke, be coated with, method such as wiping, all have zest, dose is difficult to control, the drug distribution inequality, shortcomings such as that medicine is easily gone into is pharyngeal, curative effect instability are so be difficult to extensive popularization.
The Chinese patent medicine of treatment acute and chronic rhinitis mainly contains following three classes at present: 1. be the oral liquid class of representative with the BIYUANSHU; 2. with the ' Biyanwan ' for treating rhinitis pill class of representative; 3. BIYANKANG tablet class.This three classes medicine is oral medication, needs to bring into play through gastrointestinal absorption the effect of treatment rhinitis, and the local blood drug level of nose is low, and produce effects is slower, and curative effect is not high.Owing to need to have certain untoward reaction through gastrointestinal absorption.
Summary of the invention
The objective of the invention is to solve above-mentioned medicine or therapy the curative effect instability, need through gastrointestinal absorption cause untoward reaction, the problems such as (nasal mucosa or nasal sinuses), dosage are inaccurate that can not directly act on target organ, and provide a kind of spray for the treatment of acute and chronic rhinitis and preparation method thereof.Its technology contents is as follows:
A kind of Chinese patent medicine for the treatment of acute and chronic rhinitis, make by the following weight proportion raw material:
Fructus Xanthii 3.0-5.0kg; Radix Angelicae Dahuricae 6.0-8.0kg; Fel Ursi powder 0.8-1.2kg;
Matrii Sulfas Exsiccatus 2.8-3.2kg; Calcine Alumen 1.3-1.7kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween 80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
The Chinese patent medicine formula that preparation the present invention treats acute and chronic rhinitis preferably than scope is:
Fructus Xanthii 4.0-5.0kg; Radix Angelicae Dahuricae 7.0-8.0kg; Fel Ursi powder 1.0-1.1kg;
Matrii Sulfas Exsiccatus 2.9-3.1kg; Calcine Alumen 1.4-1.5kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween 80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
The optimum weight proportioning that the present invention treats the Chinese patent medicine of acute and chronic rhinitis is:
Fructus Xanthii 4.5kg; Radix Angelicae Dahuricae 7.5kg; Fel Ursi powder 1.05kg;
Matrii Sulfas Exsiccatus 3.0kg; Calcine Alumen 1.5kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween 80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
The Chinese patent medicine of treatment acute and chronic rhinitis, wherein the weight proportion of each raw material is:
Fructus Xanthii 5.0kg; Radix Angelicae Dahuricae 8.0kg; Fel Ursi powder 1.2kg;
Matrii Sulfas Exsiccatus 3.2kg; Calcine Alumen 1.7kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween 80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
Above-mentioned each component is made the preparation method that the present invention treats the Chinese patent medicine of acute and chronic rhinitis is:
1) with Fructus Xanthii, Radix Angelicae Dahuricae pulverize separately, it is standby to sieve No. two sieves with concussion.
2) percolation method: adopt enamel percolation cylinder, end opening pad disc screen, compress with the bulk cobblestone, reuse fritter cobblestone is filled up, spread the absorbent cotton of about 2 cm thicks above, take by weighing Fructus Xanthii, the Radix Angelicae Dahuricae by prescription, even spreading, 70% soak with ethanol that is mixed with purified water, exceeding medical material face 3cm with liquid level of solution is advisable, after 24 hours, at room temperature, flow out the speed percolation of 3ml with every kg medical material per minute, be the about 36ml of per minute, lower discharge port is tied up double-deck silk, and the filtering suspension fiber is collected percolate; The percolation time is 37 hours, and temperature is 21-29 ℃ during the percolation.
3) concentrating and the ethanol recovery of percolate:
Adopt vacuum concentration equipment, in the control warm 60-65 ℃, vacuum-0.080-0.095Mpa, continuous concentration is to stop in 0.98-0.99 (attemperation is 20 ℃ during mensuration) time to concentrated solution density.Warp is to three batches of concentrated solution determination of alcohol content, and the result is 2.8%, 2.5%, 2.7%.Must control concentrated solution when producing later on and contain the alcohol amount, span of control can be defined as 2.5%-3.0%.Reclaim the about 40kg of ethanol, concentration is about 65%, must the about 28-30kg of concentrated solution.
4) a kind of preparation for the treatment of the spray of acute and chronic rhinitis:
Concentrated solution is added purified water to 135L, stir evenly, add recipe quantity calcine Alumen, Fel Ursi powder, Matrii Sulfas Exsiccatus, slowly be heated to moltenly, be cooled to room temperature then, left standstill 12 hours, use buchner funnel, fill up double-deck silk and do the filter material filtration, filtrate was left standstill 24 hours, use G
3Incipient fusion glass sand hourglass decompression fine straining gets stock solution; Take by weighing recipe quantity Borneolum Syntheticum, Mentholum, sorbic acid, use dissolve with ethanol, add tween 80, add in the stock solution behind the mix homogeneously, add cyclamate behind the mix homogeneously, stirring and dissolving is mended purified water to 150L, and mix homogeneously left standstill 24 hours, used G
3Incipient fusion glass sand hourglass decompression fine straining, packing promptly.
Major advantage of the present invention:
A, prescription and dosage form are reasonable in design, without gastrointestinal absorption, directly act on target organ, and be safe in utilization, almost do not see untoward reaction, through the second stage of clinical research confirmation.Confirm through pharmacodynamic study that in addition this product has tangible antiinflammatory action, regulates immunity function, antibacterial action, analgesic activity, anti-allergic effects.Confirm that through toxicologic study this product does not almost have acute toxicity, long term toxicity and zest.
B, to signs such as nasal obstruction sneeze, xeromycteria burning sensation, bitter taste in the mouth and dry throat, headache or giddy, nasal mucosa congestion and edema, nasal sinuses district pain, the improvement effect is all arranged.Be applicable to that tcm diagnosis is diseases caused by exogenous pathogenic factor ailment said due to cold or exposure and the damp and hot disease of liver, can remove most of acute and chronic rhinitis patients' misery.
C, this product are the Chinese medicine nasal spray, and its trade name can be compoiste bear gall spray for treating rhinocleisis, and its dosage form has uniqueness, and is easy to use, and dosage is accurate.In clinical research, be subjected to medical personnel and patient's favorable comment deeply.
D, finished product do not contain the destructible atmospheric ozone layer freon.Production process is almost pollution-free, is fit to middle-size and small-size pharmaceutical factory and produces.
F, production technology are easy, controlled, and reliable product quality has been set up perfect quality standard.Finished product stability is good.2 years effect duration.Very convenient in transportation, storage, sale, use.
Description of drawings
Fig. 1 is a process chart of the present invention.
The specific embodiment
One, optimum formula:
Prescription 1,10000 bottles in every material (cumulative volume 150L).
Fructus Xanthii 5.0kg Radix Angelicae Dahuricae 8.0kg Fel Ursi powder 1.2kg
Matrii Sulfas Exsiccatus 3.2kg calcine Alumen 1.7kg Borneolum Syntheticum 0.15kg
Mentholum 0.15kg 95% ethanol 60kg sorbic acid 0.3kg
Tween 80 1.5L cyclamate 1.2kg purified water adds to 150L
Prescription 2,10000 bottles in every material (cumulative volume 150L).
Fructus Xanthii 4.5kg Radix Angelicae Dahuricae 7.5kg Fel Ursi powder 1.05kg
Matrii Sulfas Exsiccatus 3.0kg calcine Alumen 1.5kg Borneolum Syntheticum 0.15kg
Mentholum 0.15kg 95% ethanol 60kg sorbic acid 0.3kg
Tween 80 1.5L cyclamate 1.2kg purified water adds to 150L
Prescription 3,10000 bottles in every material (cumulative volume 150L).
Fructus Xanthii 3.0kg Radix Angelicae Dahuricae 6.5kg Fel Ursi powder 0.8kg
Matrii Sulfas Exsiccatus 2.9kg calcine Alumen 1.3kg Borneolum Syntheticum 0.15kg
Mentholum 0.15kg 95% ethanol 60kg sorbic acid 0.3kg
Tween 80 1.5L cyclamate 1.2kg purified water adds to 150L
Two, preparation method:
Referring to accompanying drawing 1, optimization formula 2.
1, the pulverizing of medical material:
Adopt high speed disintegrator, control does not add screen cloth at a slow speed, and charging rate is per minute 200g.With Fructus Xanthii, Radix Angelicae Dahuricae pulverize separately, it is standby to sieve No. two sieves with concussion.Thick head is crushed to once more and sieves fully.Pulverize yield: Fructus Xanthii 98%, the Radix Angelicae Dahuricae 97%.
Qualifying point: pulverize back medical material fineness, all by No. two sieves.With No. two sub-sieve inspections.
2, percolation method: adopt 200L enamel percolation cylinder, end opening pad disc screen, compress with the bulk cobblestone, reuse fritter cobblestone is filled up, spread the absorbent cotton of about 2 cm thicks above, take by weighing Fructus Xanthii, the Radix Angelicae Dahuricae by prescription, even spreading, after 70% ethanol (purified water preparation) of (exceeding medical material face 3cm with liquid level of solution is advisable) soaks 24 hours in right amount, at room temperature, with the speed percolation (being the about 36ml of per minute) of every kg medical material per minute outflow 3ml, lower discharge port is tied up double-deck silk, the filtering suspension fiber is collected percolate.The actual collection about percolate 65kg, the percolation time is 37 hours, temperature is 21-29 ℃ during the percolation.
Qualifying point: percolation speed, concentration of alcohol (using), suspension fiber (use the test tube inspection, should not have tangible suspension fiber) than light table look-up.
3, concentrating and the ethanol recovery of percolate:
Adopt vacuum concentration equipment, interior warm 60-65 ℃ of control, vacuum-0.080-0.095Mpa, continuous concentration, when being 0.98-0.99 (attemperation is 20 ℃ during mensuration), concentrated solution density stops (because small amount of ethanol and water formation azeotropic mixture are arranged when being concentrated near terminal point, be difficult to remove fully, so concentrated solution density is less than 1).Warp is to three batches of concentrated solution determination of alcohol content, and the result is 2.8%, 2.5%, 2.7%.Must control concentrated solution when producing later on and contain the alcohol amount, span of control can be defined as 2.5%--3.0%.Reclaim the about 40kg of ethanol, concentration is about 65%, must the about 28-30kg of concentrated solution.
Qualifying point: concentrated solution contains alcohol amount (using than light table look-up), concentrated solution is received heavy, concentrated solution density (using than light table look-up).
4, a kind of preparation for the treatment of the Chinese patent medicine of acute and chronic rhinitis:
Concentrated solution is added purified water to 135L, stir evenly, add recipe quantity calcine Alumen, Fel Ursi powder, Matrii Sulfas Exsiccatus, slowly be heated to moltenly, be chilled to room temperature then, left standstill 12 hours,, filtrate was left standstill 24 hours, use G with buchner funnel (fill up double-deck silk and make filter material) filtration
3Incipient fusion glass sand hourglass decompression fine straining gets stock solution; Take by weighing recipe quantity Borneolum Syntheticum, Mentholum, sorbic acid, with ethanol 4.5L dissolving, add tween 80 1.5L, add behind the mix homogeneously in the stock solution, add cyclamate 1.2kg behind the mix homogeneously, stirring and dissolving is mended purified water to 150L, and mix homogeneously left standstill 24 hours, used G
3Incipient fusion glass sand hourglass decompression fine straining, packing promptly.
Qualifying point: heating for dissolving time, half-finished float inspection (use the test tube inspection, should not have obvious float), semi-finished product pH behind adding recipe quantity calcine Alumen, Fel Ursi powder, the Matrii Sulfas Exsiccatus control (should be 3.5-5.5).
The washing of plastic bottle: with body and cap sleeve separately, clean respectively once with drinking water earlier, clean once with purified water respectively again, use 75% soak with ethanol 5 minutes at last, take out, body handstand sabot, the direct sabot of cap sleeve, it is air-dry, standby to put the toilet.
Qualifying point: washing back cleannes inspection.Method is: get the soak after last 75% soak with ethanol, put in the test tube, press the inspection of clarity test method, should not have float, fiber or other foreign body above 1mm.If any, should relaunder, until passed examination.
Canning means: produce and adopt liquid-filling machine.
Qualifying point: loading quantity inspection.Check that by the minimum fill inspection technique every bottled amount should be not less than 15ml.
Existing manufacturing condition: pulverizing, percolation, be concentrated in general production area and carry out.Be formulated under the sterilizing room condition and carry out.Fine straining carries out in the super-clean bench of sterilizing room.18-24 ℃ of control room temperature, relative humidity 45-65%.
Beneficial effect:
1, Chinese prescription is reasonable in design, without gastrointestinal absorption, directly acts on target organ, uses peace Entirely, almost have no bad reaction. In Chengdu City No.1 People's Hospital, three institutes, that nine institutes carry out the second phase is clinical Checking, totally 160 routine clinical trials are observed, treatment group 100 examples wherein, BIYUANSHU KOUFUYE control group 60 Example, the result: the total effective rate of this product is 93.0%, control group total effective rate 85.0%. From recovery from illness and produce effects Rate compares, and this product is 76%, and control group is 55%, through X2Checking, P＜0.05, treatment group is better than control group. Evaluation through by National Drug Administration is about to give an written reply accurate font size medicine.
2, to nasal obstruction sneeze, xeromycteria burning heat sensation, bitter taste in the mouth and dry throat, headache or giddy, the congested water of schneiderian membrane The signs such as swollen, nasal sinus district pain all are improved effect. Be applicable to that tcm diagnosis is that diseases caused by external factors ailment said due to cold or exposure and liver are wet The disease of heat.
3, this product is the Chinese medicine nasal spray, and formulation has uniqueness, and is easy to use, and dosage is accurate.
4, do not use the destructible atmospheric ozone layer freon, production process is almost pollution-free.
5, production technology is easy, controlled, reliable product quality, and finished product stability is good. The term of validity 2 years.
Claims (5)
1, a kind of spray for the treatment of acute and chronic rhinitis is characterized in that it is to be made by the following weight proportion raw material:
Fructus Xanthii 3.0-5.0kg; Radix Angelicae Dahuricae 6.0-8.0kg; Fel Ursi powder 0.8-1.2kg;
Matrii Sulfas Exsiccatus 2.8-3.2kg; Calcine Alumen 1.3-1.7kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween--80 1.5 L; Cyclamate 1.2kg; Purified water adds to 150L.
2, Chinese patent medicine according to claim 1, wherein the weight proportion of each raw material is:
Fructus Xanthii 4.0-5.0kg; Radix Angelicae Dahuricae 7.0-8.0kg; Fel Ursi powder 1.0-1.1kg;
Matrii Sulfas Exsiccatus 2.9-3.1kg; Calcine Alumen 1.4-1.5kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween--80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
3, Chinese patent medicine according to claim 2, wherein the weight proportion of each raw material is:
Fructus Xanthii 4.5kg; Radix Angelicae Dahuricae 7.5kg; Fel Ursi powder 1.05kg;
Matrii Sulfas Exsiccatus 3.0kg; Calcine Alumen 1.5kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween--80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
4, Chinese patent medicine according to claim 1, wherein the weight proportion of each raw material is:
Fructus Xanthii 5.0kg; Radix Angelicae Dahuricae 8.0kg; Fel Ursi powder 1.2kg;
Matrii Sulfas Exsiccatus 3.2kg; Calcine Alumen 1.7kg; Borneolum Syntheticum 0.15kg;
Mentholum 0.15kg; 95% ethanol 60kg; Sorbic acid 0.3kg;
Tween--80 1.5L; Cyclamate 1.2kg; Purified water adds to 150L.
5, according to the spray preparing process of claim 1,2,3 or 4 described treatment acute and chronic rhinitis, it is characterized in that comprising:
1) with Fructus Xanthii, Radix Angelicae Dahuricae pulverize separately, it is standby to sieve No. two sieves with concussion;
2) percolation method: adopt enamel percolation cylinder, end opening pad disc screen, compress with the bulk cobblestone, reuse fritter cobblestone is filled up, spread the absorbent cotton of about 2 cm thicks above, take by weighing Fructus Xanthii, the Radix Angelicae Dahuricae by prescription, even spreading is mixed with 70% soak with ethanol with purified water, exceeding medical material face 3cm with liquid level of solution is advisable, after 24 hours, at room temperature, flow out the speed percolation of 3ml with every kg medical material per minute, be the about 36ml of per minute, lower discharge port is tied up double-deck silk, and the filtering suspension fiber is collected percolate; The percolation time is 37 hours, and temperature is 21-29 ℃ during the percolation;
3) concentrating and the ethanol recovery of percolate:
Adopt vacuum concentration equipment, in the control warm 60-65 ℃, vacuum-0.080-0.095Mpa, continuous concentration stops during for 0.98-0.99 to concentrated solution density, and attemperation is 20 ℃ during mensuration;
4) a kind of preparation for the treatment of the spray of acute and chronic rhinitis:
Concentrated solution is added purified water to 135L, stir evenly, add recipe quantity calcine Alumen, Fel Ursi powder, Matrii Sulfas Exsiccatus, slowly be heated to moltenly, be chilled to room temperature then, left standstill 12 hours, use buchner funnel, fill up double-deck silk and do the filter material filtration, filtrate was left standstill 24 hours, use G
3Incipient fusion glass sand hourglass decompression fine straining gets stock solution; Take by weighing recipe quantity Borneolum Syntheticum, Mentholum, sorbic acid, the dissolve with ethanol with 95% adds tween 80, adds in the stock solution behind the mix homogeneously, adds cyclamate behind the mix homogeneously, and stirring and dissolving is mended purified water to 150L, and mix homogeneously left standstill 24 hours, used G
3Incipient fusion glass sand hourglass decompression fine straining, packing promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021137102A CN1159053C (en) | 2002-04-30 | 2002-04-30 | Compoiste bear gall spray for treating rhinocleisis and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021137102A CN1159053C (en) | 2002-04-30 | 2002-04-30 | Compoiste bear gall spray for treating rhinocleisis and its preparing process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1381255A CN1381255A (en) | 2002-11-27 |
| CN1159053C true CN1159053C (en) | 2004-07-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB021137102A Expired - Lifetime CN1159053C (en) | 2002-04-30 | 2002-04-30 | Compoiste bear gall spray for treating rhinocleisis and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1159053C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101244101B (en) * | 2008-02-29 | 2010-07-14 | 孙相如 | Chinese medicine composition for curing rhinitis |
| CN114903943A (en) * | 2022-06-22 | 2022-08-16 | 重庆科瑞制药(集团)有限公司 | Compound bear gall nose-clearing spray and preparation method thereof |
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2002
- 2002-04-30 CN CNB021137102A patent/CN1159053C/en not_active Expired - Lifetime
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| Publication number | Publication date |
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| CN1381255A (en) | 2002-11-27 |
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Owner name: CHONGQING KERUI PHARMACEUTICAL (GROUP) CO., LTD. Free format text: FORMER NAME: KERUI PHARMACEUTICAL CO LTD, CHONGQING |
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Address after: 400064 No. 2 Dashi branch, economic and Technological Development Zone, Nan'an District, Chongqing Patentee after: Chongqing Kerui Pharmaceutical (Group) Co., Ltd. Address before: 400064 No. 70 Haitang new street, Nan'an District, Chongqing Patentee before: Kerui Pharmaceutical Co., Ltd., Chongqing |
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