CN1814011A - Medicine composition for treating upper respiratory tract inflammation, preparing method, quality control method and use - Google Patents
Medicine composition for treating upper respiratory tract inflammation, preparing method, quality control method and use Download PDFInfo
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- CN1814011A CN1814011A CN 200510020325 CN200510020325A CN1814011A CN 1814011 A CN1814011 A CN 1814011A CN 200510020325 CN200510020325 CN 200510020325 CN 200510020325 A CN200510020325 A CN 200510020325A CN 1814011 A CN1814011 A CN 1814011A
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- herba houttuyniae
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Abstract
The present invention provides a medicine composition for curing upper respiratory tract infection. It is a preparation made up by using houttuynia volatile oil as active component, adding proper auxiliary components through a certain preparation process. In the houttuynia volative oil the methyl-n-nonylketone is contained. Said preparation can be made into various dosage forms, including injection and oral preparation.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of upper respiratory tract infection, particularly, is to be the pharmaceutical composition that active component is prepared from the Chinese medicine Herba Houttuyniae volatile oil.
Background technology
Herba Houttuyniae (Houttuynia cordata Thunb.) is a herbaceos perennial, but medicated diet is dual-purpose, and effective ingredient is mainly the houttuynine sodium bisulfite (houttuyninum) in the volatile oil, the tool heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome, hemostatic analgesia, the effect of cough-relieving has very strong antibiotic and antivirus action.More to Herba Houttuyniae chemical constitution study report at present, as: the chemical constituent of Herba Houttuyniae volatile oil, plant resources and environment journal, 2003,12 (3), reported several different methods extract the method for volatile oil in the Herba Houttuyniae (steam distillation, organic solvent extraction method, supercritical CO 2 extraction, the index components content that the whole bag of tricks is measured has nothing in common with each other, the mode of evaluation quality is also inequality.The research recent developments of Herba Houttuyniae injectio, Chinese medicine Leader, Hunan, the 1st volume, has reported that Herba Houttuyniae volatile oil adopts steam distillation to extract and clinical application in October, 1994.The clinical practice of Herba Houttuyniae injectio, Chinese Medicine and clinical, October in 2002, the 2nd the 5th phase of volume disclosed the clinical multiple use of Herba Houttuyniae injectio.But,, still do not have the relevant report of Herba Houttuyniae quality control at present and be the relevant report of the peroral dosage form treatment upper respiratory tract infection that is prepared from of active component with the Herba Houttuyniae volatile oil because the prescription of injection is higher.
Summary of the invention
The invention provides a kind of pharmaceutical composition for the treatment of upper respiratory tract infection, it is to be the preparation that active component is prepared from by Herba Houttuyniae volatile oil, and the present invention also provides this preparation of drug combination method and method of quality control, purposes.
The invention provides a kind of pharmaceutical composition for the treatment of upper respiratory tract infection, it is characterized in that: it is to be active component by Herba Houttuyniae volatile oil, add the preparation that acceptable accessories or complementary composition are prepared from, wherein contain methylnonanone Methyl-n-nonylketone in the Herba Houttuyniae volatile oil.
Wherein, described preparation is oral formulations, injection.
Described oral formulations is soft capsule, drop pill.
Wherein, described injection is injection, powder pin, infusion solutions, freeze-dried powder.
The present invention also provides a kind of method for quality of controlling this pharmaceutical composition, it is characterized in that: it is to adopt the mode of high effective liquid chromatography for measuring finger printing to carry out quality control.
The present invention also provides a kind of method for preparing this pharmaceutical composition, it is characterized in that: described injection is to be prepared by following steps:
A, get Herba Houttuyniae and put into volatile oil extractor, vapor distillation is collected Herba Houttuyniae volatile oil;
B, get Herba Houttuyniae volatile oil, stirring adds down in the Herba Houttuyniae distillate, adds the tween 80 stirring and evenly mixing, regulates pH value 5.7～5.9, adds the sodium chloride stirring and dissolving, fine straining, and embedding, sterilization promptly gets injection of the present invention.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation oral medication viral upper respiratory tract infection.
The present invention also provides the purposes of pharmaceutical composition in the medicine of preparation intramuscular injection, intravenous injection treatment viral upper respiratory tract infection.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation treatment of urinary tract infections.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation treatment acquired immune deficiency syndrome (AIDS).
Herba Houttuyniae preparation provided by the invention is the index composition with the methylnonanone, control the Herba Houttuyniae volatile oil preparation of the inventive method preparation effectively, steady quality, controllability are strong, the present invention also provides the different dosage form of Herba Houttuyniae preparation, comprise injection and oral formulations, satisfying clinical different needs, is the new selection of clinical treatment upper respiratory tract infection medicine.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Experimentation Herba Houttuyniae volatile oil extraction process technology Study on Conditions
1. the investigation of water absorption rate
Vegetable drug all has the ability of absorption solvent in various degree, and the big young pathbreaker who absorbs the solvent amount influences the effect of extraction.Therefore, bright Herba Houttuyniae is carried out the investigation of water absorption rate.
Get Herba Houttuyniae 1000g, add 2 times of amounts of water, soak after 1 hour.Filter, the weighing medical material, heavy 1150g, then water absorption rate is:
Herba Houttuyniae is fresh medical material, and its water absorption rate is lower, can ignore.
2. amount of water is to the influence of volatile oil collecting amount
If three groups of A, B, C get bright Herba Houttuyniae (herb) 1000g for every group.The water that A group, B group, C group add 1 times, 2 times, 3 times amount respectively extracts volatile oil under the same conditions, measures the volatilization oil mass of extraction in 0.5 to 4.5 hour, the results are shown in Table 1.
Table 1 amount of water is to the influence of volatile oil receipts amount
| Time (h) | 1 | 1.5 | 2 | 2.5 | 3 | 3.5 | 4 | 4.5 |
| A group (ml) B group (ml) C group (ml) | 0.14 0.15 0.12 | 0.22 0.23 0.25 | 0.28 0.28 0.30 | 0.3 0.34 0.32 | 0.31 0.34 0.33 | 0.31 0.35 0.34 | 0.32 0.35 0.34 | 0.32 0.35 0.34 |
The result shows: amount of water is that the volatile oil receipts amount of 2 times of groups is higher than 1 times of group and 3 times of groups.Therefore, volatile oil extracts and is advisable with the water that adds 2 times of amounts.
3. extraction time is to the influence of volatile oil collecting amount
The extraction time deficiency of volatile oil then can not be extracted fully; Extraction time too again energy charge man-hour, prolongs the production cycle, therefore is necessary the extraction time of volatile oil is investigated.As can be seen from Table 1, when extraction time was 2.5 hours, gained volatile oil had accounted for more than 95% of total receipts oil mass (in 4.5 hours).Be energy savings, shorten the production cycle, will be decided to be 2.5 hours extraction time.
4. Herba Houttuyniae different parts volatile oil collecting amount and finger printing comparative study
Get fresh fish raw meat grass subterraneous stem (A), the aerial stem of plant (B), each 1000g of leaf (C), add 2 times of water gagings respectively, distillation extraction 2.5 hours.Measurement collection volatile oil situation sees Table 2
Table 2 Herba Houttuyniae different parts volatile oil collecting amount relatively
| Time (h) | 1 | 1.5 | 2 | 2.5 | 3 | 3.5 | 4 | 4.5 |
| A group (ml) B group (ml) C group (ml) | 0.26 0.03 0.08 | 0.55 0.05 0.12 | 0.70 0.05 0.12 | 0.74 0.05 0.12 | 0.76 0.05 0.12 | 0.76 0.05 0.12 | 0.77 0.05 0.12 | 0.77 0.05 0.12 |
The result shows: stem portion is collected the volatilization oil mass and is 0.74ml/1000g at most under the fresh fish raw meat meadow, and leaf is partly collected the volatilization oil mass and taken second place and be 0.12ml/1000g, and the aerial stem of plant collects partly that the volatilization oil mass is minimum to be 0.05ml/1000g.
5. the different collecting time volatile oil of Herba Houttuyniae collecting amount research
Get the bright Herba Houttuyniae herb (A) of gathering May, July bright Herba Houttuyniae herb (B), August each 1000g of bright Herba Houttuyniae herb (C) that gathers that gathers, add 2 times of water gagings, distillation extraction 2.5 hours.Measurement collection volatile oil situation sees Table 3
The different collecting time volatile oil of table 3 Herba Houttuyniae collecting amount relatively
| Time (h) | 2.5 |
| A group (ml) B group (ml) C group (ml) | 0.29 0.31 0.60 |
Different collecting time Herba Houttuyniae volatile oil collecting amounts have certain difference, through further analyzing, think that different collecting time Herba Houttuyniae volatile oil collecting amounts have the different collecting time subterraneous stems with Herba Houttuyniae of certain difference, relevant with the ratio of aerial parts.The aerial parts large percentage of gathering in May, July, the volatile oil collecting amount is relatively low; The aerial parts ratio of gathering August is less, and the volatile oil collecting amount is higher.
5, the stability study of Herba Houttuyniae volatile oil
If four groups of A, B, C, D get same crowd Herba Houttuyniae volatile oil 5ml for every group and be loaded in the tool plug volumetric flask, do 030501,030,701 two batch of Herba Houttuyniae volatile oil parallel sample simultaneously.37 ℃ of A group sealings are deposited, B group closed chamber is gentlely put, 0-5 ℃ of C group sealing deposited, the D group is opened wide 60 ℃ and deposited, and place respectively 2 months, provide fingerprint atlas detection method and similarity calculating method to measure finger printing and calculate similarity by research unit in every month.The results are shown in Table 4
The different storage requirements of table 4 are to the Herba Houttuyniae volatile oil stability influence
| Time (moon) | 0 | 1 | 2 |
| A1 group (similarity) B1 group (similarity) C1 group (similarity) D1 group (similarity) | 1 1 1 1 | 0.99 0.99 0.99 0.75 | 0.99 0.99 0.99 |
| A2 group (similarity) B2 group (similarity) C2 group (similarity) D2 group (similarity) | 1 1 1 1 | 0.99 0.99 0.99 0.70 | 0.99 0.98 0.99 --- |
Annotate: the collection of illustrative plates during with 0 month is the similarity situation that contrast is calculated.
"---" represent that sample loses, detect.
Show from each storage requirement testing result of 2 batch samples: Herba Houttuyniae volatile oil adopts that closed chamber is gentle to be put and seal 0-5 ℃ and deposited 2 months, provide fingerprint atlas detection method and similarity calculating method to measure finger printing and calculate similarity by research unit, the quality situation is all stable.
6 Herba Houttuyniae volatile oil quality standard researches
Herba Houttuyniae volatile oil quality standard research data is waited to replenish.
The research of 7 preparing process
7.1 the research of preparing process technical conditions
Compound method: measure Herba Houttuyniae volatile oil 0.5ml, stirring adds down in the 40000 ml Herba Houttuyniae distillates, adds 120g tween 80 stirring and evenly mixing, regulate pH value 5.7～5.9 with 10% citric acid or 10% sodium citrate, add 360g sodium chloride stirring and dissolving, fine straining, embedding, sterilization.
The ratio of Herba Houttuyniae volatile oil and Herba Houttuyniae distillate when 1. preparing.Whether content, other quality index with preparation sample methylnonanone meet the index that existing quality standard is the measurement process conditions.Design A group, B group, C group, D group, E group, F group are respectively the 1ml Herba Houttuyniae volatile oil and add in 10,000 ml, 20,000 ml, 30,000 ml, 40,000 ml, 60,000 ml, the 80000 ml Herba Houttuyniae distillates, preparation Herba Houttuyniae injectio sample, and embedding, sterilization back testing result sees Table 5
Table 5 volatile oil and Herba Houttuyniae distillate different proportion preparation sample quality
| Quality index | Character | Differentiate | Methylnonanone content |
| A group B group C group D group E group F group | Qualified qualified | Qualified qualified | 12.3ug/ml 6.5ug/ml 3.9ug/ml 2.5ug/ml 1.5ug/ml 0.9ug/ml |
The result shows: D group sample quality is more consistent with existing injection, and promptly the 0.5ml Herba Houttuyniae volatile oil adds in the 40000 ml Herba Houttuyniae distillates and is formulated as optimal proportion.With determining ratio more than the different batches Herba Houttuyniae volatile oil repeated authentication.A group, B group, C group are blent preparation with Herba Houttuyniae volatile oil 030501,030701,030801 respectively.The results are shown in Table 6
Table 6 different batches Herba Houttuyniae volatile oil is to determine ratio preparation sample quality
| Quality index | Character | Differentiate | Check | Methylnonanone content |
| A group B group C group | Qualified qualified | Qualified qualified | Qualified qualified | 2.4ug/ml 2.6ug/ml 2.8ug/ml |
Be formulated as 40,000 ml quality situations from 3 batches of different batches Herba Houttuyniae volatile oils in definite ratio 0.5ml and can illustrate tentatively that this configuration proportion is more stable.
The addition of solubilizing agent tween 80 and adding order when 2. preparing.Whether content, other quality index with preparation sample methylnonanone meet the index that existing quality standard is the measurement process conditions.If A group, B group C group, D group add tween 80 respectively when preparation be 0.2%, 0.3%, 0.4%, 0.5% of amount of preparation.Adding tween 80 before the Herba Houttuyniae volatile oil adding Herba Houttuyniae distillate is 1; Adding tween 80 behind the Herba Houttuyniae volatile oil adding Herba Houttuyniae distillate is 2.Preparation Herba Houttuyniae injectio sample, embedding, sterilization back testing result sees Table 7
The tween 80 of table 7 different proportion and adding sequencing are to the influence of preparation sample quality
| Quality index | Character | Differentiate | Check | Methylnonanone content |
| A1 group B1 group C1 group D1 group A2 group B2 group C2 group D2 group | Qualified | Qualified | The defective qualified qualified clarity of clarity is defective qualified qualified | 2.4ug/ml 2.6ug/ml 2.8ug/ml 2.5ug/ml 2.8ug/ml 2.9ug/ml 3.0ug/ml 2.7ug/ml |
The result shows: when adding amount of preparation 0.2% tween 80, preparation sample clarity is all defective, and promptly solubilizing effect can not reach requirement.Add all qualified the least possible additives that add of intravenous injection liquid product of considering of amount of preparation 0.3%～0.5 tween 80 preparation sample, the tween 80 consumption is defined as 0.3% of amount of preparation.The adding sequencing that can get tween 80 from last table is considered the convenience of operation to solubilizing effect and the not obviously influence of preparation sample quality, and volatile oil adds tween 80 after adding in the Herba Houttuyniae distillate again.
Claims (10)
1, a kind of pharmaceutical composition for the treatment of upper respiratory tract infection, it is characterized in that: it is to be active component by Herba Houttuyniae volatile oil, add the preparation that acceptable accessories or complementary composition are prepared from, wherein contain methylnonanone Methyl-n-nonylketone in the Herba Houttuyniae volatile oil.
2, pharmaceutical composition according to claim 1 is characterized in that: described preparation is oral formulations, injection.
3, pharmaceutical composition according to claim 2 is characterized in that: described oral formulations is soft capsule, drop pill.
4, pharmaceutical composition according to claim 2 is characterized in that: described injection is injection, powder pin, infusion solutions, freeze-dried powder.
5, a kind of method for quality of controlling the described pharmaceutical composition of claim 4 is characterized in that: described injection is to adopt the mode of high effective liquid chromatography for measuring finger printing to carry out quality control.
6, a kind of method for preparing the described pharmaceutical composition of claim 4 is characterized in that: described injection is to be prepared by following steps:
A, get Herba Houttuyniae and put into volatile oil extractor, vapor distillation is collected Herba Houttuyniae volatile oil;
B, get Herba Houttuyniae volatile oil, stirring adds down in the Herba Houttuyniae distillate, adds the tween 80 stirring and evenly mixing, regulate pH value 5.7～5.9 with 10% Chinese holly Citron acid or 10% Chinese holly Citron acid sodium, add the sodium chloride stirring and dissolving, fine straining, embedding, sterilization promptly gets injection of the present invention.
7, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation oral medication viral upper respiratory tract infection.
8, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation intramuscular injection, intravenous injection treatment viral upper respiratory tract infection.
9, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment of urinary tract infections.
10, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment acquired immune deficiency syndrome (AIDS).
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| CN 200510020325 CN1814011B (en) | 2005-02-04 | 2005-02-04 | Preparing method of injection for treating upper respiratory tract inflammation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766725A (en) * | 2010-03-09 | 2010-07-07 | 四川省中医药科学院 | Anti-inflammatory and antiviral medicine |
| CN102266420A (en) * | 2011-07-21 | 2011-12-07 | 湖南正清制药集团股份有限公司 | Method for preparing heartleaf houttuynia herb injection |
| CN102462771A (en) * | 2010-11-18 | 2012-05-23 | 裘建社 | Preparation method of traditional Chinese medicine houttuynia cordata injection |
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2005
- 2005-02-04 CN CN 200510020325 patent/CN1814011B/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766725A (en) * | 2010-03-09 | 2010-07-07 | 四川省中医药科学院 | Anti-inflammatory and antiviral medicine |
| CN102462771A (en) * | 2010-11-18 | 2012-05-23 | 裘建社 | Preparation method of traditional Chinese medicine houttuynia cordata injection |
| CN102266420A (en) * | 2011-07-21 | 2011-12-07 | 湖南正清制药集团股份有限公司 | Method for preparing heartleaf houttuynia herb injection |
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| CN1814011B (en) | 2011-02-09 |
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