CN104983876B - A kind of cordate houttuynia eye drops and preparation method thereof - Google Patents
A kind of cordate houttuynia eye drops and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of cordate houttuynia eye drops and preparation method thereof, cordate houttuynia eye drops be by houttuynia extract be active constituent, in addition pharmaceutically acceptable eye-drops preparations auxiliary material is prepared, contain 1~10 μ g/ml of methylnonanone in the houttuynia extract, 4 terpineol, 0.1~10 μ g/ml, 0.01~2.5 μ g/ml of ɑ terpinols, 0.01~2.5 μ g/ml of Bronyl acetate.The preparation method of cordate houttuynia eye drops includes the following steps：Immersion, distillation, redistillation and addition auxiliary material.It is eye drops definite ingredients provided by the invention, stable quality, controllable；There is preparation method easy to operate, preparation conveniently, suitable for industrialization to mass produce.
Description
Technical field
The invention belongs to drug fields, and in particular to a kind of cordate houttuynia eye drops and preparation method thereof.
Background technology
Cordate houttuynia is that the band root of Saururaceae herbaceos perennial heartleaf houttuynia Houttuynia cordata Thunb. is complete
Grass, famous root of picking up the ears, purple Ji, hog snout hole, Rhizoma Rohdeae Japonicae etc., Fresh Plants have pungent bad smell after crushing, be distributed widely in
Central China, each provinces and regions in the southeast and southwest, are saved in the majority with Hunan, Hubei, Sichuan, Jiangsu etc. especially.Cordate houttuynia have it is clearing heat and detoxicating,
The effect of carbuncle that disappears apocenosis, inducing diuresis for treating strangurtia, is clinically used for the diseases such as lung carbuncle pyemesis, phlegm heat panting cough, hot dysentery, heat gonorrhea, carbuncle sore tumefacting virus.Research
Show in cordate houttuynia containing ingredients such as volatile ingredient, flavonoids, organic acid, sterols, alkaloids.Cordate houttuynia mainly with
For vegetable consumption, complete stool fresh or dried can be used as medicine for young stem and leaf and subterranean stem work, is formally determined as " both by health ministry
Be drug, and be food " one of the resource of great exploitation potential, be increasingly subject to the concern of people.
Cordate houttuynia eye drops are prepared by steam distillation, and main component is its volatile ingredient.Currently for fish
The report of raw meat grass eye-drops preparations has：Cao Jun is bis- etc., the pharmacological action and clinical practice of cordate houttuynia, modern combination of Chinese tradiational and Western medicine magazine,
2001,10 (6), disclosing cordate houttuynia has the purposes for the treatment of ophthalmology disease, and wherein main component herb contains volatile oil
0.0049%, there are kind of decanoy acetaldehyde containing antimicrobial component (i.e. decanoyl acetaldehyde) methylnonanone, laurene, capric acid etc., still contain and whether there is
For example potassium chloride, potassium sulfate, cordarine, flower spike, fruit ear are containing isoquercitrin for machine salt, and leaf is containing quercitin etc..Above-mentioned report is merely illustrative
The main component of cordate houttuynia, due to crude drug complicated component, it is impossible to it determines to play the specific ingredient of drug effect, the preparation of preparation
Quality is difficult to control, it is also difficult to find suitable index components and be effectively controlled.
Invention content
The shortcomings that it is an object of the invention to overcome the prior art, provides a kind of cordate houttuynia eye drops, the eye drops ingredient
Clearly, stable quality, controllable；
Another object of the present invention is to provide the preparation method of the eye drops, this method is easy to operate, it is convenient, suitable to prepare
It is mass produced for industrializing.
The purpose of the present invention is achieved through the following technical solutions：A kind of cordate houttuynia eye drops, it is extracted by cordate houttuynia
Object is active constituent, in addition pharmaceutically acceptable eye-drops preparations auxiliary material is prepared, contains first in the houttuynia extract
Base positive 1~10 μ g/ml, 4- terpineol of nonanone, 0.1~10 μ g/ml, 0.01~2.5 μ g/ml of ɑ-terpinol, Bronyl acetate 0.01
~2.5 μ g/ml.
Preferably, 2 μ g/ml, 4- terpineol of methylnonanone 6 μ g/ml, ɑ-pine tar are contained in houttuynia extract
1.2 μ g/ml of alcohol, 1.0 μ g/ml of Bronyl acetate.
Further, the eye-drops preparations auxiliary material delays including surfactant, osmotic pressure regulator, bacteriostatic agent, pH value
Electuary and antioxidant.
Further, the surfactant is spans, glucitols, poloxamer, 15- hydroxy stearic acids-poly-
Any one in glycol ester or Tweens；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is benzalkonium chloride, benzene
Prick any one in bromine ammonia, ethyl hydroxy benzoate or anesin；The pH buffer is phosphate, citrate, acetic acid
Any one in salt, carbonate, tartrate, borate and lactate；The antioxidant is Vc, Vc- palmitate, Asia
Any one in niter cake, sodium sulphate or cysteine.
Further, the pH value of the cordate houttuynia eye drops is 5~7.
A kind of preparation method of cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 1~10 times of cordate houttuynia weight is impregnated,
The temperature of the immersion is 60~100 DEG C, and soaking time is 0.5~2h；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 60~100 DEG C, collects fish
A raw meat distillate of grass, the volume of a distillate are 0.1~2 times of cordate houttuynia weight, the temperature of a distillate≤
40 DEG C, obtain cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.1~1 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains
Houttuynia extract；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 5~7 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Further, a concentration of 0.1~10g/100ml of the sodium chloride solution.
The present invention has the following advantages：
1. the present invention specifies ingredient and content, i.e. 1~10 μ g/ml, 4- terpineol of methylnonanone, 0.1~10 μ g/ml,
0.01~2.5 μ g/ml of ɑ-terpinol, 0.01~2.5 μ g/ml of Bronyl acetate, the eye drops definite ingredients, stable quality, can
Control.
2. antioxidant is increased in cordate houttuynia eye drops of the present invention, since cordate houttuynia active ingredient is easy to aoxidize,
Increase the validity and stability of ingredient.
3. pH buffer is increased in cordate houttuynia eye drops of the present invention, since cordate houttuynia eye drops are sterilizing, placing
PH easily declines in journey.Therefore, it increases pH buffer and stablizes liquid pH, make it with human body tear pH closer to avoiding eye
Generate excitement.
4. the preparation method of cordate houttuynia eye drops of the present invention impregnates fresh cordate houttuynia using sodium chloride solution,
Sodium chloride is continuously added during redistillation distilled, compared with prior art, more conducively cordate houttuynia active ingredient carries
Go out.The utilization rate of medicinal material is significantly improved, production cost is reduced, saves herb resource.
5. method of the present invention is easy to operate, it is convenient to prepare, is mass produced suitable for industrialization.
Specific embodiment
With reference to embodiment, the present invention will be further described, and protection scope of the present invention is not limited to following institute
It states：
Embodiment 1
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 1 μ g/ml, 4- terpineol of methylnonanone 0.1 μ g/ml, ɑ-pine are contained in the houttuynia extract
0.01 μ g/ml of oleyl alcohol, 0.01 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is spans；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is pricked for benzene
Oronain；The pH buffer is phosphate；The antioxidant is Vc.The pH value of the cordate houttuynia eye drops is 5.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 1 times of cordate houttuynia weight is impregnated, described
The temperature of immersion is 60 DEG C, soaking time 0.5h；Concentration of sodium chloride solution is 0.1g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 60 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 0.1 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain
Cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.1 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish
Raw meat grass extract；Concentration of sodium chloride solution is 0.1g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 5 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Embodiment 2
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 10 μ g/ml, 4- terpineol of methylnonanone 10 μ g/ml, ɑ-pine are contained in the houttuynia extract
2.5 μ g/ml of oleyl alcohol, 2.5 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is glucitols；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is benzene
Prick bromine ammonia；The pH buffer is citrate；The antioxidant is Vc- palmitates.The cordate houttuynia eye drops
PH value is 7.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 10 times of cordate houttuynia weight is impregnated, institute
The temperature for stating immersion is 100 DEG C, soaking time 2h；Concentration of sodium chloride solution is 10g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 100 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 2 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain fish
Raw meat grass crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 1 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish raw meat
Careless extract；Concentration of sodium chloride solution is 10g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 7 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Embodiment 3
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 2 μ g/ml, 4- terpineol of methylnonanone 6 μ g/ml, ɑ-pine tar are contained in the houttuynia extract
1.2 μ g/ml of alcohol, 1.0 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is poloxamer；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is hydroxyl
Phenethyl ester；The pH buffer is acetate；The antioxidant is sodium hydrogensulfite.The pH value of the cordate houttuynia eye drops
It is 6.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 2 times of cordate houttuynia weight is impregnated, described
The temperature of immersion is 70 DEG C, soaking time 1h；Concentration of sodium chloride solution is 1g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 68 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 0.5 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain
Cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.3 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish
Raw meat grass extract；Concentration of sodium chloride solution is 0.1g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 6 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Embodiment 4
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 3 μ g/ml, 4- terpineol of methylnonanone 2 μ g/ml, ɑ-pine tar are contained in the houttuynia extract
0.05 μ g/ml of alcohol, 0.8 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is 15- hydroxy stearic acids-macrogol ester；The osmotic pressure regulator is chlorination
Sodium；The bacteriostatic agent is anesin；The pH buffer is carbonate；The antioxidant is sodium sulphate.The fish
The pH value of raw meat grass eye drops is 6.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 3 times of cordate houttuynia weight is impregnated, described
The temperature of immersion is 70 DEG C, soaking time 1.2h；Concentration of sodium chloride solution is 2g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 70 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 0.5 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain
Cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.3 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish
Raw meat grass extract；Concentration of sodium chloride solution is 2g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 6 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Embodiment 5
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 5 μ g/ml, 4- terpineol of methylnonanone 4 μ g/ml, ɑ-pine tar are contained in the houttuynia extract
1.8 μ g/ml of alcohol, 1 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is Tweens；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is trichlorine
The tert-butyl alcohol；The pH buffer is tartrate；The antioxidant is cysteine.The pH value of the cordate houttuynia eye drops
It is 7.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 7 times of cordate houttuynia weight is impregnated, described
The temperature of immersion is 88 DEG C, soaking time 1.5h；Concentration of sodium chloride solution is 7g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 82 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 1.5 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain
Cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.5 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish
Raw meat grass extract；Concentration of sodium chloride solution is 0.1~10g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 7 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Embodiment 6
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 9 μ g/ml, 4- terpineol of methylnonanone 8.5 μ g/ml, ɑ-pine are contained in the houttuynia extract
2.2 μ g/ml of oleyl alcohol, 2 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is spans；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is pricked for benzene
Bromine ammonia；The pH buffer is borate；The antioxidant is sodium sulphate.The pH value of the cordate houttuynia eye drops is 6.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 9 times of cordate houttuynia weight is impregnated, described
The temperature of immersion is 98 DEG C, soaking time 1.8h；Concentration of sodium chloride solution is 8g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 92 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 1.8 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain
Cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.8 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish
Raw meat grass extract；Concentration of sodium chloride solution is 8g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 6 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Embodiment 7
A kind of cordate houttuynia eye drops, it be by houttuynia extract be active constituent, in addition pharmaceutically acceptable ophthalmically acceptable
Pharmaceutical adjunct is prepared, and 1 μ g/ml, 4- terpineol of methylnonanone 5 μ g/ml, ɑ-pine tar are contained in the houttuynia extract
2.5 μ g/ml of alcohol, 1.8 μ g/ml of Bronyl acetate.
Wherein, the eye-drops preparations auxiliary material includes surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer
And antioxidant.The surfactant is poloxamer；The osmotic pressure regulator is sodium chloride；The bacteriostatic agent is benzene
Prick bromine ammonia；The pH buffer is lactate；The antioxidant is sodium hydrogensulfite.The pH value of the cordate houttuynia eye drops
It is 5.
The preparation method of above-mentioned cordate houttuynia eye drops, it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 10 times of cordate houttuynia weight is impregnated, institute
The temperature for stating immersion is 65 DEG C, soaking time 1h；Concentration of sodium chloride solution is 5g/100ml；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 100 DEG C, collects cordate houttuynia
Distillate, the volume of a distillate are 2 times of cordate houttuynia weight, and temperature≤40 DEG C of a distillate obtain fish
Raw meat grass crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collect body
Secondary distillate of the product for 0.1 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish
Raw meat grass extract；Concentration of sodium chloride solution is 5g/100ml；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, fills water for injection,
PH to 5 is adjusted, filters, is filling, sterilizing to get cordate houttuynia eye drops.
Below by way of description of test beneficial effects of the present invention：
1st, extraction process adds in each component content comparison in extract after sodium chloride solution impregnates：
Fresh cordate houttuynia 200kg is taken, 1.0% sodium chloride solution that volume is 10 times of cordate houttuynia weight is added in, is heated to 90
DEG C, soaking time 1h, then steam distillation is passed through, the control of distillate temperature is at 40 DEG C hereinafter, collecting 1 times of cordate houttuynia weight
The distillate of volume obtains cordate houttuynia crude extract, and cordate houttuynia crude extract is added in half amount water, water vapour redistillation is passed through, evaporates
Go out the control of liquid temperature at 40 DEG C hereinafter, collecting the distillate of 0.5 times of volume of cordate houttuynia weight, distillate carries out primary with method again
Redistillation collects the distillate of 0.4 times of volume of cordate houttuynia weight, obtains houttuynia extract (lot number：S1)；Separately take fresh fish raw meat
Careless 200kg, impregnates without using sodium chloride solution, is passed directly into water vapour with method distillation and redistillation, obtains houttuynia extract and (criticize
Number：S2).Sapn 0.5kg, sodium chloride 0.9kg, benzalkonium chloride 0.03kg, Asia are separately added by above-mentioned 2 kinds of methods are extract obtained
Niter cake 0.05kg, borax 0.1kg, stirring and dissolving inject water to 100L, and adjust pH to 7, filter, is filling, going out
Bacterium is to get cordate houttuynia eye drops.Component content each in product is compared respectively, as a result as described in Table 1.As known from Table 1：Fish
Raw meat grass 1.0% sodium chloride solution of addition is passed through steam distillation products obtained therefrom active constituent content after impregnating and significantly improves again.It is bright
The aobvious utilization rate for improving medicinal material saves herb resource, better efficacy.
Table 1：Different Extraction Method prepares product content comparison
2nd, product stability compares after adding in antioxidant：
Take the houttuynia extract 80L of 0.4 times of volume collection by cordate houttuynia weight.Add in sapn 0.5kg, sodium chloride
0.9kg, benzalkonium chloride 0.03kg, sodium hydrogensulfite 0.5kg, borax 0.2kg stirring and dissolvings, inject water to 100L, and adjust
PH to 7 is saved, filters, is filling, sterilizing to get cordate houttuynia eye drops (lot number：S3).Sodium hydrogensulfite is only added without with method preparation
Sample (lot number：S4).Sample is placed for 25 DEG C ± 2 DEG C in room temperature, is measured by sampling respectively at the 0th, 3,6,9,12,18,24 the end of month outer
Sight, pH value, visible foreign matters, content compare the stability of product, and the results are shown in Table 2, as known from Table 2：Add in antioxygen
Each component content stability of agent product improves, the effect of advantageously ensuring that product.
Table 2：Influence of the antioxidant to product stability
3rd, product pH stability contrasts after addition pH buffer：
Take the houttuynia extract 8L of 0.4 times of volume collection by cordate houttuynia weight.Add in sapn 30g, sodium chloride 90g,
Benzalkonium chloride 3g, sodium hydrogensulfite 20g, borax 20g stirring and dissolvings, inject water to 10L, and adjust pH to 7, and filtering fills
Dress, sterilizes to get cordate houttuynia eye drops (lot number：S5).Sample (the lot number of borax is only not added with method preparation：S6).Sample is in room
60 DEG C of ± 2 DEG C of placements of temperature, were measured by sampling appearance, pH value, visible foreign matters, content, to the stabilization of product respectively at the 0th, 5,10 day
Property is compared, and the results are shown in Table 3, as shown in Table 3：Each component content stability for adding in pH buffer product improves, and has
Conducive to the quality for ensureing product and reduce Ocular irritation.
Table 3：Influence of the pH buffer to product stability
Claims (7)
1. a kind of preparation method of cordate houttuynia eye drops, which is characterized in that it includes the following steps：
S1. it impregnates：Fresh cordate houttuynia is taken, the sodium chloride solution for adding in volume as 1~10 times of cordate houttuynia weight is impregnated, institute
The temperature for stating immersion is 60~100 DEG C, and soaking time is 0.5~2h；
S2. it distills：Cordate houttuynia after immersion is passed through steam distillation, the vapo(u)rizing temperature is 60~100 DEG C, collects fish raw meat
A careless distillate, the volume of a distillate are 0.1~2 times of cordate houttuynia weight, temperature≤40 of a distillate
DEG C, obtain cordate houttuynia crude extract；
S3. redistillation：Cordate houttuynia crude extract is added in into sodium chloride solution, water vapour is passed through and carries out redistillation, collected volume is
The secondary distillate of 0.1~1 times of cordate houttuynia weight controls secondary distillate temperature≤40 DEG C, and repeats to distill once, obtains fish raw meat
Careless extract；
S4. auxiliary material is added：Eye-drops preparations auxiliary material is added in houttuynia extract, stirring and dissolving, adds water for injection, adjusted
PH to 5~7 is filtered, is filling, sterilizing to get cordate houttuynia eye drops.
2. a kind of preparation method of cordate houttuynia eye drops as described in claim 1, which is characterized in that the sodium chloride solution
A concentration of 0.1~10g/100ml.
3. a kind of cordate houttuynia eye drops being prepared using method described in claim 1, it is to be by houttuynia extract
Active constituent, in addition pharmaceutically acceptable eye-drops preparations auxiliary material is prepared, which is characterized in that in the houttuynia extract
Contain 1~10 μ g/ml, 4- terpineol of methylnonanone, 0.1~10 μ g/ml, 0.01~2.5 μ g/ml of ɑ-terpinol, acetic acid borneol
0.01~2.5 μ g/ml of ester.
4. a kind of cordate houttuynia eye drops as claimed in claim 3, which is characterized in that contain the positive nonyl of methyl in houttuynia extract
2 μ g/ml, 4- terpineol of ketone 6 μ g/ml, 1.2 μ g/ml of ɑ-terpinol, 1.0 μ g/ml of Bronyl acetate.
5. a kind of cordate houttuynia eye drops as described in claim 3 or 4, which is characterized in that the eye-drops preparations auxiliary material includes
Surfactant, osmotic pressure regulator, bacteriostatic agent, pH buffer and antioxidant.
6. a kind of cordate houttuynia eye drops as claimed in claim 5, which is characterized in that the surfactant is spans,
Any one in glucitols, poloxamer, 15- hydroxy stearic acids-macrogol ester or Tweens；The osmotic pressure is adjusted
Agent is sodium chloride；The bacteriostatic agent is any one in benzalkonium chloride, benzene bundle bromine ammonia, ethyl hydroxy benzoate or anesin；Institute
It is any one in phosphate, citrate, acetate, carbonate, tartrate, borate and lactate to state pH buffer
Kind；The antioxidant is any one in Vc, Vc- palmitate, sodium hydrogensulfite, sodium sulphate or cysteine.
A kind of 7. cordate houttuynia eye drops as described in claim 3 or 4, which is characterized in that the pH value of the cordate houttuynia eye drops
It is 5~7.
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| CN111643568A (en) * | 2020-06-30 | 2020-09-11 | 陕西功能食品工程中心有限公司 | Fermentation treatment process and application of houttuynia cordata |
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