CN104983876A - Houttuynia eyedrop and preparation method thereof - Google Patents
Houttuynia eyedrop and preparation method thereof Download PDFInfo
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Abstract
The invention discloses houttuynia eyedrop and a preparation method thereof. The houttuynia eyedrop is prepared by houttuynia extract as an active ingredient and ophthalmic preparations auxiliary materials accepted pharmaceutically. The houttuynia extract contains 1-10 micrograms/ml of 2-undecanone, 0.1-10 micrograms/ml of 4-carvomenthenol, 0.01-2.5 micrograms/ml of alpha-terpineol and 0.01-2.5 micrograms/ml of bornyl acetate. The preparation method of the houttuynia eyedrop comprises the steps of soaking, distillation, redistillation and addition of auxiliary materials. The houttuynia eyedrop is definite in ingredient and stable and controllable in quality; the preparation method is easy to operate, the houttuynia eyedrop is convenient to prepare, and the houttuynia eyedrop and the preparation method thereof are suitable for large-scale industrial production.
Description
Technical field
The invention belongs to drug world, be specifically related to a kind of cordate houttuynia eye drops and preparation method thereof.
Background technology
Herba Houttuyniae is the whole herb with root of Saururaceae herbaceos perennial Herba Houttuyniae Houttuynia cordata Thunb., famous Herba Houttuyniae, purple Ji, hog snout hole, Rhizoma Rohdeae Japonicae etc., pungent bad smell is had after its Fresh Plants fragmentation, be distributed widely in Central China, the southeast and southwestern each provinces and regions, especially economize in the majority with Hunan, Hubei, Sichuan, Jiangsu etc.Herba Houttuyniae has effect of heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, inducing diuresis for treating stranguria syndrome, clinically to cough for lung abscess vomiting pus, expectorant dyspnea of heat type, the disease such as hematodiarrhoea, pyretic stranguria, carbuncle sore tumefacting virus.Research shows, containing compositions such as volatile ingredient, flavonoid, organic acid, sterols, alkaloidss in Herba Houttuyniae.Herba Houttuyniae mainly eats with young stem and leaf and subterraneous stem work vegetable, and Herb can using fresh herb or dry be used as medicine, and is formally defined as one of resource of the great exploitation potential for its of " being medicine, is again food " by health ministry, day by day receives the concern of people.
Cordate houttuynia eye drops is through steam distillation preparation and obtains, and main component is its volatile ingredient.Report at present for Herba Houttuyniae ophthalmic preparation has: Cao Jun is two, the pharmacological action of Herba Houttuyniae and clinical practice, modern combination of Chinese and Western medicine magazine, 2001,10 (6), disclose the purposes that Herba Houttuyniae has treatment ophthalmic diseases, wherein main component herb is containing volatile oil 0.0049%, have and plant containing antimicrobial component houttuynine sodium bisulfite (i.e. decanoylacetaldehyde) methylnonanone, myrcene, capric acid etc., still contain inorganic salt if potassium chloride, potassium sulfate, cordarine, spica, fruit ear are containing isoquercitrin, leaf is containing Quercitroside etc.Above-mentioned report only illustrates the main component of Herba Houttuyniae, and due to crude drug complicated component, can not determine the concrete composition playing drug effect, the quality of the preparation of preparation is restive, is also difficult to find applicable index components effectively to control.
Summary of the invention
The object of the invention is to the shortcoming overcoming prior art, a kind of cordate houttuynia eye drops is provided, this eye drop definite ingredients, steady quality, controlled;
Another object of the present invention is to the preparation method that this eye drop is provided, the method is simple to operate, easy to prepare, be applicable to industrialization large-scale production.
Object of the present invention is achieved through the following technical solutions: a kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 1 ~ 10 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 0.1 ~ 10 μ g/ml, ɑ-terpineol 0.01 ~ 2.5 μ g/ml, borneol acetate 0.01 ~ 2.5 μ g/ml.
Preferably, methylnonanone 2 μ g/ml, 4-terpinol 6 μ g/ml, ɑ-terpineol 1.2 μ g/ml, borneol acetate 1.0 μ g/ml is contained in Herba Houttuyniae extract.
Further, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.
Further, described surfactant is any one in spans, glucitols, poloxamer, 15-hydroxy stearic acid-macrogol ester or Tweens; Described osmotic pressure regulator is sodium chloride; Described antibacterial is benzalkonium chloride, benzene is pricked in bromine ammonia, ethyl hydroxybenzoate or chlorobutanol any one; Described pH value buffer agent is any one in phosphate, citrate, acetate, carbonate, tartrate, borate and lactate; Described antioxidant is any one in Vc, Vc-cetylate, sodium sulfite, sodium sulfate or cysteine.
Further, the pH value of described cordate houttuynia eye drops is 5 ~ 7.
A preparation method for cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 1 ~ 10 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 60 ~ 100 DEG C, and soak time is 0.5 ~ 2h;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 60 ~ 100 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 0.1 ~ 2 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, pass into water vapour and carry out redistillation, collected volume is the secondary distillate of Herba Houttuyniae weight 0.1 ~ 1 times, controls secondary distillate temperature≤40 DEG C, and repeat distillation once, obtain Herba Houttuyniae extract;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 5 ~ 7, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Further, the concentration of described sodium chloride solution is 0.1 ~ 10g/100ml.
The present invention has the following advantages:
1. the present invention specify that composition and content, i.e. methylnonanone 1 ~ 10 μ g/ml, 4-terpinol 0.1 ~ 10 μ g/ml, ɑ-terpineol 0.01 ~ 2.5 μ g/ml, borneol acetate 0.01 ~ 2.5 μ g/ml, this eye drop definite ingredients, steady quality, controlled.
2. add antioxidant in cordate houttuynia eye drops of the present invention, because Herba Houttuyniae effective ingredient is easy to oxidation, therefore, add effectiveness and the stability of composition.
3. add pH value buffer agent in cordate houttuynia eye drops of the present invention, because cordate houttuynia eye drops pH in sterilizing, put procedure easily declines.Therefore, adding pH value buffer agent and stablize medicinal liquid pH, making itself and human body tear pH produce excitement closer to avoiding eye.
4. the preparation method of cordate houttuynia eye drops of the present invention adopts sodium chloride solution to soak to fresh Herba Houttuyniae, continues to add sodium chloride and distills, compared with prior art, be more conducive to the proposition of Herba Houttuyniae effective ingredient in redistillation process.Significantly improve the utilization rate of medical material, reduce production cost, save herb resource.
5. method of the present invention simple to operate, easy to prepare, be applicable to industrialization large-scale production.
Detailed description of the invention
Below in conjunction with embodiment, the present invention will be further described, and protection scope of the present invention is not limited to the following stated:
Embodiment 1
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 1 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 0.1 μ g/ml, ɑ-terpineol 0.01 μ g/ml, borneol acetate 0.01 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is spans; Described osmotic pressure regulator is sodium chloride; Described antibacterial is benzalkonium chloride; Described pH value buffer agent is phosphate; Described antioxidant is Vc.The pH value of described cordate houttuynia eye drops is 5.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 1 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 60 DEG C, and soak time is 0.5h; Concentration of sodium chloride solution is 0.1g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 60 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 0.1 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 0.1 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 0.1g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 5, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Embodiment 2
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 10 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 10 μ g/ml, ɑ-terpineol 2.5 μ g/ml, borneol acetate 2.5 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is glucitols; Described osmotic pressure regulator is sodium chloride; Described antibacterial is that benzene pricks bromine ammonia; Described pH value buffer agent is citrate; Described antioxidant is Vc-cetylate.The pH value of described cordate houttuynia eye drops is 7.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 10 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 100 DEG C, and soak time is 2h; Concentration of sodium chloride solution is 10g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 100 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 2 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 1 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 10g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 7, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Embodiment 3
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 2 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 6 μ g/ml, ɑ-terpineol 1.2 μ g/ml, borneol acetate 1.0 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is poloxamer; Described osmotic pressure regulator is sodium chloride; Described antibacterial is ethyl hydroxybenzoate; Described pH value buffer agent is acetate; Described antioxidant is sodium sulfite.The pH value of described cordate houttuynia eye drops is 6.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 2 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 70 DEG C, and soak time is 1h; Concentration of sodium chloride solution is 1g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 68 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 0.5 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 0.3 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 0.1g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 6, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Embodiment 4
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 3 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 2 μ g/ml, ɑ-terpineol 0.05 μ g/ml, borneol acetate 0.8 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is 15-hydroxy stearic acid-macrogol ester; Described osmotic pressure regulator is sodium chloride; Described antibacterial is chlorobutanol; Described pH value buffer agent is carbonate; Described antioxidant is sodium sulfate.The pH value of described cordate houttuynia eye drops is 6.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 3 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 70 DEG C, and soak time is 1.2h; Concentration of sodium chloride solution is 2g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 70 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 0.5 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 0.3 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 2g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 6, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Embodiment 5
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, adds that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 5 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 4 μ g/ml, ɑ-terpineol 1.8 μ g/ml, borneol acetate 1 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is Tweens; Described osmotic pressure regulator is sodium chloride; Described antibacterial is chlorobutanol; Described pH value buffer agent is tartrate; Described antioxidant is cysteine.The pH value of described cordate houttuynia eye drops is 7.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 7 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 88 DEG C, and soak time is 1.5h; Concentration of sodium chloride solution is 7g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 82 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 1.5 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 0.5 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 0.1 ~ 10g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 7, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Embodiment 6
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 9 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 8.5 μ g/ml, ɑ-terpineol 2.2 μ g/ml, borneol acetate 2 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is spans; Described osmotic pressure regulator is sodium chloride; Described antibacterial is that benzene pricks bromine ammonia; Described pH value buffer agent is borate; Described antioxidant is sodium sulfate.The pH value of described cordate houttuynia eye drops is 6.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 9 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 98 DEG C, and soak time is 1.8h; Concentration of sodium chloride solution is 8g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 92 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 1.8 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 0.8 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 8g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 6, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Embodiment 7
A kind of cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, containing methylnonanone 1 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 5 μ g/ml, ɑ-terpineol 2.5 μ g/ml, borneol acetate 1.8 μ g/ml.
Wherein, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.Described surfactant is poloxamer; Described osmotic pressure regulator is sodium chloride; Described antibacterial is that benzene pricks bromine ammonia; Described pH value buffer agent is lactate; Described antioxidant is sodium sulfite.The pH value of described cordate houttuynia eye drops is 5.
The preparation method of above-mentioned cordate houttuynia eye drops, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 10 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 65 DEG C, and soak time is 1h; Concentration of sodium chloride solution is 5g/100ml;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 100 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 2 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, passes into water vapour and carries out redistillation, and collected volume is the secondary distillate of Herba Houttuyniae weight 0.1 times, controls secondary distillate temperature≤40 DEG C, and repeats distillation once, obtains Herba Houttuyniae extract; Concentration of sodium chloride solution is 5g/100ml;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 5, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
Below by way of description of test beneficial effect of the present invention:
1, after extraction process adds sodium chloride solution immersion, in extract, each component content contrasts:
Get fresh Herba Houttuyniae 200kg, add 1.0% sodium chloride solution that volume is Herba Houttuyniae weight 10 times, be heated to 90 DEG C, soak time is 1h, pass into steam distillation again, distillate temperature controls below 40 DEG C, collect the distillate of 1 times of volume of Herba Houttuyniae weight, obtain Herba Houttuyniae crude extract, Herba Houttuyniae crude extract is added half water gaging, pass into water vapour redistillation, distillate temperature controls below 40 DEG C, collect the distillate of 0.5 times of volume of Herba Houttuyniae weight, distillate carries out a redistillation with method again, collect the distillate of 0.4 times of volume of Herba Houttuyniae weight, obtain Herba Houttuyniae extract (lot number: S1), separately get fresh Herba Houttuyniae 200kg, do not use sodium chloride solution to soak, directly pass into water vapour with method distillation and redistillation, obtain Herba Houttuyniae extract (lot number: S2).Add span 0.5kg, sodium chloride 0.9kg, benzalkonium chloride 0.03kg, sodium sulfite 0.05kg, Borax 0.1kg respectively by extract obtained for above-mentioned 2 kinds of methods, stirring and dissolving, injects water to 100L, and regulate pH to 7, filtration, fill, sterilizing, obtains cordate houttuynia eye drops.Contrast component content each in product respectively, result is as described in Table 1.As known from Table 1: Herba Houttuyniae passes into steam distillation products obtained therefrom active constituent content again after adding 1.0% sodium chloride solution immersion and significantly improves.Significantly improve the utilization rate of medical material, save herb resource, better efficacy.
Table 1: Different Extraction Method preparing product content balance
2, after adding antioxidant, product stability contrasts:
Get the Herba Houttuyniae extract 80L of 0.4 times of volume collection by Herba Houttuyniae weight.Add span 0.5kg, sodium chloride 0.9kg, benzalkonium chloride 0.03kg, sodium sulfite 0.5kg, Borax 0.2kg stirring and dissolving, inject water to 100L, and regulate pH to 7, filtration, fill, sterilizing, obtains cordate houttuynia eye drops (lot number: S3).With the standby sample (lot number: S4) only not adding sodium sulfite of legal system.Sample is in room temperature 25 DEG C ± 2 DEG C placements, respectively at the 0th, 3,6,9,12,18,24 the end of month sampling and measuring outward appearance, pH value, visible foreign matters, content, the stability of product is contrasted, result is as shown in table 2, as known from Table 2: each component content stability adding antioxidant product improves, the curative effect ensureing product is conducive to.
Table 2: antioxidant is on the impact of product stability
3, after adding pH buffer agent, product pH stability contrasts:
Get the Herba Houttuyniae extract 8L of 0.4 times of volume collection by Herba Houttuyniae weight.Add span 30g, sodium chloride 90g, benzalkonium chloride 3g, sodium sulfite 20g, Borax 20g stirring and dissolving, inject water to 10L, and regulate pH to 7, filtration, fill, sterilizing, obtains cordate houttuynia eye drops (lot number: S5).With the standby sample (lot number: S6) only not adding Borax of legal system.Sample is in room temperature 60 DEG C ± 2 DEG C placements, respectively at the 0th, 5,10 day sampling and measuring outward appearance, pH value, visible foreign matters, content, the stability of product is contrasted, result is as shown in table 3, as shown in Table 3: each component content stability adding pH buffer agent product improves, be conducive to the quality of guarantee product and reduce Ocular irritation.
Table 3:pH buffer agent is on the impact of product stability
Claims (7)
1. a cordate houttuynia eye drops, it is active component by Herba Houttuyniae extract, add that pharmaceutically acceptable ophthalmic preparation adjuvant is prepared from, it is characterized in that, containing methylnonanone 1 ~ 10 μ g/ml in described Herba Houttuyniae extract, 4-terpinol 0.1 ~ 10 μ g/ml, ɑ-terpineol 0.01 ~ 2.5 μ g/ml, borneol acetate 0.01 ~ 2.5 μ g/ml.
2. a kind of cordate houttuynia eye drops as claimed in claim 1, is characterized in that, containing methylnonanone 2 μ g/ml, 4-terpinol 6 μ g/ml, ɑ-terpineol 1.2 μ g/ml, borneol acetate 1.0 μ g/ml in Herba Houttuyniae extract.
3. a kind of cordate houttuynia eye drops as claimed in claim 1 or 2, is characterized in that, described ophthalmic preparation adjuvant comprises surfactant, osmotic pressure regulator, antibacterial, pH value buffer agent and antioxidant.
4. a kind of cordate houttuynia eye drops as claimed in claim 3, is characterized in that, described surfactant is any one in spans, glucitols, poloxamer, 15-hydroxy stearic acid-macrogol ester or Tweens; Described osmotic pressure regulator is sodium chloride; Described antibacterial is benzalkonium chloride, benzene is pricked in bromine ammonia, ethyl hydroxybenzoate or chlorobutanol any one; Described pH value buffer agent is any one in phosphate, citrate, acetate, carbonate, tartrate, borate and lactate; Described antioxidant is any one in Vc, Vc-cetylate, sodium sulfite, sodium sulfate or cysteine.
5. a kind of cordate houttuynia eye drops as claimed in claim 1 or 2, is characterized in that, the pH value of described cordate houttuynia eye drops is 5 ~ 7.
6. the preparation method of a kind of cordate houttuynia eye drops as claimed in claim 1 or 2, it is characterized in that, it comprises the following steps:
S1. soak: get fresh Herba Houttuyniae, adding volume is that the sodium chloride solution of 1 ~ 10 times of Herba Houttuyniae weight soaks, and the temperature of described immersion is 60 ~ 100 DEG C, and soak time is 0.5 ~ 2h;
S2. distill: the Herba Houttuyniae after soaking is passed into vapor distillation, described vapo(u)rizing temperature is 60 ~ 100 DEG C, and collect Herba Houttuyniae distillate, the volume of a described distillate is 0.1 ~ 2 times of Herba Houttuyniae weight, temperature≤40 DEG C of a distillate, obtain Herba Houttuyniae crude extract;
S3. redistillation: Herba Houttuyniae crude extract is added sodium chloride solution, pass into water vapour and carry out redistillation, collected volume is the secondary distillate of Herba Houttuyniae weight 0.1 ~ 1 times, controls secondary distillate temperature≤40 DEG C, and repeat distillation once, obtain Herba Houttuyniae extract;
S4. add adjuvant: join in Herba Houttuyniae extract by ophthalmic preparation adjuvant, stirring and dissolving, filling water for injection, regulates pH to 5 ~ 7, and filtration, fill, sterilizing, obtains cordate houttuynia eye drops.
7. the preparation method of a kind of cordate houttuynia eye drops as claimed in claim 6, is characterized in that, the concentration of described sodium chloride solution is 0.1 ~ 10g/100ml.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108904778A (en) * | 2018-09-28 | 2018-11-30 | 永州职业技术学院 | A kind of collyrium for alleviating visual fatigue |
| CN109908080A (en) * | 2019-04-26 | 2019-06-21 | 深圳市瑞霖医药有限公司 | A kind of cordate houttuynia eye drops and preparation method thereof |
| CN110013506A (en) * | 2019-04-30 | 2019-07-16 | 龙岩学院 | A kind of extracting method and application of the effective sterilization component of cordate houttuynia |
| 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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| JP2000063260A (en) * | 1998-08-20 | 2000-02-29 | Shiseido Co Ltd | Lipid decomposition accelerator and skin preparation for external use for weight reduction |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108904778A (en) * | 2018-09-28 | 2018-11-30 | 永州职业技术学院 | A kind of collyrium for alleviating visual fatigue |
| CN109908080A (en) * | 2019-04-26 | 2019-06-21 | 深圳市瑞霖医药有限公司 | A kind of cordate houttuynia eye drops and preparation method thereof |
| CN110013506A (en) * | 2019-04-30 | 2019-07-16 | 龙岩学院 | A kind of extracting method and application of the effective sterilization component of cordate houttuynia |
| 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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| CN104983876B (en) | 2018-06-15 |
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