CN100348231C - Medicine composition for resisting exogenous cold and high fever, and its preparing method - Google Patents
Medicine composition for resisting exogenous cold and high fever, and its preparing method Download PDFInfo
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- CN100348231C CN100348231C CNB2006100204201A CN200610020420A CN100348231C CN 100348231 C CN100348231 C CN 100348231C CN B2006100204201 A CNB2006100204201 A CN B2006100204201A CN 200610020420 A CN200610020420 A CN 200610020420A CN 100348231 C CN100348231 C CN 100348231C
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Abstract
The present invention provides a medicament composition having the function of exogenous cold and fever resistance, and a preparation method thereof. The volatile oil of houttuynia and the volatile oil of bupleurum roots which are taken as effective medicinal components, and acceptable auxiliary adding components in a medicament together form the medicament composition. The proportion of the houttuynia and the bupleurum roots, which is measured by the parts by weight of freshness houttuynia and the crude medicament of the bupleurum roots of extracted raw materials of the medicament composition, is 10/1 to 10/5. The medicament composition not only can effectively solve the problem that a current single formal bupleurum root injection solution and/or a houttuynia injection solution have weak refrigeration fever relieving functions in clinical use, but also can have marked cooperation and effect increasing functions in the aspects of comprehensive fever relieving and antiviral action. The effect of the medicament composition is obviously superior to the independent function of the bupleurum roots and the houttuynia.
Description
Technical field
What the present invention relates to is the pharmaceutical composition of a kind of extract with natural medicinal raw material as effective ingredient, specifically is the pharmaceutical composition that can have the high heat effect of resisting exogenous cold.
Background technology
Herba Houttuyniae is fresh herb or its exsiccant aerial parts of saururaceae plant houttuynia cordata (Houttuynia cordata Thunb.), it is the conventional Chinese medicine that records for Chinese Pharmacopoeia, has heat-clearing and toxic substances removing, the eliminating carbuncle evacuation of pus, the effect of inducing diuresis for treating stranguria syndrome can be used for the lung abscess vomiting pus, the expectorant dyspnea of heat type is coughed, hematodiarrhoea, pyretic stranguria, the treatment of carbuncle sore tumefacting virus.The main effective ingredient of Herba Houttuyniae is its contained volatile oil.The extracorporeal antivirus effect test confirms, the profit mixed form distillation that contains Herba Houttuyniae volatile oil by the vapor distillation collection, influenza A virus, Influenza B virus, mumps virus, herpes simplex I type virus, human immunity shortage I type virus etc. all had tangible antivirus action, the antiviral scope is wide, and no cytotoxicity.The pharmaceutical preparation of being processed into by the Herba Houttuyniae volatile oil extract, Herba Houttuyniae injectio and cordate houttuynia eye drops etc. are arranged at present, popularity hemorrhagic fever virus, adenovirus type III, 7 types and herpes simplex virus I type etc. have the cytopathic effect of inhibition, have been clinical being extensive use of.Wherein Herba Houttuyniae injectio has antibiotic, antiinflammatory, antipyretic effect, mainly treats indication and comprises as upper respiratory tract infection, chronic bronchitis, bronchiectasis, infantile pneumonia, chronic rhinitis sinusitis, atrophic rhinitis, herpes simplex keratitis and intractable pyelonephritis etc.Herba Houttuyniae injectio records in the 17th in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation, the sterile water solution of being processed into through vapor distillation for bright Herba Houttuyniae.
Radix Bupleuri also is the conventional Chinese medicine simply that Chinese Pharmacopoeia recorded, and the property hardship, is slightly cold, have with tabulation in, soothing the liver, the effect of yang invigorating is used for cold, fever, alternate attack of chill and fever etc.The main effective ingredient of Radix Bupleuri is its contained volatile oil and saikoside.Li Xiuqin etc. are at " research of Radix Bupleuri volatile oil extracting method " (" Chinese Pharmaceutical Journal " 2004,39 (2): once reported 103-105), and contained 0.15% volatile oil in the Radix Bupleuri approximately.Radix Bupleuri volatile oil toxicity is low, and certain refrigeration function is arranged, and the existing clinically injection made from Radix Bupleuri volatile oil is used for the treatment of the heating of flu, influenza and malaria etc. for intramuscular injection.The injection of Radix Bupleuri that records in the 17th in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation is the sterile water solution made from the vapor distillation liquid of Radix Bupleuri.
No matter find in the clinical use, be injection of Radix Bupleuri, or Herba Houttuyniae injectio, a little less than its effect aspect analgesic, still has incompatible part with the needs of actual therapeutic exogenous high fever.
For example, Xu Jingsong etc. had once reported Radix Bupleuri, Herba Houttuyniae and penicillin use in conjunction research (" clinical observation of Radix Bupleuri, Herba Houttuyniae injectio and penicillin coupling treatment exogenous high fever disease ", " Guiyang College of Traditional Chinese Medicine's journal " 2002.Vol.24 (4): 18) with treatment exogenous high fever disease.Zhoukou City defends the attached institute in school department of otorhinolaryngology and reported the research of Radix Bupleuri pin, Herba Houttuyniae pin and Herba Andrographis pin being united and adopt acupoint injection therapy and atomizing suction and usefulness clinically in " clinical observation of acupoint injection therapy and atomization inspiration treatment intractable cough " (" periodical is cured in Central Plains " 2003, Vol.30 (8)).No. 94110745 Chinese patent open source literatures have also been reported volatilization liquid of a kind of Radix Bupleuri, Herba Houttuyniae and the Herba Pogostemonis that will be extracted by the way of distillation and the externally applied liniment that ethanol is mixed with jointly, at a kind of external application preparation that is used to replace oral medicine when adopting inner disease outer treat.Research that these are relevant and report show, uses when containing the medicine of Radix Bupleuri and Herba Houttuyniae volatile oil composition uniting clinically, needs match with other corresponding medicine simultaneously, to reach raising in the analgesic and purpose anti-virus aspect action and efficacy.
Summary of the invention
At above-mentioned situation, the present invention's purpose at first provides a kind of pharmaceutical composition that can have the high heat effect of resisting exogenous cold of even more ideal effect.Further aim of the present invention also comprises will provide a kind of said this preparation of drug combination method.
The said pharmaceutical composition of the present invention with the high heat effect of resisting exogenous cold, with Herba Houttuyniae volatile oil and Radix Bupleuri volatile oil is effective medicinal ingredient, form jointly with the auxiliary adding ingredient of acceptable in the medicine, in its proportion that extracts the Herba Houttuyniae/Radix Bupleuri of fresh Herba Houttuyniae of raw material and Radix Bupleuri crude drug weight portion is 10/1～10/5, better proportion is 10/2～10/4, and is good with 10/2 ratio.
Test of pesticide effectiveness result after above-mentioned two kinds of mutual compatible combination of the volatile oil component that extracts from natural medicinal raw material shows that it can produce unexpected Synergistic promising result aspect analgesic and the antivirus action.
With above-mentioned two volatile oil is effective medicinal ingredient, with auxiliary interpolation compositions such as acceptable accessories or carriers, can be prepared to the medicine of dosage forms such as corresponding oral formulations, injection, nasal drop, spray, aerosol and/or spray preparation.For example, after the commonly used auxiliary interpolation composition of acceptable disintegrating agent, excipient, lubricant, binding agent, filler etc. in the oral formulations mixes, handle by corresponding common process method, promptly may be made in the oral drugs of the solid preparation forms such as slow releasing agent, controlled release agent of tablet, drop pill, capsule or appropriate format; Mix with surfactant, pH regulator agent, diluent, stabilizing agent, thickening agents etc. such as the solubilizing agent of using always, cosolvent, emulsifying agent, wetting agent, handle, promptly may be made in Emulsion, spray or aerosol, nasal drop etc. by corresponding common process method.Press in the injectable drug preparation and to allow the appropriate solvent that uses and after additives cooperate and corresponding technological operation handles, can be prepared into the injection agent medicine of muscle such as corresponding Emulsion or powder pin or vein form.Wherein be worth to propose especially, be emulsion-type nasal drop, spray or the aerosol that can be made for high concentration, absorb by nasal cavity and mouth mucosa drug administration, thereby not only can avoid hidden dangers such as Chinese medicine allergy, can also have than injection of Radix Bupleuri and the better drug action of Herba Houttuyniae injectio, and easy to use, be easy to be accepted by Most patients.
Show by analgesic and antivirus test result, the pharmaceutical composition that the present invention is above-mentioned, can be widely used in the clinical treatment of exogenous high fever disease that flu, influenza, upper respiratory tract infection, acute bronchitis, infantile pneumonia, acute pharyngolaryngitis, the dense property of change tonsillitis etc. are caused, also can be used for the treatment of viral diseases such as chronic rhinitis sinusitis, atrophic rhinitis, viral pneumonia, viral enteritis and viral myocarditis, encephalitis.
One of above-mentioned preparation of drug combination method of the present invention with the high heat effect of resisting exogenous cold, can be undertaken by following step:
A, Herba Houttuyniae and Radix Bupleuri raw material are extracted its volatile oil component in the distillation mode, with the two-phase system formed jointly by acceptable water insoluble oil composition and water in the medicine trapping medium, make collected volatile oil component separated and be enriched in the oil phase layer as distillate;
Acceptable auxiliary adding ingredient is prepared into corresponding pharmaceutical preparation in b, the volatile oil component that obtains with a step and the medicine.
The said Herba Houttuyniae volatile oil that can be used as extracts raw material in above-mentioned preparation method, for well, also can use the Herba Houttuyniae dry product that meets pharmacopeia regulation and requirement with fresh Herba Houttuyniae.According to universal experience, the aquatic foods product of Herba Houttuyniae and the usage ratio of dry product approximately are that 1 part of dried Herba Houttuyniae is equivalent to 2 parts of bright Herba Houttuyniae.
In the distillate trapping medium of above-mentioned said biphase form, acceptable water insoluble oil composition commonly used can have one or more in soybean oil, safflower oil, Oleum Gossypii semen, Semen Maydis oil, olive oil, Oleum sesami, light mineral oil, liquid paraffin, stearic acid, the silicone oil in the medicine that can be used.
Extract the distillation of volatile oil in the said method, both can adopt conventional direct distillation, also can adopt steam distillation.During distillation, after can distilling respectively Herba Houttuyniae and Radix Bupleuri two raw materials, the volatile oil component that to collect respectively again is used for preparation after merging, also Herba Houttuyniae and Radix Bupleuri two crude drug raw materials can be mixed common distillation, be enriched with oil phase mixed liquor in the distillate trapping medium of two kinds of volatile oil components and need not to separate and to be directly used in down the preparation that goes on foot.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
The specific embodiment
Embodiment 1:
Get Radix Bupleuri 750g, pulverize, merge, add water temperature and soak with bright Herba Houttuyniae 1500g, through vapor distillation, collect just distillate 2000ml, redistillation again, collect the about 1000ml of double distilled liquid, it is an amount of to add polyoxyethylene sorbitan monoleate, stirs oil is dissolved fully, add sodium chloride 8g again, after the dissolving, filter, add the injection water to 1000ml, regulate pH value, fine straining, embedding, sterilization promptly gets the solution-type injection.
Embodiment 2:
With Radix Bupleuri 1kg, pulverize, merge with bright Herba Houttuyniae 10kg, in the conventional vapor distillation device of packing into, with common oil water separator as the distillate gathering-device, and the suitable quantity of water of packing into of lower floor therein, soybean oil 50g packs on the upper strata.Vapor distillation 5 hours, the oil phase layer segment in the separated and collected medium, the soybean oil that obtains being enriched with Radix Bupleuri volatile oil and Herba Houttuyniae volatile oil is standby.Soybean lecithin 12.5g adding distil water 250ml is disperseed, it is an amount of to add glycerol 12.5g, carbomer 5g, ethyl hydroxybenzoate 0.5g and edible essence, stirs and makes dissolving, is heated to 70 ℃, and continue to stir, slowly add the oil-phase component that above-mentioned distillation is collected simultaneously, high speed homogenization made colostrum in 8 minutes, and colostrum is crossed high pressure dispersing emulsification machine circulation 6 times, adding distil water is to 500ml under stirring at low speed, filtration, packing are put in the special-purpose collunarium bottle or in the spray bottle, promptly get nasal drop and spray.
Embodiment 3:
With Radix Bupleuri 500g, pulverize, add water temperature and soak, through vapor distillation, collect distillate 1000ml just, redistillation is collected the about 500ml of double distilled liquid again, and the Aromatic water that must contain Radix Bupleuri volatile oil is standby.Get bright Herba Houttuyniae 2500g, in the distillator of the routine of packing into, with common oil water separator as the distillate gathering-device, and the suitable quantity of water of packing into of lower floor therein, the upper strata injection soybean oil 20g that packs into was through vapor distillation 5 hours, oil phase layer segment in the separated and collected medium, the soybean oil of Herba Houttuyniae volatile oil be must be enriched with, soybean oil 80g and vitamin E2 g added again, standby as oil-phase component.Get injection soybean phospholipid 10g, poloxamer 188 20g and glycerol 25g, add above-mentioned Radix Bupleuri double distilled liquid and make abundant dispersion, make water in 50 ℃ of-80 ℃ of stirrings.Water is mixed with standby oil-phase component, make colostrum in 50 ℃ of-80 ℃ of high-speed stirred.Get primary emulsion, add the injection water to 1000ml, adjustings pH value is 5.0-7.0, is transferred in the high pressure dispersing emulsification machine, and emulsifying is to emulsion droplet particle diameter≤0.5 micron repeatedly, aseptic filtration, and the inflated with nitrogen fill is sterilized, and promptly gets the emulsion-type injection.
Embodiment 4:
Radix Bupleuri 3kg and dried Herba Houttuyniae 5kg pulverize, be respectively charged in the conventional distillator, with common oil water separator as the distillate gathering-device, and the suitable quantity of water of packing into of lower floor therein, soybean oil 25g packs on the upper strata.Distillation extraction 6 hours, the oil phase layer in the separated and collected medium obtains being enriched with the soybean oil of Radix Bupleuri volatile oil and Herba Houttuyniae volatile oil respectively.Two oil phase composition of layer merge, and are preheated to 80 ℃, join in the PEG-6000 fused solution, and stirring and evenly mixing is made 2000 drop pill in the drop pill machine, be described pill-type medicine.
The pharmaceutical composition of different proportion composition form that with volatile oil in Herba Houttuyniae volatile oil and the Radix Bupleuri is effective medicinal ingredient has carried out the pharmacodynamics test of refrigeration function as trial drug.Extract bright Herba Houttuyniae and/or Radix Bupleuri volatile oil by the foregoing description 2～3 steam distillations, the emulsion-type injection of making respective concentration respectively is as trial drug, and amounting to of its compound method and dosage sees Table 1.
Amounting to of the compound method of table 1 trial drug and dosage
| Group | Trial drug | Drug level (g/ml) | Administration volume (ml/kg) | Dosage (g/kg) |
| The blank group | Normal saline | - | 4 | - |
| The I group | Radix Bupleuri | 0.625 | 4 | 2.5 |
| The II group | Radix Bupleuri | 0.5 | 4 | 2 |
| The III group | Radix Bupleuri | 0.25 | 4 | 1 |
| The IV group | Radix Bupleuri | 0.125 | 4 | 0.5 |
| The V group | Herba Houttuyniae | 1.25 | 4 | 5 |
| The VI group | Herba Houttuyniae/Radix Bupleuri=10/5 | 1.25/0.625 | 4 | 5/2.5 |
| The VII group | Herba Houttuyniae/Radix Bupleuri=10/4 | 1.255/0.5 | 4 | 5/2 |
| The VIII group | Herba Houttuyniae/Radix Bupleuri=10/2 | 1.25/0.25 | 4 | 5/1 |
| The IX group | Herba Houttuyniae/Radix Bupleuri=10/1 | 1.25/0.125 | 4 | 5/0.5 |
| The X group | Herba Houttuyniae/Radix Bupleuri=10/0.5 | 1.25/0.0625 | 4 | 5/0.25 |
Get the healthy rabbits of body weight 2.0-2.5kg, the male and female dual-purpose, fasting 2h before the experiment, measure the rabbit normal body temperature 2 times, the 30min of being separated by chooses body temperature between 38.0-39.0 ℃, and the difference of twice body temperature is no more than 0.2 ℃ 66 of rabbit, be divided into 11 groups (blank group, I group～X groups) at random, 6 every group.Respectively through auricular vein injection triple vaccine 1ml/kg, when fervescence more than 1 ℃ when (about 2h), press table 1 respectively intramuscular injection sterile saline and trial drug (I group～X organizes, 4ml/kg), measured animal heat in 1,2,3,4,5 hour after administration, the record rabbit body temperature changes.Result of the test sees Table 2.
By table 2 as seen, pharmaceutical composition group of the present invention (VI group～X group) has obvious or significant cooling effect to the pyrogenicity rabbit body temperature, compare through the t check in 5h with normal saline group (blank), significant difference (p＜0.05 is arranged, p＜0.01), obviously is better than the Radix Bupleuri list of identical or close dosage with organizing (I group～IV group) and Herba Houttuyniae list with organizing (V).And single with Radix Bupleuri group or Herba Houttuyniae group and normal saline group in 5h through t check comparison, difference that there are no significant (p＞0.05).Above-mentioned result of the test fully shows: pharmaceutical composition of the present invention has tangible refrigeration function, and shows synergistic function, is better than the Radix Bupleuri and the Herba Houttuyniae of independent type of service, and wherein preferred ratio is 10/4～10/1 (VII group～IV group).
On the basis of above-mentioned result of the test, be the test that trial drug resists the protective effect of adenovirus type III infecting mouse with Herba Houttuyniae (aquatic foods)/Radix Bupleuri (10/3).
With 4 age in week male and female body weight 11～13g Kunming mouse of half and half be the experimental animal random packet, 16 every group.Press listed medicine and dosage intravenous administration in the table 3, every day 1 time, continuous 5 days.On the same day after the last administration, each organizes mice under the ether light anaesthesia, infects every Mus 50ul (50 LD with viral allantois drop nose
50Challenging dose).Observe zoogenetic infection sequela symptom, record infects death toll in back 15 days, and the result is as shown in table 3.
The result of the test of table 3 shows that viral infection model group mouse death rate is 93.8%, and the mortality rate of pharmaceutical composition group of the present invention is 37.5%, obviously is better than single with Radix Bupleuri group and Herba Houttuyniae group (mortality rate is respectively 75.0% and 56.3%).
Above-mentioned result of the test is clear to be shown, by the volatile oil that extracts from Herba Houttuyniae and Radix Bupleuri is the pharmaceutical composition of the present invention of effective medicinal ingredient, can have remarkable role in synergy aspect the comprehensive analgesic and antivirus action, its result obviously is better than wherein the effectively independent effect of medicinal ingredient Radix Bupleuri and Herba Houttuyniae, thereby has gratifying DEVELOPMENT PROSPECT and value.
Table 2 refrigeration function experimental result (x ± s)
| Group | Dosage (Herba Houttuyniae/Radix Bupleuri) (g/kg) | Normal body temperature (℃) | Different time after the administration (h) body temperature (℃) | ||||
| 1h | 2h | 3h | 4h | 5h | |||
| Physiological saline I group II group III group IV group V group VI group VII group VIII group IX group X group | 4ml/kg 0/2.5 0/2 0/1 0/0.5 5/0 5/2.5 5/2 5/1 5/0.5 5/0.25 | 38.5±0.4 38.7±0.2 38.4±0.3 38.6±0.4 38.5±0.5 38.4±0.4 38.7±0.3 38.6±0.4 38.5±0.2 38.6±0.3 38.5±0.4 | 40.1±0.5 39.7±0.4 39.7±0.5 39.8±0.5 39.9±0.6 39.7±0.6 39.6±0.4 * 39.6±0.5 * 39.5±0.4 * 39.6±0.4 * 39.6±0.6 | 39.9±0.5 39.5±0.5 39.6±0.6 39.7±0.4 39.7±0.4 39.5±0.5 39.4±0.5 * 39.3±0.3 ** 39.1±0.5 ** 39.3±0.5 * 39.4±0.4 * | 39.8±0.4 39.4±0.3 39.5±0.5 39.7±0.5 39.8±0.5 39.5±0.3 39.3±0.6 39.3±0.4 * 39.0±0.4 ** 39.2±0.6 * 39.3±0.5 * | 39.7±0.5 39.4±0.5 39.5±0.6 39.6±0.4 39.7±0.3 39.4±0.6 39.2±0.4 * 39.2±0.4 * 38.9±0.6 ** 39.2±0.5 * 39.4±0.6 | 39.7±0.6 39.3±0.4 39.4±0.5 39.5±0.6 39.6±0.4 39.4±0.5 39.2±0.6 39.1±0.5 * 38.8±0.3 ** 39.1±0.4 * 39.3±0.4 |
Compare with the normal saline group:
*P＜0.05,
*P＜0.01
The protective effect of table 3 pair adenovirus type III infecting mouse
| Group | Drug level (g/ml) | Administration volume (ml/kg) | Dosage (g/kg) | Test Mus number (only) | Death toll (only) in the group | Mortality rate (%) |
| I group (viral infection model group) II group (virazole group) III group (Radix Bupleuri group) IV group (Herba Houttuyniae group) V group (Herba Houttuyniae/Radix Bupleuri=10/3) | 0.9％NaCl 0.02 1.8 6 6/1.8 | 5 5 5 5 5 | - 0.1 9 30 30/9 | 16 16 16 16 16 | 15 5 12 9 6 | 93.8 31.3 75.0 56.3 37.5 |
Claims (9)
1. the pharmaceutical composition that has the high heat effect of resisting exogenous cold, it is characterized in that with Herba Houttuyniae volatile oil and Radix Bupleuri volatile oil be effective medicinal ingredient, forming jointly with the auxiliary adding ingredient of acceptable in the medicine, is 10/1～10/5 in its ratio of extracting the Herba Houttuyniae/Radix Bupleuri of fresh Herba Houttuyniae of raw material and Radix Bupleuri crude drug weight portion.
2. the pharmaceutical composition with the high heat effect of resisting exogenous cold as claimed in claim 1 is characterized in that said ratio in Herba Houttuyniae/Radix Bupleuri of extracting fresh Herba Houttuyniae of raw material and Radix Bupleuri crude drug weight portion is 10/2～10/4.
3. the pharmaceutical composition with the high heat effect of resisting exogenous cold as claimed in claim 1 is characterized in that said ratio in Herba Houttuyniae/Radix Bupleuri of extracting fresh Herba Houttuyniae of raw material and Radix Bupleuri crude drug weight portion is 10/2.
4. as the described pharmaceutical composition of one of claim 1 to 3, it is characterized in that said pharmaceutical composition is the medicine of oral, injection, collunarium, spraying or aerosol formulations form with the high heat effect of resisting exogenous cold.
5. prepare the method with pharmaceutical composition of the high heat effect of resisting exogenous cold as claimed in claim 1, it is characterized in that being undertaken by following step:
A, Herba Houttuyniae and Radix Bupleuri raw material are extracted its volatile oil component in the distillation mode, with the two-phase system formed jointly by acceptable water insoluble oil composition and water in the medicine trapping medium, make collected volatile oil component separated and be enriched in the oil phase layer as distillate;
Acceptable auxiliary adding ingredient is prepared into corresponding pharmaceutical preparation in b, the volatile oil component that obtains with a step and the medicine.
6. preparation method as claimed in claim 5 is characterized in that said Herba Houttuyniae is fresh Herba Houttuyniae.
7. preparation method as claimed in claim 5, it is characterized in that said being extracted as of volatile oil being extracted volatile oil component in the distillation mode respectively with Herba Houttuyniae and Radix Bupleuri crude drug, the oil-phase component that will be enriched with then in the distillate trapping medium of volatile oil component merges, and need not to separate to be directly used in b step preparation.
8. preparation method as claimed in claim 5 is characterized in that the said mixed material that is extracted as Herba Houttuyniae and Radix Bupleuri to volatile oil distills jointly, is enriched with oil-phase component in the distillate trapping medium of volatile oil component and need not to separate and be directly used in b step preparation.
9. as preparation method as described in the claim 5, it is characterized in that water insoluble oil composition in the said distillate trapping medium is at least a in soybean oil, safflower oil, Oleum Gossypii semen, Semen Maydis oil, olive oil, Oleum sesami, light mineral oil, liquid paraffin, stearic acid, the silicone oil.
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