CN106924290A - A kind of Pulvis Fellis Suis menthol ointment and its production technology - Google Patents
A kind of Pulvis Fellis Suis menthol ointment and its production technology Download PDFInfo
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- CN106924290A CN106924290A CN201710310652.9A CN201710310652A CN106924290A CN 106924290 A CN106924290 A CN 106924290A CN 201710310652 A CN201710310652 A CN 201710310652A CN 106924290 A CN106924290 A CN 106924290A
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- fellis suis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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Abstract
The invention discloses a kind of Pulvis Fellis Suis menthol ointment and its production technology, the Pulvis Fellis Suis menthol ointment includes glycerine, water, Pulvis Fellis Suis, menthol, lanolin and phenmethylol, and the mass ratio of the total amount of G ＆ W, Pulvis Fellis Suis, menthol, lanolin and phenmethylol is 279~285：560：12：98~102：24.5~25.5.
Description
Technical field
The present invention relates to a kind of Pulvis Fellis Suis menthol ointment and its production technology.
Background technology
Pulvis Fellis Suis are the dry product of porcine animals pig Sus scrofadomesticaBrisson. bile, and its preparation method is：Take
Pig's bile, filtration, concentration dry, pulverize, and obtain final product.Pig's bile head sees《Mingyi Bielu》One book, say its " be slightly cold, cure the wound it is cold,
It is hot thirsty ", later age book on Chinese herbal medicine is also on the books.As written by Ming Dynasty's Li Shizhen《Compendium of Materia Medica》Cloud, " Fan family's pig gall, takes its cold energy victory heat,
Cunning can moisturize, and hardship can enter the heart, the fire of the liver and gall that can dispel again." pig's bile bitter is micro- salty, cold in nature, Return liver, courage, lung, large intestine channel；Have
Clearing heat and moistening dryness, relieving cough and asthma, effect of removing toxic substances.Pulvis Fellis Suis now record kind for Chinese Pharmacopoeia, for treating the dry thirsty, mesh of pyreticosis
The diseases such as red, jaundice, pertussis, asthma, dysentery, ulcerative carbuncle pyogenic infections.Modern study finds that the main chemical compositions in Pulvis Fellis Suis are courage
Acids (CA), BILE PIGMENTS (bilichrome), mucoprotein, lecithin lipid and salt, urea, polypeptide compound and various amino
Acid etc..Pharmaceutical research shows that bile acid has the bioactivity such as antibacterial, anti-inflammatory, anticancer, cholagogic, reducing blood lipid.
Menthol for labiate peppermint MenthahaplocalyxBriq. fresh stem and Ye Jing steam distillations,
A kind of cyclic alcohol of the saturation freeze, being recrystallized to give, is l-1- methyl -4- isopropyl cyclohexanols -3.Menthol can be used for outward
Pruitus and pruritus dermatopathy that a variety of causes causes.
Pulvis Fellis Suis menthol ointment is made up of Pulvis Fellis Suis and the taste medicine of menthol two, mainly with it is clearing heat and detoxicating the effect of, face
It is mainly used in the treatment of malignant boil, furuncle, carbuncle swells etc. on bed, its quality standard is recorded and rises to national standard in chemicals provincial standard
Part the 9th.For Pulvis Fellis Suis menthol ointment, prescription is only disclosed in national standard：Pulvis Fellis Suis 560g, menthol 12g and
Auxiliary material 428g, but searching document does not find the concrete scheme of this complex preparation.
The content of the invention
The first object of the present invention is to provide a kind of Pulvis Fellis Suis menthol ointment.
Above-mentioned technical purpose of the invention technical scheme is that：
A kind of Pulvis Fellis Suis menthol ointment, including glycerine, water, Pulvis Fellis Suis, menthol, lanolin and phenmethylol, G ＆ W
The mass ratio of total amount, Pulvis Fellis Suis, menthol, lanolin and phenmethylol is 279~285：560：12：98~102：24.5~
25.5。
More preferably：The mass ratio of the total amount of G ＆ W, Pulvis Fellis Suis, menthol, lanolin and phenmethylol is
282：560：12：100：25.0.
More preferably：The mass ratio of the G ＆ W is 0.2~5：1.
More preferably：Also include Mint Essence and Sodium Benzoate, the quality of Pulvis Fellis Suis, Mint Essence and Sodium Benzoate
Than being 560：10.5~11.1：9.8~10.2.
The second object of the present invention is to provide a kind of preparation method of Pulvis Fellis Suis menthol ointment.
Above-mentioned technical purpose of the invention technical scheme is that：
A kind of preparation method of Pulvis Fellis Suis menthol ointment, comprises the following steps：
(1) Pulvis Fellis Suis and water mixing are taken, is heated and is stirred and evenly mixed, be brewed into porcine bile paste；
(2) lanolin of melting is added in the porcine bile paste of step (1), is stirred and evenly mixed；
(3) in mixture, glycerine that phenmethylol and menthol are added in the mixture of step (2), stir and evenly mix；
(4) cool down, discharge and pack.
More preferably：In step (3), Mint Essence is dispersed with glycerine.
More preferably：In step (3), the mixture of Sodium Benzoate and water is also added with.
More preferably：Step (2) is carried out at 80~85 DEG C.
More preferably：In step (4), the temperature of discharging is 50~58 DEG C.
More preferably：In step (4), during packaging, first aluminum pipe is disinfected, then carried out at filling and sealing
Reason.
In sum, the invention has the advantages that：
1st, the active component of the Pulvis Fellis Suis menthol ointment of the application is made up of Pulvis Fellis Suis and the taste medicine of menthol two, main to have clearly
The effect of thermal detoxification, clinically it is mainly used in the treatment of malignant boil, furuncle, carbuncle swells etc., with preferable curative effect；
2nd, the Pulvis Fellis Suis menthol ointment of the application is using specific formula and technique so that prepare Pulvis Fellis Suis menthol ointment
Mode can be controllable with large-scale production, production process conditional, improve different batches between stability, it is ensured that the medicine of product
Effect；
3rd, the Pulvis Fellis Suis menthol ointment obtained using the formula and technique of the application, loss of effective components amount is relatively few, carries
The utilization rate of raw material high；
4th, the Pulvis Fellis Suis menthol ointment obtained using the formula and technique of the application, is damaged a period of time active ingredient is placed
Vector is few, good stability, reduces accessory substance and produces volume possibility, keeps excellent drug effect.
Specific embodiment
This specific embodiment is only explanation of the invention, and it is not limitation of the present invention, people in the art
Member can make the modification without creative contribution to the present embodiment as needed after this specification is read, but as long as at this
All protected by Patent Law in the protection domain of invention.
Embodiment 1-3：A kind of Pulvis Fellis Suis menthol ointment, its preparation process is comprised the following steps：
(1) Pulvis Fellis Suis and water mixing are taken, is heated and is stirred and evenly mixed, be brewed into porcine bile paste；
(2) lanolin of melting is added in the porcine bile paste of step (1), is stirred and evenly mixed at 80~85 DEG C；
(3) in the mixing of mixture, Mint Essence and the glycerine that phenmethylol and menthol are separately added into the mixture of step (2)
The mixture of thing, Sodium Benzoate and water, stirs and evenly mixs；
(4) cooling, in 50~58 DEG C of bottom discharges and packaging, during packaging first by aluminum pipe sterilization it is filling again and sealing；Embodiment 1-3's
Formula is as shown in table 1.
The formula (kg) of the embodiment 1-3 of table 1
Embodiment 4-8：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is, using as shown in table 2
Formula.
The formula (kg) of the embodiment 4-8 of table 2
Embodiment 9：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is, in step (2), melts sheep
The temperature of hair fat is 70 DEG C.
Embodiment 10：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is, in step (2), melting
The temperature of lanolin is 95 DEG C.
Embodiment 11：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is that the temperature of discharging is 40
℃。
Embodiment 12：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is that the temperature of discharging is 70
℃。
Performance characterization is tested
1st, with reference to the preparation of sample
With reference to sample 1：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is that lanolin is substituted with vaseline.
With reference to sample 2：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is, benzene first
Sour sodium is substituted with ethyl hydroxy benzoate.
With reference to sample 3：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is, without glycerine.
With reference to sample 4-5：A kind of Pulvis Fellis Suis menthol ointment, the difference with embodiment 1 is, using as shown in table 3
Formula.
Formula (kg) of the table 3 with reference to sample 4-5
2nd, the existing performance characterization of product processed
(1) test sample：Embodiment 1-12 and reference sample 1-5.
(2) content is tested：The test sample of enchashment, observes its outward appearance and determines the active constituent content in it respectively；
Each place experiment it is parallel carry out 3 times, as a result take its average value.
Pulvis Fellis Suis in terms of hyodesoxycholic acid, its assay referring to Chinese Pharmacopoeia, i.e.,：Test sample 0.25g accurately is weighed,
10wt% sodium hydroxide solutions 10ml is added, 120 DEG C are heated 5 hours, are let cool, and are transferred in separatory funnel, with water 10ml by several times
Washing container, washing lotion is incorporated in separatory funnel, with salt acid for adjusting pH value to 1, is shaken up, with ethyl acetate extract 4 times, every time
30ml, merges extract solution, is evaporated, and residue adds ethanol to be quantitatively transferred in 25ml volumetric flasks, plus ethanol is to scale, shakes up, and stands,
Filtrate is filtered to take as need testing solution；Another accurately weighing deoxygenates by the drier drying under reduced pressure pig of 24 hours of phosphorus pentoxide
Cholic acid reference substance is appropriate, plus ethanol dissolves and quantifies dilution and is made the solution containing 0.9mg in every 1ml, used as reference substance solution.According to
Thin-layered chromatography is tested, and draws the μ l of need testing solution 1, the μ l of reference substance test solution 1 and 2 μ l, and crosspoint is in same silica G thin layer respectively
On, with n-hexane-ethyl acetate-acetic acid-methyl alcohol (20:52:2:3) upper solution is solvent, is launched, and is taken out, and is dried, and is sprayed
With 5% ethanol solution of sulfuric acid, spot development is heated at 105 DEG C clearly, taken out, an equal amount of glass is covered on thin layer half
Plate, around uses immobilization with adhesive tape, is scanned according to thin-layered chromatography, wavelength rs=375nm, rR=650nm, measurement test sample absorbs
Degree integrated value is calculated in reference substance trap integrated value, is obtained final product.
The assay of menthol is determined referring to Chinese Pharmacopoeia, i.e.,：Determined according to gas chromatography.Accurately weigh test sample
1000mg, is placed in the volumetric flask of 10ml, plus anhydrous alcohol solution and is diluted to scale, shakes up, and obtains final product, and filters to take filtrate conduct
Need testing solution；10mg menthol reference substances are accurately separately weighed, is placed in the volumetric flask of 10ml, plus anhydrous alcohol solution and diluted
To scale, shake up, obtain final product reference substance solution.Accurate reference substance solution of drawing is in each 1 μ l of need testing solution, injection meteorology color respectively
Spectrometer, determines, and obtains final product.
Test result is counted with deviation A, A=100%* (Xl-Xs)/Xl, wherein XsFor hyodesoxycholic acid content or
The actual measured value of Determination of menthol, XlIt is hyodesoxycholic acid content or the theoretical detected value of Determination of menthol.
3rd, test result：As shown in table 4.Table 4 shows, with compared with sample, the hyodesoxycholic acid of embodiment 1-12 and
The content deviation value of menthol is smaller, illustrates the loss of effective components amount of the Pulvis Fellis Suis menthol of the application in preparation process
Relatively few, wherein embodiment 1,5-7 is most preferred embodiment.
Table 4 now the performance characterization of product processed result statistics
3rd, stability test
(1) test sample：Embodiment 1-12 and reference sample 1-5.
(2) content is tested：The test sample of enchashment, observes its outward appearance and determines the active constituent content in it respectively；
Then test sample pack with the aluminum pipe sterilized, with the glass bottle packaging sterilized, test sample is divided after encapsulation process
It is not placed under 4 DEG C/20%RH, 25 DEG C/60%RH and 40 DEG C/75%RH, observes its outward appearance again after placing for a period of time and determine
Content in it.Each is placed in experiment, and the amount of test sample is 10g；Each places that experiment is parallel to carry out 3 times, as a result
Take its average value.
The assay of hyodesoxycholic acid and menthol is identical with " the now performance characterization of product processed " part.
Test result is counted with rate of change B, B=100%* (Xi-Xo)/Xo, wherein XiFor the pig measured after placement goes
Oxycholic acid content or Determination of menthol, XiIt is the hyodesoxycholic acid content or Determination of menthol that are measured before placement.
3rd, test result：As illustrated in tables 5-7.
The different samples on same form (or table 5 or table 6 or table 7) are contrasted, can draw to draw a conclusion：With reference sample phase
Than the hyodesoxycholic acid of embodiment 1-12 and the rate of change of menthol are smaller, illustrate the pig of the application in placement process
The loss of effective components amount of courage powder menthol relatively less, good stability, wherein embodiment 1,5-7 be most preferred embodiment.
The same sample on different forms is contrasted, can draw to draw a conclusion：With compared with sample, the pig of embodiment 1-12 goes
The rate of change of oxycholic acid and menthol is also smaller under critical conditions, and the Pulvis Fellis Suis menthol of the application is transferred in critical conditions
Putting also has preferable stability, keeps excellent drug effect.
Result statistics (4 DEG C/20%RH) of the stability test of table 5
Result statistics (25 DEG C/60%RH) of the stability test of table 6
Result statistics (40 DEG C/75%RH) of the stability test of table 7
Claims (10)
1. a kind of Pulvis Fellis Suis menthol ointment, it is characterised in that including glycerine, water, Pulvis Fellis Suis, menthol, lanolin and benzene first
Alcohol, the mass ratio of the total amount of G ＆ W, Pulvis Fellis Suis, menthol, lanolin and phenmethylol is 279~285：560：12：98~
102：24.5~25.5.
2. Pulvis Fellis Suis menthol ointment according to claim 1, it is characterised in that the total amount of G ＆ W, Pulvis Fellis Suis, thin
The mass ratio of lotus brain, lanolin and phenmethylol is 282：560：12：100：25.0.
3. Pulvis Fellis Suis menthol ointment according to claim 1, it is characterised in that the mass ratio of the G ＆ W is
0.2~5：1.
4. Pulvis Fellis Suis menthol ointment according to claim 1, it is characterised in that also including Mint Essence and benzoic acid
Sodium, the mass ratio of Pulvis Fellis Suis, Mint Essence and Sodium Benzoate is 560：10.5~11.1：9.8~10.2.
5. the preparation method of a kind of Pulvis Fellis Suis menthol ointment as described in claim any one of 1-4, it is characterised in that including
Following steps：
(1) Pulvis Fellis Suis and water mixing are taken, is heated and is stirred and evenly mixed, be brewed into porcine bile paste；
(2) lanolin of melting is added in the porcine bile paste of step (1), is stirred and evenly mixed；
(3) in mixture, glycerine that phenmethylol and menthol are added in the mixture of step (2), stir and evenly mix；
(4) cool down, discharge and pack.
6. preparation method according to claim 5, it is characterised in that in step (3), Mint Essence is dispersed with glycerine.
7. preparation method according to claim 5, it is characterised in that in step (3), is also added with Sodium Benzoate and water
Mixture.
8. preparation method according to claim 5, it is characterised in that step (2) is carried out at 80~85 DEG C.
9. preparation method according to claim 5, it is characterised in that in step (4), the temperature of discharging is 50~58 DEG C.
10. preparation method according to claim 5, it is characterised in that in step (4), during packaging, first by aluminum pipe sterilization
Reason, then carries out filling and encapsulation process.
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| CN201710310652.9A CN106924290A (en) | 2017-05-05 | 2017-05-05 | A kind of Pulvis Fellis Suis menthol ointment and its production technology |
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| CN201710310652.9A CN106924290A (en) | 2017-05-05 | 2017-05-05 | A kind of Pulvis Fellis Suis menthol ointment and its production technology |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102379880A (en) * | 2010-08-30 | 2012-03-21 | 殷峰林 | Preparation method of compound benzoic acid ointment |
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2017
- 2017-05-05 CN CN201710310652.9A patent/CN106924290A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102379880A (en) * | 2010-08-30 | 2012-03-21 | 殷峰林 | Preparation method of compound benzoic acid ointment |
Non-Patent Citations (3)
| Title |
|---|
| 刘涛等: "猪胆汁的药理与临床应用", 《南京中医药大学学报(自然科学版)》 * |
| 王重九: "猪胆汁膏外用治疗各种表浅化脓性感染的初步观察", 《中国农村医学》 * |
| 胡献国等: "《中国膏药配方配制全书》", 30 April 2014, 辽宁科学技术出版社 * |
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Application publication date: 20170707 |