CN116687993B - Radix arnebiae and safflower cream and preparation method thereof - Google Patents
Radix arnebiae and safflower cream and preparation method thereof Download PDFInfo
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- CN116687993B CN116687993B CN202310787521.5A CN202310787521A CN116687993B CN 116687993 B CN116687993 B CN 116687993B CN 202310787521 A CN202310787521 A CN 202310787521A CN 116687993 B CN116687993 B CN 116687993B
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- 239000006071 cream Substances 0.000 title claims abstract description 99
- 238000002360 preparation method Methods 0.000 title claims abstract description 38
- 244000020518 Carthamus tinctorius Species 0.000 title claims abstract description 22
- 235000003255 Carthamus tinctorius Nutrition 0.000 title claims abstract description 22
- 241001071917 Lithospermum Species 0.000 claims abstract description 41
- 206010012444 Dermatitis diaper Diseases 0.000 claims abstract description 15
- 208000003105 Diaper Rash Diseases 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims description 60
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 58
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 43
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- XDOFQFKRPWOURC-UHFFFAOYSA-N 16-methylheptadecanoic acid Chemical compound CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 claims description 4
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- 235000010268 sodium methyl p-hydroxybenzoate Nutrition 0.000 description 3
- PESXGULMKCKJCC-UHFFFAOYSA-M sodium;4-methoxycarbonylphenolate Chemical compound [Na+].COC(=O)C1=CC=C([O-])C=C1 PESXGULMKCKJCC-UHFFFAOYSA-M 0.000 description 3
- 238000013517 stratification Methods 0.000 description 3
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- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 description 2
- CFKMVGJGLGKFKI-UHFFFAOYSA-N 4-chloro-m-cresol Chemical compound CC1=CC(O)=CC=C1Cl CFKMVGJGLGKFKI-UHFFFAOYSA-N 0.000 description 2
- 206010015150 Erythema Diseases 0.000 description 2
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 2
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- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
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- MINDHVHHQZYEEK-UHFFFAOYSA-N (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-(beta)-methyl-2H-pyran-2-crotonic acid ester with 9-hydroxynonanoic acid Natural products CC(O)C(C)C1OC1CC1C(O)C(O)C(CC(C)=CC(=O)OCCCCCCCCC(O)=O)OC1 MINDHVHHQZYEEK-UHFFFAOYSA-N 0.000 description 1
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- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 description 1
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- BMCQMVFGOVHVNG-TUFAYURCSA-N cortisol 17-butyrate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)CO)(OC(=O)CCC)[C@@]1(C)C[C@@H]2O BMCQMVFGOVHVNG-TUFAYURCSA-N 0.000 description 1
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- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 description 1
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 description 1
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- WOFMFGQZHJDGCX-ZULDAHANSA-N mometasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(Cl)[C@@]4(C)C=CC(=O)C=C4CC[C@H]3[C@@H]2C[C@H]1C)C(=O)CCl)C(=O)C1=CC=CO1 WOFMFGQZHJDGCX-ZULDAHANSA-N 0.000 description 1
- 229960003128 mupirocin Drugs 0.000 description 1
- 229930187697 mupirocin Natural products 0.000 description 1
- DDHVILIIHBIMQU-YJGQQKNPSA-L mupirocin calcium hydrate Chemical compound O.O.[Ca+2].C[C@H](O)[C@H](C)[C@@H]1O[C@H]1C[C@@H]1[C@@H](O)[C@@H](O)[C@H](C\C(C)=C\C(=O)OCCCCCCCCC([O-])=O)OC1.C[C@H](O)[C@H](C)[C@@H]1O[C@H]1C[C@@H]1[C@@H](O)[C@@H](O)[C@H](C\C(C)=C\C(=O)OCCCCCCCCC([O-])=O)OC1 DDHVILIIHBIMQU-YJGQQKNPSA-L 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/286—Carthamus (distaff thistle)
-
- 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
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
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- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
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- General Chemical & Material Sciences (AREA)
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- Alternative & Traditional Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
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Abstract
The invention discloses a lithospermum safflower cream and a preparation method thereof, belonging to the technical field of medicinal preparations. According to the invention, lithospermum and safflower are selected as model medicines to cooperatively treat diaper rash of infants, a W/O type cream matrix is used as a medicine carrier, a single-factor experimental method is adopted to screen the prescription and the preparation process of the W/O type lithospermum safflower cream respectively, and the appearance property and the physical stability of the cream are used as evaluation indexes, so that the cream which is fine and uniform in appearance, easy to apply, free of pungent smell and good in physical stability is finally obtained. The preparation process is simple, easy to operate and easy to produce and amplify.
Description
Technical Field
The invention relates to a lithospermum safflower cream and a preparation method thereof, belonging to the technical field of medicinal preparations.
Background
Diaper rash, also known as diaper dermatitis, refers to irritant, contact dermatitis that occurs in the skin of the diaper area, and occurs in infants within three years of age, especially infants from 9 to 12 months. Diaper rash is mainly characterized in that the skin of a diaper contact area is provided with erythema-shaped pimples or slight erythema, bacterial infection can be caused at skin ulceration parts of severe patients, bacteremia and septicemia can occur, and even the lives of infants can be endangered, so that great trouble is brought to the infants and families where the infants are located.
Methods of treating diaper rash are largely divided into physical therapy and chemical therapy. Oxygen blowing is a physical method capable of effectively treating diaper rash, subcutaneous capillary microcirculation at the dermatitis area of infants is hindered, an anaerobic environment is formed, anaerobic metabolism of cells is increased, and thus tissue hypoxia is aggravated. Oxygen is blown to the dermatitis affected part to effectively improve oxygen content in blood, increase oxygen metabolism of local tissues, and keep the dermatitis affected part dry. However, the equipment required for this therapy is limited to medical sites and is expensive, so this therapy has not been commonly used. Topical zinc oxide cream, mupirocin cream, are traditional chemotherapy for the treatment of infant diaper rash, but have poor efficacy. At present, chemotherapy mainly comprises glucocorticoids and antibiotics, such as hydrocortisone butyrate cream and mometasone furoate cream. Although the chemical medicine has obvious treatment effect, because the immune system of the infant is not developed completely, although the glucocorticoid medicine can take effect in a short time, long-term use can lead to telangiectasia, rapid weight growth and the like of the infant, and meanwhile, the adverse symptoms such as hypodynamia, somnolence and syncope and the like are accompanied; the long-term use of antibiotics can cause dysbacteriosis in infants, increase the drug resistance of bacteria, and finally cause the effect of antibiotics to be worse and the recurrence rate to be high.
For the treatment of diaper rash of infants, the Chinese traditional medicine field also has quite abundant experience, and natural Chinese herbal medicines are rapidly and widely applied due to the advantages of low toxicity, small irritation, high curative effect and the like. The common Chinese herbal medicines include coptis root, safflower, lithospermum and the like, wherein the lithospermum has the best curative effect and the most widely applied. The existing medicinal preparation for treating the diaper rash of the infants mainly comprises cream, lotion and powder, and the compound lithospermum oil produced by the Jianmi group has good market response and has been widely applied to the treatment of the diaper rash of the infants and has good clinical curative effect. The powder has quick effect, but has the defects of short residence time, easy staining of clothes and the like, and the lotion has short residence time, needs to be decocted by itself and has complicated preparation process. Compared with powder and lotion, the cream has long retention time and convenient use, and greatly improves the medication compliance of patients. Although lithospermum preparations for treating infant diaper rash are commercially available, most of the lithospermum preparations have problems of pungent smell, poor physical stability and high recurrence rate.
The existing lithospermum external preparations for infant diaper rash in the domestic market at present comprise lithospermum oil (Guangzhou Runner infant products Co., ltd.) and lithospermum infant cream (Yunnan Kang Enbei vegetable drugs Co., ltd.), and the following problems generally exist in the products: the compliance of the patients is poor, and the lithospermum extract and the safflower extract have pungent odor; the physical stability is poor, and the cream is subjected to oil-water separation phenomenon due to external factors.
Disclosure of Invention
In order to solve at least one problem, lithospermum and safflower are selected as model medicines to cooperatively treat diaper rash of infants, a W/O type cream matrix is used as a medicine carrier, a single-factor experimental method is adopted to screen the prescription and the preparation process of the W/O type lithospermum and safflower cream respectively, and the appearance property and the physical stability of the cream are used as evaluation indexes, so that the cream which is fine and uniform in appearance, easy to smear, free of pungent smell and good in physical stability is finally obtained.
The first object of the invention is to provide a lithospermum safflower cream, which comprises 15 parts of glyceryl monostearate, 62 parts of liquid paraffin, 4.7 parts of polyglycerol-3 diisostearate, 2.3 parts of oleoyl polyoxyethylene glyceride, 5 parts of lithospermum extract, 10 parts of safflower extract and a preservative in parts by weight.
In one embodiment, the preservative is 0.05 to 0.2 parts. Optionally, the preservative is 0.1 parts. Alternatively, the preservative may be ethylparaben, hydroxyphenyl esters, chlorocresol, chlorobutanol, chlorhexidine, and the like.
In one embodiment, the arnebia root and safflower cream further contains essence, and further, the essence is peach essence. Optionally, the total amount of essence added is 0.5-1.4, and further 0.9 parts.
The second object of the invention is to provide a preparation method of the lithospermum safflower cream, which comprises the following steps: setting the emulsification temperature to 85 ℃ and the stirring speed to 260rpm, centrifuging the oil phase and the water phase, and heating to the emulsification temperature; adding the water phase 1 into a stirring container, immediately dripping the oil phase into the container, and stirring and emulsifying for 10min; finally, adding the water phase 2 into a stirring container, stirring and emulsifying for 10min; stirring, stopping heating, cooling to 35deg.C, stirring for 10min, cooling to 18deg.C, and stirring for 10min to obtain cream; wherein the emulsifier is added to the oil phase.
In one embodiment, the oil phase contains glyceryl monostearate and liquid paraffin; the water phase 1 contains safflower extract and partial essence; the water phase 2 contains radix Arnebiae extract and part of essence; the emulsifier is polyglycerol-3 bis isostearate and oleoyl polyoxyethylene glyceride; the preservative is ethylparaben.
In one embodiment, the fragrance is added to the aqueous phase and the preservative and emulsifier are added to the oil phase.
In one embodiment, the oil phase is prepared by weighing various auxiliary materials in the oil phase according to the prescription amount, placing the auxiliary materials in a water bath kettle, stirring and heating the auxiliary materials to a preset temperature, and obtaining a clear transparent state.
In one embodiment, the oil phase contains glyceryl monostearate and liquid paraffin, and further, the ratio of glyceryl monostearate to liquid paraffin is 15:62.
In one embodiment, the aqueous phase 1 is prepared by weighing safflower extract and a portion of essence according to a prescribed amount; the water phase 1 is placed in a water bath kettle and heated to a preset temperature.
In one embodiment, the water phase 2 is prepared by weighing radix Arnebiae extract and part of essence according to the prescription amount; the water phase 2 is placed in a water bath kettle and heated to a preset temperature.
In one embodiment, the emulsifier is polyglycerin-3 bis-isostearate, oleoyl polyoxyethylene glyceride, further the ratio of polyglycerin-3 bis-isostearate to oleoyl polyoxyethylene glyceride is 4.7:2.3.
The third object of the invention is to provide a cream for treating or improving infant diaper rash, which comprises, by weight, 15 parts of glyceryl monostearate, 62 parts of liquid paraffin, 4.7 parts of polyglycerol-3 diisostearate, 2.3 parts of oleoyl polyoxyethylene glyceride, 5 parts of lithospermum extract, 10 parts of safflower extract and 0.1 part of preservative.
The invention has the advantages and effects that:
In the lithospermum safflower emulsifiable paste, the lithospermum and the safflower are both Chinese herbal medicines, so the lithospermum safflower emulsifiable paste has high safety, small side effect and no irritation, and is suitable for long-term treatment of skin diseases which are easy to repeatedly attack and are of inflammatory types such as diaper rash.
The lithospermum safflower cream prepared by the invention can obviously cover the pungent smell of lithospermum and safflower extract by the water-in-oil emulsification technology, increase the physical stability of the cream, and the W/O type cream matrix can increase the affinity of the cream to skin, thereby having good absorption effect and avoiding the adverse symptoms of reabsorption of exudates and the like caused by the oil-in-water type cream. Meanwhile, the invention discovers that precipitation can be generated after the lithospermum extract and the safflower extract are mixed, the stability of the lithospermum safflower emulsifiable paste is greatly influenced by the preparation process, and the stability of the paste is improved by effectively controlling the preparation process, such as two-step emulsification, the addition sequence of the extracts and the like.
The preparation method is simple, easy to operate and easy for large-scale production.
Drawings
Fig. 1 shows the results of the centrifugal test, the heat-resistant test, and the cold-resistant test performed on the cream 1 obtained in example 1, in this order from left to right.
Fig. 2 shows the results of the centrifugal test, the heat-resistant test, and the cold-resistant test performed on the cream 2 obtained in example 1, in this order from left to right.
Fig. 3 shows the results of the centrifugal test, the heat-resistant test, and the cold-resistant test performed on the cream 3 obtained in example 1, in this order from left to right.
Fig. 4 shows the results of the centrifugal test, the heat-resistant test, and the cold-resistant test performed on the cream 4 obtained in example 1, in this order from left to right.
Fig. 5 shows the appearance of the paste of formula F2.
Fig. 6 shows the results of evaluating the centrifugal stability of the pastes of the prescriptions F3, F4, and F5, and the prescriptions F3, F4, and F5 are sequentially arranged from left to right.
Fig. 7 shows the results of evaluating the thermal stability of the pastes of prescriptions F3, F4, and F5, and prescriptions F3, F4, and F5 are sequentially arranged from left to right.
Fig. 8 shows the freeze-thaw stability evaluation results of the pastes of prescriptions F3, F4, and F5, and prescriptions F3, F4, and F5 are sequentially arranged from left to right.
Fig. 9 shows the results of evaluating the centrifugal stability of the pastes of the prescriptions F6, F7, and F8, and the prescriptions F6, F7, and F8 are sequentially arranged from left to right.
Fig. 10 shows the results of evaluating the thermal stability of the pastes of prescriptions F6, F7, and F8, with prescriptions F6, F7, and F8 in this order from left to right.
Fig. 11 shows the results of evaluating the centrifugal stability of the pastes of the prescriptions F9, F10, and F11, and the prescriptions F9, F10, and F11 are sequentially arranged from left to right.
Fig. 12 shows the results of evaluating the thermal stability of the pastes of prescriptions F9, F10, and F11, and prescriptions F9, F10, and F11 are sequentially formed from left to right.
Fig. 13 shows the results of evaluating the freeze-thaw stability of the pastes of the prescriptions F9, F10, and F11, and the prescriptions F9, F10, and F11 are sequentially arranged from left to right.
Fig. 14 shows the results of evaluating the centrifugal stability of the pastes of prescriptions F12, F13, and F14, and prescriptions F12, F13, and F14 are sequentially arranged from left to right.
Fig. 15 shows the results of evaluating the thermal stability of the pastes of prescriptions F12, F13, and F14, and prescriptions F12, F13, and F14 are sequentially arranged from left to right.
Fig. 16 shows the results of evaluating the freeze-thaw stability of the pastes of prescriptions F12, F13, and F14, respectively, from left to right.
Fig. 17 shows the results of evaluating the centrifugal stability of the pastes of the prescriptions F15, F16, F17, and F18, and the prescriptions F15, F16, F17, and F18 are sequentially arranged from left to right.
Fig. 18 shows the results of evaluating the thermal stability of the pastes of the prescriptions F15, F16, F17, and F18, and the prescriptions F15, F16, F17, and F18 are sequentially arranged from left to right.
Fig. 19 shows the results of evaluating the freeze-thaw stability of the pastes of the prescriptions F15, F16, F17, F18, and the prescriptions F15, F16, F17, F18 are sequentially arranged from left to right.
FIG. 20 shows the results of compatibility evaluation of radix Arnebiae and flos Carthami extracts, followed from left to right by radix Arnebiae+flos Carthami, radix Arnebiae+NaCl, radix Arnebiae+Mg 2SO4, radix Arnebiae+sodium methylparaben.
Detailed Description
1. Experimental materials
The reagents used in the present invention are shown in Table 1.
TABLE 1 reagents required for experiments
The apparatus used in the present invention is shown in table 2.
Table 2 instruments required for experiments
2. Evaluation of W/O-type Lithospermum erythrorhizon cream
(1) Appearance and ductility
Appearance characteristics: visually observing whether the paste has bubbles or foreign matters, and standing to determine whether oil-water delamination occurs; proper amount of ointment is smeared on the surface of skin to obtain fine and uniform skin with obvious granular sensation.
Ductility: 1.0g of the cream is weighed and placed on a 10cm glass sheet, a glass sheet with the same specification size is placed above the cream, a 100g weight is pressed on the upper glass sheet, the maximum diameter and the minimum diameter of the paste interface are measured after the cream is stood for 20min, the average value is taken, and data are recorded. The average value is in the range of 4.0-5.0cm, which means that the cream has good ductility and is suitable for application.
(2) Evaluation of physical stability
Centrifugal test: weighing a proper amount of cream, placing the cream into a centrifuge tube, setting the parameters of a high-speed centrifuge to 3000rpm for 30min, and observing whether the cream has oil-water delamination phenomenon after centrifugation.
Heat resistance test: weighing a proper amount of cream, placing into a centrifuge tube, setting the parameters of a constant temperature drying oven at 55 ℃ for 6 hours, and observing whether the cream has oil-water delamination phenomenon.
Cold resistance test: weighing a proper amount of cream, placing the cream into a centrifuge tube, placing the centrifuge tube filled with the cream into a freezer with the temperature of-4 ℃, repeatedly freezing and thawing for three times, and observing whether the appearance of the cream has obvious change or not.
Example 1: radix arnebiae and safflower cream and preparation method thereof
The lithospermum safflower cream comprises, by weight, 15% of glyceryl monostearate, 62% of liquid paraffin, 4.7% of polyglycerol-3 diisostearate, 2.3% of oleoyl polyoxyethylene glyceride, 5% of lithospermum extract, 10% of safflower extract, 0.9% of peach essence and 0.1% of ethylparaben.
The cream is prepared by adopting the following preparation process 1, the preparation process 2, the preparation process 3 and the preparation process 4. Wherein, the emulsifier is added in the oil phase; essence is added in the water phase, and preservative is added in the oil phase.
In the embodiment, the oil phase is 15% of glyceryl monostearate and 62% of liquid paraffin; the water phase 1 is 10% of safflower extract and 0.45% of peach essence; the water phase 2 is 5% of lithospermum extract and 0.45% of peach essence; the emulsifier is 4.7% of polyglycerol-3 bis isostearate and 2.3% of oleoyl polyoxyethylene glyceride; the preservative is ethylparaben.
The preparation process 1 comprises the following steps: setting the emulsification temperature at 85 ℃ and the stirring speed at 260rpm, centrifuging the oil phase and the water phase, and heating to the emulsification temperature; adding the water phase 1 into a stirring container, immediately dripping the oil phase into the container, and stirring and emulsifying for 10min after all the oil phase is dripped into the container; finally, adding the water phase 2 into a stirring container, stirring and emulsifying for 10min; stirring, cooling to 35deg.C with cold water, stirring for 10min, cooling to 18deg.C with ice water, and stirring for 10min to obtain cream 1.
The preparation process 2 comprises the following steps: setting the emulsification temperature at 85 ℃ and the stirring speed at 260rpm, adding the oil phase into a stirring container, immediately dripping the water phase 1 into the container, stirring and emulsifying for 5min; finally, dripping the water phase 2 into a stirring container, stirring and emulsifying for 10min; stirring, cooling to 35deg.C with cold water, stirring for 10min, cooling to 18deg.C with ice water, and stirring for 10min to obtain cream 2.
The preparation process 3 comprises the following steps: setting the emulsification temperature at 85 ℃ and the stirring speed at 260rpm, centrifuging the oil phase and the water phase, and heating to the emulsification temperature; adding the water phase 1 and the water phase 2 into a stirring container at the same time, then dripping the oil phase into the container, and stirring and emulsifying for 10min; stirring, cooling to 35deg.C with cold water, stirring for 10min, cooling to 18deg.C with ice water, and stirring for 10min to obtain cream 3.
The preparation process 4 comprises the following steps: setting the emulsification temperature at 85 ℃ and the stirring speed at 260rpm, centrifuging the oil phase and the water phase, and heating to the emulsification temperature; adding the water phase 2 into a stirring container, immediately dripping the oil phase into the container, and stirring and emulsifying for 10min after all the oil phase is dripped into the container; finally, dripping the water phase 1 into a stirring container, stirring and emulsifying for 10min; stirring, cooling to 35deg.C with cold water, stirring for 10min, cooling to 18deg.C with ice water, and stirring for 10min to obtain cream 4.
Analysis of the prepared cream 1-4 shows that the obtained cream has fine and uniform appearance and no obvious peculiar smell; the resulting creams 1 to 4 were subjected to centrifugation, heat resistance and cold resistance tests as shown in fig. 1, 2, 3, 4 and table 3. The results show that the cream 1 obtained in the preparation process 1 has no layering in a centrifugal test, no layering in a heat-resistant test and no precipitation of substances in a cold-resistant test, and the prepared cream has good appearance and physical stability; and the obtained cream 2-4 has layering or precipitation phenomenon in centrifugal test, heat-resistant test and cold-resistant test.
TABLE 3 evaluation results of stability
| Centrifugal test | Heat resistance test | Cold resistance test | |
| Cream 1 | Not layered | Not layered | Is not precipitated out |
| Cream 2 | Layering | Layering | Precipitation of |
| Cream 3 | Layering | Layering | Precipitation of |
| Cream 4 | Layering | Layering | Precipitation of |
Comparative example 1: screening of oil phases
The oil phase auxiliary material is one of important components of the cream, and the type composition of the oil phase auxiliary material can influence the ductility, the fineness, the physical stability and the like of the cream. In order to ensure the physical stability of the W/O type cream, the oil phase proportion is far greater than the water phase proportion, and the cream prepared by using the single high-melting-point oil phase auxiliary material has obvious external granular feel and rough texture, and the patient has poor using feel, so the oil phase auxiliary material with low melting point is matched and used when the oil phase auxiliary material of the cream is screened.
In this example, liquid paraffin was used as the low-melting point component in the oil phase, and glyceryl behenate and glyceryl monostearate were used as the high-melting point oil phase auxiliary materials for prescription screening, and the prescription is shown in Table 4. Experiments were performed with the preparation process 1 of example 1, and subsequent experiments were performed with the ductility, fineness, taste masking effect and physical stability of the cream as evaluation indexes to determine the type of oil phase auxiliary materials.
TABLE 4 composition and dosage ratio of screening prescription
Table 5 stability evaluation results of screening prescriptions
As shown in Table 5 and FIG. 5, the melting point of glyceryl behenate was too high, and the resulting cream was too coarse and hard, and had a pronounced grainy feel; the cream prepared from the glyceryl monostearate has fine and uniform appearance and no obvious peculiar smell, and the cream prepared from the glyceryl monostearate is not layered in a stability evaluation experiment, so that the glyceryl monostearate and the liquid paraffin are used as mixed oil phase auxiliary materials for further screening in a subsequent experiment.
Comparative example 2: screening of proportion of glyceryl monostearate to liquid Paraffin
Adjusting the proportion of the oil phase auxiliary materials is an important step for preparing the cream, and different proportions of the oil phase auxiliary materials influence the ductility, physical stability and the like of the cream. When the proportion of the high-melting-point oil-phase auxiliary materials is too large, the prepared cream is too hard, the granular sensation is obvious, and the cream is too coarse; when the proportion of the high-melting-point oil-phase auxiliary material is too small, the prepared cream is too thin. Meanwhile, the ratio of the oil phase auxiliary materials can influence the emulsification effect of the cream. The three prescriptions of 10%, 15% and 20% of glyceryl monostearate and liquid paraffin are respectively screened by using the glyceryl monostearate and the liquid paraffin as mixed oil phase auxiliary materials, wherein the total oil phase accounts for 77%, and the prescriptions are shown in table 6, and an experiment is carried out by using the preparation process 1 in the embodiment 1. And (3) taking the ductility, taste masking effect and physical stability of the cream as evaluation indexes, determining the proportion of the oil phase auxiliary materials, and carrying out subsequent experiments.
Table 6 prescription screening of the ratio of glyceryl monostearate to liquid Paraffin
Table 7 results of stability evaluation of glycerin monostearate and liquid Paraffin ratio screening
The results are shown in Table 7, FIG. 6, FIG. 7 and FIG. 8, the average diameter of the paste after 20min of pressurization in the prescription F3 is 6.90cm, the paste is too thin, and the centrifugal stability and the heat-resistant stability are poor; the ductility result of the prescription F4 shows that the average diameter of the paste is 4.50cm after the paste is pressurized for 20min, the paste is fine and uniform, the paste is easy to paint, and the centrifugal stability and the heat-resistant stability are good; the average diameter of the paste after the prescription F5 is pressurized for 20min is 3.20, the paste is rough and too hard, and the granular feel is obvious. Thus, the oil phase was determined to be 77% with glycerol monostearate at 15%.
Comparative example 3: screening of emulsification temperature
The emulsification process needs to provide a certain amount of heat, and the emulsification temperature has a great influence on the emulsification effect and the emulsion droplet size. In general, the temperature of the oil phase and the water phase is controlled to be preferably 75-85 ℃, the emulsification temperature is too low, and the paste is easy to generate oil-water delamination; too high an emulsification temperature can damage the emulsion film resulting in breakage of the formed emulsion droplets.
The oil phase is placed in a water bath kettle and is heated while being stirred, and when the temperature reaches 55 ℃, the solid oil phase begins to melt, so that the emulsification temperature cannot be lower than 55 ℃. Therefore, three levels of 65 ℃, 75 ℃ and 85 ℃ were selected for emulsification temperature screening, the prescription is shown in table 8, the preparation process 1 in example 1 was used for experiments, and the ductility, taste masking effect and physical stability of the cream were used as evaluation indexes to determine the emulsification temperature for subsequent experiments.
Table 8 prescription screening for emulsion temperatures
Table 9 stability evaluation results of screening prescriptions
The results are shown in Table 9, FIG. 9 and FIG. 10, and the prescriptions F6 to F8 are all fine and uniform in appearance and have no obvious offensive odor. The centrifugal stability and the thermal stability of the prescriptions F6 and F7 are poor, and oil-water delamination appears, which indicates that the emulsification temperature is too low and the supplied energy is insufficient; the centrifugal stability and the thermal stability of the prescription F8 are good, so that the emulsification temperature in the experiment is selected to be 85 ℃.
Comparative example 4: effect of emulsifier species and HLB value on cream stability
The kind and HLB value of the emulsifier as a key component of the cream directly affect the formation, physical stability and efficacy of the cream. The emulsifier plays the following two roles in the process of preparing the cream: the surface tension is reduced, so that the formation of emulsion drops is facilitated; the energy required in the preparation process of the cream is reduced, and the preparation of the cream can be completed by shaking or stirring. The different emulsion types need to select a single emulsifier or mixed emulsifier with corresponding HLB value, and the hydrophilicity is enhanced along with the increase of the HLB value, otherwise, the lipophilicity is enhanced. The HLB value of the emulsifier of the general O/W type emulsion is between 8 and 16, and the HLB value of the emulsifier of the W/O type emulsion is between 3 and 8.
In this example, the combination of different emulsifiers and the HLB value are screened, and the physical stability is used as an evaluation index to determine the proper type of the emulsifier and the HLB value for subsequent experiments.
(1) Influence of span 80 and tween 20 mixed emulsifier on cream stability
The span 80 has an HLB value of 4.3, tween 20 has an HLB value of 16.7, the total amount of emulsifiers is maintained at 7%, the emulsification temperature is 85 ℃, the stirring speed is 260rpm, three mixed emulsifiers having different HLB values are obtained by adjusting the ratio between the two emulsifiers, the HLB values of which are respectively 7.0, 7.7 and 8.0, and the screening prescription of the HLB is shown in Table 10, and the experiment is performed by the preparation process 1 in example 1.
Table 10 composition and dosage ratio of screening prescription
Table 11 stability evaluation results of screening prescriptions
As shown in table 11, fig. 12, and fig. 13, the freeze thawing stability of the formulations F9 to F11 was good, and the appearance of the paste was not significantly changed after repeating the freeze thawing three times. The centrifugal stability and the thermal stability of the prescription F9 are poor, and oil-water delamination occurs; the centrifugal stability and the thermal stability of the prescription F10 are good; after centrifugation, formulation F11 did not show oil-water stratification, but had poor thermal stability and slight oil-water stratification. In summary, the physical stability of the prescription F10 is good, but the mixed emulsifier composed of span 80 and tween 20 is condensed to room temperature and then has obvious uneven stirring phenomenon, so that other emulsifiers are continuously screened.
(2) Effect of PLUROL and Gelot TM 64 Mixed emulsifiers on cream stability
The three mixed emulsifiers having different HLB values, which were 7.0, 7.7 and 8.0 respectively, were obtained by adjusting the ratio between the two emulsifiers, the HLB value of which was shown in Table 12, and the screening recipe for the HLB was shown in Table 12, and the experiment was conducted in preparation Process 1 in example 1, while keeping the total amount of the emulsifiers at 7%, the emulsification temperature at 85℃and the stirring speed at 260rpm, with the HLB value of the polyglycerin-3 diisostearate Diisostearique PLUROL, and the HLB value of the mixture Gelot TM of glyceryl monostearate at 10.0.
Table 12 screening prescription composition and dosage ratio
Table 13 stability evaluation results of screening prescriptions
As shown in table 13, fig. 14, fig. 15, and fig. 16, the external properties of prescriptions F12 to F14 were not changed after freeze thawing, but the centrifugal stability and the thermal stability were poor, and oil-water separation occurred, so that other emulsifiers were continuously screened.
(3) Effect of PLIROL and M1944 CS mixed emulsifier on cream stability
The auxiliary emulsifier plays a positive role in an emulsifying system generally, and can increase the physical stability and fineness of the cream. The co-emulsifier acts mainly for the following reasons: (1) Adjusting the HLB value of the system, and reducing the interfacial tension to form smaller emulsion drops; (2) Certain co-emulsifiers may form complexes with the emulsifier to increase the strength of the emulsion film; (3) The emulsion droplets are adsorbed on the surface of the emulsion droplets to form mutually collided and coalesced so as to increase the stability of the system. Oleoyl polyoxyethylene glyceride M1944CS is a co-emulsifier having an HLB value of 9.0, a plurol HLB value of 4.5, a total amount of the emulsifiers maintained at 7%, an emulsification temperature of 85 ℃, and a stirring speed of 260rpm, four kinds of mixed emulsifiers having different HLB values, having an HLB value of 4.75, 5.0, 6.0, and 7.0, respectively, were obtained by adjusting the ratio between the emulsifiers and the co-emulsifier, and each formulation was composed as shown in table 23, and an experiment was performed in the preparation process 1 of example 1.
TABLE 14 composition and dosage ratio of prescriptions F30 to F33
Table 15 stability evaluation results of prescriptions F30 to F33
The results are shown in Table 15, FIG. 17, FIG. 18 and FIG. 19, and the appearances of the prescriptions F15 to F18 are fine and uniform, have no obvious peculiar smell, have good freeze thawing stability, and have no obvious appearance property change. The prescriptions F15, F17 and F18 have slight layering phenomenon after centrifugation, and the centrifugal stability of the prescriptions F16 is the best; the formulations F15 to F18 were good in thermal stability, and no oil-water stratification occurred, but with decreasing HLB value, very little sedimentation occurred at the bottom of the centrifuge tube.
Comparative example 5: compatibility of radix Arnebiae and Carthami flos extractive solution
In order to explore the source of sediment at the bottom of the centrifuge tube, the lithospermum and safflower extract are weighed according to the prescription amount and heated after being evenly mixed; the lithospermum extract and deionized water in the same amount as the safflower extract were weighed according to the prescription, naCl, mg 2SO4, peach essence and sodium methyl parahydroxybenzoate were added respectively, and the evaluation results are shown in Table 16.
TABLE 16 compatibility of radix Arnebiae and Carthami flos extract
The results are shown in Table 16 and FIG. 20, the extracts of radix Arnebiae and flos Carthami were mixed and heated to precipitate out, so that the two aqueous phases could not be added into the oil phase at the same time for emulsification; inorganic salt can cause precipitation of lithospermum extract, so inorganic salt cannot be added in the prescription; sodium methylparaben can cause the lithospermum extract to change from purple to blue, so that other preservatives need to be replaced.
While the invention has been described with reference to the preferred embodiments, it is not limited thereto, and various changes and modifications can be made therein by those skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (3)
1. The lithospermum safflower cream is characterized by comprising 15 parts of glyceryl monostearate, 62 parts of liquid paraffin, 4.7 parts of polyglycerol-3 diisostearate, 2.3 parts of oleoyl polyoxyethylene glyceride, 5 parts of lithospermum extract, 10 parts of safflower extract, 0.1 part of ethylparaben and 0.9 part of peach essence in parts by weight;
the preparation method of the lithospermum safflower cream comprises the following steps: setting the emulsification temperature to be 85 ℃ and the stirring speed to be 260 rpm, centrifuging the oil phase and the water phase, and heating to the emulsification temperature; adding the water phase 1 into a stirring container, immediately dripping the oil phase into the container, and stirring and emulsifying for 10min; finally, adding the water phase 2 into a stirring container, stirring and emulsifying for 10min; then stirring, stopping heating, cooling to 35deg.C, stirring for 10min, cooling to 18deg.C, and stirring for 10min to obtain cream; wherein, the emulsifying agent and the preservative are added into the oil phase;
Wherein the oil phase is 15 parts of glyceryl monostearate and 62 parts of liquid paraffin; the water phase 1 is 10 parts of safflower extract and 0.45 part of peach essence; the water phase 2 is 5 parts of lithospermum extract and 0.45 part of peach essence; the emulsifier is 4.7 parts of polyglycerol-3 bis isostearate and 2.3 parts of oleoyl polyoxyethylene glyceride; the preservative is ethylparaben.
2. The arnebia root-safflower cream of claim 1, wherein said oil phase, water phase 1 and water phase 2 are all stirred and heated to a predetermined temperature in a water bath kettle according to a prescribed amount.
3. The cream for treating or improving infant diaper rash is characterized by comprising 15 parts of glyceryl monostearate, 62 parts of liquid paraffin, 4.7 parts of polyglycerol-3 diisostearate, 2.3 parts of oleoyl polyoxyethylene glyceride, 5 parts of lithospermum extract, 10 parts of safflower extract, 0.1 part of ethylparaben and 0.9 part of peach essence in parts by weight;
the preparation method of the lithospermum safflower cream comprises the following steps: setting the emulsification temperature to be 85 ℃ and the stirring speed to be 260 rpm, centrifuging the oil phase and the water phase, and heating to the emulsification temperature; adding the water phase 1 into a stirring container, immediately dripping the oil phase into the container, and stirring and emulsifying for 10min; finally, adding the water phase 2 into a stirring container, stirring and emulsifying for 10min; then stirring, stopping heating, cooling to 35deg.C, stirring for 10min, cooling to 18deg.C, and stirring for 10min to obtain cream; wherein, the emulsifying agent and the preservative are added into the oil phase;
Wherein the oil phase is 15 parts of glyceryl monostearate and 62 parts of liquid paraffin; the water phase 1 is 10 parts of safflower extract and 0.45 part of peach essence; the water phase 2 is 5 parts of lithospermum extract and 0.45 part of peach essence; the emulsifier is 4.7 parts of polyglycerol-3 bis isostearate and 2.3 parts of oleoyl polyoxyethylene glyceride; the preservative is ethylparaben.
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