WO2022160548A1 - 一种治疗神经根型颈椎病的软膏及其制备方法 - Google Patents
一种治疗神经根型颈椎病的软膏及其制备方法 Download PDFInfo
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- WO2022160548A1 WO2022160548A1 PCT/CN2021/098699 CN2021098699W WO2022160548A1 WO 2022160548 A1 WO2022160548 A1 WO 2022160548A1 CN 2021098699 W CN2021098699 W CN 2021098699W WO 2022160548 A1 WO2022160548 A1 WO 2022160548A1
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- Prior art keywords
- ointment
- ethanol
- radiculopathy
- cervical spondylosis
- treatment
- Prior art date
Links
- 239000002674 ointment Substances 0.000 title claims abstract description 69
- 206010037779 Radiculopathy Diseases 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 95
- 235000003143 Panax notoginseng Nutrition 0.000 claims abstract description 43
- 241000180649 Panax notoginseng Species 0.000 claims abstract description 43
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims abstract description 39
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 37
- 239000000341 volatile oil Substances 0.000 claims abstract description 35
- 239000000284 extract Substances 0.000 claims abstract description 34
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 31
- 239000000843 powder Substances 0.000 claims abstract description 30
- 239000003814 drug Substances 0.000 claims abstract description 25
- 239000000706 filtrate Substances 0.000 claims abstract description 24
- 150000001875 compounds Chemical class 0.000 claims abstract description 17
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical compound CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 claims abstract description 14
- 241000218176 Corydalis Species 0.000 claims abstract description 14
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 14
- 235000011187 glycerol Nutrition 0.000 claims abstract description 14
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 14
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000008117 stearic acid Substances 0.000 claims abstract description 14
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 claims abstract description 13
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 claims abstract description 13
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 12
- 239000001116 FEMA 4028 Substances 0.000 claims abstract description 12
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims abstract description 12
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims abstract description 12
- 229960004853 betadex Drugs 0.000 claims abstract description 12
- VYQNWZOUAUKGHI-UHFFFAOYSA-N monobenzone Chemical compound C1=CC(O)=CC=C1OCC1=CC=CC=C1 VYQNWZOUAUKGHI-UHFFFAOYSA-N 0.000 claims abstract description 9
- 238000010992 reflux Methods 0.000 claims abstract description 9
- 239000011347 resin Substances 0.000 claims abstract description 9
- 229920005989 resin Polymers 0.000 claims abstract description 9
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- 238000001556 precipitation Methods 0.000 claims abstract description 5
- 206010041591 Spinal osteoarthritis Diseases 0.000 claims description 30
- 208000036319 cervical spondylosis Diseases 0.000 claims description 30
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- 238000011282 treatment Methods 0.000 claims description 26
- 210000005036 nerve Anatomy 0.000 claims description 19
- 239000001397 quillaja saponaria molina bark Substances 0.000 claims description 19
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- 150000007949 saponins Chemical class 0.000 claims description 19
- 239000000203 mixture Substances 0.000 claims description 14
- 239000003921 oil Substances 0.000 claims description 13
- 206010050217 Cervical radiculopathy Diseases 0.000 claims description 12
- 239000003883 ointment base Substances 0.000 claims description 12
- 239000008713 qiang-huo Substances 0.000 claims description 12
- 239000008916 wei-ling-xian Substances 0.000 claims description 12
- 239000000243 solution Substances 0.000 claims description 9
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- 239000004264 Petrolatum Substances 0.000 claims description 7
- 229940066842 petrolatum Drugs 0.000 claims description 7
- 235000019271 petrolatum Nutrition 0.000 claims description 7
- 238000010298 pulverizing process Methods 0.000 claims description 7
- -1 Baishao Substances 0.000 claims description 6
- 241000219780 Pueraria Species 0.000 claims description 6
- 239000007864 aqueous solution Substances 0.000 claims description 6
- 244000236658 Paeonia lactiflora Species 0.000 claims 1
- 235000008598 Paeonia lactiflora Nutrition 0.000 claims 1
- 244000046146 Pueraria lobata Species 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 239000001257 hydrogen Substances 0.000 claims 1
- 229910052739 hydrogen Inorganic materials 0.000 claims 1
- 229910001950 potassium oxide Inorganic materials 0.000 claims 1
- 238000011084 recovery Methods 0.000 claims 1
- 206010040880 Skin irritation Diseases 0.000 abstract description 6
- 230000036556 skin irritation Effects 0.000 abstract description 6
- 231100000475 skin irritation Toxicity 0.000 abstract description 6
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- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/488—Pueraria (kudzu)
-
- 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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/716—Clematis (leather flower)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Definitions
- the invention relates to the technical field of traditional Chinese medicine preparations, in particular to an ointment for treating cervical spondylosis of nerve root type and a preparation method thereof.
- cervical radiculopathy The incidence of cervical radiculopathy is 50%-60%, and it is more common in middle-aged and elderly people. Clinically, patients with cervical radiculopathy not only have discomfort in the cervical spine, but also have limited movement of the upper limbs or numbness in the fingers. Cervical radiculopathy is due to unilateral or bilateral spinal nerve root stimulation or compression, resulting in movement disorders, pain, numbness and other symptoms of the neck, shoulders, back and upper arms. The symptoms of cervical spondylosis of the nerve root have obvious radicular symptoms, and its numbness, pain symptoms and range are consistent with the area innervated by the cervical spinal nerve, which can seriously lead to muscle weakness and even atrophy. This stimulation or compression is mainly caused by the following aspects: 1.
- the bone hyperplasia of the posterior facet joint is lighter; 4.
- Loosening and displacement of intervertebral body joints, uncinate joints and posterior facet joints. 5. Traumatic arthritis.
- Ningtong Granules, Ningtong Tablets and Ningtong Capsules are all oral traditional Chinese medicine compound preparations for cervical spondylosis of nerve root type. They have the effects of promoting blood circulation and removing blood stasis, promoting qi and relieving pain, and have a satisfactory effect in clinical treatment.
- These preparations Zhongdu includes Panax notoginseng, Chuanxiong, Yanhusuo, Qianghuo, Baishao, Weilingxian and Pueraria, which can promote blood circulation and remove blood stasis, regulate Qi and relieve pain.
- Transdermal absorption can solve the deficiencies caused by gastrointestinal absorption, but transdermal absorption often has problems such as high skin irritation, low permeability and low absorption rate.
- the purpose of the present invention is to provide an ointment for the treatment of cervical spondylosis of nerve root type and a preparation method thereof.
- the ointment for the treatment of cervical spondylosis of nerve root type is an ointment with little irritation, high quality stability, and good permeability and absorption rate.
- a kind of ointment for the treatment of cervical spondylosis of nerve root type is provided, and the preparation method of the ointment for the treatment of cervical spondylosis of nerve root type is as follows:
- the volatile oil is extracted from Qianghuo and Weilingxian, and then the volatile oil is included with ⁇ -cyclodextrin to obtain the volatile oil inclusion compound;
- Pueraria lobata and Radix Paeoniae Alba are boiled with water, the filtrate is concentrated and alcohol precipitation is obtained to obtain clear paste;
- the Chuanxiong and Corydalis are extracted by refluxing with ethanol, and the extract is recovered with ethanol and concentrated into a clear paste;
- the above preparation is mixed with petrolatum, stearic acid, rosin, glycerin, potassium hydroxide, and azone evenly, sterilized by ultraviolet rays, and packed into small tanks.
- a second aspect of the present invention there is provided an application of the ointment for treating cervical spondylosis of radiculopathy described in the first aspect in combination with Ningtong Granules in the treatment of cervical spondylosis of radiculopathy.
- the Panax notoginseng is pulverized and then the effective components are extracted to obtain Panax notoginseng saponin powder.
- the effective components in Panax notoginseng can be more effectively applied, and the Enhance the quality stability of the ointment, making the ointment less prone to oil-water separation;
- the absorption of the active ingredients in the ointment by the skin can be accelerated, and the onset time of the ointment can be shortened; and the present invention
- the coordination between the various components can also effectively avoid the skin irritation of the patient when the cream is directly applied to the skin, without any allergic reaction.
- the nerve root type cervical pain ointment prepared in the embodiment of the present invention has the advantages of high permeability and high absorption rate, the product does not stimulate the digestive tract and other organs, and has few side effects.
- Ointment is a semi-solid external preparation that can be easily applied to the skin, mucous membranes or wounds by adding drugs into a suitable base.
- the composition of ointment is mainly drug and base.
- the matrix is not only the excipient of the ointment, but also has an important influence on the release and absorption of the drug.
- an ointment for the treatment of cervical spondylosis of nerve root type and the preparation method of the ointment for the treatment of cervical spondylosis of nerve root type is as follows:
- the volatile oil is extracted from Qianghuo and Weilingxian, and then the volatile oil is included with ⁇ -cyclodextrin to obtain the volatile oil inclusion compound;
- Pueraria lobata and Radix Paeoniae Alba are boiled with water, the filtrate is concentrated and alcohol precipitation is obtained to obtain clear paste;
- the Chuanxiong and Corydalis are extracted by refluxing with ethanol, and the extract is recovered with ethanol and concentrated into a clear paste;
- the traditional Chinese medicine extract is mixed evenly with petrolatum, stearic acid, rosin, glycerin, potassium hydroxide and azone, sterilized by ultraviolet rays, and packed into small jars to obtain an ointment for treating cervical spondylosis of nerve root type.
- the mass ratio of Panax notoginseng, Chuanxiong, Corydalis, Qianghuo, Baishao, Weilingxian and Pueraria is 30-40:75-90:55-70:100:95:100:95;
- the mass ratio of Panax notoginseng, Chuanxiong, Corydalis, Qianghuo, Baishao, Weilingxian and Pueraria is 35-38:80-85:60-65:100:95:100:95;
- notoginseng is pulverized with a wall breaker, and then passed through a 20-mesh sieve after pulverization, and then extracted with a 75% ethanol solution, filtered to combine the filtrate, ethanol was recovered under reduced pressure, water was added to pass through the macroporous resin, and the effluent was washed with water until no effluent was present. After coloring, 50% ethanol was used to elute, and the filtrate was vacuum-frozen to obtain Panax notoginseng saponin powder;
- Pueraria lobata and Radix Paeoniae Alba are boiled twice with water, the first time is 2 hours, the second time is 1 hour, the filtrate is combined with the above-mentioned two aqueous solutions, concentrated, and alcohol-precipitated, ethanol is recovered, and after concentration, the relative density is 1.25-1.30 clear cream;
- Chuanxiong and Corydalis are back-extracted with ethanol, the residue is discarded, the extract is recovered with ethanol, and concentrated into a clear paste with a relative density of 1.25-1.30 at 50°C;
- the percentage of the following components in the total mass of the ointment is: stearic acid 10-15%, glycerol 4-8%, azone 2-4%, rosin 0.5-1.5%, potassium hydroxide 0.1-1.5%, vaseline 1-3%;
- the stearic acid accounts for 12% of the total mass of the ointment, 6% of glycerin, 3% of azone, 1% of rosin, 1% of potassium hydroxide, and 2% of vaseline;
- vaseline, stearic acid, rosin and azone are heated and melted to make a homogeneous oil phase
- glycerin, potassium hydroxide and water are mixed to make a homogeneous water phase, heated to 80°C, and then added to the oil phase , made into an ointment base;
- the traditional Chinese medicine extract is added to the base, and the mixture is stirred and mixed evenly.
- the absorption of the effective components in the ointment by the skin can be accelerated, and the onset time of the ointment can be shortened;
- the cooperation between the components can also effectively avoid the skin irritation of the patient when the cream is directly applied to the skin, without any allergic reaction.
- a kind of ointment for the treatment of radiculopathy cervical spondylosis is as follows:
- the volatile oil was extracted from 1000g of Qianghuo and 1000g of Weilingxian, and then the volatile oil was clathrated with ⁇ -cyclodextrin, and the dosage ratio of volatile oil and ⁇ -cyclodextrin was 1mL: 2.1g to obtain volatile oil inclusion compound;
- the traditional Chinese medicine extract is added to the base, stirred and mixed evenly, sterilized by ultraviolet rays, and packed into small pots to obtain an ointment for treating cervical radiculopathy.
- a kind of ointment for the treatment of radiculopathy cervical spondylosis is as follows:
- the volatile oil was extracted from 1000g of Qianghuo and 1000g of Weilingxian, and then the volatile oil was clathrated with ⁇ -cyclodextrin, and the dosage ratio of volatile oil and ⁇ -cyclodextrin was 1mL: 2.1g to obtain volatile oil inclusion compound;
- the traditional Chinese medicine extract is added to the base, stirred and mixed evenly, sterilized by ultraviolet rays, and packed into small pots to obtain an ointment for treating cervical radiculopathy.
- a kind of ointment for the treatment of radiculopathy cervical spondylosis is as follows:
- the volatile oil was extracted from 1000g of Qianghuo and 1000g of Weilingxian, and then the volatile oil was clathrated with ⁇ -cyclodextrin, and the dosage ratio of volatile oil and ⁇ -cyclodextrin was 1mL: 2.1g to obtain volatile oil inclusion compound;
- the traditional Chinese medicine extract is added to the base, stirred and mixed evenly, sterilized by ultraviolet rays, and packed into small pots to obtain an ointment for treating cervical radiculopathy.
- a kind of ointment for the treatment of radiculopathy cervical spondylosis is as follows:
- the volatile oil was extracted from 1000g of Qianghuo and 1000g of Weilingxian, and then the volatile oil was clathrated with ⁇ -cyclodextrin, and the dosage ratio of volatile oil and ⁇ -cyclodextrin was 1mL: 2.1g to obtain volatile oil inclusion compound;
- the traditional Chinese medicine extract is added to the base, stirred and mixed evenly, sterilized by ultraviolet rays, and packed into small pots to obtain an ointment for treating cervical radiculopathy.
- Test conditions temperature 60°C, test time: 12h, test results are shown in the following table:
- test conditions temperature -5°C, test time: 24h, test results are shown in the following table:
- Test conditions temperature 60°C, test time: 12h, test results are shown in the following table:
- test conditions temperature -5°C, test time: 24h, test results are shown in the following table:
- the ointment for the treatment of cervical spondylosis of nerve root type prepared in the embodiment 1 is applied to the skin surface after the rat depilation, the dosage is 1g/kg, and 10 rats were observed. There is no abnormality on the skin surface, indicating that the ointment prepared by the present invention has no sensitization effect, and the sensitization reaction is grade 0;
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Abstract
一种治疗神经根型颈椎病的软膏及其制备方法：先将三七进行破碎制成粉末，通过乙醇溶液提取得到三七皂苷提取液，再通过大孔树脂，将滤液真空冷冻后得到三七皂苷粉末；从羌活、威灵仙中提取挥发油，用β-环糊精进行包合，得到挥发油包合物；将葛根和白芍加水煎煮，滤液浓缩、醇沉，得到清膏；将川芎、延胡索用乙醇回流提取，提取液回收乙醇，浓缩成清膏；将两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物，得到中药提取物；将中药提取物与凡士林、硬脂酸、松香、甘油、氢氧化钾、氮酮，混合均匀，得到治软膏。得到的软膏皮肤刺激性小、质量稳定性高，且渗透性和吸收率好。
Description
本发明涉及中药制剂技术领域，具体涉及一种治疗神经根型颈椎病的软膏及其制备方法。
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解，而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
神经根型颈椎病发病率为50％-60％，中老年人多见，在临床上，神经根型颈椎病患者不仅颈椎不舒服，上肢也会活动受限或手指发麻。神经根型颈椎病是由于单侧或双侧脊神经根受刺激或受压，导致颈肩背和上臂的活动障碍、疼痛、麻木等症状。神经根颈椎病症状有明显的根性症状，它的麻木、疼痛症状以及范围与颈脊神经所支配的区域相一致，严重会导致肌肉无力，乃至萎缩。这种刺激或压迫主要是以下几个方面造成的：一、髓核的突出或脱出-较重，二、后方小关节的骨质增生较轻，三、钩椎关节的骨刺形成-较轻，四、椎间体关节、钩椎关节、后方小关节的松动、移位，五、创伤性关节炎。
神经根型颈椎病的治疗方式很多，其中包括目前已经在售的颈痛颗粒、颈痛片和颈痛胶囊。颈痛颗粒、颈痛片和颈痛胶囊都是用于神经根型颈椎病的口服中药复方制剂，具有活血化瘀，行气止痛的功效，在临床治疗中具有令人满意的疗效，这些制剂中都包括三七、川芎、延胡索、羌活、白芍、威灵仙和葛 根，能够起到活血化瘀，理气止痛的功效。
但是，由于通过消化道内服的剂型往往会造成病人的胃肠副作用，使得用药人群受限，并且经消化道用药时由于肝脏的首过效应，造成进入血循环的原形药量减少的现象。通过透皮吸收可以解决胃肠道吸收带来的不足，但是透皮吸收又往往存在皮肤刺激性大、渗透性和吸收率低等问题。现有技术中还没有将治疗神经根型颈椎病的组方制备成软膏制剂的技术方案。
发明内容
为了解决现有技术中存在的技术问题，本发明的目的是提供一种治疗神经根型颈椎病的软膏及其制备方法，通过对中药原料加工方式的改进以及对软膏基质的选择，制备得到皮肤刺激性小、质量稳定性高，且渗透性和吸收率好的治疗神经根型颈椎病的软膏。
具体地，本发明的技术方案如下所述：
在本发明的第一方面，提供一种治疗神经根型颈椎病的软膏，所述治疗神经根型颈椎病的软膏制备方法如下：
先将三七进行破碎制成粉末，然后通过乙醇溶液提取得到三七皂苷提取液，再通过大孔树脂，将滤液真空冷冻后得到三七皂苷粉末；
从羌活、威灵仙中提取挥发油，然后将挥发油用β-环糊精进行包合，得到挥发油包合物；
将葛根和白芍加水煎煮，滤液浓缩、醇沉，得到清膏；
将川芎、延胡索用乙醇回流提取，提取液回收乙醇，浓缩成清膏；
将上述两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物；
将上述制得物与凡士林、硬脂酸、松香、甘油、氢氧化钾，氮酮，混合均匀，经紫外线灭菌，分装至小罐。
在本发明的第二方面，提供一种第一方面所述治疗神经根型颈椎病的软膏与颈痛颗粒联用在治疗神经根型颈椎病中的应用。
本发明的具体实施方式具有以下有益效果：
本发明实施方式中将三七粉碎后进行有效成分的提取得到三七皂苷粉末，相比直接将三七加工成微粉制备软膏，能够将三七中的有效成分更加有效得应用之外，还能够增强软膏的质量稳定性，使得软膏不容易出现油水分离的现象；
本发明实施方式中通过对中药成分与相应基质的配伍，并且对中药成分和基质之间的用量比例进行调控，能够加快皮肤对软膏中有效成分的吸收，缩短软膏的起效时间；并且本发明中各个组份之间的配合还可以有效避免乳膏直接涂覆于皮肤上时对患者皮肤的刺激，无任何过敏反应。
本发明实施方式中制备的神经根型颈椎疼软膏具有高渗透性，吸收率高的优势，产品使用不刺激消化道等脏器，副作用少，配合颈痛颗粒，内服外用，效果更佳。
应该指出，以下详细说明都是例示性的，旨在对本申请提供进一步的说明。除非另有指明，本申请使用的所有技术和科学术语具有与本申请所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是，这里所使用的术语仅是为了描述具体实施方式，而非意图限制根据本申请的示例性实施方式。如在这里所使用的，除非上下文另外明确指出，否则单数形式也意图包括复数形式，此外，还应当理解的是，当在本说明 书中使用术语“包含”和/或“包括”时，其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
软膏剂是将药物加入适宜的基质中，制成容易涂布于皮肤、粘膜或创面的半固体外用制剂。软膏剂的组成主要是药物与基质。基质不仅是软膏剂的赋形剂，同时它对药物的释放与吸收都有重要的影响。
本发明的一种实施方式中，提供了一种治疗神经根型颈椎病的软膏，所述治疗神经根型颈椎病的软膏制备方法如下：
先将三七进行破碎制成粉末，然后通过乙醇溶液提取得到三七皂苷提取液，再通过大孔树脂，将滤液真空冷冻后得到三七皂苷粉末；
从羌活、威灵仙中提取挥发油，然后将挥发油用β-环糊精进行包合，得到挥发油包合物；
将葛根和白芍加水煎煮，滤液浓缩、醇沉，得到清膏；
将川芎、延胡索用乙醇回流提取，提取液回收乙醇，浓缩成清膏；
将上述两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物，得到中药提取物；
将中药提取物与凡士林、硬脂酸、松香、甘油、氢氧化钾，氮酮，混合均匀，经紫外线灭菌，分装至小罐，得到治疗神经根型颈椎病的软膏。
优选的，三七、川芎、延胡索、羌活、白芍、威灵仙和葛根的质量比为30～40：75～90：55～70：100：95：100：95；
优选的，三七、川芎、延胡索、羌活、白芍、威灵仙和葛根的质量比为35～38：80～85：60～65：100：95：100：95；
优选的，将三七用破壁机进行粉碎，粉碎后过20目筛，然后使用75％的乙 醇溶液进行提取，过滤合并滤液，减压回收乙醇，加水通过大孔树脂，水洗至流出液无色后使用50％的乙醇洗脱，将滤液真空冷冻后得到三七皂苷粉末；
优选的，葛根、白芍加水煎煮两次，第一次2小时，第二次1小时，滤液与上述两水溶液合并、浓缩、醇沉，回收乙醇，浓缩后成为在50℃下相对密度为1.25-1.30的清膏；
优选的，川芎、延胡索用乙醇回流提取，弃去残渣，提取液回收乙醇，浓缩成50℃下相对密度为1.25-1.30的清膏；
优选的，以下组分占软膏总质量的百分比为：硬脂酸10-15％、甘油4-8％、氮酮2-4％、松香0.5-1.5％、氢氧化钾0.1-1.5％，凡士林1-3％；
进一步优选的，所述硬脂酸占软膏总质量的12％、甘油6％、氮酮3％、松香1％、氢氧化钾1％，凡士林2％；
优选的，先将凡士林、硬脂酸、松香、氮酮加热熔融制成均一的油相，将甘油、氢氧化钾和水混合制成均一水相，加热至80℃后将其加入到油相中，制成软膏基质；
然后软膏基质温度降低到60℃以下后将中药提取物加入基质中，搅拌混合均匀。
申请人在试验中发现，将三七粉碎后进行有效成分的提取得到三七皂苷粉末，相比直接将三七加工成微粉制备软膏，能够将三七中的有效成分更加有效得应用之外，还能够增强软膏的质量稳定性，原因在于三七微粉在软膏中有效成分的溶出较差，且其以微粉形式存在的颗粒状会破坏软膏的稳定性，使得软膏容易出现油水分离的现象。
本发明中通过对中药成分与相应基质的配伍，并且对中药成分和基质之间 的用量比例进行调控，能够加快皮肤对软膏中有效成分的吸收，缩短软膏的起效时间；并且本发明中各个组份之间的配合还可以有效避免乳膏直接涂覆于皮肤上时对患者皮肤的刺激，无任何过敏反应。
下面结合实施例对本发明作进一步的解释和说明。
实施例1
一种治疗神经根型颈椎病的软膏，制备方法如下：
将三七350g用破壁机进行粉碎，粉碎后过20目筛，然后使用75％的乙醇溶液提取2h，过滤合并滤液，减压回收乙醇，加水通过大孔树脂，水洗至流出液无色后使用50％的乙醇洗脱，将滤液在-20℃，0.1MPa条件下真空冷冻后得到三七皂苷粉末；
从羌活1000g、威灵仙1000g中提取挥发油，然后将挥发油用β-环糊精进行包合，挥发油与β-环糊精的用量比为1mL：2.1g，得到挥发油包合物；
葛根950g、白芍950g加水煎煮两次，第一次2小时，第二次1小时，滤液与上述两水溶液合并、浓缩、醇沉，回收乙醇，浓缩后成为在50℃下相对密度为1.25的清膏；
川芎800g、延胡索600g用乙醇回流提取2h，弃去残渣，提取液回收乙醇，浓缩成50℃下相对密度为1.25的清膏；
将上述两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物，得到中药提取物；
按照比例称取凡士林、硬脂酸、松香和氮酮加热熔融制成均一的油相，将甘油、氢氧化钾和3倍量的水混合制成均一水相，加热至80℃后将其加入到油相中，制成软膏基质；
然后软膏基质温度降低到60℃以下后将中药提取物加入基质中，搅拌混合均匀，经紫外线灭菌，分装至小罐，得到治疗神经根型颈椎病的软膏。
实施例2
一种治疗神经根型颈椎病的软膏，制备方法如下：
将三七380g用破壁机进行粉碎，粉碎后过20目筛，然后使用75％的乙醇溶液提取2h，过滤合并滤液，减压回收乙醇，加水通过大孔树脂，水洗至流出液无色后使用50％的乙醇洗脱，将滤液在-20℃，0.1MPa条件下真空冷冻后得到三七皂苷粉末；
从羌活1000g、威灵仙1000g中提取挥发油，然后将挥发油用β-环糊精进行包合，挥发油与β-环糊精的用量比为1mL：2.1g，得到挥发油包合物；
葛根950g、白芍950g加水煎煮两次，第一次2小时，第二次1小时，滤液与上述两水溶液合并、浓缩、醇沉，回收乙醇，浓缩后成为在50℃下相对密度为1.25的清膏；
川芎850g、延胡索650g用乙醇回流提取2h，弃去残渣，提取液回收乙醇，浓缩成50℃下相对密度为1.25的清膏；
将上述两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物；
按照比例称取凡士林、硬脂酸、松香和氮酮加热熔融制成均一的油相，将甘油、氢氧化钾和3倍量的水混合制成均一水相，加热至80℃后将其加入到油相中，制成软膏基质；
然后软膏基质温度降低到60℃以下后将中药提取物加入基质中，搅拌混合均匀，经紫外线灭菌，分装至小罐，得到治疗神经根型颈椎病的软膏。
实施例3
一种治疗神经根型颈椎病的软膏，制备方法如下：
将三七370g用破壁机进行粉碎，粉碎后过20目筛，然后使用75％的乙醇溶液提取2h，过滤合并滤液，减压回收乙醇，加水通过大孔树脂，水洗至流出液无色后使用50％的乙醇洗脱，将滤液在-20℃，0.1MPa条件下真空冷冻后得到三七皂苷粉末；
从羌活1000g、威灵仙1000g中提取挥发油，然后将挥发油用β-环糊精进行包合，挥发油与β-环糊精的用量比为1mL：2.1g，得到挥发油包合物；
葛根950g、白芍950g加水煎煮两次，第一次2小时，第二次1小时，滤液与上述两水溶液合并、浓缩、醇沉，回收乙醇，浓缩后成为在50℃下相对密度为1.25的清膏；
川芎830g、延胡索630g用乙醇回流提取2h，弃去残渣，提取液回收乙醇，浓缩成50℃下相对密度为1.25的清膏；
将上述两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物；
按照比例称取凡士林、硬脂酸、松香和氮酮加热熔融制成均一的油相，将甘油、氢氧化钾和3倍量的水混合制成均一水相，加热至80℃后将其加入到油相中，制成软膏基质；
然后软膏基质温度降低到60℃以下后将中药提取物加入基质中，搅拌混合均匀，经紫外线灭菌，分装至小罐，得到治疗神经根型颈椎病的软膏。
对比例1
一种治疗神经根型颈椎病的软膏，制备方法如下：
将三七350g粉碎至200目成为三七微粉；
从羌活1000g、威灵仙1000g中提取挥发油，然后将挥发油用β-环糊精进行包合，挥发油与β-环糊精的用量比为1mL：2.1g，得到挥发油包合物；
葛根950g、白芍950g加水煎煮两次，第一次2小时，第二次1小时，滤液与上述两水溶液合并、浓缩、醇沉，回收乙醇，浓缩后成为在50℃下相对密度为1.25的清膏；
川芎800g、延胡索600g用乙醇回流提取2h，弃去残渣，提取液回收乙醇，浓缩成50℃下相对密度为1.25的清膏；
将上述两清膏合并，加入三七微粉，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物；
按照比例称取凡士林、硬脂酸和氮酮加热熔融制成均一的油相，将甘油、氢氧化钾和3倍量的水混合制成均一水相，加热至80℃后将其加入到油相中，制成软膏基质；
然后软膏基质温度降低到60℃以下后将中药提取物加入基质中，搅拌混合均匀，经紫外线灭菌，分装至小罐，得到治疗神经根型颈椎病的软膏。
质量稳定性试验
取实施例1制备的治疗神经根型颈椎病的软膏，分为2等份，1份至于60℃的环境中放置12h，1份至于-5℃的环境中放置24h，并进行观察，2份样品均未出现油水分离现象，可以看出本发明实施例1制备的治疗神经根型颈椎病的软膏质量稳定性较好。
试验条件：温度60℃，试验时间：12h，试验结果如下表所示：
表1：
试验条件：温度-5℃，试验时间：24h，试验结果如下表所示：
表2：
取对比例1制备的治疗神经根型颈椎病的软膏，分为2等份，1份至于60℃的环境中放置12h，1份至于-5℃的环境中放置24h，并进行观察，60℃环境中的样品在9h出现了油水分离现象，-5℃环境中的样品在18h出现了油水分离现象，可以看出对比例1制备的治疗神经根型颈椎病的软膏质量稳定性较差。
试验条件：温度60℃，试验时间：12h，试验结果如下表所示：
表3：
试验条件：温度-5℃，试验时间：24h，试验结果如下表所示：
表4：
皮肤致敏试验
选用SD大鼠，雌雄各5只，将实施例1中制备的治疗神经根型颈椎病的软膏涂敷于大鼠褪毛后的皮肤表面，给药剂量为1g/kg，观察10只大鼠皮肤表面均无异常，表明本发明制备的软膏无致敏作用，致敏反应为0级；
皮肤刺激试验
选取体重2kg的中国白兔，雌雄各5只，将白兔手肘皮肤褪毛后涂抹实施例1制备的软膏，12h后将皮肤上剩余的软膏擦净，观察是否出现皮肤刺激现象，观察发现涂药处皮肤柔软、红润，且病理组织学检查未见异常，表明本发明的软膏对皮肤无刺激作用。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
- 一种治疗神经根型颈椎病的软膏，其特征在于，所述治疗神经根型颈椎病的软膏制备方法如下：先将三七进行破碎制成粉末，然后通过乙醇溶液提取得到三七皂苷提取液，再通过大孔树脂，将滤液真空冷冻后得到三七皂苷粉末；从羌活、威灵仙中提取挥发油，然后将挥发油用β-环糊精进行包合，得到挥发油包合物；将葛根和白芍加水煎煮，滤液浓缩、醇沉，得到清膏；将川芎、延胡索用乙醇回流提取，提取液回收乙醇，浓缩成清膏；将上述两清膏合并，加入三七皂苷粉末，混合均匀，并干燥，粉碎成细粉加入上述挥发油包合物，得到中药提取物；将中药提取物与凡士林、硬脂酸、松香、甘油、氢氧化钾、氮酮，混合均匀，得到治疗神经根型颈椎病的软膏。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，三七、川芎、延胡索、羌活、白芍、威灵仙和葛根的质量比为30～40：75～90：55～70：100：95：100：95。
- 如权利要求2所述治疗神经根型颈椎病的软膏，其特征在于，三七、川芎、延胡索、羌活、白芍、威灵仙和葛根的质量比为35～38：80～85：60～65：100：95：100：95。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，以下组分占软膏总质量的百分比为：硬脂酸10-15％、甘油4-8％、氮酮2-4％、松香0.5-1.5％、氢氧化钾0.1-1.5％，凡士林1-3％。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，以下组分占软膏总质量的百分比为：硬脂酸12％、甘油6％、氮酮3％、松香1％、氢 氧化钾1％，凡士林2％。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，将三七用破壁机进行粉碎，粉碎后过20目筛，然后使用75％的乙醇溶液进行提取，过滤合并滤液，减压回收乙醇，加水通过大孔树脂，水洗至流出液无色后使用50％的乙醇洗脱，将滤液真空冷冻后得到三七皂苷粉末。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，葛根、白芍加水煎煮两次，第一次2小时，第二次1小时，滤液与上述两水溶液合并、浓缩、醇沉，回收乙醇，浓缩后成为在50℃下相对密度为1.25-1.30的清膏。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，川芎、延胡索用乙醇回流提取，弃去残渣，提取液回收乙醇，浓缩成50℃下相对密度为1.25-1.30的清膏。
- 如权利要求1所述治疗神经根型颈椎病的软膏，其特征在于，先将凡士林、硬脂酸、松香、氮酮加热熔融制成均一的油相，将甘油、氢氧化钾和水混合制成均一水相，加热至80℃后将其加入到油相中，制成软膏基质。
- 如权利要求9所述治疗神经根型颈椎病的软膏，其特征在于，将软膏基质温度降低到60℃以下后将中药提取物加入基质中，搅拌混合均匀。
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