CN111956743B - Acupoint external preparation for treating chronic nervous headache and preparation method thereof - Google Patents

Acupoint external preparation for treating chronic nervous headache and preparation method thereof Download PDF

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CN111956743B
CN111956743B CN202010794463.5A CN202010794463A CN111956743B CN 111956743 B CN111956743 B CN 111956743B CN 202010794463 A CN202010794463 A CN 202010794463A CN 111956743 B CN111956743 B CN 111956743B
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acupoint
ligusticum wallichii
external preparation
radix
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CN111956743A (en
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吕志阳
杨雨微
陈静
宋文沁
姜泽楠
李乐潇
陈雯婕
陈宇昕
周业頔
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Nanjing University Of Chinese Medicine Hanlin College
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Nanjing University Of Chinese Medicine Hanlin College
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Abstract

The invention discloses an acupoint external preparation for treating chronic nervous headache, which is prepared from raw materials of 20-40 parts of ligusticum wallichii, 10-30 parts of gastrodia elata, 5-20 parts of angelica dahurica, 5-20 parts of radix paeoniae alba, 5-20 parts of radix bupleuri, 5-10 parts of borneol and 5-10 parts of liquorice. The invention screens the medicinal components and the specific dosage of each medicinal component through a large number of experiments, and prepares the external preparation to be stuck at a specific acupuncture point.

Description

Acupoint external preparation for treating chronic nervous headache and preparation method thereof
Technical Field
The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to an acupoint external preparation capable of effectively treating chronic nervous headache and a preparation method thereof.
Background
The chronic nervous headache is a recurrent disease caused by primary intracranial vascular motor and nerve function regulation disorder, belongs to the category of headache and head wind in the traditional Chinese medicine, and has the characteristics of high morbidity, severe pain, quick attack and difficult recovery. In recent years, the incidence of the disease is on the rise, and the world health organization considers the disease as serious disabling diseases like quadriplegia, dementia and the like. At present, western medicine is mainly used for treating neuropathic headache by methods such as analgesia, sedation and the like, medicines such as carbamazepine, fenmust, ergotamine and the like only temporarily relieve symptoms, the long-term administration cost is high, the side effect is great, the addiction is easy, and the long-term curative effect cannot be perfectly perfected and cannot be accepted by a plurality of patients; the oral medicine has slow effect, low bioavailability and uncertain long-term curative effect; inconvenient intravenous administration, troublesome administration of the traditional Chinese medicine decoction, large dosage, great adverse reaction and the like.
The invention develops the traditional Chinese medicine heritage, takes the proved recipe 'the large ligusticum wallichii recipe' for treating the migraine in the 'Xuanming Lun recipe' as the basis of the prescription, is prepared according to the clinical effective proved recipe, combines the research of modern medicine on the pathogenesis, human anatomy and physiological pathology of the nervous headache, adopts the novel preparation technology and the traditional Chinese medicine acupoint plaster to treat the chronic nervous headache, and solves the problems of long headache treatment time, high cost, difficult cure, vexation treatment and the like in the prior art.
Disclosure of Invention
The invention aims to provide an external preparation which has scientific and reasonable component proportion, good treatment effect on chronic nervous headache and low adverse reaction.
The technical scheme is as follows: in order to realize the purpose, the invention adopts the technical scheme that:
an acupoint external preparation for treating chronic nervous headache is prepared from the following raw materials in parts by weight:
20-40 parts of ligusticum wallichii, 10-30 parts of gastrodia elata, 5-20 parts of radix angelicae, 5-20 parts of radix paeoniae alba, 5-20 parts of radix bupleuri, 5-10 parts of borneol and 5-10 parts of liquorice.
As a preferred scheme, the external preparation for acupuncture points for treating chronic nervous headache is prepared from the following raw materials in parts by weight:
20-30 parts of ligusticum wallichii, 10-20 parts of gastrodia elata, 5-10 parts of radix angelicae, 5-10 parts of radix paeoniae alba, 10-15 parts of radix bupleuri, 5-10 parts of borneol and 5-10 parts of liquorice.
Preferably, the external preparation for acupuncture points for treating chronic nervous headache is prepared from the following raw materials in parts by weight:
30 parts of ligusticum wallichii, 10 parts of gastrodia elata, 10 parts of angelica dahurica, 10 parts of radix paeoniae alba, 15 parts of radix bupleuri, 5 parts of borneol and 5 parts of liquorice.
Preferably, the above-mentioned acupoint external preparation for treating chronic nervous headache is in the form of paste, ointment, patch or gel.
Preferably, the preparation method of the acupoint external preparation for treating chronic nervous headache comprises the following steps:
(1) weighing the ligusticum wallichii according to the weight parts of the raw materials, and performing steam distillation or supercritical extraction to obtain ligusticum wallichii volatile oil; wrapping rhizoma ligustici wallichii volatile oil with beta-cyclodextrin (beta-CD), weighing 2-8 parts of beta-CD, adding a proper amount of distilled water to dissolve to obtain a saturated aqueous solution, dropwise adding 1-4 parts of rhizoma ligustici wallichii volatile oil ethanol solution, continuously stirring, cooling to room temperature, transferring to a refrigerator at 4 ℃ for refrigeration for more than 24 hours, performing suction filtration, washing and drying to obtain a rhizoma ligustici wallichii volatile oil inclusion compound;
(2) weighing radix Angelicae Dahuricae and radix Paeoniae alba, adding 5-10 times of 50-90% ethanol, extracting for 1-3 times (0.5-2 hr each time), mixing extractive solutions, and recovering ethanol to obtain ethanol extractive solution of radix Angelicae Dahuricae and radix Paeoniae alba;
(3) weighing rhizoma Gastrodiae, bupleuri radix, Glycyrrhrizae radix and above rhizoma Ligustici Chuanxiong residue, radix Angelicae Dahuricae residue and radix Paeoniae alba residue, adding 5-10 times of water, and extracting for two times, each time for 0.5-2 hr to obtain water extractive solution;
(4) mixing the ethanol extract of the angelica dahurica and the white paeony root in the step (2) with the water extract in the step (3), concentrating to the relative density of 1.20-1.35, filtering to obtain a concentrate, and refrigerating for later use;
(5) and (3) adding the ligusticum wallichii volatile oil inclusion compound in the step (1) and the concentrate in the step (4) into a pharmaceutically acceptable carrier to prepare an external preparation.
Preferably, the method for preparing the acupoint external preparation for treating chronic nervous headache comprises the steps of preparing a paste, an ointment, a patch or a gel; the preparation method of the gel comprises the following steps:
weighing 5-10 parts of glycerol, 1-2 parts of absolute ethyl alcohol, 1-2 parts of sodium polyacrylate and 5-10 parts of borneol, and uniformly mixing to obtain a phase I;
weighing 7-14 parts of swelled carbomer 940 solution with concentration of 0.3%, adding rhizoma Ligustici Chuanxiong volatile oil clathrate and the above concentrate, and mixing to obtain phase II;
dissolving citric acid and aluminum trichloride in water to obtain phase III;
adding phase I into phase III, mixing, adding phase II, stirring, spreading on nonwoven fabric, standing overnight, covering with anti-sticking layer, cutting, and packaging to obtain gel patch.
Preferably, the method for preparing the acupoint external preparation for treating chronic nervous headache comprises the steps of preparing a paste, an ointment, a patch or a gel; the preparation method of the patch comprises the following steps:
mixing the clathrate with the above concentrate, heating to melt, adding 5-10 parts of Borneolum at temperature below 50 deg.C, spreading on medical non-woven fabric or sterilized silk fabric, and making into circular patch with diameter of 2.0 cm.
As a preferred scheme, the acupoint external preparation for treating chronic nervous headache has the acupoint selection modes as follows:
(1) headache due to taiyang meridians: yintang acupoint, Yangbai acupoint and Hegu acupoint. 1. Printing a hall: on the forehead, the midpoint of the line between the two eyebrows is the acupoint; 2. yang and white: on the forehead, 1 cun above the eyebrow (1 cun transverse to the interphalangeal joint of the thumb) directly above the pupil, this point is known. 3. And (3) grain blending: on the back of the hand, between the 1 st and 2 nd metacarpals, at the radial midpoint of the 2 nd metacarpal.
(2) Headache due to yangming meridians: temple, Fengchi, Waiguan: 1. sun: at the temple, between the tip of the eyebrow and the outer canthus, in the depression about 1 lateral finger posteriorly. 2. A phoenix pool: on the neck, below the occipital bone, in parallel with the Fengfu, in the depression between the sternocleidomastoid muscle and the upper end of the trapezius muscle. 3. And (3) turning off: on the dorsal aspect of the forearm, 2 cun above the transverse crease of the dorsal wrist, between the ulna and radius, on the line connecting the cisterna yang and the tip of the elbow.
(3) Headache of shaoyang meridians: tianzhu acupoint, Fengchi acupoint, Houxi acupoint: 1. and (4) column casting: in the depression posterior to the lateral border of the greater tendon (trapezius muscle), 1.3 cun lateral to the midline of the posterior hairline. 2. An air pool: on the neck, below the occiput, level with the Fengfu, in the depression between the sternocleidomastoid muscle and the upper end of the trapezius muscle 3. posterior stream: on the ulnar side, the little fist, the red and white flesh of the distal palmar striatum posterior to the little finger segment (5 th finger-palm joint).
(4) Points commonly used for headache: zusanli, Zhongjinu, Fenglong, Lieque: 1. zusanli: on the anterior lateral aspect of the calf, 3 cun below the nasal point of the calf, 1 lateral finger (middle finger) from the anterior border of the tibia. 2. The epigastric: on the epigastrium, on the midline of the abdomen, 4 cun above the umbilicus. 3. Fenglong: on the anterior-lateral aspect of the calf, 8 cun above the lateral malleolus, lateral to the notch, 2 cun transverse to the anterior border of the tibia (middle finger). 4. Lack of the column: on the radial border of the forearm, above the styloid process of the radius, 1.5 cun above the transverse crease of the wrist, between the tendon of extensor hallucis longus and the radial muscle of the brachiorum.
Has the advantages that: the acupuncture point external preparation for treating the chronic nervous headache, provided by the invention, is prepared by screening the medicinal ingredient components and the specific dosage of each medicinal ingredient through a large number of experiments and is prepared to be pasted on acupuncture points.
Detailed Description
Example 1
1. An acupoint external preparation for treating chronic nervous headache is prepared from the following raw materials in parts by weight: 30g of ligusticum wallichii, 10g of gastrodia elata, 10g of angelica dahurica, 10g of radix paeoniae alba, 15g of radix bupleuri, 5g of borneol and 5g of liquorice.
2. The preparation method of the acupoint external preparation for treating chronic nervous headache comprises the following steps: which comprises the following steps:
(1) taking 30g of ligusticum wallichii, and distilling and extracting the ligusticum wallichii for 2 hours by adopting steam to obtain ligusticum wallichii volatile oil; weighing beta-CD 2g, adding 40ml of distilled water, heating for dissolving, preparing saturated aqueous solution, dropwise adding 1ml of 50% ligusticum wallichii volatile oil ethanol solution, continuously stirring for 2h, cooling to room temperature, transferring to a refrigerator at 4 ℃ for refrigeration for 24h, performing suction filtration, sequentially washing with 10ml of distilled water and 30ml of absolute ethanol, and drying at 45 ℃ to obtain the ligusticum wallichii volatile oil inclusion compound.
(2) Adding 10g of radix angelicae and 10g of radix paeoniae alba into 70% ethanol in an amount which is 8 times that of the radix angelicae, performing reflux extraction for 2 times, and extracting for 1 hour each time, and combining extracting solutions to obtain an ethanol extracting solution of the radix angelicae and the radix paeoniae alba;
(3) mixing the ligusticum wallichii residue in the step (1) and the radix angelicae and radix paeoniae alba residue in the step (2), taking 10g of gastrodia elata, 15g of radix bupleuri and 5g of liquorice, adding 10 times of water for decocting and extracting for 1 hour, transferring the extracting solution, adding 8 times of water for decocting and extracting for 0.5 hour, combining the twice extracted liquid medicines, and concentrating to the relative density of 1.25 to obtain a concentrate;
(4) weighing 5g of glycerol, 1g of absolute ethyl alcohol, 1.25g of sodium polyacrylate, 0.25g of bentonite and 5 parts of borneol, and uniformly mixing to obtain a phase I. Weighing 7g of swelled carbomer 940 (0.3%) solution, adding 2g of the ligusticum wallichii volatile oil inclusion compound in the step (1) and the concentrate obtained in the step (3), and uniformly mixing to obtain a phase II. 25mg each of citric acid and aluminum trichloride was weighed, and 5ml of water was added as phase III. Adding phase I into phase III, mixing, adding phase II, stirring, spreading on non-woven fabric, standing overnight, and covering with anti-sticking layer to obtain gel patch.
Example 2
Taking 2g of the ligusticum wallichii volatile oil inclusion compound prepared in the example 1 and the concentrate obtained in the step (3), heating and melting the mixture, adding 5-10 parts of borneol at the temperature of below 50 ℃, and spreading the mixture on medical non-woven fabrics or sterilized silk fabrics while the mixture is hot, wherein the size of the mixture is a circular patch with the diameter of 2.0 cm.
Example 3
1. An acupoint external preparation for treating chronic nervous headache is prepared from the following raw materials in parts by weight: 40g of ligusticum wallichii, 20g of gastrodia elata, 15g of radix bupleuri, 5g of borneol and 5g of liquorice.
2. The preparation method of the acupoint external preparation for treating chronic nervous headache comprises the following steps: which comprises the following steps:
(1) taking 30g of ligusticum wallichii, and distilling and extracting the ligusticum wallichii for 2 hours by adopting steam to obtain ligusticum wallichii volatile oil; weighing beta-CD 2g, adding 40ml of distilled water, heating for dissolving, preparing saturated aqueous solution, dropwise adding 1ml of 50% ligusticum wallichii volatile oil ethanol solution, continuously stirring for 2h, cooling to room temperature, transferring to a refrigerator at 4 ℃ for refrigeration for 24h, performing suction filtration, sequentially washing with 10ml of distilled water and 30ml of absolute ethanol, and drying at 45 ℃ to obtain the ligusticum wallichii volatile oil inclusion compound.
(2) Taking the ligusticum wallichii residue in the step (1), 10g of gastrodia elata, 15g of radix bupleuri and 5g of liquorice, adding 10 times of water for decocting and extracting for 1 hour, transferring the extracting solution, adding 8 times of water for decocting and extracting for 0.5 hour, combining the twice extracted liquid medicines, and concentrating to the relative density of 1.25 to obtain a concentrate;
(3) weighing 5g of glycerol, 1g of absolute ethyl alcohol, 1.25g of sodium polyacrylate, 0.25g of bentonite and 5 parts of borneol, and uniformly mixing to obtain a phase I. Weighing 7g of swelled carbomer 940 (0.3%) solution, adding 2g of the ligusticum wallichii volatile oil inclusion compound in the step (1) and the concentrate obtained in the step (3), and uniformly mixing to obtain a phase II. 25mg each of citric acid and aluminum trichloride was weighed, and 5ml of water was added as phase III. Adding phase I into phase III, mixing, adding phase II, stirring, spreading on non-woven fabric, standing overnight, and covering with anti-sticking layer to obtain gel patch.
EXAMPLE 4 Observation of clinical efficacy
1. Cases of disease
Randomly selecting 100 nervous headache patients, wherein the age is 25-60 years, the course of disease is 1-10 years, 50 male patients and 50 female patients. The treatment groups (40 patients), the control group (30 patients) and the control group (30 patients) of the ligusticum wallichii tea-blending particles in example 1 were randomly divided into 3 groups.
2. Diagnostic criteria
The western medicine diagnosis conforms to the diagnosis standard about angioneurotic headache formulated by the International Headache Society (IHS), and the traditional Chinese medicine diagnosis conforms to the relevant standard of 'diagnosis standard of symptoms and signs of headache'. Exclusion criteria: the former patients with craniocerebral trauma, intracranial space occupying lesion, cerebral infarction and cerebral hemorrhage, the patients with rhinogenic and drug-induced trigeminal headache, hypertension, diabetes and allergic constitution.
3. Method of treatment
The gel patch is applied to the treatment group in example 1 and the control group in example 3, and is applied to Yintang acupoint, Yangbai acupoint and Hegu acupoint for 3 times every night and for 14 days. The control group orally administered the rhizoma Ligustici Chuanxiong tea granule 1 bag each time, 2 times daily for 14 days.
4. Standard of therapeutic effect
Clinical cure: the clinical symptoms are relieved, and the disease does not relapse within 3 months after the medicine is stopped; the effect is shown: clinical symptoms are obviously relieved, but relapse occurs within 3 months after the medicine is stopped, but the duration, the frequency and the degree of the relapse are obviously lighter than those before treatment: the method has the following advantages: clinical symptoms were reduced, but relapsed after discontinuation, and headache symptoms were less severe at relapse than before treatment: and (4) invalidation: the clinical symptoms are not reduced or even aggravated.
5. Results of the experiment
The specific experimental results are shown in table 1, and the experimental results in table 1 show that the gel external patch provided by the invention has a good effect of treating the nervous headache, 12 cases are clinically cured, compared with 6 cases in the control group in example 3, the gel external patch is twice as much as the control group, which shows that radix angelicae and radix paeoniae alba have a remarkable effect of treating the nervous headache, and the total effective rate of example 1 is 90% higher than 73.3% of the control group in example 3 and 77.5% of the control group of the ligusticum wallichii tea-conditioning granules. And the external administration has weak toxic and side effects, weak first-pass elimination effect and definite curative effect.
TABLE 1
Figure BDA0002625019580000051
The above embodiments are only exemplary embodiments of the present invention, and are not intended to limit the present invention, and the scope of the present invention is defined by the claims. Various modifications and equivalents may be made by those skilled in the art within the spirit and scope of the present invention, and such modifications and equivalents should also be considered as falling within the scope of the present invention.

Claims (6)

1. An acupoint external preparation for treating chronic nervous headache is characterized by being prepared from the following raw materials in parts by weight:
20-40 parts of ligusticum wallichii, 10-30 parts of gastrodia elata, 5-20 parts of radix angelicae, 5-20 parts of radix paeoniae alba, 5-20 parts of radix bupleuri, 5-10 parts of borneol and 5-10 parts of liquorice;
the preparation method of the acupoint external preparation is characterized by comprising the following steps:
(1) weighing the ligusticum wallichii according to the weight parts of the raw materials, and performing steam distillation or supercritical extraction to obtain ligusticum wallichii volatile oil; wrapping beta-cyclodextrin and ligusticum wallichii volatile oil, weighing 2-8 parts of beta-CD, adding a proper amount of distilled water to dissolve the beta-CD to obtain a saturated aqueous solution, dropwise adding 1-4 parts of ligusticum wallichii volatile oil ethanol solution, continuously stirring, cooling to room temperature, transferring to a refrigerator at 4 ℃ for refrigeration for more than 24 hours, performing suction filtration, washing and drying to obtain a ligusticum wallichii volatile oil inclusion compound;
(2) weighing radix Angelicae Dahuricae and radix Paeoniae alba, adding 5-10 times of 50-90% ethanol, extracting for 1-3 times (0.5-2 hr each time), mixing extractive solutions, and recovering ethanol to obtain ethanol extractive solution of radix Angelicae Dahuricae and radix Paeoniae alba;
(3) weighing rhizoma Gastrodiae, bupleuri radix, Glycyrrhrizae radix and above rhizoma Ligustici Chuanxiong residue, radix Angelicae Dahuricae residue and radix Paeoniae alba residue, adding 5-10 times of water, and extracting for two times, each time for 0.5-2 hr to obtain water extractive solution;
(4) mixing the ethanol extract of the angelica dahurica and the white paeony root in the step (2) with the water extract in the step (3), concentrating to the relative density of 1.20-1.35, filtering to obtain a concentrate, and refrigerating for later use;
(5) adding the ligusticum wallichii volatile oil inclusion compound in the step (1) and the concentrate in the step (4) into a pharmaceutically acceptable carrier to prepare an external preparation;
the acupoint selection mode is as follows:
(1) headache due to taiyang meridians: yintang, Yangbai and Hegu acupoints
(2) Headache due to yangming meridians: taiyang, Fengchi and Waiguan points
(3) Headache of shaoyang meridians: tianzhu acupoint, Fengchi acupoint, Hexi acupoint
(4) Points commonly used for headache: zusanli, Zhongjinu, Fenglong and Lieque.
2. The acupoint external preparation for treating chronic nervous headache according to claim 1, which is prepared from the following raw materials in parts by weight:
20-30 parts of ligusticum wallichii, 10-20 parts of gastrodia elata, 5-10 parts of radix angelicae, 5-10 parts of radix paeoniae alba, 10-15 parts of radix bupleuri, 5-10 parts of borneol and 5-10 parts of liquorice.
3. The acupoint external preparation for treating chronic nervous headache according to claim 2, which is prepared from the following raw materials in parts by weight:
30 parts of ligusticum wallichii, 10 parts of gastrodia elata, 10 parts of angelica dahurica, 10 parts of radix paeoniae alba, 15 parts of radix bupleuri, 5 parts of borneol and 5 parts of liquorice.
4. The acupoint external preparation for treating chronic nervous headache according to any one of claims 1 to 3, wherein the external preparation is in the form of paste, ointment, patch or gel.
5. The method for preparing an acupoint external preparation for treating chronic nervous headache according to claim 4, wherein the gel is prepared by the steps of:
weighing 5-10 parts of glycerol, 1-2 parts of absolute ethyl alcohol, 1-2 parts of sodium polyacrylate and 5-10 parts of borneol, and uniformly mixing to obtain a phase I;
weighing 7-14 parts of swelled carbomer 940 solution with concentration of 0.3%, adding the rhizoma Ligustici Chuanxiong volatile oil clathrate of step (1) and the concentrate of step (4) in claim 1, and mixing to obtain phase II;
dissolving citric acid and aluminum trichloride in water to obtain phase III;
adding phase I into phase III, mixing, adding phase II, stirring, spreading on nonwoven fabric, standing overnight, covering with anti-sticking layer, cutting, and packaging to obtain gel patch.
6. The method for preparing an acupoint external preparation for treating chronic nervous headache according to claim 4, wherein the patch preparation method comprises the steps of:
heating and melting the inclusion compound of ligusticum wallichii volatile oil in the step (1) and the concentrate in the step (4) in the claim 1, adding 5-10 parts of borneol at the temperature of below 50 ℃, spreading the mixture on medical non-woven fabrics or sterilized silk fabrics while the mixture is hot, and preparing the circular patch with the diameter of 2.0 cm.
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