CN112121079A - Acupuncture needle capable of enhancing pain relieving efficacy and preparation method and application thereof - Google Patents
Acupuncture needle capable of enhancing pain relieving efficacy and preparation method and application thereof Download PDFInfo
- Publication number
- CN112121079A CN112121079A CN202011014734.7A CN202011014734A CN112121079A CN 112121079 A CN112121079 A CN 112121079A CN 202011014734 A CN202011014734 A CN 202011014734A CN 112121079 A CN112121079 A CN 112121079A
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- parts
- drug coating
- acupuncture needle
- pain
- preparing
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/402—Anaestetics, analgesics, e.g. lidocaine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/428—Vitamins, e.g. tocopherol, riboflavin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
Abstract
The invention provides an acupuncture needle capable of enhancing an analgesic effect and a preparation method and application thereof, and belongs to the technical field of acupuncture needles. The invention extracts effective components which can enhance the pain relieving effect and particularly can effectively treat the lumbar vertebrae metastatic cancer pain from the medicines such as astragalus, codonopsis pilosula, cinnamon, asarum, salvia miltiorrhiza, frankincense, myrrh and the like, and then lidocaine and vitamin E acetate are supplemented, a proper high polymer material PLGA is taken as a framework, a film layer containing the pain relieving effective components is formed on the surface of an acupuncture needle by a spraying method, the high polymer material PLGA for carrying the medicine can be stably combined with the traditional Chinese medicine active components, can be quickly released in a human body, increases the medicine penetration amount, and obtains good effects of enhancing the pain relieving effect and treating the lumbar vertebrae metastatic cancer pain in clinical tests.
Description
Technical Field
The invention belongs to the technical field of acupuncture needles, and particularly relates to an acupuncture needle capable of enhancing pain relieving efficacy, and a preparation method and application thereof.
Background
With the rapid development of society, people's consciousness on health care is gradually strengthened, the requirements on diagnosis and treatment modes and effects are gradually increased, and the traditional non-drug therapy shows better and better development trend, wherein the traditional means of acupuncture is most prominent in terms of the characteristics of high efficiency, convenience and the like. However, the acupuncture therapy method has several disadvantages, such as a narrow therapeutic range and a slow or weak therapeutic effect on some diseases, so that the combination of drug therapy and acupuncture therapy is a new therapeutic method to make the acupuncture therapy better serve the public. In China, the research of the medicine-carrying acupuncture needle has been originally achieved, some records related to the medicine-carrying acupuncture needle are available at present, in the aspect of the design of the needle body, the medicine-carrying acupuncture needle needs to coat a coating on each part of the needle body to achieve the expected effect, the positions of the coatings are different, the achieved effects are different, the coating part of the medicine-carrying acupuncture needle recorded at present comprises the needle body and a needle handle, the outer surface of the needle body is coated with a medicine layer, different preparations of the medicine layer are also one of important factors influencing the effect of the medicine-carrying acupuncture needle, the medicine layer formed by the needle body comprises oil medicines, emulsifier medicines, water medicines or alcohol medicines, the medicine layer is coated with the medicine, the medicine is more the core of the medicine-carrying acupuncture needle in the process of acupuncture, and different medicine preparations can play different roles, and the aim of improving the acupuncture treatment effect is achieved. The factors influencing the therapeutic effect of the drug-loaded acupuncture needle are more, including the drug effect of the specific components of the drug layer, the release rate of the drug in the body and the like.
According to the traditional Chinese medicine, the pain of the human body is caused by the reasons of incapability of moistening and communicating, malnutrition of qi and blood in the pulse channel, incapability of moistening the pulse channel, pain, stagnation of qi and blood in the pulse channel and incapability of communicating and various pains. Therefore, tonifying middle-jiao and Qi, warming yang and dispelling cold, promoting blood circulation and removing blood stasis should be the basis of the pain treatment principle. However, as for the pain of the lumbar metastatic cancer, compared with the common pain such as the pain caused by cervical spondylosis and lumbar disc herniation, the pain of the lumbar metastatic cancer is more severe, the pain gradually worsens, and the cancer history is relatively fixed at the pain part, so that the pain of the lumbar metastatic cancer is more difficult to treat than the common pain, the pain of the lumbar metastatic cancer is obviously stronger than the common pain, at present, no record that a medicine capable of obviously enhancing the pain-relieving efficacy is loaded on an acupuncture needle, no record that the medicine for treating the pain of the lumbar metastatic cancer is loaded on the acupuncture needle, and no report that the medicine for treating the pain of the lumbar metastatic cancer is loaded on the acupuncture needle exist.
Disclosure of Invention
In view of the above, the present invention aims to provide an acupuncture needle capable of enhancing pain relieving efficacy, a preparation method and an application thereof, and achieve a good therapeutic effect.
In order to achieve the above purpose, the invention provides the following technical scheme:
the invention provides a pharmaceutical composition capable of enhancing an analgesic effect, which comprises the following raw material medicines, by weight, 16-20 parts of astragalus membranaceus, 16-20 parts of codonopsis pilosula, 16-20 parts of cinnamon, 4-5 parts of asarum, 16-20 parts of salvia miltiorrhiza, 16-20 parts of frankincense, 16-20 parts of myrrh, 32-40 parts of lidocaine and 16-20 parts of vitamin E acetate.
The invention also provides a drug coating capable of enhancing the analgesic effect, and the drug coating is prepared from the drug composition.
The invention also provides a preparation method of the drug coating, which comprises the following steps:
(1) preparing alcohol extracts of radix astragali, radix Codonopsis, cortex Cinnamomi, herba asari, radix Salviae Miltiorrhizae, Olibanum, and Myrrha;
(2) mixing the polylactic acid-polyglycolic acid copolymer solution with lidocaine, vitamin E acetate and the alcohol extract obtained in the step (1), and stirring and dissolving to obtain the drug coating.
Preferably, the step (1) is specifically: extracting radix astragali, radix codonopsis, cinnamon, asarum, salvia miltiorrhiza, frankincense and myrrh with 80-95% ethanol in a refluxing manner, collecting extract, concentrating and drying to obtain an ethanol extract.
Preferably, the reflux extraction times are 1-4 times, and the time of each reflux extraction is 0.5-3 h.
Preferably, the mass ratio of the polylactic acid-polyglycolic acid copolymer solution in step (2) to the alcohol extract is 1: 0.3-0.5.
Preferably, the mass ratio of glycolide to lactide in the polylactic-co-glycolic acid copolymer obtained in the step (2) is 2-3: 3-2.
The present invention also provides an acupuncture needle capable of enhancing analgesic effect, the surface of which is coated with the above-mentioned drug coating, or the surface of which is coated with the drug coating prepared by any one of the above-mentioned preparation methods.
The invention also provides a preparation method of the acupuncture needle capable of enhancing the analgesic effect, wherein the drug coating or the drug coating prepared by any one of the methods is sprayed on the surface of the acupuncture needle and dried; the spraying speed of the spraying is 0.3-0.8m/s, and the spraying time is 15-30 min.
The invention also provides the application of the pharmaceutical composition, the pharmaceutical coating and the acupuncture needle in preparing medical instruments for treating lumbar metastatic cancer pain.
Compared with the prior art, the technical scheme of the invention has the following beneficial effects:
1) the astragalus root in the medicine composition is the key medicine for tonifying middle-jiao and Qi, so that the qi and blood can be vigorous, and the effects of activating stagnancy and dredging collaterals can be achieved; cinnamon, pungent and sweet in flavor and with strong heat, warms kidney and dispels cold, and warms and unblocks meridians; the red sage root is good at activating blood, dissolving stasis and relieving pain, benefiting joints and dredging collaterals, and the waist and the knees are healthy and obvious in arthralgia movement, and is used as a monarch drug together to achieve the effects of tonifying middle-jiao and Qi, warming yang and dispelling cold, and activating blood and dissolving stasis. The radix codonopsitis for tonifying qi and the frankincense and the myrrh for promoting blood circulation and relieving pain are used as ministerial drugs, and the astragalus root has the functions of tonifying qi and blood and promoting the circulation of blood, dissolving stasis and relieving pain. The pungent and warm herbs are added to assist the herbs to enter the waist, so as to expel the fragrance and relieve pain. The medicinal compositions of the invention have synergistic effect, can obviously enhance the pain-relieving effect, can effectively treat the lumbar metastatic cancer pain, and has good curative effect on the lumbar metastatic cancer pain in clinical tests.
2) The pharmaceutical composition not only contains traditional Chinese medicine raw materials, but also is added with a proper amount of western medicines of lidocaine and vitamin E acetate, wherein the lidocaine is an amide local anesthetic and has the advantages of strong penetrating power, quick action, long maintenance time, no influence on blood vessels and the like, so that the lidocaine can be used as a surface anesthetic and can further enhance the analgesic effect; the vitamin E acetate has antioxidant activity, can prevent peroxidation of unsaturated fatty acid, has the function of stabilizing cell membrane, can improve immunity, promote energy metabolism of organisms, enhance cell activity, can promote proliferation of capillaries and small blood vessels in large dose, has the stable protection function of the vitamin E acetate, and can further improve the pain relieving function of lidocaine. The invention creatively limits the proper dosage of the lidocaine and the vitamin E acetate which are compatible with the astragalus, the codonopsis pilosula, the cinnamon, the asarum, the salvia miltiorrhiza, the frankincense and the myrrh, plays a synergistic effect, further enhances the pain relieving effect of the pharmaceutical composition, and can effectively treat the lumbar metastatic cancer pain.
3) The invention takes polylactic acid-polyglycolic acid copolymer which is a degradable high molecular organic compound as a framework, has good biocompatibility, no toxicity and good properties of encapsulation and film formation, can be stably combined with active ingredients of Chinese and western medicines to form a medicament film layer, can be quickly released in a human body, increases the medicine penetration amount, and further obtains the good effect of treating the lumbar metastatic cancer pain by combining acupuncture and moxibustion with the Chinese and western medicines.
4) The preparation method of the drug coating is simple and easy to implement, and bioactive substances for effectively treating lumbar metastatic cancer pain can be obtained from all components, so that the drug coating prepared by the method has stable drug effect.
5) The invention extracts the effective components for relieving pain from the medicines such as astragalus, codonopsis pilosula, cinnamon, asarum, salvia miltiorrhiza, frankincense, myrrh and the like, takes proper high polymer material PLGA as a framework, forms a film layer containing the effective components for relieving pain on the surface of an acupuncture needle by a spraying method, and the high polymer material for carrying the medicine can be stably combined with the active components of the traditional Chinese medicine, can be quickly released in a human body, increases the medicine penetration amount, and obtains good treatment effect in clinical tests.
Detailed Description
The invention provides a pharmaceutical composition capable of enhancing an analgesic effect, which comprises the following raw material medicines, by weight, 16-20 parts of astragalus membranaceus, 16-20 parts of codonopsis pilosula, 16-20 parts of cinnamon, 4-5 parts of asarum, 16-20 parts of salvia miltiorrhiza, 16-20 parts of frankincense, 16-20 parts of myrrh, 32-40 parts of lidocaine and 16-20 parts of vitamin E acetate.
Preferably, the composition comprises the following components in parts by weight: 17-19 parts of astragalus membranaceus, 17-19 parts of codonopsis pilosula, 17-19 parts of cinnamon, 4.25-4.75 parts of asarum, 17-19 parts of salvia miltiorrhiza, 17-19 parts of frankincense, 17-19 parts of myrrh, 34-38 parts of lidocaine and 17-19 parts of vitamin E acetate, and more preferably comprises the following components in parts by weight: 18 parts of astragalus membranaceus, 18 parts of codonopsis pilosula, 18 parts of cinnamon, 4.5 parts of asarum, 18 parts of salvia miltiorrhiza, 18 parts of frankincense, 18 parts of myrrh, 36 parts of lidocaine and 18 parts of vitamin E acetate. The sources of the raw materials are not particularly limited, and the raw materials can be prepared from conventional commercial products.
The invention also provides a drug coating capable of enhancing the analgesic effect, and the drug coating is prepared from the drug composition. The method for preparing the drug coating from the pharmaceutical composition is not particularly limited, and the method for preparing the drug coating conventionally in the field can be adopted. Preferably, the preparation method of the drug coating comprises the following steps:
(1) preparing alcohol extracts of radix astragali, radix Codonopsis, cortex Cinnamomi, herba asari, radix Salviae Miltiorrhizae, Olibanum, and Myrrha;
(2) mixing the polylactic acid-polyglycolic acid copolymer solution with lidocaine, vitamin E acetate and the alcohol extract obtained in the step (1), and stirring and dissolving to obtain the drug coating.
In the invention, astragalus, codonopsis pilosula, cinnamon, asarum, salvia miltiorrhiza, frankincense and myrrh are extracted by alcohol to obtain alcohol extract. The specific steps are preferably as follows: extracting radix astragali, radix codonopsis, cinnamon, asarum, salvia miltiorrhiza, frankincense and myrrh with 80-95% ethanol in a refluxing manner, collecting extract, concentrating and drying to obtain an ethanol extract. Wherein the volume fraction of the ethanol is preferably 90%, the reflux extraction time is preferably 1-4 times, more preferably 3 times, and the time of each reflux extraction is preferably 0.5-3h, more preferably 2 h. The concentration method in the present invention is not particularly limited, and any conventional concentration method in the art may be used, such as vacuum concentration, and the pressure of the vacuum concentration is preferably 0.02 to 0.06MPa, more preferably 0.03 to 0.05 MPa. The content of the effective components of the concentrated solution after vacuum concentration is preferably 80-90%. The drying is preferably spray drying, the air inlet temperature of the spray drying is preferably 166-170 ℃, and the time of the spray drying is preferably 15-30 min.
In the present invention, the source of polylactic-co-glycolic acid (PLGA) is not particularly limited, and conventional commercial products may be used, and in the present invention, the mass ratio of glycolide to lactide in PLGA is preferably 2 to 3: 3-2, more preferably 1: 1, the organic solvent is easier to dissolve. In the invention, the PLGA solution is preferably a PLGA chloroform solution, the mass concentration of PLGA in the PLGA chloroform solution is preferably 1-3%, more preferably 2%, and the PLGA chloroform solution with the mass concentration can better dissolve PLGA to achieve the optimal solubility. The mass ratio of the PLGA solution to the alcohol extract is preferably 1: 0.3 to 0.5, more preferably 1: 0.4, the alcohol extract is better dissolved.
The present invention also provides an acupuncture needle capable of enhancing analgesic effect, the surface of which is coated with the above-mentioned drug coating, or the surface of which is coated with the drug coating prepared by any one of the above-mentioned preparation methods. The present invention is not particularly limited with respect to the type of the needle, and a needle conventionally used in the art may be used.
The invention also provides a preparation method of the acupuncture needle capable of enhancing the analgesic effect, wherein the drug coating or the drug coating prepared by any one of the methods is sprayed on the surface of the acupuncture needle and dried; the spraying rate of the spraying is 0.3-0.8m/s, preferably 0.5-0.7m/s, more preferably 0.6m/s, and the spraying time of the spraying is 15-30min, preferably 20-25min, more preferably 23 min. In the present invention, the surface of the needle refers to the surface of the needle excluding the shank (excluding the shank). The drying mode of the present invention is not particularly limited, any drying method known in the art may be used, and in the specific embodiment of the present invention, vacuum drying is preferably performed, the vacuum degree of the vacuum drying is preferably-0.054 to-0.09395 MPa, more preferably-0.06 to-0.08 MPa, the temperature of the vacuum drying is preferably 40 to 80 ℃, more preferably 50 to 70 ℃, and the time of the vacuum drying is preferably 8 to 20 hours, more preferably 12 to 16 hours.
The invention also provides the application of the pharmaceutical composition, the pharmaceutical coating and the acupuncture needle in preparing medical instruments for treating lumbar metastatic cancer pain.
The technical solutions provided by the present invention are described in detail below with reference to examples, but they should not be construed as limiting the scope of the present invention.
Example 1
(1) Reflux-extracting radix astragali 20g, radix Codonopsis 20g, cortex Cinnamomi 20g, herba asari 5g, Saviae Miltiorrhizae radix 20g, Olibanum 20g and Myrrha 20g with 90% ethanol for 3 times (2 hr each time), collecting 3 times of reflux-obtained extractive solutions, vacuum-concentrating under 0.05MPa until the content of effective components in the concentrated solution is 80.4%, and drying for 30min by spray drying at 168 deg.C to obtain 40g of ethanol extract.
(2) The mass ratio of glycolide to lactide is 1: and (2) adding PLGA of 1 into a chloroform solution for dissolving to prepare a PLGA chloroform solution with the PLGA mass concentration of 2%, mixing 80g of PLGA chloroform solution with 40g of lidocaine, 20g of vitamin E acetate and the alcohol extract obtained in the step (1), and stirring and dissolving to obtain the drug coating.
(3) Spraying the medicinal coating on the surface of the acupuncture needle by spraying method with spraying rate of 0.6m/s and spraying time of 23min, and vacuum drying at-0.078 MPa and 60 deg.C for 12 hr to obtain the final product.
Example 2
(1) Extracting radix astragali 16g, radix Codonopsis 16g, cortex Cinnamomi 16g, herba asari 4g, Saviae Miltiorrhizae radix 16g, Olibanum 16g and Myrrha 16g with 92% ethanol under reflux for 4 times (each time for 1.5 hr), collecting the extractive solution obtained by 4 times of reflux, vacuum concentrating under 0.04MPa until the content of effective component in the concentrated solution is 83%, and drying for 15min by spray drying at 169 deg.C to obtain 32g of ethanol extract.
(2) And (2) mixing glycolide and lactide in a mass ratio of 2: and 3, adding PLGA into a chloroform solution for dissolving to obtain a PLGA chloroform solution with the PLGA mass concentration of 1%, mixing 64g of PLGA chloroform solution with 32g of lidocaine, 16g of vitamin E acetate and the alcohol extract obtained in the step (1), and stirring and dissolving to obtain the drug coating.
(3) Spraying the medicinal coating on the surface of the acupuncture needle by spraying method with spraying rate of 0.7m/s and spraying time of 25min, and vacuum drying at-0.08 MPa and 70 deg.C for 14 hr to obtain acupuncture needle with medicine.
Example 3
(1) Reflux-extracting radix astragali 18g, radix Codonopsis 18g, cortex Cinnamomi 18g, herba asari 4.5g, Saviae Miltiorrhizae radix 18g, Olibanum 18g and Myrrha 18g with 80% ethanol for 2 times (2.5 hr each time), collecting the extractive solution obtained by 4 times reflux, vacuum-concentrating under 0.04MPa until the content of effective components in the concentrated solution is 83%, and spray-drying at 166 deg.C for 20min to obtain 36g of ethanol extract.
(2) And (3) mixing glycolide and lactide in a mass ratio of 3: and 2, adding PLGA into a chloroform solution for dissolving to obtain a PLGA chloroform solution with the PLGA mass concentration of 3%, mixing 90g of PLGA chloroform solution with 36g of lidocaine, 18g of vitamin E acetate and the alcohol extract obtained in the step (1), and stirring and dissolving to obtain the drug coating.
(4) Spraying the medicinal coating on the surface of the acupuncture needle by spraying method with spraying rate of 0.5m/s and spraying time of 20min, and vacuum drying at-0.06 MPa and 50 deg.C for 16h to obtain the final product.
Example 4
Clinical test of pain of patient suffering from lumbar metastatic cancer pain by using medicine-carrying acupuncture needle
Clinical data
The patients with the survival period of more than 4 months are predicted, and the patients with the following cases can be excluded: firstly, radiation therapy, chemotherapy or nerve blocking therapy is used for the affected part or the pain part of the tumor within 1 month before the observation period begins; ② noncancerous pain, such as pain associated with a tumor emergency, other neuralgia associated with a tumor, such as postherpetic neuralgia and the like; ③ the disabled patients (blind, deaf, dumb, intellectual disability, mental disorder, physical disability) stipulated by law; fourthly, allergic constitution, such as people with allergic history to two or more foods or medicines; or allergic to the medicinal component; according to the judgment of researchers, other conditions that the possibility of entering the group is reduced or the group is complicated are provided, for example, the working environment is frequently changed and the like, the missed visit is easily caused, the medicine is not taken according to the regulation, and the judgment that the curative effect or the data are not completely influenced the curative effect or the safety can not be judged; sixthly, the patients participating in other clinical studies. The number of the patients is 60, 28 men and 32 women, the average age is 51 years, the medical history is shortest 1 month and longest one year and half. Patients were randomized into two groups: the treatment group (the drug-loaded acupuncture needle of the invention) and the control group (the common acupuncture needle) have 30 cases in each group, and the sex, age, course of disease and the like of patients in each group are comparable through statistical treatment.
Method of treatment
Get the West of CommissionChengshan, Chengjin, Zusanli, Yintang, Baihui, Du Yu and Ashi acupoints. Taking a patient in a prone position, conventionally sterilizing, taking an acupuncture needle to perform acupuncture on the acupuncture points, keeping the needle for 15 minutes after obtaining qi, 1 time every day, 10 times as 1 course of treatment, starting the 2 nd course of treatment after resting for 3 days, and treating for 2 courses of treatment. Clinical symptoms and signs before and after treatment are observed. Analyzing with SPSS19.0 statistical software, expressing the measured data with average value + -standard deviation, performing t-test, and counting data with X-ray2Inspection, P<Differences at 0.05 were statistically significant.
Criteria for therapeutic effect
Pain scores were assessed on day 1 and day 24. Level 0: the pain is basically and completely relieved after treatment, and the life is normal; level 1: the pain symptom is obviously relieved, the sleep is basically not influenced, and the people can normally live; and 2, stage: the pain is relieved, and the normal life is influenced by certain interference on sleep; and 3, level: no significant improvement was seen.
Results
The results of pain assessment before and after treatment in both groups are shown in table 1, and statistical analysis shows that the objective remission rate and disease control rate of the treatment group and the control group have statistical significance (P < 0.05). The effect of the medicine-carrying acupuncture needle for treating the lumbar metastatic cancer pain is obviously superior to that of the simple acupuncture point acupuncture treatment.
TABLE 1 two evaluation tables for pain before and after treatment
Example 5
The clinical data and the treatment method of the drug-loaded acupuncture needle for improving the traditional Chinese medicine clinical symptoms of the lumbar metastatic cancer pain patient are the same as in example 3.
Criteria for therapeutic effect
The improvement of the clinical symptoms of the traditional Chinese medicine is evaluated on the 1 st and 24 th days in the invention. The symptoms of the lumbar vertebrae metastatic cancer pain yang deficiency and blood stasis type are divided into cold pain of the waist such as stabbing, continuous and non-moving pain, absently white complexion, cold hands and feet, deficiency of qi and disinclination to talk, cool legs, pale and dark tongue, thin and white tongue fur and unsmooth pulse, wherein the grading quantization integral of each symptom is divided into 4 levels which are 3, 2, 1 and 0 respectively.
The clinical cure is as follows: the clinical symptoms and physical signs of the traditional Chinese medicine disappear or basically disappear, and the symptom integral is reduced by more than 95 percent; the effect is shown: clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the symptom integral is reduced by more than 70%; the method has the following advantages: the clinical symptoms and physical signs of the traditional Chinese medicine are improved, and the symptom integral is reduced by more than 30%; and (4) invalidation: clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved or aggravated, and the symptom integral is reduced by less than 30%. The above formula for calculating the integral of each symptom adopts nimodipine method, specifically [ (integral before treatment-integral after treatment)/integral before treatment ] × 100%.
Results
The clinical symptoms of the Chinese medicine before and after the treatment of the two groups are shown in table 2, compared with the total effective value of the control group, the treatment group has P of 0.015 and P of 0.05 through chi fang test, and the difference has statistical significance.
TABLE 2 comparison of the therapeutic effects of the two groups before and after treatment
| n | Recovery method | Show effect | Is effective | Invalidation | Total effective | |
| Treatment group | 30 | 8 | 10 | 6 | 6 | 24 |
| Control group | 30 | 3 | 5 | 10 | 12 | 18 |
The effective rate changes of the traditional Chinese medicine symptoms before and after two groups of treatment are shown in table 3, which shows that the drug-loaded acupuncture needle can effectively improve the symptoms of cold pain of the waist, such as stabbing, lingering pain parts, abstinence and white complexion, cold hands and feet, cool legs, light and dark tongue quality, thin and white tongue fur and deep and unsmooth pulse of patients with lumbar vertebra metastatic cancer compared with a control group, and the effect is obviously better than that of the control group.
TABLE 3 comparison of the effective rate of the two groups of Chinese medicine symptoms after treatment
As can be seen from tables 2 and 3, the drug-loaded acupuncture needle of the present invention has significant advantages in improving the clinical symptoms of patients with metastatic cancer pain of lumbar vertebra in traditional Chinese medicine, improving the quality of life, etc.
Example 6
The medicine-carrying acupuncture needle of the invention scores and improves the condition of lumbar metastatic cancer pain patients in a card mode
The clinical data and treatment methods were the same as in example 3.
Criteria for therapeutic effect
Card score improvement was assessed on day 1 and day 24. 100 min: normal, asymptomatic and signs; and (5) 90 min: normal activities with mild symptoms and signs; 80 minutes: there were some symptoms or signs, reluctant to perform normal activities; 70 min: the life can be self-care, but the normal life and work can not be maintained; and (5) 60 min: the life can be mostly self-care, but occasionally needs help of others; and (3) 50 min: people are often required to attend; and (4) dividing by 40: the life cannot be self-managed, and special care and help are needed; 30 min: the life is serious and the person cannot take care of himself; 20 min: severe disease, hospitalization and active supportive care; 10 min: critical, near-death; 0 minute: and death.
Wherein, the KPS score is increased by more than or equal to 20 points compared with the previous KPS score, and the KPS score is regarded as 'effective'; the score is increased by 10 points or more, and the score is considered to be effective when the score is less than 20 points; the score fluctuates up and down within 10 points, and then the score is considered to be stable; if the score is reduced by more than 10 points, the score is regarded as invalid; both significant and significant are considered valid ranges, and both stable and non-valid are considered non-valid ranges. The effective rate is the ratio of the sum of the KPS improvement effect and the effective number to the total number.
Results
The improvement in the Ka-score is shown in Table 4, and after treatment, the Ka-score of more than 86.67% of patients with lumbar metastatic cancer was improved or relatively stable, while the Ka-score of 50.00% of patients in the control group was stable or improved. The two groups of differences with P <0.05 have statistical significance through testing, and P is 0.02.
TABLE 4 comparison of before and after treatment Ka's score for effective rate
| n | Improvement of | Stabilization | Reduce | Total effective | |
| Treatment group | 30 | 21 | 5 | 4 | 86.67％ |
| Control group | 30 | 3 | 12 | 10 | 50.00％ |
Example 7
The medicine-carrying acupuncture needle of the invention improves the life quality of patients with lumbar vertebrae metastatic cancer pain
The clinical data and treatment methods were the same as in example 3.
Criteria for therapeutic effect
Quality of life improvement was evaluated on day 1 and day 24. The standard for judging the treatment effect of life quality is as follows: appetite: (ii) almost no food intake; ② the food intake is less than normal 1/2; ③ 1/2 the food intake is normal; fourthly, the food consumption is slightly less; normal food intake. Spirit: is very poor; ② worse; ③ good time and bad time, but have influence; fourthly, good; the fifth step is normal, which is the same as before disease. Sleeping: firstly, the user is difficult to fall asleep; secondly, the sleep is very poor; poor sleep; fourthly, the sleep is slightly poor; almost normal. Fatigue: firstly, fatigue is frequent; ② the self-consciousness is weak; ③ fatigue sometimes; fourthly, sometimes slight fatigue; no fatigue.
The full life quality is 20 points, the extremely bad life quality is less than 4 points, the bad life quality is 5 to 8 points, generally 9 to 12 points, better 13 to 16 points and better 17 to 20 points.
Results
The improvement in quality of life of the two groups of cases is shown in table 5, the improvement in quality of life of the treatment group and the control group before and after treatment is greatly different, the average value of the treatment group is greatly improved in appetite, spirit, sleep and fatigue degree compared with the control group, and the difference in average value of the two groups is 8.35.
TABLE 5 comparison of quality of life improvement before and after treatment of two groups
| Appetite stimulation | Spirit of the invention | Sleep mode | Fatigue caused by fatigue | Total of | |
| Mean value of control group | 2.50 | 2.00 | 2.25 | 2.55 | 9.3 |
| Mean of treatment groups | 4.75 | 4.00 | 4.15 | 4.75 | 17.65 |
| Two sets of comparisons (treatment-control) | 2.25 | 2.00 | 1.9 | 2.2 | 8.35 |
According to the above results, the present invention provides a pharmaceutical composition and a drug-loaded acupuncture needle for effectively treating lumbar metastatic cancer pain, which can significantly reduce pain. The pain syndrome of the lumbar metastatic cancer is a yang deficiency with blood stasis type, the disease position is mainly in the waist and the back, and the pathogenesis is as follows: yang qi deficiency, congealing cold and blood stasis, and can be used for warming yang, dispelling cold, invigorating spleen and stomach, invigorating qi, promoting blood circulation and removing blood stasis; the pharmaceutical composition and the drug-loaded acupuncture needle can effectively improve the clinical symptoms and the quality of life of the traditional Chinese medicine, improve the card type score and obviously improve the relevant physicochemical examination.
The acupuncture treatment provided by the invention can pay attention to the holism concept, emphasize treatment based on syndrome differentiation, simultaneously gives consideration to individuation, can effectively improve clinical symptoms and treat the root cause, has relatively small adverse reaction, and has wide development prospect. The invention is used for treating lumbar vertebrae metastatic cancer pain (yang deficiency with blood stasis) by taking the traditional Chinese medicine theory as guidance, the definite clinical time as a basis, the modern scientific research method as a means and the treatment rules of warming yang to dissipate blood stasis and promoting blood circulation to relieve pain.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (10)
1. The pharmaceutical composition capable of enhancing the analgesic effect is characterized by comprising the following raw material medicines, by weight, 16-20 parts of astragalus membranaceus, 16-20 parts of codonopsis pilosula, 16-20 parts of cinnamon, 4-5 parts of asarum, 16-20 parts of salvia miltiorrhiza, 16-20 parts of frankincense, 16-20 parts of myrrh, 32-40 parts of lidocaine and 16-20 parts of vitamin E acetate.
2. A drug coating for enhancing analgesic efficacy, wherein said coating is made from the pharmaceutical composition of claim 1.
3. A method for preparing the drug coating of claim 2, comprising the steps of:
(1) preparing alcohol extracts of radix astragali, radix Codonopsis, cortex Cinnamomi, herba asari, radix Salviae Miltiorrhizae, Olibanum, and Myrrha;
(2) mixing the polylactic acid-polyglycolic acid copolymer solution with lidocaine, vitamin E acetate and the alcohol extract obtained in the step (1), and stirring and dissolving to obtain the drug coating.
4. The method for preparing the drug coating according to claim 3, wherein the step (1) is specifically: extracting radix astragali, radix codonopsis, cinnamon, asarum, salvia miltiorrhiza, frankincense and myrrh with 80-95% ethanol in a refluxing manner, collecting extract, concentrating and drying to obtain an ethanol extract.
5. The method for preparing the drug coating according to claim 4, wherein the reflux extraction is performed 1-4 times, and the time of each reflux extraction is 0.5-3 h.
6. The method for preparing the drug coating according to claim 4 or 5, wherein the mass ratio of the polylactic-co-glycolic acid solution to the alcohol extract in the step (2) is 1: 0.3-0.5.
7. The method for preparing the drug coating according to claim 3, wherein the mass ratio of glycolide to lactide in the polylactic-co-glycolic acid copolymer of step (2) is 2-3: 3-2.
8. An acupuncture needle for enhancing analgesic effect, wherein the surface of the acupuncture needle is coated with the drug coating of claim 2, or the surface of the acupuncture needle is coated with the drug coating prepared by the method of any one of claims 3 to 7.
9. A method for preparing an acupuncture needle capable of enhancing analgesic effect, characterized in that the drug coating according to claim 2 or the drug coating prepared by any one of the methods according to claims 3 to 7 is sprayed on the surface of the acupuncture needle and dried; the spraying speed of the spraying is 0.3-0.8m/s, and the spraying time is 15-30 min.
10. Use of the pharmaceutical composition of claim 1, the pharmaceutical coating of claim 2, and the needle of claim 8 for the preparation of a medical device for treating pain due to lumbar metastatic cancer.
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Cited By (1)
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| CN115990108A (en) * | 2022-11-01 | 2023-04-21 | 山东海天智能工程有限公司 | Acupuncture control system based on brain electrical signals, readable storage medium and electronic equipment |
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