CN113952384A - Rongjinqubi prescription and preparation method and application thereof - Google Patents

Rongjinqubi prescription and preparation method and application thereof Download PDF

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CN113952384A
CN113952384A CN202111467384.4A CN202111467384A CN113952384A CN 113952384 A CN113952384 A CN 113952384A CN 202111467384 A CN202111467384 A CN 202111467384A CN 113952384 A CN113952384 A CN 113952384A
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parts
pharmaceutical composition
radix
preparation
treatment
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陈俊
吴广文
张婷
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Fujian University of Traditional Chinese Medicine
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Fujian University of Traditional Chinese Medicine
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Abstract

The invention provides a rong jin arthralgia-dispelling prescription and a preparation method and application thereof, the rong jin arthralgia-dispelling prescription is a composition for expelling wind, clearing away cold, removing dampness, promoting blood circulation, removing blood stasis and relieving pain, and is prepared from the following raw material medicines in parts by weight: 5-15 parts of notopterygium root, 5-15 parts of radix angelicae pubescentis, 5-15 parts of radix angelicae, 5-15 parts of radix sileris, 5-10 parts of radix aconiti, 13-18 parts of ligusticum wallichii, 5-15 parts of angelica sinensis, 5-15 parts of frankincense, 5-15 parts of myrrh, 5-15 parts of safflower and 5-15 parts of asarum. The prescription disclosed by the invention is proper in compatibility, simple in medicinal taste, capable of treating knee osteoarthritis through external fumigation treatment, high in effective rate, convenient to take and small in toxic and side effects, has obvious advantages in the aspects of relieving pain, improving clinical symptoms and recovering joint functions, and has wide application prospects in the aspects of prevention and recovery of knee osteoarthritis.

Description

Rongjinqubi prescription and preparation method and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a rong jin qubi prescription and a preparation method and application thereof.
Background
Knee Osteoarthritis (Knee Osteoarthritis,KOA) is a chronic disease characterized by degenerative changes, injuries and secondary hyperosteogeny of knee cartilage caused by various causes, with the main clinical symptoms of joint pain, limited mobility and joint deformity. The data show that the prevalence rate of the symptomatic knee osteoarthritis (namely, the diagnosis is clear, the symptoms such as knee joint pain exist and the diagnosis is needed) in China at present is 8.1 percent[1]. The prevalence of the disease increases year by year as the pace of life increases and as inappropriate motor patterns impair. At present, western medicine treatment can temporarily relieve the joint pain symptoms of knee osteoarthritis patients, but the long-term curative effect is unsatisfactory, and adverse reactions are unavoidable. The traditional Chinese medicine has unique characteristics in the aspect of improving the clinical symptoms of knee osteoarthritis, so that the full play of the role of the traditional Chinese medicine in diagnosis and treatment of the disease is a focus of attention. The knee osteoarthritis belongs to the category of bone rheumatism in the traditional Chinese medicine, and the basic pathogenesis of the knee osteoarthritis is that exogenous pathogens such as wind, cold, dampness and the like easily enter the body of a patient while the body is deficient, tendons and collaterals are blocked, qi and blood cannot be nourished, and deficiency and excess are mixed to cause pain, so the treatment principle is to dispel wind and remove dampness, activate blood and dredge channels, remove stasis and relieve pain.
Compared with the internal treatment, the external treatment of traditional Chinese medicine has the advantages of small toxic and side effects, direct action on the diseased region and the like, and is widely applied to the treatment of knee osteoarthritis. At present, lotion and patch for external use for treating osteoarthritis are reported. For example, patent application CN105641165A discloses a Chinese medicinal lotion for treating osteoarthritis, which is prepared from 18 kinds of herbs including zanthoxylum bungeanum, orienavine, safflower, dahurian angelica root, notopterygium root, pubescent angelica root, etc., by decocting in water for fumigation, and simultaneously improving the symptoms of osteoarthritis by external application; patent application CN106668782A discloses a composition for treating knee osteoarthritis, which is prepared from more than twenty kinds of medicinal herbs such as lycopodium clavatum, garden balsam stem, pubescent angelica root, notopterygium root and the like, and is prepared into acupoint application for improving the symptoms of knee osteoarthritis. However, the externally applied preparation reported at present has more medicinal flavors and no clear compatibility, not only has high cost, but also requires further research and standardization on the scientific property and the rationality of the medicine.
In order to widen the clinical choice of treating knee osteoarthritis, the research on an external traditional Chinese medicine preparation which is simple in medicine flavor, proper in compatibility, remarkable in effect and high in safety is further carried out, and the external traditional Chinese medicine preparation still has important significance.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating arthritis, which has the advantages of simple medicinal flavor, proper compatibility, obvious effect and high safety.
The invention provides a pharmaceutical composition for expelling wind, clearing away cold, removing dampness, promoting blood circulation, removing blood stasis and relieving pain, which is characterized by being prepared from the following raw material medicines in parts by weight:
5-15 parts of notopterygium root, 5-15 parts of radix angelicae pubescentis, 5-15 parts of radix angelicae, 5-15 parts of radix sileris, 5-10 parts of radix aconiti, 13-18 parts of ligusticum wallichii, 5-15 parts of angelica sinensis, 5-15 parts of frankincense, 5-15 parts of myrrh, 5-15 parts of safflower and 5-15 parts of asarum.
Further, the traditional Chinese medicine is prepared from the following raw material medicines in parts by weight:
10 parts of notopterygium root, 10 parts of radix angelicae pubescentis, 10 parts of radix angelicae, 10 parts of radix sileris, 6 parts of radix aconiti, 15 parts of ligusticum wallichii, 10 parts of angelica sinensis, 10 parts of frankincense, 10 parts of myrrh, 10 parts of safflower and 10 parts of asarum.
Furthermore, the traditional Chinese medicine composition is a preparation prepared by taking crude drug powder of the raw drug materials, water and/or organic solvent extract as active ingredients and adding or not adding pharmaceutically acceptable auxiliary materials.
Further, the above preparation is an external preparation.
Further, the external preparation is a fumigant.
Further, the external preparation is in the form of solution, powder, tincture, spirit, lotion, oil, emulsion, ointment, plaster, cataplasm, plastics, pellicle, cataplasma, gel, liniment, aerosol, and granule.
The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:
(1) taking the raw materials in parts by weight;
(2) soaking the raw materials in water, and decocting to obtain decoction.
Further, in the step (2), the soaking time is 20-40 min, and the decocting time is 10-20 min.
The invention also provides application of the pharmaceutical composition in preparing a medicament for preventing and treating arthritis.
Furthermore, the medicine is a medicine for preventing and treating knee osteoarthritis.
The invention has the beneficial effects that: the medicinal composition (Rongjinqubi prescription) is used for fumigating and treating knee osteoarthritis, has obvious advantages in relieving pain, improving clinical symptoms and recovering joint functions, has the total effective rate of 88.2 percent, and has wide application prospect in the aspects of prevention and treatment and rehabilitation of the knee osteoarthritis due to the characteristics of a non-invasive treatment mode.
In the formula, notopterygium root and radix angelicae pubescentis are used as monarch drugs for dispelling wind and eliminating dampness and dredging collaterals and relieving pain, the notopterygium root is good at treating wind-cold-dampness arthralgia of the upper half body, the radix angelicae pubescentis is good at treating wind-cold-dampness arthralgia of the lower half body such as lumbago, knee pain and foot pain, the radix angelicae pubescentis is compatible with the radix angelicae pubescentis and the radix angelicae pubescentis, so that pathogenic factors are completely dispelled outside, and the effects of dispelling wind-damp and dispelling wind-cold are enhanced. Pharmacological research shows that the notopterygium root and radix angelicae pubescentis can play an anti-inflammatory role through multi-channel mediation, and the compatibility effect of the two medicines is superior to that of a single medicine, so that the medicine has an exact curative effect on knee osteoarthritis. The prescription uses three medicines of angelica dahurica, radix sileris and radix aconiti preparata to eliminate arthralgia pain of the whole body so as to strengthen the efficacy of monarch medicine in dispelling wind, eliminating dampness and relieving pain. The record of Yunnan herbal medicine: the angelica dahurica dispels wind of skin wandering and pain of whole body cold-dampness, the angelica dahurica dispels wind and dampness to stop pain of yangming, the notopterygium root enters the sun to clear wind and the angelica pubescens enters the shaoyin to clear latent wind, and the three medicines are combined to dispel wind evil of three channels and stop pain. Ledebouriella root, radix Saposhnikoviae mainly treats internode pain, has the effects of dispelling wind, relieving exterior syndrome, eliminating dampness, relieving pain and relieving spasm, and can be used for treating arthralgia due to wind-cold-dampness or arthralgia due to wind-damp-heat. The prepared radix aconiti has obvious pain relieving effect, is a key medicine for dispelling wind-damp and stopping arthralgia, is clinically applied to chronic pain diseases such as knee osteoarthritis and the like, and has very obvious pain relieving effect. Chuan Xiong and Dang Gui are also the important constituents of the recipe, which combines the therapeutic effect of wind-treating first and the self-extinguishing effect of blood-moving wind. The ligusticum wallichii is pungent, warm, fragrant and dry, moves without staying on the ground, has the effects of activating blood and promoting qi, dispelling wind and relieving pain, the angelica sinensis is sweet in taste and can be used for enriching blood, has the effects of pungent powder and blood circulation and tonifying during moving, and the ligusticum wallichii and the angelica sinensis are used together, so that the blood circulation is promoted without blood cutting and the blood is enriched without stagnation while the blood circulation is strengthened; frankincense and myrrh are mutually reinforced to activate blood and promote qi circulation, and relieve swelling and pain, and are used for treating all pains caused by obstruction of veins; safflower, pungent and warm in property, activates blood circulation to dissipate blood stasis and relieves pain, is the essential herb for traumatic injury, and is an adjuvant drug. The asarum herb warms yang and unblocks collaterals, dispels cold and relieves pain, so that the efficacy of the medicine can reach the affected part directly, and the absorption of the medicine is promoted to be used as a guiding medicine. The traditional Chinese medicine composition can fully grasp the principal symptoms of knee osteoarthritis, expel wind, dispel cold and remove dampness, activate blood circulation, remove blood stasis and relieve pain, and has good effect on treating diseases such as blood stasis blockage, channel obstruction and the like caused by pathogenic wind, cold and dampness.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
The starting materials and equipment used in the present invention are, unless otherwise stated, known products obtained by purchasing commercially available products.
Example 1 preparation of a pharmaceutical composition of the invention
Prescription: 10g of notopterygium root, 10g of pubescent angelica root, 10g of dahurian angelica root, 10g of divaricate saposhnikovia root, 6g of common monkshood mother root, 15g of szechuan lovage rhizome, 10g of Chinese angelica, 10g of frankincense, 10g of myrrh, 10g of safflower and 10g of manchurian wildginger
Weighing the medicines according to the proportion, adding 2000mL of water, soaking for 30min, boiling with strong fire, and then decocting with slow fire for 15min to obtain the fumigation liquid medicine.
Example 2 preparation of a pharmaceutical composition of the invention
Prescription: 5g of notopterygium root, 5g of pubescent angelica root, 5g of dahurian angelica root, 5g of divaricate saposhnikovia root, 5g of common monkshood mother root, 13g of szechuan lovage rhizome, 5g of Chinese angelica, 5g of frankincense, 5g of myrrh, 5g of safflower and 5g of manchurian wildginger
Weighing the medicines according to the proportion, adding 2000mL of water, soaking for 30min, boiling with strong fire, and then decocting with slow fire for 15min to obtain the fumigation liquid medicine.
Example 3 preparation of a pharmaceutical composition of the invention
Prescription: 15g of notopterygium root, 15g of radix angelicae pubescentis, 15g of radix angelicae, 15g of divaricate saposhnikovia root, 10g of radix aconiti, 18g of ligusticum wallichii, 15g of angelica, 15g of frankincense, 15g of myrrh, 15g of safflower and 15g of asarum
Weighing the medicines according to the proportion, adding 2000mL of water, soaking for 30min, boiling with strong fire, and then decocting with slow fire for 15min to obtain the fumigation liquid medicine.
The beneficial effects of the present invention are demonstrated by the following experimental examples.
Experimental example 1 clinical treatment results of the composition of the present invention
1. Data and method
1.1 general data
35 patients with knee osteoarthritis were enrolled from 2 months to 2021 months in 2021. According to the regulations of medical institution management[2]All patients participating in the study gave informed consent to the treatment and signed an informed consent form. During the study, 1 patient stopped treatment due to business trip, and the number of actually completed cases was 34. The basic data of patients on sex, age, BMI, course of disease, etc. are shown in Table 1.
TABLE 1 patient gender, age, BMI, course of disease
Figure BDA0003390072350000031
1.2 diagnostic criteria
Refer to the guidelines for diagnosis and treatment of osteoarthritis, 2007 edition of the Association of orthopedics, the Chinese medical society.
1.3 inclusion criteria
(ii) those meeting the above diagnostic criteria. ② no related treatment medicine is adopted in about 1 week. Age 40-75 years old. Volunteer participation in the study and signing of the relevant informed consent.
1.4 exclusion criteria
Women in pregnancy or lactation. ② complications affecting joints such as psoriasis, gouty arthritis, etc. ③ the knee joint structure has been seriously deformed or malformed. Patients with serious internal diseases and mental diseases. Fifthly, for those allergic to the test operation, the treatment is not matched.
1.5 methods of treatment
The liquid medicine (rongguanqubi prescription) prepared in example 1 was poured into a fumigation therapy apparatus (manufactured by shengchang medical instruments ltd, of south of Henan, model number: SCZ-IA, production license number: yu Shi Yao Zhi machinery, production permit No. 20080023, fumigates the local part of knee joint, 30min each time, 1 time daily for 2 weeks.
1.6 Observation index
1.6.1 simplified McGill pain Scoring reference to simplified McGill pain Scale method[4]A visual analog scoring method is used.
1.6.2 clinical symptom scoring reference & lt guidance in clinical research of New Chinese medicine & gt[5]And (5) formulating. The degree of symptoms of the patients before and after treatment is observed and scored one by one (the integral symptom is shown in the attached table). Mild degree of<10 minutes; medium 10-18 points; severe degree>And 18 minutes.
1.6.3Lysholm Knee joint movement function score reference Lysholm Knee joint movement function score scale[6]。
1.7 therapeutic efficacy evaluation criteria
Refer to "Standard of curative Effect for diagnosis of TCM disease syndrome[7]The curative effect is divided into three stages of obvious effect, effective effect and ineffective effect. The method comprises the following specific steps:
the effect is shown: the symptoms of knee joint pain and swelling disappear, and the joint movement function returns to normal;
the method has the following advantages: the symptoms of knee joint pain and swelling are obviously relieved, pain occasionally occurs, and work and life are not affected;
and (4) invalidation: the symptoms of knee joint pain and swelling are not relieved or aggravated, the joint movement function is limited, and the work and the life are influenced.
1.8 safety
Adverse reactions during treatment were observed, and drug safety was judged.
1.9 statistical methods
Statistical analysis is carried out on the data by using SPSS20.0 statistical software, and the measured data are adopted according with the normal distribution
Figure BDA0003390072350000041
Non-fit to a normal distribution is described as represented by the median (quartile). And (3) adopting independent sample t test when the measured data meets the normality and the homogeneity of the variance, adopting rank sum test when the measured data does not meet the normality and the homogeneity of the variance, and adopting paired t test for the comparison before and after the measurement in a group. P<A difference of 0.05 is significant.
Integral watch of symptom of attached table
Figure BDA0003390072350000051
2. Results
2.1 clinical efficacy
The total effective rate of the rong muscle and arthralgia removing prescription for treating knee osteoarthritis by fumigation is 88.2 percent. See table 2.
TABLE 2 clinical curative effect record table
Figure BDA0003390072350000061
2.2 comparison of McGill pain scores before and after treatment
The McGill pain score was significantly reduced after treatment compared to before treatment, with statistical significance for the difference (P < 0.05). See table 3.
TABLE 3 McGill pain score comparison (score) before and after treatment
Figure BDA0003390072350000062
Note: compared with the treatment before the treatment,1)P<0.05。
2.3 comparison of clinical symptom scores before and after treatment
Clinical symptom scores were significantly lower after treatment compared to before treatment, and the differences were statistically significant (P < 0.05). See table 4.
TABLE 4 comparison of clinical symptom scores before and after treatment (score)
Figure BDA0003390072350000063
Note: compared with the treatment before the treatment,1)P<0.05。
2.4 Knee Joint movement function Scoring comparison before and after treatment
Compared with the pretreatment, the knee joint motor function score is increased after the treatment, and the difference has statistical significance (P < 0.05). See table 5.
TABLE 5 Knee joint movement function score comparison before and after treatment (score)
Figure BDA0003390072350000064
Note: compared with the treatment before the treatment,1)P<0.05。
2.5 adverse reactions
No adverse reaction cases such as rash, dermatitis and the like are found in the treatment process.
In conclusion, the invention provides a composition (rongguang and arthralgia removing formula) for expelling wind, removing cold, removing dampness, promoting blood circulation, removing blood stasis and relieving pain, which has proper compatibility and simple medicinal flavor, can treat knee osteoarthritis by external treatment through fumigation, has obvious advantages in relieving pain, improving clinical symptoms and recovering joint functions, and has the total effective rate of 88.2 percent; due to the characteristics of a non-invasive treatment mode, the traditional Chinese medicine composition is convenient to take, has small toxic and side effects, and has wide application prospect in the aspects of prevention and treatment and rehabilitation of knee osteoarthritis.
[1] Chenweiheng, a Chinese medical diagnosis and treatment guideline for knee osteoarthritis (2020 edition) [ J ] Chinese medical bonesetting, 2020,32(10) and 1-14.
[2] State Council of the people's republic of China, medical institutional administration regulation, No. 149: 1994.2.26.
[3] The bone science of the Chinese medical society, the guidelines for the diagnosis and treatment of osteoarthritis (2007 edition), the journal of Chinese orthopedics, 2007,27(10): 793-.
[4] Roxijia, simplified clinical application evaluation of McGill pain Scale Table [ J ] Chinese rehabilitation, 1992,7(4): 160-.
[5] Zhengxian cornus and Chinese medicine clinical research guiding principle [ M ]. Beijing, China pharmaceutical science and technology Press, 2002: 352-.
[6]Tegner Y,Lysholm J.Rating systems in the evaluation of knee ligament injuries.Clin Orthop Relat Res,1985,198:43-49.
[7] The national administration of traditional Chinese medicine, the standard of curative effect of diagnosis of traditional Chinese medicine symptoms [ M ]. Nanjing, Nanjing university Press, 1994: 51-52.

Claims (10)

1. A pharmaceutical composition for expelling wind, clearing away cold, removing dampness, promoting blood circulation, removing blood stasis and relieving pain is characterized by being prepared from the following raw material medicines in parts by weight:
5-15 parts of notopterygium root, 5-15 parts of radix angelicae pubescentis, 5-15 parts of radix angelicae, 5-15 parts of radix sileris, 5-10 parts of radix aconiti, 13-18 parts of ligusticum wallichii, 5-15 parts of angelica sinensis, 5-15 parts of frankincense, 5-15 parts of myrrh, 5-15 parts of safflower and 5-15 parts of asarum.
2. The pharmaceutical composition of claim 1, which is prepared from the following raw material medicines in parts by weight:
10 parts of notopterygium root, 10 parts of radix angelicae pubescentis, 10 parts of radix angelicae, 10 parts of radix sileris, 6 parts of radix aconiti, 15 parts of ligusticum wallichii, 10 parts of angelica sinensis, 10 parts of frankincense, 10 parts of myrrh, 10 parts of safflower and 10 parts of asarum.
3. The pharmaceutical composition of claim 1 or 2, which is a preparation prepared from crude drug powder of the raw materials, water and/or organic solvent extract as active ingredients, with or without pharmaceutically acceptable adjuvants.
4. The pharmaceutical composition of claim 3, wherein the formulation is an external formulation.
5. The pharmaceutical composition of claim 4, wherein the topical formulation is a fumigant.
6. The pharmaceutical composition of claim 5, wherein the external preparation is a solution, powder, tincture, spirit, lotion, oil, emulsion, ointment, plaster, cataplasm, film coating agent, pellicle, gel, liniment, aerosol, granule.
7. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 6, comprising the steps of:
(1) taking the raw materials in parts by weight;
(2) soaking the raw materials in water, and decocting to obtain decoction.
8. The preparation method according to claim 7, wherein the soaking time in the step (2) is 20 to 40min, and the decocting time is 10 to 20 min.
9. Use of the pharmaceutical composition according to any one of claims 1 to 6 in a medicament for the prevention and treatment of arthritis.
10. The use according to claim 9, wherein the medicament is a medicament for the prevention and treatment of knee osteoarthritis.
CN202111467384.4A 2021-12-02 2021-12-02 Rongjinqubi prescription and preparation method and application thereof Pending CN113952384A (en)

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