Preparation method of traditional Chinese medicine external prescription with bone fracture rehabilitation effect

Abstract

The invention discloses a preparation method of a traditional Chinese medicine external formula with a bone fracture rehabilitation effect. The preparation method comprises the following steps: step 1, preparing a traditional Chinese medicine extract; the preparation method comprises the following steps: 1, weighing the following raw material medicines in proportion: radix clematidis, cortex mori radicis, flos carthami, radix stephaniae tetrandrae, herba lycopodii, fructus liquidambaris, radix gentianae macrophyllae, radix saposhnikoviae, radix angelicae sinensis, radix angelicae dahuricae, fructus chaenomelis, vinegar-processed rhizoma corydalis, poria peel, processed frankincense and processed myrrh; 2, the raw material medicines are smashed and then mixed or the raw material medicines are mixed and then smashed, and a mixture is obtained.On the basis of the PCT concept, in-vitro shock wave treatment and an external formula are applied to treatment of a patient suffering from plantar fasciitis, compared with single in-vitro shock wave treatment, the inflammatory factor level can be better reduced through combination of the in-vitro shock wave treatment and the external formula, and the curative effect is better. Meanwhile, the production method of the external use formula disclosed by the invention is few in steps and simple to operate.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and relates to a preparation method of a traditional Chinese medicine external use formula with bone fracture rehabilitation effect. BACKGROUND

[0002] Plantar fasciitis (PF) is a syndrome mainly characterized by chronic pain in the heel caused by chronic degenerative changes and biomechanical changes of the proximal plantar fascia. Conservative treatment is the main way to treat the disease clinically. Extracorporeal shock wave therapy (ESWT) is widely used in the treatment of the disease due to its simple operation, non-invasiveness, significant analgesic effect, and small side effects. However, the use of ESWT alone to treat pain in patients is relatively slow, which affects treatment compliance and is not conducive to recovery. In order to accelerate the improvement of pain in patients, a traditional Chinese medicine formula is usually externally applied, but the preparation process of the conventional traditional Chinese medicine formula is complicated. SUMMARY

[0003] The application provides a preparation method of a traditional Chinese medicine external use formula with bone fracture rehabilitation effect.

[0004] In order to achieve the above-mentioned purpose, the following technical scheme is adopted in the application: a preparation method of a traditional Chinese medicine external use formula with bone fracture rehabilitation effect, comprising the following steps:

[0005] Step 1: preparation of traditional Chinese medicine extract

[0006] 1. The raw medicinal materials are weighed according to the proportion: Weilingxian, Sangbaipi, Honghua, Fangji, Shentongcao, Lulutong, Qin'e, Fangfeng, Danggui, Baizhi, Mugua, Yichuanhusuo, Fulingpi, Zhiluoxiang, Zhimeiyangcao;

[0007] 2. The raw medicinal materials are mixed after being ground or ground after being mixed to obtain a mixture;

[0008] 3. Distilled water is added to the mixture to prepare a suspension, and the suspension is uniformly nano-ground in a liquid grinder to prepare a traditional Chinese medicine emulsion;

[0009] 4. The traditional Chinese medicine emulsion is filtered, and the filtrate is concentrated to obtain a traditional Chinese medicine extract containing effective components of each traditional Chinese medicine component;

[0010] Step 2: preparation of the traditional Chinese medicine external use formula

[0011] The traditional Chinese medicine extract is added with a pharmaceutically acceptable excipient to prepare the traditional Chinese medicine external use formula.

[0012] Further, the traditional Chinese medicine external use formula is in the form of an external preparation.

[0013] Further, the traditional Chinese medicine external use formula is prepared from raw medicinal materials in the following proportions by weight:

[0014] Clematis chinensis 8-12g, Morus alba root bark 8-12g, Carthamus tinctorius 8-12g, Stephania tetrandra 8-12g, Lycopodium clavatum 8-12g, Liquidambar formosana 8-12g, Gentiana macrophylla 8-12g, Saposhnikovia divaricata 10g, Angelica sinensis 13-17g, Angelica dahurica 13-17g, Chaenomeles speciosa 13-17g, Corydalis yanhusuo (processed) 13-17g, Poria cocos peel 13-17g, Prepared frankincense 4-8g, Prepared myrrh 4-8g.

[0015] Furthermore, the ingredients are: Clematis chinensis 10g, Morus alba root bark 10g, Carthamus tinctorius 10g, Stephania tetrandra 10g, Lycopodium clavatum 10g, Liquidambar formosana 10g, Gentiana macrophylla 10g, Saposhnikovia divaricata 10g, Angelica sinensis 15g, Angelica dahurica 15g, Chaenomeles speciosa 15g, Corydalis yanhusuo (processed with vinegar) 15g, Poria cocos peel 15g, processed frankincense 6g, and processed myrrh 6g.

[0016] In summary, the advantages of this invention are:

[0017] Based on the PCT concept, this invention combines extracorporeal shock wave therapy and a topical formula in the treatment of plantar fasciitis. Compared with using extracorporeal shock wave therapy alone, the combination of the two can better reduce the level of inflammatory factors, alleviate pain, and accelerate the disappearance of symptoms and signs. At the same time, the production method of the topical formula of this invention has fewer steps and is simple to operate. Detailed Implementation

[0018] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0019] Due to installation errors and other reasons, the parallel relationship referred to in the embodiments of the present invention may actually be an approximate parallel relationship, and the perpendicular relationship may actually be an approximate perpendicular relationship.

[0020] Example 1:

[0021] A method for preparing a traditional Chinese medicine external application formula with bone injury rehabilitation effects includes the following steps:

[0022] Step 1: Preparation of Chinese herbal extracts;

[0023] 1. Weigh the raw materials according to the following proportions: Clematis chinensis, Morus alba root bark, Carthamus tinctorius, Stephania tetrandra, Lycopodium clavatum, Liquidambar formosana, Gentiana macrophylla, Saposhnikovia divaricata, Angelica sinensis, Angelica dahurica, Chaenomeles speciosa, vinegar-processed Corydalis yanhusuo, Poria cocos peel, processed frankincense, and processed myrrh;

[0024] 2, the raw materials are mixed after being crushed or the raw materials are crushed after being mixed, to obtain a mixture;

[0025] 3, a proper amount of distilled water is added to the mixture to form a suspension, and the mixture is uniformly nano-ground in a liquid grinder to obtain a traditional Chinese medicine emulsion;

[0026] The traditional Chinese medicine emulsion is filtered, and the filtrate is concentrated to obtain a traditional Chinese medicine extract containing effective components of each traditional Chinese medicine component;

[0027] Step two, preparation of a traditional Chinese medicine external use formula;

[0028] The traditional Chinese medicine extract is added with a pharmaceutically acceptable excipient to form a traditional Chinese medicine external use formula;

[0029] The traditional Chinese medicine external use formula is in the form of external use.

[0030] The traditional Chinese medicine external use formula is prepared from the following raw materials by weight:

[0031] Wei Lingxian 10g, Sangbaipi 10g, Honghua 10g, Fangji 10g, Shenzhengjuncao 10g, Lulutong 10g, Qinvae 10g, Fangfeng 10g, Danggui 15g, Baizhi 15g, Mugua 15g, Yechuanhusuo 15g, Fulingpi 15g, Zhiluoxiang 6g, Zhimie 6g.

[0032] When the traditional Chinese medicine external use formula is used, 100mL of concentrated decoction is diluted in 1500ml of hot water, and the medicine is applied to the bone pain site through fumigation and washing.

[0033] The present inventor has found that the plantar fascia tissue and its insertion are repeatedly subjected to overload traction, which causes the fibers of the fascia to continuously tear, inducing inflammation of the plantar fascia, and secondly, the abnormal structure or biomechanics of the arch of the foot causes repeated micro-injuries to the insertion of the plantar fascia to the calcaneus, leading to sterile inflammation, thus it can be seen that inflammation is the main cause of the disease and the main cause of pain in patients.

[0034] The Chinese medicine external use formula of the present application has the effects of activating blood and resolving stasis, dispelling wind and dampness, and tonifying liver and kidney. In addition, the fumigation and washing method can make the medicine directly act on the pain site, so that the medicine can better penetrate into the skin and better play the role of the medicine, thereby achieving the purposes of relieving pain, playing an anti-inflammatory role, and improving clinical symptoms.

[0035] The clinical efficacy test of the present application is introduced in detail as follows:

[0036] I. Clinical efficacy experiment

[0037] 1. Data and methods

[0038] 1.1 Case source

[0039] 50 patients with plantar fasciitis treated in the Third People's Hospital of Hangzhou City from April 2022 to April 2024 were selected as the observation objects.

[0040] The present study has obtained the audit approval of the Ethics Committee of the Third People's Hospital of Hangzhou City.

[0041] 1.2 Case selection

[0042] 1.2.1 Inclusion criteria

[0043] ① Meet the diagnostic criteria for plantar fasciitis;

[0044] ② Age 18-60 years old;

[0045] ③ Course of disease 13-36 months;

[0046] ④ Single foot onset;

[0047] ⑤ Written informed consent of the patient and family members was obtained.

[0048] 1.2.2 Exclusion criteria

[0049] ① Patients with damaged skin on the foot;

[0050] ② With limb dysfunction;

[0051] ③ Poor treatment compliance;

[0052] ④ Accompanied by important organ organic lesions;

[0053] ⑤ Foot structure abnormalities;

[0054] ⑥ Poor compliance.

[0055] Diagnosis criteria of plantar fasciitis:

[0056] Refer to the diagnosis criteria of American Physical Therapy Association Orthopedic Branch. International Classification of Functioning, Disability and Health: Clinical Practice Guidelines for Heel Pain / Plantar Fasciitis: 2014 Revision [J]. Journal of Rehabilitation, 2019, 29(1): 2-20.

[0057] 1.3 Case grouping

[0058] All the included observation objects were divided into two groups according to random number table method, 25 cases in the control group, 15 cases of male and 10 cases of female; age 18-60 years old, average (45.67±10.27) years old; BMI 19-27 kg / m 2 , average (24.67±2.11) kg / m 2 ; course of disease 1-3 years, average course of disease (1.98±0.54) years. 25 cases in the observation group, 18 cases of male and 7 cases of female; age 18-60 years old, average (45.85±10.70) years old; BMI 19-28 kg / m 2 , average (24.78±2.02) kg / m 2 ; course of disease 1-3 years, average course of disease (1.97±0.58) years. There was no significant difference in baseline data between the two groups (P>0.05), which was comparable.

[0059] 1.4 Treatment plan

[0060] 1.4.1 Basic treatment plan:

[0061] The patients in the control group and the observation group were treated with cognitive rehabilitation diagnosis and treatment system according to the doctor's advice.

[0062] 1.4.2 Treatment plan of control group

[0063] The control group was treated with extracorporeal shock wave therapy: MP200ESWT pain therapy instrument produced by Storz Company of Switzerland was used for treatment. The pain site was marked under non-narcotic state, the coupling agent was applied to the marked position, and the shock treatment head was fixed. The shock wave parameters were set as follows: pressure 100-200 kPa, frequency 10 Hz, shock amount 1500 times, energy density 0.18-0.28 mJ / mm 2 , 3 times a week, for 12 weeks.

[0064] 1.4.3 Treatment plan of observation group

[0065] On the basis of the control group treatment, the traditional Chinese medicine external use method of traditional Chinese medicine external use method in this embodiment was used for fumigation and washing treatment.

[0066] Traditional Chinese medicine external use method composition: Wilingxian, mulberry bark, safflower, radix stephaniae tetrandrae, Strehnjincao, luyetong, gentiana, fangfeng each 10g, angelica, white peony root, papaya, vinegar corydalis, fuling skin each 15g, prepared frankincense, prepared myrrh each 6g;

[0067] Each time choose traditional Chinese medicine external use method 100ml, mix traditional Chinese medicine external use method into 1500ml hot water, ask the patient to fumigate and wash, 5 times a week, continuous treatment for 12 weeks.

[0068] 1.5 Observation index and evaluation standard

[0069] 1.5.1 Efficacy determination standard,

[0070] After 12 weeks of treatment, according to the efficacy determination standard in Wang Zhengyi. Chinese orthopedics · foot and ankle surgery volume [M]. Beijing: People's Medical Publishing House, 2010, according to the improvement degree of symptoms and signs before and after treatment, the clinical efficacy is divided into cure, marked effect, improvement, invalid, as follows:

[0071] Cure: foot pain completely disappeared.

[0072] Marked effect: pain symptoms were significantly relieved.

[0073] Improvement: pain slightly relieved.

[0074] Invalid: no improvement in pain symptoms.

[0075] 1.5.2 Inflammatory factors

[0076] Before treatment and after 12 weeks of treatment, 3ml of fasting venous blood was taken, and ELISA method was used to detect IL-6, TNF-α and CRP.

[0077] 1.5.3 Pain degree

[0078] Before treatment, after 4 weeks of treatment, after 8 weeks of treatment and after 12 weeks of treatment, the visual analogue scale (VAS) was used to evaluate the pain of the patient's standing foot. The total score of the scale is 10 points, and the score is proportional to the degree of pain.

[0079] 1.6 Statistical processing

[0080] SPSS 26.0 was used for statistical analysis, measurement data was expressed as (±s), t test was used; count data was expressed as n (%), χ 2 test was used. P<0.05 indicates that the difference is significant.

[0081] n (%) is a percentage value.

[0082] 2 Treatment results

[0083] 2.1 Comparison of treatment results

[0084] The treatment effects of the control group and the observation group were compared after 12 weeks of treatment, and the results are shown in Table 1. According to Table 1, the total effective rate of the observation group was 92.00%, and the total effective rate of the control group was 68.00% (P < 0.05). The total effective rate of the observation group was significantly higher than that of the control group.

[0085] Table 1 Comparison of treatment effects of the control group and the observation group [n (%)]

[0086]

[0087]

[0088] The χ2 value and P value were calculated by the conventional method, which is not described here.

[0089] 2.2 Comparison of inflammatory factor levels in the control group and the observation group

[0090] After 12 weeks of treatment, the expression levels of IL-6, TNF-α, and CRP in the control group and the observation group were shown in Table 2. According to Table 2, the expression levels of IL-6, TNF-α, and CRP in the control group and the observation group were decreased compared with those before treatment, indicating that the control group and the observation group could effectively reduce inflammatory factors. According to the numerical comparison of the two groups, the observation group was lower than the control group (P < 0.05), indicating that the treatment effect of the observation group was better than that of the control group.

[0091] Table 2 Comparison of inflammatory factor levels in the control group and the observation group before and after treatment

[0092]

[0093] Note: * P < 0.05 compared with the same group before treatment

[0094] The mean value.

[0095] 2.3 Comparison of pain degrees in the control group and the observation group

[0096] As shown in Table 3, after 4, 8, and 12 weeks of treatment, the VAS scores of the control group and the observation group were decreased compared with those before treatment, indicating that the control group and the observation group could effectively improve the bone injury pain symptoms of patients. According to the numerical comparison of the two groups, the observation group was lower than the control group (P < 0.05), indicating that the treatment effect of the observation group was better than that of the control group, as shown in Table 3.

[0097] Table 3 Comparison of pain degree between control group and observation group Divided

[0098]

[0099] Note: * P<0.05 compared with the same group before treatment

[0100] 3. Result analysis

[0101] 3.1 Total effective rate

[0102] In this experiment, the total effective rate of the control group was 68%, and the total effective rate of the observation group was 92%. The curative effect of the observation group was significantly better than that of the control group (P<0.05). The VAS scores of the observation group at different time nodes were lower than those of the control group (P<0.05), which indicated that the curative effect of extracorporeal shock wave treatment combined with external use of the prescription for treating PE patients was better than that of single extracorporeal shock wave treatment.

[0103] The inventor analyzed the reasons:

[0104] Firstly, ESWT focuses high-amplitude sound waves on the corresponding treatment site, and the pain site is positioned by moving the probe. In this process, the shock wave generated by the probe can stimulate the axon and affect the pain-related factors, and then locally anesthetize the pain fiber without myelin sheath, so as to achieve the effect of relieving pain. In addition, the high-amplitude sound waves generated by the probe can change the chemical environment around the receptors of the treatment site, inhibit the release of pain chemicals, and change the mechanical transduction pathway through mechanical vibration, activate cell metabolism and tissue regeneration ability, and reduce the release of pain factors, so as to achieve the purpose of relieving pain. The Weilingxian in the external use prescription has the effects of expelling wind and dampness, and dredging meridians; Sangbaipi has the effect of promoting water and reducing swelling; Honghua has the effects of promoting blood circulation and unblocking channels, and removing blood stasis and relieving pain; Fangji, Shentongcao, Lulutong, and Fulingpi have the effects of expelling wind and relieving pain, relaxing muscles and tendons, promoting water and reducing swelling; Qinjiao has the effects of expelling wind and dampness, clearing damp-heat, relieving pain, and reducing virtual heat; Fangfeng and Mugua have the effects of expelling wind and relieving superficies, and relieving convulsion and pain; Danggui and vinegar Dihuosu have the effects of tonifying blood and invigorating blood, regulating menstruation and relieving pain; Baizhi has the effects of relieving superficies and dispelling cold, expelling wind and relieving pain; Ruxiang and Ruangong have the effects of invigorating blood and unblocking channels, relieving pain, reducing swelling, and promoting tissue regeneration. The above-mentioned prescriptions have the effects of invigorating blood and removing blood stasis, expelling wind and removing dampness, and tonifying liver and kidney. In addition, the fumigation and washing method can make the drugs directly act on the pain site, so that the drugs can better penetrate into the skin and better play the role of the drugs, and then achieve the purpose of relieving pain and improving clinical symptoms.

[0105] The results of the present study showed that the expression levels of IL-6, TNF-α and CRP in the observation group were lower than those in the control group after 12 weeks of treatment (P<0.05), indicating that the combination of the two treatment methods can reduce the body's inflammatory level. The reason is that ESWT can gradually soften the inflammatory tissue of the body by high-frequency amplitude micro-massage impact on hard tissue, reduce the pressure of inflammatory tissue, relieve the condition of tissue congestion, improve microcirculation and accelerate the removal of metabolic products, so as to achieve the purpose of reducing the level of inflammatory factors in the body. The main components of safflower in the external use formula are safflower ketone and safflower alcohol, which have anti-inflammatory effect and can reduce inflammatory reaction and relieve discomfort caused by inflammation; the main component of mulberry bark in the external use formula is flavonoids, which can not only inhibit the activity of COX-2 enzyme, but also inhibit the activity of NF-kB and IKBα, inhibit the production of NO and the expression of iNOS, down-regulate the synthesis of pro-inflammatory factors, and up-regulate the synthesis of anti-inflammatory factors, thereby fully exerting the anti-inflammatory effect; the main active components of Wulingteng are pentacyclic triterpenoid saponins and alkaloids, which have certain anti-inflammatory analgesic and immune regulating effects. And other antipyretic and analgesic drugs in the formula can also play an anti-inflammatory role. At the same time, the above formula can fully exert the effect of the drug through fumigation and washing, thereby playing an anti-inflammatory role.

[0106] In summary, based on the PCT concept, the extracorporeal shock wave therapy and the external use formula are used for the treatment of plantar fasciitis patients. Compared with the single use of extracorporeal shock wave therapy, the combination of the two can better reduce the level of inflammatory factors, relieve pain and accelerate the disappearance of symptoms and signs.

[0107] Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should belong to the scope of protection of the present application.

Claims

1. A preparation method of a traditional Chinese medicine external use formula with bone injury rehabilitation effect, characterized in that: The method comprises the following steps: ​ Step one, preparation of traditional Chinese medicine extract; Step 1, weigh the raw medicinal materials according to the proportion: Wulingxian, Sangbaipi, Honghua, Fangji, Shenjincao, Lulutong, Qinjie, Fangfeng, Danggui, Baizhi, Mugua, Yechuansu, Fulingpi, Shiluoxiang, Shihongya; Step 2, mix or grind the raw medicinal materials after mixing to obtain a mixture; Step 3, add an appropriate amount of distilled water to the mixture to prepare a suspension, and uniformly nanoize and grind the suspension in a liquid grinder to obtain a traditional Chinese medicine emulsion; Step 4, filter the traditional Chinese medicine emulsion, and concentrate the filtrate to obtain a traditional Chinese medicine extract containing effective components of each traditional Chinese medicine component; Step two, preparation of a traditional Chinese medicine external use formula; Add pharmaceutically acceptable adjuvants to the traditional Chinese medicine extract to prepare a traditional Chinese medicine external use formula.

2. The preparation method of the external use of traditional Chinese medicine with bone injury rehabilitation effect according to claim 1, characterized in that: The traditional Chinese medicine external use formula is in the form of an external use preparation.

3. The preparation method of the external use of traditional Chinese medicine with bone injury rehabilitation effect according to claim 2, characterized in that: The traditional Chinese medicine external use formula is prepared from the following raw medicinal materials by weight: Wulingxian 8-12g, Sangbaipi 8-12g, Honghua 8-12g, Fangji 8-12g, Shenjincao 8-12g, Lulutong 8-12g, Qinjie 8-12g, Fangfeng 10g, Danggui 13-17g, Baizhi 13-17g, Mugua 13-17g, Yechuansu 13-17g, Fulingpi 13-17g, Shiluoxiang 4-8g, Shihongya 4-8g.

4. The preparation method of the external use of traditional Chinese medicine with bone injury rehabilitation effect according to claim 3, characterized in that: Wulingxian 10g, Sangbaipi 10g, Honghua 10g, Fangji 10g, Shenjincao 10g, Lulutong 10g, Qinjie 10g, Fangfeng 10g, Danggui 15g, Baizhi 15g, Mugua 15g, Yechuansu 15g, Fulingpi 15g, Shiluoxiang 6g, Shihongya 6g.

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