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Objective:To evaluate the clinical efficacy of warm acupuncture combined with external application of Tibetan medicine Baimai Ointment in the treatment of low-back pain with cold-dampness type.Methods:Randomized controlled trial. Totally 60 outpatients in Tibetan Medicine Hospital of Cuona County from May to July of 2021 were selected as the observation objects, and they were divided into two groups by random number table method, with 30 cases in each group. The control group was treated with Baimai Ointment, and the treatment group was treated with warm acupuncture and Baimai Ointment. Both groups were treated for 2 weeks and followed up for 3 months. VAS scale and Oswestry disability index (ODI) were used to evaluate the low-back pain and dysfunction, and the clinical efficacy was evaluated.Results:The VAS scores of the treatment group were lower than those in the control group immediately after treatment and at the last follow-up ( t=-18.17, -6.05, P<0.01). The ODI score of the treatment group was lower than that of the control group at the last follow-up ( t=-15.86, P<0.01). The total effective rate was 96.7% (29/30) in the treatment group and 93.3% (28/30) in the control group, without statistical significance ( χ2=0.001, P=1.000). Conclusion:Warm acupuncture combined with Tibetan medicine Baimai Ointment can effectively improve the clinical symptoms of low-back pain with cold-dampness type, improve the quality of life of patients, and the clinical effect is satisfactory.
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Baimai is a complex of structure and function with the characteristics of wide distribution, complex structure, and multi-dimensional functions. Baimai, consisting of the channels in brain, the internal hidden channels connecting the viscera, and the external channels linking the limbs, governs the sensory, motor, and information transmission functions of human. According to Tibetan medicine, Baimai functions via "Long"(Qi) which moves in Baimai. "Long" is rough, light, cold, tiny, hard, and dynamic. The dysfunction of Baimai is manifested as numbness, swelling and pain, stiffness, atrophy, contracture, disability, hyperactivity, etc. The clinical manifestations of Baimai disease are facial paralysis, limb numbness, hemiplegia, contracture and rigidity, pain, opistho-tonos, paralysis, unconsciousness, head tremor, aphasia and tongue stiffness, and other abnormalities in facial consciousness, limb movement, and tactile sensation. Baimai Ointment for external use is used for the treatment of Baimai disease. It is mainly composed of medicinals which are spicy and bitter, warm, soft, mild, heavy, moist, and stable, and thus it is effective for the rough, light, cold, tiny, hard, and dynamic "Long" of Baimai disease. In clinical practice, it is mainly used for musculoskeletal diseases, such as osteoarthritis, scapulohumeral periarthritis, cervical spondylosis, low back pain, myofascitis, and tenosynovitis, nervous system diseases, such as paralysis and shoulder-hand syndrome, and limb stiffness caused by stroke, spastic cerebral palsy, trigeminal neuralgia, and facial neuritis, and limb motor and sensory dysfunction caused by trauma. According to the main symptoms of Baimai disease such as stiffness, rigidity, contraction, numbness, sensory disturbance and pain, clinicians should apply the Baimai Ointment via the inunction treatment of Tibetan medicine and in combination with Huo'ermai therapy and physiotherapy.
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Humans , Drugs, Chinese Herbal , Edema , Medicine, Tibetan Traditional , PainABSTRACT
Objective:To explore the mechanism and compatibility characteristics of Baimai ointment （BMO） in the treatment of white vein disease from the network perspective based on system theory， so as to provide biological basis for its clinical application. Method:The chemical components and the corresponding candidate target spectra of BMO were obtained from The Encyclopedia of Traditional Chinese Medicine （ETCM） and Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine （TCMIP）. According to the clinicopathological characteristics of white vein disease， focusing on four diseases/symptoms including neuropathic pain， inflammatory pain， chronic pain and lumbar disc herniation root neuralgia， the gene sets related to white vein disease were collected in Human Phenotype Ontology （HPO）， DisGeNET and other databases， then the interaction network of the targets of active components in BMO-gene sets related to white vein disease was constructed. On this basis， the hub network nodes were selected and enriched for exploring the mechanism of four functional groups of BMO in the treatment of white vein disease such as Huoxue Tongluo group （Curcumae Longae Rhizoma， Moschus， Tronae）， Xingqi Zhitong group （Myristicae Semen， Nardostachyos Radix et Rhizoma， Acori Calami Rhizoma）， Wenjing Sanhan Tongluo group （Zingiberis Rhizoma， Zanthoxyli Pericarpium， Caraway） and Jianpi Wenshen Qianggu group （Actinolite， Glycyrrhizae Radix et Rhizoma）. Result:The enriched pathways of the four functional groups in BMO were mainly distributed in three modules of nervous system function， inflammation-immune system regulation and body energy metabolism， and each module was connected by common target genes especially had its own focus. Among them， the regulation of nervous system function in Huoxue Tongluo group and Xingqi Zhitong group could be summarized as Huoxue Buqi and Xingshen Kaiqiao. Xingqi Zhitong group and Jianpi Wenshen Qianggu group were mainly used to promote the operation of Qi， promote blood metaplasia， enhance immunity and maintain the regulation of inflammation-immune system. Jianpi Wenshen Qianggu group and Wenjing Sanhan Tongluo group mainly regulated body energy metabolism by invigorating the spleen and supplementing Qi as well as warm-heat medicine. The whole formula focused on the multi-dimensional and multi-level mechanism of BMO in the intervention of white vein disease. Each functional group emphasized its respective characteristics in nervous system function， inflammation-immune regulation， and body energy metabolism. Two types of networks analysis models complemented and verified each other. Conclusion:BMO plays a role in the treatment of white vein disease mainly by regulating the function of nervous system， maintaining the balance of inflammation-immune system and interfering with energy metabolism. The relevant research results can provide reference for the in-depth exploration of the mechanism of BMO， and help to guide the clinical rational use of this preparation.
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Objective: To establish a fingerprint method of Baimai Ointment (BO) and determine the content of its main components. The BO of 14 batches from two production areas was scientifically and comprehensively evaluated based on multivariate statistical analysis, which provided the basis for the quality control. Methods: HPLC method was used to determine the content of liquiritin, ammonium glycyrrhizinate, nardosinone and curcumin in BO, and the fingerprint of BO was established. The fingerprint similarity analysis, cluster analysis, principal component analysis (PCA) and factor analysis were performed to comprehensively evaluate the different batches of BO in two producing areas. Results: The methodological determination of liquiritin, ammonium glycyrrhizinate, nardosinone and curcumin met the requirements, and the content was 0.051-0.200 mg/g, 0.136-0.622 mg/g, 0.030-0.345 mg/g, 0.001-0.069 mg/g, respectively. The established fingerprints of BO were calibrated with 17 common peaks. Three chromatographic peaks of liquiritin, ammonium glycyrrhizinate and nardosinone were identified by reference. The similarity of 14 batches of sample was greater than 0.975. In the cluster analysis, 14 batches of BO from two producing areas can be divided into four categories, among which batches S1-S11 produced by Linzhi City of Tibet were grouped into one category. And S12 produced in Lanzhou City of Gansu Province was clustered into one class, and S13 was clustered into one class, S14 was grouped into one class. The results of PCA and factor analysis showed that the comprehensive scores of the three batches of S12-S14 produced in Lanzhou City of Gansu Province were higher than the 11 batches of S1-S11 produced by Linzhi City of Tibet, presumably because of the changes in production conditions or sources of medicinal materials. The result was consistent with cluster analysis. Conclusion: This study is the first to establish a scientific and reliable quality control method of Tibetan medicine BO based on multi-component determination, fingerprint and multivariate statistical analysis. It can be used not only for the quality control of Baimai Ointment, but also for the comprehensive evaluation of batch quality consistency. It provides reference for the improvement of the quality standard of BO and the quality evaluation among Chinese medicine batches.
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To establish a determination method for the contents of ammonium glycyrrhetate,nardosinone,and curcumin in transdermal receptor liquid of Baimai Ointment,and investigate the percutaneous permeability of Baimai Ointment and the effects of two kinds of penetration enhancers on percutaneous absorption of three components. The contents of ammonium glycyrrhetate,nardosinone,and curcumin in transdermal receptor liquid were determined by high pressure liquid chromatography( HPLC). The vertical modified Franz diffusion cell was used to perform a transdermal experiment in vitro with the abdominal skin of mice( treated and untreated). The transdermal receptor liquid was preferably used to investigate the transdermal absorption rule of the Baimai Ointment and the effect of the penetration enhancer. The results showed that the comprehensive solubility of PEG-ET-NS( 3 ∶3 ∶4) was best among three types of receptor liquid PG-ET-NS( 3 ∶3 ∶4),PEG-ET-NS( 3 ∶3 ∶4),ET-NS( 3 ∶7). PEG-ET-NS was used as the receptor liquid for in vitro transdermal experiments. The cumulative permeation area of ammonium glycyrrhetate,nardosinone and curcumin within 24 h was 5. 73,18. 99,0. 38 μg·cm~(-2)respectively. Taking QEFand ER as comprehensive evaluation indicators of permeation performance,the comprehensive penetration-promoting performance of ammonium glycyrrhizinate: 3% PEG 400-ethanol-normal saline ≈ 1. 19 times( 3%azone) = 1. 94 times( blank); comprehensive penetration-promoting performance of nardosinone: 3% PEG 400-ethanol-normal saline≈1. 28 times( 3% azone) = 1. 37 times( blank); the comprehensive penetration performance of curcumin: 3% PEG 400-ethanol-normal saline≈1. 77 times( 3% azone) ≈3. 42 times( blank). The comprehensive penetration enhancement properties of the two penetration enhancers were as follows: 3% PEG 400-ethanol-normal saline>3%azone>blank. The transdermal absorption curve of ammonium glycyrrhetate,nardosinone and curcumin in Baimai Ointment were consistent with the zero-order equation,indicating that the transdermal absorption process was irrelevant to the concentration of three components,and its was a diffusion process. This experiment provides reference for the study of ointment transdermal preparations.
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Animals , Mice , Administration, Cutaneous , Ointments , Pharmacokinetics , Permeability , Skin , Skin AbsorptionABSTRACT
Objective To observe the preventive and therapeutic effect of Baimai Ointment on stoke,and explore the principle of promoting blood circulation and removing blood stasis.Method By dermal administration,the crude drug contents of Baimai Ointment given to rats were 0.075,0.150,and 0.300 g/kg respectively.Focal cerebral ischemic model was induced by the middle cerebral artery occlusion (MCAO),and the preventive and therapeutic effect of Baimai Ointment was evaluated.The degree of hematoma absorption in rats was measured to observe the effect on promoting blood circulation and removing blood stasis of Baimai Ointmnent.The acute blood stasis model and carotid thrombosis model were established in rats to study the effects on blood viscosity and thrombosis time.Results Baimai Ointment had no significant prevent effect on stroke in rats.It effectively improved behavior coordination in stroke model rats.It also significantly decreased the area of hematoma on rats,speeded up the repairment of local demage.After administration of Baimai Ointment,blood viscosity of blood stasis model rats was obviously decreased,while thrombosis time was effectively prolonged on carotid thrombosis model.Conclusion Baimai Ointment can significantly improve the behavior coordination in stroke model rats,plays a significant role in treatment,but no significant preventive effect,a preliminary study shows that the possible therapeutic principles may be promoting blood circulation and removing blood stasis.
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OBJECTIVE:To study the protective effects of Baimai ointment on sciatic nerve injury in rabbit. METHODS:The rabbit sciatic nerve injury model was induced by forceps operation. 180 rabbits were randomly divided into 6 groups,with 30 rab-bits in each group (10 rabbits of 7,14,28 d),including sham operation group (blank matrix of Baimai ointment for external use),model group(same as sham operation group),positive group [ig Mecobalamine tablet solution 1.25×10-4 g/(kg·d)] and Bai-mai low-dose,medium-dose and high-dose groups [Baimai ointment 0.33,0.67 and 1.34 g/(kg·d)for external use],once a day, for consecutive 7,14 and 28 d. Gait instrument was used to test the foot-touch-land force of rabbit;pathology examination was conducted for sciatic nerve resection;immunohistochemistry was used to detect the levels of NOS and NMDA in nerve tissue. RE-SULTS:Baimai ointment can significantly relieve sciatic nerve injury,edema and inflammatory reaction;7,14 and 28 d after med-ication,compared with model group,foot-touch-land force decreased significantly in rabbits with sciatic nerve injury (P<0.01);14,28 d after medication,foot-touch-land force of rabbits increased significantly in positive group,Baimai ointment groups,while the levels of NOS and NMDA decreased in nervous tissue(P<0.05). CONCLUSIONS:Baimai ointment can protect sciatic nerve with function injury in rabbits.
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Objective To compare the effects of Baimai ointment and baclofen in stroke patients with spas-ticity.Methods 84 cases accompanied by limb spasticity in stroke patients by digital table were randomly divided into Baimai ointment group and baclofen group,42 cases in each group.The Baimai ointment group were treated with Baimai ointment on the spastic limbs,the baclofen group received oral baclofen tablets 30 -75mg/days for 2 weeks, 4 weeks,8 weeks.The curative effects of the two groups were compared before and after treatment.Results Before and after treatment in the two groups,the levels of spasticity,pain and activities of daily living (ADL)differences were statistically significant and Baimai ointment in the treatment of spasm.After 4 weeks and 8 weeks,the Ashworth score of the Baimai ointment group were (1.59 ±0.46)points,(0.89 ±0.56)points,and those of baclofen group were (1.75 ±0.64)points,(1.45 ±0.48)points,the differences were statistically significant(t values were 2.916, 3.367,all P <0.05).After 2 weeks,4 weeks and 8 weeks,the VAS score of the Baimai ointment group were (2.72 ± 0.54)points,(2.02 ±0.24)points,(1.24 ±0.12)points,and baclofen group were (3.56 ±0.44)points,(3.15 ± 0.48)points,(2.58 ±0.26)points,the differences were statistically significant(t values were 2.975,3.359,5.416, all P <0.05),activities of daily living (ADL)was higher than that of the baclofen group.After 8 weeks,the MBI score of the Baimai ointment group was (64.46 ±10.78)points,and baclofen group was (50.74 ±9.18)points,the difference was statistically significant between the two groups (t values was 3.562,P <0.05).Conclusion Baimai ointment has the better antispasmodic effect than baclofen in patients with stroke.