Traditional Chinese medicine composition for treating prosopalgia and preparation method and quality control method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating prosopalgia as well as a preparation method and a quality control method thereof, and belongs to the technical field of traditional Chinese medicines. On one hand, the invention provides a traditional Chinese medicine composition for treating prosopalgia; secondly, the invention provides a preparation method of the traditional Chinese medicine composition for treating trigeminal neuralgia. Thirdly, the invention further provides application of the traditional Chinese medicine composition in preparation of drugs for treating prosopalgia. Fourthly, the invention further provides a fingerprint spectrum construction method of the traditional Chinese medicine composition for treating trigeminal neuralgia. In the fifth aspect, the invention also provides application of the fingerprint spectrum in detection and quality control of drugs for treating trigeminal neuralgia.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular, to a traditional Chinese medicine composition for treating trigeminal neuralgia, a preparation method thereof, and a quality control method thereof. Background Art

[0002] Trigeminal neuralgia is divided into two types: primary and secondary. Primary trigeminal neuralgia (PTN), also known as idiopathic trigeminal neuralgia, is a paroxysmal severe pain in the distribution area of the trigeminal nerve in the head, face, and oral cavity. Secondary trigeminal neuralgia is one of the symptoms accompanying other diseases. Here, we mainly study primary trigeminal neuralgia.

[0003] According to domestic and foreign literature reports, the incidence rate of PTN is about 47.8 / 100,000 to 182 / 100,000 people; it is more common in middle-aged and elderly people, 70% - 80% occurs in adults over 40 years old, the peak age is 48 - 69 years old, and females are in the majority. This disease is intractable, recurrent, and difficult to completely cure, which not only has an adverse impact on the physiological functions, physical and mental health, and quality of life of patients, but also causes a relatively large economic burden on families and society. At present, the PTN diagnosis and treatment plans and consensus available for clinical reference are mostly Western medicine drugs and surgical plans, without involving the methods of traditional Chinese medicine syndrome differentiation and treatment and good diagnosis and treatment effects.

[0004] Through more than 60 years of medical practice and theoretical research by the applicant, while excavating the essence of traditional medicine, a unique view and theoretical system have been gradually formed. Lutongning is composed of two herbs, Ligusticum chuanxiong and Piper longum. In the formula, Ligusticum chuanxiong is used in large amounts. Ligusticum chuanxiong is pungent, warm, and aromatic, enters the Shaoyang meridian, is good at dispersing, moving but not staying, can go up to the head, down to the blood sea, penetrate the skin externally, and connect to the limbs on the side. Although it enters the blood aspect, it can also promote qi movement, and is known as the "qi medicine in blood", and is an excellent product for dispelling wind and relieving pain. Ligusticum chuanxiong is the monarch drug, playing the role of dispelling wind and relieving pain. Piper longum is good at promoting qi movement to relieve pain and warming the middle to dispel cold, and can effectively treat patients with toothache and headache caused by fire stagnating inside and cold pathogen condensing externally. Piper longum in the Sanchatong Pills formula serves as the ministerial drug, which can produce the effect of pungent dispersion and pain relief. When paired with Ligusticum chuanxiong, Piper longum is partial to promoting qi movement, and Ligusticum chuanxiong is partial to promoting blood circulation. The two, one qi and one blood, are used in mutual assistance, and work together to go up, jointly exerting the effects of promoting blood circulation to relieve pain and dispersing wind and cold. However, the original preparation process of Lutongning is rough, which restricts the exertion of the drug effect.

[0005] In view of this, the present invention provides a traditional Chinese medicine composition for treating trigeminal neuralgia, a preparation method thereof, and a quality control method thereof. Summary of the Invention

[0006] Currently, the PTN diagnosis and treatment plans and consensus available for clinical reference are mostly Western medicine's drug and surgical plans. The first-line drugs for primary trigeminal neuralgia include carbamazepine and oxcarbazepine. If any of the above sodium channel blockers is ineffective, surgical treatment should be considered next. We know from the instructions that carbamazepine has many adverse reactions.

[0007] The natural recovery of typical primary trigeminal neuralgia is almost impossible. The effect of drug treatment may alternate between partial remission, complete remission, and recurrence. Therefore, patients adjust the drug dosage according to the frequency of attacks. All these bring great difficulties to patients.

[0008] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating trigeminal neuralgia, a preparation method thereof, and a quality control method thereof.

[0009] In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:

[0010] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating trigeminal neuralgia, which is composed of the following components: Ligusticum chuanxiong water extract, Piper longum alcohol extract, and Piper longum residue enzymatic hydrolysis acid water extract.

[0011] Further, the traditional Chinese medicine composition is obtained from the following raw materials in parts by weight: 2 parts of Ligusticum chuanxiong and 1 part of Piper longum.

[0012] In the second aspect, the present invention provides a preparation method of a traditional Chinese medicine composition for treating trigeminal neuralgia, which includes the following steps: crushing Ligusticum chuanxiong slices into coarse powder, extracting with water, drying the medicinal liquid to obtain Ligusticum chuanxiong water extract; crushing Piper longum slices into coarse powder, refluxing and extracting, drying the medicinal liquid to obtain Piper longum alcohol extract; for the residue after Piper longum alcohol extraction, adding water for enzymatic hydrolysis, then boiling and extracting, drying the medicinal liquid to obtain Piper longum residue enzymatic hydrolysis acid water extract; mixing the Ligusticum chuanxiong water extract, Piper longum alcohol extract, and Piper longum residue enzymatic hydrolysis acid water extract to obtain the composition.

[0013] Further, the specific steps of the preparation method of the traditional Chinese medicine composition are as follows:

[0014] Crush Ligusticum chuanxiong slices into coarse powder, extract with water twice. For the first time, add 8 - 12 times the amount of water, boil and extract for 1 hour, filter. For the second time, add 7 - 9 times the amount of water, boil and extract for 1 hour, filter. Concentrate the combined medicinal liquid under reduced pressure at 60 - 90 °C and dry. Crush the dry extract through a 60-mesh sieve to obtain Ligusticum chuanxiong water extract;

[0015] Crush Piper longum slices into coarse powder, reflux and extract twice. For the first time, add 7 - 9 times the amount of 85 - 95% ethanol, extract for 1 hour, filter. For the second time, add 6 - 8 times the amount of 85 - 95% ethanol, extract for 1 hour, filter. Concentrate the combined medicinal liquid under reduced pressure at 50 - 70 °C and dry. Crush the dry extract through a 60-mesh sieve to obtain Piper longum alcohol extract;

[0016] The medicinal residues after piperlongumine extraction are extracted with water twice. For the first extraction, 8 - 12 times the amount of water is added, the pH value is adjusted to 4.3 - 5.3, 1000 - 3000 U of hemicellulase is added per kilogram of piperlongum officinale decoction pieces, and enzymatic hydrolysis is carried out at 40 - 50 °C for 5 - 7 hours, then extraction is carried out by boiling for 1 hour, followed by centrifugation. For the second extraction, 7 - 9 times the amount of water is added, the pH value is adjusted to 4.3 - 5.3, extraction is carried out by boiling for 1 hour, followed by centrifugation. The combined medicinal liquid is concentrated under reduced pressure and dried at 60 - 90 °C, and the dry extract is pulverized and sieved through a 60 - mesh sieve to obtain the enzymatic hydrolysis acid - water extract of piperlongum officinale residues;

[0017] Furthermore, in a preferred embodiment of the present invention, for the preparation method of the traditional Chinese medicine composition, the pH value for enzymatic hydrolysis is 4.8, the dosage of hemicellulase per kilogram of piperlongum officinale decoction pieces is 2000 U, the enzymatic hydrolysis temperature is 45 °C, and the enzymatic hydrolysis time is 6 hours.

[0018] The above - mentioned ligusticum wallichii water extract, piperlongumine extract, and enzymatic hydrolysis acid - water extract of piperlongum officinale residues are mixed evenly to obtain the composition.

[0019] In the third aspect, the present invention also provides an application of the above - mentioned composition in the preparation of a drug for treating trigeminal neuralgia.

[0020] Further, the dosage form of the drug for treating trigeminal neuralgia is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, decoctions, or pills.

[0021] In the fourth aspect, the present invention also provides a method for constructing a fingerprint of a traditional Chinese medicine composition for treating trigeminal neuralgia. The method for constructing a fingerprint of a traditional Chinese medicine composition for treating trigeminal neuralgia includes the following steps:

[0022] Take reference substances of piperine, ferulic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, senkyunolide I, senkyunolide A, and piperlonguminine to prepare a reference substance solution;

[0023] Take the traditional Chinese medicine composition for treating trigeminal neuralgia to prepare a test solution of the traditional Chinese medicine composition for treating trigeminal neuralgia;

[0024] Perform high - performance liquid chromatography analysis on the test solution and the reference substance solution of the traditional Chinese medicine composition for treating trigeminal neuralgia respectively to construct a fingerprint of the traditional Chinese medicine composition for treating trigeminal neuralgia;

[0025] Among them, the conditions for high performance liquid chromatography analysis include: mobile phase A is acetonitrile, and mobile phase B is 0.1% phosphoric acid solution; gradient elution is adopted; the program of gradient elution includes: from 0 min to 5 min, the volume of mobile phase A is 8%; from 5 min to 25 min, the volume percentage of mobile phase A changes from 8% to 40%; from 25 min to 45 min, the volume percentage of mobile phase A changes from 40% to 60%; from 45 min to the end, the volume percentage of mobile phase A is 8%.

[0026] The fingerprint of the traditional Chinese medicine composition for treating trigeminal neuralgia contains 17 common peaks; among them, taking ferulic acid of peak 7 as the reference peak, the relative retention time of peak 1 is 0.68 ± 10%, the relative retention time of peak 2 is 0.71 ± 10%, the relative retention time of peak 3 is 0.77 ± 10%, the relative retention time of peak 4 is 0.85 ± 10%, the relative retention time of peak 5 is 0.91 ± 10%, the relative retention time of peak 6 is 0.94 ± 10%, the relative retention time of peak 8 is 1.03 ± 10%, the relative retention time of peak 9 is 1.15 ± 10%, the relative retention time of peak 10 is 1.21 ± 10%, the relative retention time of peak 11 is 1.25 ± 10%, the relative retention time of peak 12 is 1.44 ± 10%, the relative retention time of peak 13 is 1.65 ± 10%, the relative retention time of peak 14 is 1.97 ± 10%, the relative retention time of peak 15 is 2.06 ± 10%, the relative retention time of peak 16 is 2.10 ± 10%, and the relative retention time of peak 17 is 2.14 ± 10%.

[0027] In the fifth aspect, the present invention also provides an application of the fingerprint in the drug detection and quality control for treating trigeminal neuralgia.

[0028] Compared with the prior art, the beneficial effects of the present invention at least include:

[0029] Based on clinical practice, the present invention dispenses herbs according to syndrome types. The prescription feature is "few and refined medicinal flavors, large and astonishing dosages". Ligusticum chuanxiong is used as the monarch drug, and Piper longum is used as the minister drug. Piper longum and Ligusticum chuanxiong are paired. Piper longum is partial to promoting qi, and Ligusticum chuanxiong is partial to promoting blood circulation. The two, one qi and one blood, are used in combination and work together to ascend, jointly exerting the effects of promoting blood circulation to relieve pain and dispelling wind and cold.

[0030] 1. The raw material ratio of the pharmaceutical composition of the present invention:

[0031] 2 parts of Ligusticum chuanxiong and 1 part of Piper longum.

[0032] 2. By changing the extraction solvent of the product and optimizing the process parameters, the adverse drug reactions are greatly reduced, and at the same time, the effectiveness of the drug is ensured.

[0033] 3. By establishing the characteristic spectrum method, the product quality and batch-to-batch consistency can be more effectively controlled. Description of the Drawings

[0034] Figure 1 It is a spectrum for determining characteristic peaks.

[0035] Figure 2 It is a spectrum of the extract of Ligusticum chuanxiong Hort.

[0036] Figure 3 It is a spectrum of the extract of Piper longum L. Detailed Embodiments

[0037] The embodiments of the present invention will be described in detail below in conjunction with the examples. However, those skilled in the art will understand that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention. For those not specified in the examples, the operations are carried out under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments not specified by the manufacturer can all be obtained as conventional products through commercial purchase.

[0038] The features and properties of the present invention will be further described in detail below in conjunction with the examples:

[0039] I. Examples and Comparative Examples of the Composition and Its Preparation Method

[0040] Example 1

[0041] 750 g of Ligusticum chuanxiong Hort. and 375 g of Piper longum L.

[0042] The Ligusticum chuanxiong Hort. slices are crushed into coarse powder, and extracted with water twice. For the first time, 8 times the amount of water is added, boiled for 1 hour, filtered, and for the second time, 7 times the amount of water is added, boiled for 1 hour, filtered. The combined medicinal liquid is concentrated under reduced pressure at 90 °C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the water extract of Ligusticum chuanxiong Hort.

[0043] The Piper longum L. slices are crushed into coarse powder and extracted by reflux twice. For the first time, 9 times the amount of 85% ethanol is added, extracted for 1 hour, filtered, and for the second time, 6 times the amount of 95% ethanol is added, extracted for 1 hour, filtered. The combined medicinal liquid is concentrated under reduced pressure at 50 °C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the ethanol extract of Piper longum L.

[0044] The residue after ethanol extraction of Piper longum L. is extracted with water twice. For the first time, 12 times the amount of water is added, the pH value is adjusted to 4.3, 3000 U of hemicellulase is added per kilogram of Piper longum L. slices, enzymolyzed at 40 °C for 7 hours, then boiled for 1 hour, centrifuged. For the second time, 9 times the amount of water is added, the pH value is adjusted to 5.3, boiled for 1 hour, centrifuged. The combined medicinal liquid is concentrated under reduced pressure at 60 °C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the acid water extract of the residue of Piper longum L. enzymolyzed.

[0045] The above-mentioned water extract of Ligusticum chuanxiong Hort., ethanol extract of Piper longum L., and acid water extract of the residue of Piper longum L. enzymolyzed are mixed evenly to obtain a composition; sucrose powder and other excipients are added to the composition, mixed evenly, made into granules, and dried at 70 °C to make 1000 g, thus obtaining.

[0046] Example 2

[0047] 750 g of Ligusticum chuanxiong Hort. and 375 g of Piper longum L.

[0048] The Ligusticum chuanxiong Hort. pieces are crushed into coarse powder, extracted with water twice. For the first time, add 12 times the amount of water, boil and extract for 1 hour, filter. For the second time, add 9 times the amount of water, boil and extract for 1 hour, filter. The combined medicinal liquid is concentrated under reduced pressure and dried at 60 °C. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the water extract of Ligusticum chuanxiong Hort.

[0049] The Piper longum L. pieces are crushed into coarse powder, refluxed and extracted twice. For the first time, add 7 times the amount of 95% ethanol, extract for 1 hour, filter. For the second time, add 8 times the amount of 85% ethanol, extract for 1 hour, filter. The combined medicinal liquid is concentrated under reduced pressure and dried at 70 °C. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the ethanol extract of Piper longum L.

[0050] The residue after ethanol extraction of Piper longum L. is extracted with water twice. For the first time, add 8 times the amount of water, adjust the pH value to 5.3, add 1000 U of hemicellulase per kilogram of Piper longum L. pieces, enzymatically hydrolyze at 50 °C for 5 hours, then boil and extract for 1 hour, centrifuge. For the second time, add 7 times the amount of water, adjust the pH value to 4.3, boil and extract for 1 hour, centrifuge. The combined medicinal liquid is concentrated under reduced pressure and dried at 90 °C. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the enzymatically hydrolyzed acidic water extract of the Piper longum L. residue.

[0051] The above-mentioned water extract of Ligusticum chuanxiong Hort., ethanol extract of Piper longum L., and enzymatically hydrolyzed acidic water extract of the Piper longum L. residue are mixed evenly to obtain a composition; sucrose powder and other adjuvants are added to the composition, mixed evenly, made into granules, and dried at 70 °C to make 1000 g, thus obtaining.

[0052] Example 3

[0053] 750 g of Ligusticum chuanxiong Hort. and 375 g of Piper longum L.

[0054] The Ligusticum chuanxiong Hort. pieces are crushed into coarse powder, extracted with water twice. For the first time, add 10 times the amount of water, boil and extract for 1 hour, filter. For the second time, add 8 times the amount of water, boil and extract for 1 hour, filter. The combined medicinal liquid is concentrated under reduced pressure and dried at 75 °C. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the water extract of Ligusticum chuanxiong Hort.

[0055] The Piper longum L. pieces are crushed into coarse powder, refluxed and extracted twice. For the first time, add 8 times the amount of 90% ethanol, extract for 1 hour, filter. For the second time, add 7 times the amount of 90% ethanol, extract for 1 hour, filter. The combined medicinal liquid is concentrated under reduced pressure and dried at 60 °C. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the ethanol extract of Piper longum L.

[0056] The medicinal residues after extracting piperlongum alcohol are extracted with water twice. For the first time, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of hemicellulase is added per kilogram of piperlongum decoction pieces, enzymolysis is carried out at 45 °C for 6 hours, then boiling extraction is carried out for 1 hour, and centrifugation is performed. For the second time, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiling extraction is carried out for 1 hour, and centrifugation is performed. The combined liquid is concentrated under reduced pressure and dried at 75 °C. The dry extract is pulverized and passed through a 60-mesh sieve to obtain the enzymolysis acid water extract of piperlongum medicinal residues;

[0057] The above-mentioned ligusticum wallichii water extract, piperlongum alcohol extract, and enzymolysis acid water extract of piperlongum medicinal residues are mixed to obtain a composition; sucrose powder and other adjuvants are added to the composition, mixed evenly, made into granules, dried at 70 °C, and made into 1000 g, thus obtaining.

[0058] Original formula of Yuanlutongning

[0059] Ligusticum wallichii 750 g, Piperlongum 375 g

[0060] According to the national drug standard WS - 6010(B - 0010)-2014Z - 2017, the clear extract is obtained by the manufacturing method. Sucrose powder and other adjuvants are added, mixed evenly, made into granules, dried at 70 °C, and made into 1000 g, thus obtaining.

[0061] Control Example 1

[0062] Ligusticum wallichii 750 g, Piperlongum 375 g

[0063] The ligusticum wallichii decoction pieces are pulverized into coarse powder and extracted by refluxing twice. For the first time, 8 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtration is performed, for the second time, 7 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtration is performed, the combined liquid is concentrated under reduced pressure and dried at 60 °C. The dry extract is pulverized and passed through a 60-mesh sieve to obtain the ligusticum wallichii alcohol extract;

[0064] The medicinal residues after extracting ligusticum wallichii alcohol are extracted with water twice. For the first time, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of hemicellulase is added per kilogram of ligusticum wallichii decoction pieces, enzymolysis is carried out at 45 °C for 6 hours, then boiling extraction is carried out for 1 hour, and centrifugation is performed. For the second time, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiling extraction is carried out for 1 hour, and centrifugation is performed. The combined liquid is concentrated under reduced pressure and dried at 75 °C. The dry extract is pulverized and passed through a 60-mesh sieve to obtain the enzymolysis acid water extract of ligusticum wallichii medicinal residues;

[0065] The piperlongum decoction pieces are pulverized into coarse powder and extracted by refluxing twice. For the first time, 8 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtration is performed, for the second time, 7 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtration is performed, the combined liquid is concentrated under reduced pressure and dried at 60 °C. The dry extract is pulverized and passed through a 60-mesh sieve to obtain the piperlongum alcohol extract;

[0066] The medicinal residues after extracting piperlongum alcohol are extracted with water twice. For the first time, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of hemicellulase is added per kilogram of piperlongum decoction pieces, enzymolysis is carried out at 45 °C for 6 hours, then boiling extraction is carried out for 1 hour, and centrifugation is carried out. For the second time, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiling extraction is carried out for 1 hour, and centrifugation is carried out. The combined liquid is concentrated under reduced pressure and dried at 75 °C. The dry extract is pulverized and sieved through a 60-mesh sieve to obtain the enzymolysis acid water extract of piperlongum medicinal residues;

[0067] The above-mentioned extracts are mixed to obtain a composition; sucrose powder and other excipients are added to the composition, mixed evenly, made into granules, and dried at 70 °C to make 1000 g, thus obtaining.

[0068] Control Example 2

[0069] 750 g of ligusticum wallichii, 375 g of piperlongum

[0070] The ligusticum wallichii and piperlongum decoction pieces are pulverized into coarse powder, mixed evenly, and extracted by refluxing twice. For the first time, 8 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtered, for the second time, 7 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtered, the combined liquid is concentrated under reduced pressure and dried at 60 °C. The dry extract is pulverized and sieved through a 60-mesh sieve to obtain the ethanol extract;

[0071] The medicinal residues after ethanol extraction are extracted with water twice. For the first time, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of hemicellulase is added per kilogram of decoction pieces, enzymolysis is carried out at 45 °C for 6 hours, then boiling extraction is carried out for 1 hour, and centrifugation is carried out. For the second time, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiling extraction is carried out for 1 hour, and centrifugation is carried out. The combined liquid is concentrated under reduced pressure and dried at 75 °C. The dry extract is pulverized and sieved through a 60-mesh sieve to obtain the enzymolysis acid water extract of the medicinal residues;

[0072] The above-mentioned extracts are mixed to obtain a composition; sucrose powder and other excipients are added to the composition, mixed evenly, made into granules, and dried at 70 °C to make 1000 g, thus obtaining.

[0073] Control Example 3

[0074] 750 g of ligusticum wallichii, 375 g of piperlongum

[0075] The piperlongum decoction pieces are pulverized into coarse powder, extracted with water twice. For the first time, 10 times the amount of water is added, boiling extraction is carried out for 1 hour, filtered, for the second time, 8 times the amount of water is added, boiling extraction is carried out for 1 hour, filtered, the combined liquid is concentrated under reduced pressure and dried at 75 °C. The dry extract is pulverized and sieved through a 60-mesh sieve to obtain the water extract of piperlongum;

[0076] The ligusticum wallichii decoction pieces are pulverized into coarse powder, extracted by refluxing twice. For the first time, 8 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtered, for the second time, 7 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtered, the combined liquid is concentrated under reduced pressure and dried at 60 °C. The dry extract is pulverized and sieved through a 60-mesh sieve to obtain the ethanol extract of ligusticum wallichii;

[0077] The medicinal residues after extracting ligustilide are extracted with water twice. For the first extraction, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of hemicellulase is added per kilogram of ligusticum wallichii decoction pieces, enzymolysis is carried out at 45 °C for 6 hours, then boiling extraction is carried out for 1 hour, and centrifugation is carried out. For the second extraction, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiling extraction is carried out for 1 hour, and centrifugation is carried out. The combined medicinal liquid is concentrated under reduced pressure and dried at 75 °C, and the dry extract is pulverized and passed through a 60-mesh sieve to obtain the enzymolysis acid water extract of ligusticum wallichii medicinal residues;

[0078] The above extracts are mixed to obtain a composition; sucrose powder and other excipients are added to the composition, mixed evenly, made into granules, and dried at 70 °C to make 1000 g, thus obtaining.

[0079] Control Example 4

[0080] 750 g of ligusticum wallichii, 375 g of piper longum

[0081] The ligusticum wallichii decoction pieces are pulverized into coarse powder, extracted with water twice. For the first extraction, 10 times the amount of water is added, boiling extraction is carried out for 1 hour, filtered, for the second extraction, 8 times the amount of water is added, boiling extraction is carried out for 1 hour, filtered, the combined medicinal liquid is concentrated under reduced pressure and dried at 75 °C, and the dry extract is pulverized and passed through a 60-mesh sieve to obtain the water extract of ligusticum wallichii;

[0082] The piper longum decoction pieces are pulverized into coarse powder, extracted with water twice. For the first extraction, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of hemicellulase is added per kilogram of piper longum decoction pieces, enzymolysis is carried out at 45 °C for 6 hours, then boiling extraction is carried out for 1 hour, and centrifugation is carried out. For the second extraction, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiling extraction is carried out for 1 hour, and centrifugation is carried out. The combined medicinal liquid is concentrated under reduced pressure and dried at 75 °C, and the dry extract is pulverized and passed through a 60-mesh sieve to obtain the enzymolysis acid water extract of piper longum;

[0083] The medicinal residues after enzymolysis acid water extraction of piper longum are extracted by refluxing twice. For the first extraction, 8 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtered, for the second extraction, 7 times the amount of 90% ethanol is added, extraction is carried out for 1 hour, filtered, the combined medicinal liquid is concentrated under reduced pressure and dried at 60 °C, and the dry extract is pulverized and passed through a 60-mesh sieve to obtain the alcohol extract of piper longum medicinal residues;

[0084] The above extracts are mixed to obtain a composition; sucrose powder and other excipients are added to the composition, mixed evenly, made into granules, and dried at 70 °C to make 1000 g, thus obtaining.

[0085] Control Example 5

[0086] 750 g of ligusticum wallichii, 375 g of piper longum

[0087] The ligusticum wallichii decoction pieces are pulverized into coarse powder, extracted with water twice. For the first extraction, 10 times the amount of water is added, boiling extraction is carried out for 1 hour, filtered, for the second extraction, 8 times the amount of water is added, boiling extraction is carried out for 1 hour, filtered, the combined medicinal liquid is concentrated under reduced pressure and dried at 75 °C, and the dry extract is pulverized and passed through a 60-mesh sieve to obtain the water extract of ligusticum wallichii;

[0088] The Piper longum L. decoction pieces are crushed into coarse powder, and extracted by refluxing twice. For the first time, 8 times the amount of 90% ethanol is added and extracted for 1 hour, then filtered. For the second time, 7 times the amount of 90% ethanol is added and extracted for 1 hour, then filtered. The combined medicinal liquid is concentrated under reduced pressure at 60°C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the Piper longum L. ethanol extract;

[0089] The medicinal residues after Piper longum L. ethanol extraction are extracted with water twice. For the first time, 10 times the amount of water is added, the pH value is adjusted to 4.8, and boiled for extraction for 1 hour, then centrifuged. For the second time, 8 times the amount of water is added, the pH value is adjusted to 4.8, and boiled for extraction for 1 hour, then centrifuged. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the Piper longum L. medicinal residue acid water extract;

[0090] The above-mentioned Ligusticum wallichii Franch. water extract, Piper longum L. ethanol extract, and Piper longum L. medicinal residue acid water extract are mixed evenly to obtain a composition; sucrose powder and other adjuvants are added to the composition, mixed evenly, made into granules, and dried at 70°C to make 1000 g, thus obtaining.

[0091] Control Example 6

[0092] 750 g of Ligusticum wallichii Franch. and 375 g of Piper longum L.

[0093] The Ligusticum wallichii Franch. decoction pieces are crushed into coarse powder and extracted with water twice. For the first time, 10 times the amount of water is added and boiled for extraction for 1 hour, then filtered. For the second time, 8 times the amount of water is added and boiled for extraction for 1 hour, then filtered. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the Ligusticum wallichii Franch. water extract;

[0094] The Piper longum L. decoction pieces are crushed into coarse powder, and extracted by refluxing twice. For the first time, 8 times the amount of 90% ethanol is added and extracted for 1 hour, then filtered. For the second time, 7 times the amount of 90% ethanol is added and extracted for 1 hour, then filtered. The combined medicinal liquid is concentrated under reduced pressure at 60°C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the Piper longum L. ethanol extract;

[0095] The medicinal residues after Piper longum L. ethanol extraction are extracted with water twice. For the first time, 10 times the amount of water is added, the pH value is adjusted to 7, 2000 U of hemicellulase is added per kilogram of Piper longum L. decoction pieces, enzymolyzed at 45°C for 6 hours, then boiled for extraction for 1 hour, and centrifuged. For the second time, 8 times the amount of water is added, the pH value is adjusted to 7, and boiled for extraction for 1 hour, then centrifuged. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed and sieved through a 60-mesh sieve to obtain the Piper longum L. medicinal residue enzymolyzed water extract;

[0096] The above-mentioned Ligusticum wallichii Franch. water extract, Piper longum L. ethanol extract, and Piper longum L. medicinal residue enzymolyzed water extract are mixed evenly to obtain a composition; sucrose powder and other adjuvants are added to the composition, mixed evenly, made into granules, and dried at 70°C to make 1000 g, thus obtaining.

[0097] Control Example 7

[0098] 750 g of Ligusticum wallichii Franch. and 375 g of Piper longum L.

[0099] The prepared Ligusticum wallichii Fritsch slices are crushed into coarse powder, and extracted with water twice. For the first extraction, 10 times the amount of water is added, and it is boiled for 1 hour and filtered. For the second extraction, 8 times the amount of water is added, and it is boiled for 1 hour and filtered. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed through a 60-mesh sieve to obtain the water extract of Ligusticum wallichii Fritsch;

[0100] The prepared Piper longum L. slices are crushed into coarse powder and extracted by refluxing twice. For the first extraction, 8 times the amount of 90% ethanol is added, and it is extracted for 1 hour and filtered. For the second extraction, 7 times the amount of 90% ethanol is added, and it is extracted for 1 hour and filtered. The combined medicinal liquid is concentrated under reduced pressure at 60°C and dried. The dry extract is crushed through a 60-mesh sieve to obtain the ethanol extract of Piper longum L.;

[0101] The residue after the ethanol extraction of Piper longum L. is extracted with water twice. For the first extraction, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of cellulase is added per kilogram of Piper longum L. slices, enzymolysis is carried out at 45°C for 6 hours, then it is boiled for 1 hour and centrifuged. For the second extraction, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiled for 1 hour and centrifuged. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed through a 60-mesh sieve to obtain the enzymolysis acid water extract of the Piper longum L. residue;

[0102] The above-mentioned water extract of Ligusticum wallichii Fritsch, ethanol extract of Piper longum L., and enzymolysis acid water extract of the Piper longum L. residue are mixed evenly to obtain a composition; sucrose powder and other adjuvants are added to the composition, mixed evenly, made into granules, and dried at 70°C to make 1000 g, thus obtaining the product.

[0103] Control Example 8

[0104] 750 g of Ligusticum wallichii Fritsch, 375 g of Piper longum L

[0105] The prepared Ligusticum wallichii Fritsch slices are crushed into coarse powder, and extracted with water twice. For the first extraction, 10 times the amount of water is added, and it is boiled for 1 hour and filtered. For the second extraction, 8 times the amount of water is added, and it is boiled for 1 hour and filtered. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed through a 60-mesh sieve to obtain the water extract of Ligusticum wallichii Fritsch;

[0106] The prepared Piper longum L. slices are crushed into coarse powder and extracted by refluxing twice. For the first extraction, 8 times the amount of 90% ethanol is added, and it is extracted for 1 hour and filtered. For the second extraction, 7 times the amount of 90% ethanol is added, and it is extracted for 1 hour and filtered. The combined medicinal liquid is concentrated under reduced pressure at 60°C and dried. The dry extract is crushed through a 60-mesh sieve to obtain the ethanol extract of Piper longum L.;

[0107] The residue after the ethanol extraction of Piper longum L. is extracted with water twice. For the first extraction, 10 times the amount of water is added, the pH value is adjusted to 4.8, 2000 U of pectinase is added per kilogram of Piper longum L. slices, enzymolysis is carried out at 45°C for 6 hours, then it is boiled for 1 hour and centrifuged. For the second extraction, 8 times the amount of water is added, the pH value is adjusted to 4.8, boiled for 1 hour and centrifuged. The combined medicinal liquid is concentrated under reduced pressure at 75°C and dried. The dry extract is crushed through a 60-mesh sieve to obtain the enzymolysis acid water extract of the Piper longum L. residue;

[0108] The above-mentioned aqueous extract of Ligusticum chuanxiong, alcoholic extract of Piper longum, and enzymatically hydrolyzed acid aqueous extract of Piper longum residue are mixed to obtain a composition; sucrose powder and other excipients are added to the composition, mixed well, made into granules, and dried at 70°C to make 1000 g, thus obtaining the product.

[0109] II. Examples of Quality Control Methods

[0110] 1 Instruments and Research Materials

[0111] 1.1 Instrumentation

[0112]

[0113] 1.2 Reagents and Test Drugs

[0114]

[0115] 2. Research on the Characteristic Chromatogram Method

[0116] 2.1

Characteristic Chromatogram

[0117]

[0118] Preparation of the test solution: Take about 5.0 g of the test powder, place it in a stoppered conical flask, add 25 ml of 70% methanol solvent, ultrasonically treat for 30 minutes (power 100 W, frequency 40 kHz), let it cool, shake well, filter, and take the subsequent filtrate, thus obtaining the solution.

[0119] 2.2 Establishment of the Characteristic Chromatogram

[0120] Generally, it should be studied and formulated based on the determination results of 10 batches or more representative samples. The characteristic peaks should be selected as the chromatographic peaks that stably appear in the chromatogram, have a certain peak area, and have good separation effect.

[0121] Relative retention time of common peaks

[0122]

[0123] Relative peak area of common peaks

[0124]

[0125] Test results: Through multi-batch determination, the chromatographic peaks that stably appear in the chromatogram, have a certain peak area, and have good resolution are selected as characteristic peaks, and there are 17 in total.

[0126] 2.3 Identification and Attribution of Characteristic Peaks

[0127] 2.3.1 Identification of characteristic peaks

[0128] Using the reference substance solution and according to the chromatographic conditions under item 2.1, the chromatographic peaks in the above samples were identified. Those chromatographic peaks that stably appeared in the samples and could not be identified were determined as unknown peaks.

[0129] Preparation of reference substance solution:

[0130] (1) Preparation of ferulic acid reference substance: Take an appropriate amount of ferulic acid reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 50 μg per 1 ml.

[0131] (2) Preparation of chlorogenic acid reference substance: Take an appropriate amount of chlorogenic acid reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 50 μg per 1 ml.

[0132] (3) Preparation of cryptochlorogenic acid reference substance: Take an appropriate amount of cryptochlorogenic acid reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 50 μg per 1 ml.

[0133] (4) Preparation of caffeic acid reference substance: Take an appropriate amount of caffeic acid reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 50 μg per 1 ml.

[0134] (5) Preparation of piperlonguminine reference substance: Take an appropriate amount of piperlonguminine reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 50 μg per 1 ml.

[0135] (6) Preparation of senkyunolide I reference substance: Take an appropriate amount of senkyunolide I reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 40 μg per 1 ml.

[0136] (7) Preparation of senkyunolide A reference substance: Take an appropriate amount of senkyunolide A reference substance, accurately weigh it, place it in a brown volumetric flask, and add methanol to make a solution containing 80 μg per 1 ml.

[0137] (8) Preparation of piperine reference substance: Take an appropriate amount of piperine reference substance, accurately weigh it, place it in a brown volumetric flask, and add 70% methanol to make a solution containing 20 μg per 1 ml.

[0138] Test results: Through the identification of characteristic peaks, the characteristic peaks were determined as follows. The obtained results are as Figure 1 shown, and it can be known from Figure 1 :

[0139]

[0140] 2.3.2 Attribution of characteristic peaks

[0141] Use the cut crude drugs to prepare the extracts of single herbs according to the extraction process, prepare the solution according to the preparation method of the test samples, and assign the characteristic peaks to the herbs.

[0142] Preparation method of the cut crude drug solution:

[0143] (1) Take 100.19 g of the cut Ligustici Chuanxiong Rhizoma, and prepare the extract of the single herb according to the preparation process. Take 1.5 g of the extract of the single herb, and prepare the Ligustici Chuanxiong Rhizoma extract solution according to the preparation method of the test sample solution under item 3.3.

[0144] (2) Take 100.17 g of the cut Piperis Longi Fructus, and prepare the extract of the single herb according to the preparation process. Take 1.5 g of the extract of the single herb, and prepare the Piperis Longi Fructus extract solution according to the preparation method of the test sample solution under item 3.3.

[0145] Results: Through the assignment of the characteristic peaks, it was determined that the characteristic peaks were assigned as follows. The obtained results are as Figure 2 、 Figure 3 shown. From Figure 2 、 Figure 3 it can be seen that:

[0146]

[0147]

[0148] 2.3.3 Selection of the reference substance

[0149] The selection of the reference substance was studied in combination with the pharmacodynamic active ingredients and the preparation process. The main active ingredients of the monarch and minister herbs were preferably selected as the reference substances, and generally those with relatively large chromatographic peak response values and intermediate retention times were selected as the reference peaks.

[0150] Results: Through the above research, the chromatographic peak of ferulic acid had a relatively large response value and an intermediate retention time. Therefore, ferulic acid was selected as the reference substance, and ferulic acid was determined as the reference peak.

[0151] 2.3.4 Evaluation method

[0152] Based on the results of the above experimental research, an evaluation method for the characteristic chromatogram was formulated. The chromatographic peak corresponding to the ferulic acid reference substance was determined as the S peak, and the relative retention times of each characteristic peak were calculated. It was stipulated that the relative retention times of each characteristic peak should be within ±10% of the specified values. The specified values were: 0.68 (peak 1), 0.71 (peak 2), 0.77 (peak 3), 0.85 (peak 4), 0.91 (peak 5), 0.94 (peak 6), 1.00 (peak 7 (S)), 1.03 (peak 8), 1.15 (peak 9), 1.21 (peak 10), 1.25 (peak 11), 1.44 (peak 12), 1.65 (peak 13), 1.97 (peak 14), 2.06 (peak 15), 2.10 (peak 16), 2.14 (peak 17).

[0153] 2.3.5 Conclusion

[0154] According to the absorption characteristics of the active ingredients of each medicinal flavor in the prescription, the characteristic chromatogram of the traditional Chinese medicine oral solid preparation for the treatment of trigeminal neuralgia established by HPLC has 17 characteristic peaks, with strong specificity. A comprehensive study has been conducted on the attribution of each characteristic peak, and each peak has been attributed to each medicinal material respectively, which can better control the quality of Chuanxiong Rhizoma and Piper Longum in the prescription; 8 index components have been identified, which can more comprehensively control the main components in the prescription, making the product quality more stable and controllable.

[0155] Beneficial effects of the present invention:

[0156] Pharmacodynamic experiment

[0157] Select qualified rats for infraorbital nerve constriction ring operation (ION-CCI). The specific operation is as follows: Anesthetize the experimental rats with Zoletil 50, fix the heads and limbs of the rats, disinfect the area of the infraorbital foramen on the operative side with 3% iodophor. Through the external nose beside the mouth: Make a longitudinal incision about 1 cm along the facial nasal groove of the rat (the anterior 1 / 3 segment of the lower edge of the zygomatic bone) in the up and down directions, bluntly separate the subcutaneous tissue towards the vibrissal pad, expose the lower edge of the zygomatic muscle of the rat, bluntly separate the fascia around the muscle, expose the infraorbital foramen, and the infraorbital nerve (ION) emerging from the infraorbital foramen can be seen, showing a fan-shaped distribution. After finding the infraorbital nerve, ligate it and then suture. After modeling, intramuscularly inject penicillin streptomycin (0.2 mL / rat / day) for 3 consecutive days to prevent infection. Select the rats with successful modeling and randomly divide them into a model control group, a carbamazepine group, a Yuanlutongning group, Example 1-3 groups, and Comparative Example 1-8 groups, with 10 rats in each group. Another group of qualified rats was divided into a normal control group and a sham operation group (only perform the operation without ligating the nerve), with 10 rats in each group.

[0158] Table 1 Effects of the composition granule on the mechanical pain threshold of rats with trigeminal neuralgia ( n = 10)

[0159]

[0160] Table 2 Effects of the composition granule on plasma viscosity and whole blood viscosity of rats with trigeminal neuralgia ( n = 10)

[0161]

[0162] Table 3 Effects of the composition granule on the coagulation function of rats with trigeminal neuralgia ( n = 10)

[0163]

[0164] The therapeutic effects of the present invention and the original product show that both can significantly increase the pain threshold of model rats, effectively reduce plasma viscosity and reduced whole blood viscosity, improve blood rheology by reducing blood viscosity, and effectively improve trigeminal neuralgia. Compared with the original Cranial Pain Relieving Granules, the present invention has better effects.

[0165] The procedures not described in detail in the present invention are all common general knowledge that can be selected by those of ordinary skill in the art. Although the present invention has been described in detail above with general descriptions and specific embodiments, based on the present invention, some modifications or improvements can be made, which are obvious to those of ordinary skill in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection required by the present invention.

Claims

1. A Chinese medicine composition for treating trigeminal neuralgia, characterized in that: The traditional Chinese medicine composition consists of the following components: water extract of chuanxiong rhizome, alcohol extract of piper longum and enzymatic acid water extract of piper longum residue.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is obtained from the following raw materials in parts by weight: 2 parts of Chuanxiong and 1 part of Piper longum.

3. A method for preparing a Chinese medicine composition for treating trigeminal neuralgia, characterized in that: The preparation method comprises the following steps: The Chuanxiong pieces are crushed into coarse powder, extracted with water, and the liquid is dried to obtain the Chuanxiong water extract; The Piper longum slices are crushed into coarse powder, subjected to reflux extraction, and the liquid is dried to obtain the Piper longum alcohol extract; The residues of Piper longum alcohol extraction are hydrolyzed with water, then boiled for extraction, and the liquid is dried to obtain the enzymatic acid water extract of Piper longum residues; The water extract of Rhizoma Chuanxiong, the alcohol extract of Rhizoma Piper Longum and the enzymatic acid water extract of Rhizoma Piper Longum residues are mixed to obtain a composition.

4. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: The specific steps of the preparation method are: The decoction pieces of Chuanxiong are crushed into coarse powder, and water is added for extraction twice, the first time the amount is 8 to 12 times, the water is boiled for extraction for 1 hour, and the water is filtered, and the second time the amount is 7 to 9 times, the water is boiled for extraction for 1 hour, and the water is filtered. The combined medicinal liquid is concentrated under reduced pressure at 60 to 90° C. and dried, and the dry paste is crushed and passed through a 60-mesh sieve to obtain the water extract of Chuanxiong; The Piper longum slices are crushed into coarse powder, and refluxed for extraction twice. For the first extraction, 7 to 9 times the amount of 85 to 95% ethanol is added, and the extraction is performed for 1 hour, and the extraction is filtered. For the second extraction, 6 to 8 times the amount of 85 to 95% ethanol is added, and the extraction is performed for 1 hour, and the extraction is filtered. The combined medicinal liquid is concentrated under reduced pressure at 50 to 70° C. and dried. The dry paste is crushed and passed through a 60-mesh sieve to obtain the Piper longum alcohol extract. The residues of Piper longum alcohol extraction are extracted with water twice, the first time the amount is 8 to 12 times, the pH value is adjusted to 4.3 to 5.3, 1000 to 3000 U of hemicellulase is added per kilogram of Piper longum decoction pieces, enzymolysis is performed at 40 to 50° C. for 5 to 7 hours, then boiling and extracting for 1 hour, centrifuging, the second time the amount is 7 to 9 times, the pH value is adjusted to 4.3 to 5.3, boiling and extracting for 1 hour, centrifuging, the combined drug solution is concentrated under reduced pressure at 60 to 90° C. and dried, the dry paste is crushed and passed through a 60-mesh sieve, and the enzymatic acid water extract of Piper longum residues is obtained; The water extract of Rhizoma Chuanxiong, the alcohol extract of Rhizoma Piper Longum and the enzymatic acid water extract of Rhizoma Piper Longum residue are mixed to obtain a composition.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The pH value is 4.8, the hemicellulase is 2000U, the enzymolysis temperature is 45°C, and the enzymolysis time is 6 hours.

6. Use of the composition according to any one of claims 1 and 2 in the preparation of a medicament for treating trigeminal neuralgia.

7. The use according to claim 6, characterized in that: The pharmaceutical dosage form for treating trigeminal neuralgia is an oral preparation, which is selected from any one of granules, tablets, capsules, powders, decoctions or pills.

8. A method for constructing a fingerprint spectrum of a traditional Chinese medicine composition for treating trigeminal neuralgia, characterized in that: The steps include: Take piperine, ferulic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, ligusticolide I, ligusticolide A, and piperonine as reference substances to prepare reference substance solutions; Taking a Chinese medicinal composition for treating trigeminal neuralgia, preparing a test solution of a Chinese medicinal composition for treating trigeminal neuralgia; The test solution of the Chinese medicine composition for treating trigeminal neuralgia and the reference solution are subjected to high performance liquid chromatography analysis respectively to construct a fingerprint of the Chinese medicine composition for treating trigeminal neuralgia; The high performance liquid chromatography analysis conditions include: mobile phase A is acetonitrile, mobile phase B is 0.1% phosphoric acid solution; gradient elution is adopted; the gradient elution program includes: 0min to 5min, the volume of mobile phase A is 8%; 5min to 25min, the volume percentage of mobile phase A changes from 8% to 40%; 25min to 45min, the volume percentage of mobile phase A changes from 40% to 60%; 45min to the end, the volume percentage of mobile phase A is 8%.

9. The method for constructing the fingerprint of the Chinese medicine composition for treating trigeminal neuralgia according to claim 8, characterized in that: The fingerprint of the traditional Chinese medicine composition for treating trigeminal neuralgia comprises 17 common peaks; wherein, taking peak 7 ferulic acid as the reference peak, the relative retention time of peak 1 is 0.68±10%, the relative retention time of peak 2 is 0.71±10%, the relative retention time of peak 3 is 0.77±10%, the relative retention time of peak 4 is 0.85±10%, the relative retention time of peak 5 is 0.91±10%, the relative retention time of peak 6 is 0.94±10%, the relative retention time of peak 8 is 1.03±10%, and the relative retention time of peak 9 is 0.84±10%. The relative retention time of peak 9 was 1.15±10%, the relative retention time of peak 10 was 1.21±10%, the relative retention time of peak 11 was 1.25±10%, the relative retention time of peak 12 was 1.44±10%, the relative retention time of peak 13 was 1.65±10%, the relative retention time of peak 14 was 1.97±10%, the relative retention time of peak 15 was 2.06±10%, the relative retention time of peak 16 was 2.10±10%, and the relative retention time of peak 17 was 2.14±10%.

10. An application of the fingerprint spectrum as claimed in claim 8 or 9 as a standard fingerprint spectrum in drug detection and quality control for the treatment of trigeminal neuralgia.

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