Traditional Chinese medicine composition for regulating qi and removing blood stasis, medicine and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for regulating qi and removing blood stasis, a medicine and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The medicine for regulating qi and dispersing blood stasis is prepared by taking the radix salviae miltiorrhizae and the calcined mother-of-pearl as monarch drugs, taking the herba lycopi, the cassia twig and the prepared rehmannia root as ministerial drugs and taking the radix curcumae, the bighead atractylodes rhizome, the longan aril, the persimmon leaf and the hawthorn as adjuvant drugs, can improve the SOD activity in skin, reduce the content of MDA, reduce the skin oxidation degree and improve the oxidation resistance, and has a remarkable effect of treating chloasma.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for regulating qi and resolving stasis, a drug, a preparation method thereof, and an application thereof. Background Art

[0002] With the continuous development of society, the working mode of modern people has gradually shifted from physical work to mental work. Mental work causes people to sit for long periods and be mentally stressed, resulting in insufficient generation and slow circulation of qi and blood in the body, and ineffective activity of muscles, which affects the smooth flow of meridians. In addition, modern people prefer greasy, spicy, raw and cold foods, which affects the transportation and transformation functions of the spleen and stomach. The spleen and stomach are the sources of qi and blood generation. Once damaged, the generation of qi and blood will be insufficient. The long-term habits of staying up late and lacking exercise further lead to qi and blood disorders and meridian blockages.

[0003] For women, poor qi and blood circulation and meridian blockages are likely to cause skin diseases such as chloasma. For skin diseases such as chloasma, common topical drugs include hydroquinone, tretinoin, azelaic acid, etc., and oral drugs include tranexamic acid. However, although topical drugs can inhibit the production of melanin, long-term use may cause adverse reactions such as irritant contact dermatitis and exogenous ochronosis; long-term use of oral drugs may cause side effects such as menstrual disorders and thrombosis, increasing potential health risks. Laser treatment is also one of the methods for removing chloasma, and its principle is to achieve the treatment purpose by destroying melanin granules. However, laser treatment may cause complications such as aggravated post-inflammatory hyperpigmentation, blisters, and scar formation, and the treatment cost is high, requiring multiple treatments, with a long treatment cycle, and patients often have poor compliance. At the same time, laser treatment only deals with the already formed skin spots and cannot fundamentally regulate the internal physiological state of the body, resulting in a high recurrence rate.

[0004] Traditional Chinese medicine believes that qi is the commander of blood, and blood is the mother of qi. Qi and blood depend on each other and function in a mutually beneficial way. If the qi and blood in the human body do not circulate smoothly, qi stagnation will lead to blood stasis. The stasis of blood stays in the facial meridians, resulting in the loss of nourishment of qi and blood in the face, and the facial skin losing its luster, thus forming chloasma. The liver is responsible for dredging and regulating qi movement. If the emotions are not smooth and the liver qi stagnates, it will affect the circulation of qi and blood, leading to unsmooth blood circulation and stasis in the face. At the same time, the liver stores blood. If the liver blood is insufficient and cannot nourish the face upward, it will also cause the facial skin to lack nourishment and appear pigmented spots. The spleen is the foundation of acquired constitution and the source of qi and blood generation. If the spleen qi is weak and the transportation and transformation function is insufficient, the generation source of qi and blood is lacking and cannot nourish the skin; or if the spleen fails to transport and transform properly, endogenous dampness is generated, and the accumulated dampness turbidity blocks the circulation of qi and blood, all of which can lead to the occurrence of chloasma. The kidney stores essence and is in charge of reproduction. If the kidney essence is deficient, it can cause the qi and blood in the face to lack nourishment, the facial skin to age, and pigmentation to appear. In addition, the heart governs blood vessels. If the heart blood is insufficient or the heart vessels are blocked by stasis, it will also affect the normal circulation of qi and blood in the face and lead to the appearance of chloasma. The occurrence of chloasma is closely related to the qi and blood and the functions of zang-fu organs in the human body. Therefore, regulating qi and resolving stasis can effectively prevent and treat chloasma. Providing a traditional Chinese medicine formula for regulating qi and resolving stasis is of great significance for preventing and treating diseases caused by unsmooth qi and blood and blocked meridians. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition, a drug, its preparation method and application for regulating qi and resolving stasis to solve the problems existing in the above-mentioned prior art. The present invention uses salvia miltiorrhiza and calcined margarita as the monarch drugs, eupatorium japonicum, cinnamon twig and rehmannia root as the minister drugs, and curcuma aromatica, atractylodes macrocephala, longan aril, persimmon leaf and hawthorn as the assistant and guiding drugs to prepare a drug for regulating qi and resolving stasis, which can improve the SOD activity in the skin, reduce the content of MDA, reduce the degree of skin oxidation, improve the antioxidant capacity, and has a significant effect on treating chloasma.

[0006] To achieve the above purpose, the present invention provides the following solutions:

[0007] The present invention provides a traditional Chinese medicine composition for regulating qi and resolving stasis, comprising the following raw materials in parts by weight: 150 - 200 parts of salvia miltiorrhiza, 100 - 120 parts of calcined margarita, 60 - 80 parts of eupatorium japonicum, 60 - 80 parts of cinnamon twig, 40 - 60 parts of rehmannia root, 40 - 60 parts of curcuma aromatica, 40 - 60 parts of atractylodes macrocephala, 20 - 30 parts of longan aril, 10 - 15 parts of persimmon leaf and 10 - 15 parts of hawthorn.

[0008] The present invention also provides a drug for regulating qi and resolving stasis, comprising the above traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0009] Optionally, the excipients include one or more of honey, polysorbate - 80, sorbic acid, stevioside and ethylparaben.

[0010] The present invention also provides a preparation method of the above drug, comprising the following steps:

[0011] (1) Mix Salvia miltiorrhiza, Lycopus lucidus, Cinnamon Twig, Rehmannia glutinosa, Curcuma aromatica, Atractylodes macrocephala, Longan Aril, Persimmon Leaf and Hawthorn, decoct twice with water, combine the decoction liquids, and obtain medicinal liquid A after filtration;

[0012] (2) Pulverize calcined nacre, decoct three times with water, combine the decoction liquids, and obtain medicinal liquid B after filtration;

[0013] (3) Mix the medicinal liquid A and the medicinal liquid B, concentrate to obtain a clear extract;

[0014] (4) Treat the clear extract with an ethanol solution, take the supernatant, recover ethanol and then concentrate it into an extract; mix the extract with adjuvants, and make up the volume with water to obtain the drug.

[0015] Further, in step (1), the decocting process is as follows: for the first decoction, add 10 times the amount of water and decoct for 2.5 h; for the second decoction, add 8 times the amount of water and decoct for 1.5 h.

[0016] Further, in step (2), the decocting process is as follows: for the first decoction, add 6 times the amount of water and decoct for 3 h; for the second decoction, add 5 times the amount of water and decoct for 2 h; for the third decoction, add 5 times the amount of water and decoct for 1 h.

[0017] Further, in step (3), the relative density of the clear extract is 1.14 - 1.18 at 50 °C; in step (4), the relative density of the extract is 1.18 - 1.22 at 50 °C.

[0018] Further, in step (4), the volume fraction of the ethanol solution is 90 - 95%; the treatment time with the ethanol solution is 40 - 52 h.

[0019] Further, the adjuvants are refined honey, sorbic acid and polysorbate - 80.

[0020] Further, the mixing ratio of the extract, refined honey, sorbic acid and polysorbate - 80 is 200 - 270 g : 80 - 120 g : 0.5 - 1.0 g : 3 - 5 mL;

[0021] The concentration of the extract in the drug is 0.5 - 0.7 kg / L.

[0022] The present invention also provides the use of the above traditional Chinese medicine composition or the above drug in the preparation of a drug for treating chloasma.

[0023] The present invention discloses the following technical effects:

[0024] The present invention provides a traditional Chinese medicine composition and a drug for regulating qi and resolving stasis. The drug uses danshen (Salvia miltiorrhiza) and calcined margarita as the monarch drugs, zeylanicum, cassia twig, and rehmannia root as the minister drugs, and curcuma aromatica, atractylodes macrocephala, longan aril, persimmon leaf, and hawthorn as the assistant and guiding drugs, jointly exerting the effect of regulating qi and resolving stasis and having the function of treating chloasma. It has been verified that the drug of the present invention for regulating qi and resolving stasis can increase the SOD activity in the skin, reduce the MDA content, decrease the degree of skin oxidation, improve the antioxidant capacity, and has a significant effect on treating chloasma. Detailed Embodiments

[0025] The various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, characteristics, and implementation schemes of the present invention.

[0026] It should be understood that the terms used in the present invention are only for describing specific embodiments and are not used to limit the present invention. Additionally, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.

[0027] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0028] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific embodiments of the specification of the present invention, which are obvious to those skilled in the art. Other embodiments obtained from the specification of the present invention are obvious to those skilled in the art. The specification and embodiments of the present invention are merely exemplary.

[0029] Regarding the terms "comprising", "including", "having", "containing", etc. used herein, they are all open-ended terms, meaning including but not limited to.

[0030] The technical solution of the present invention is as follows:

[0031] The raw materials of the traditional Chinese medicine composition of the present invention include Salvia miltiorrhiza, calcined margarita, Eupatorium japonicum Thunb., Ramulus Cinnamomi, Rehmannia glutinosa, Curcuma aromatica Salisb., Atractylodes macrocephala Koidz., Arillus Longan, Folium Diospyri, and Fructus Crataegi. Among them, Salvia miltiorrhiza: bitter in taste, slightly cold in nature; it has the functions of promoting blood circulation to remove stasis, dredging meridians to relieve pain, clearing the heart to remove vexation, and cooling blood to eliminate carbuncles; Calcined margarita: salty, cold; it has the functions of calming the liver and suppressing yang, calming the mind and relieving uneasiness, and clearing the liver and improving eyesight; Eupatorium japonicum Thunb.: bitter, pungent, slightly warm; it has the functions of promoting blood circulation and regulating menstruation, removing stasis and eliminating carbuncles, and promoting diuresis and reducing swelling; Ramulus Cinnamomi: pungent, sweet, warm; it has the functions of inducing sweating to relieve exterior syndrome, warming the meridians to relieve pain, and promoting yang qi transformation; Rehmannia glutinosa: sweet, slightly warm; it has the functions of enriching blood and nourishing yin, tonifying the kidney and strengthening yang, replenishing qi and strengthening the spleen, and having anti-inflammatory and protecting the liver and kidney; Curcuma aromatica Salisb.: pungent, bitter, cold; it has the functions of promoting blood circulation to relieve pain, regulating qi and relieving depression, clearing the heart and cooling blood, and promoting bile secretion and removing jaundice; Atractylodes macrocephala Koidz.: bitter, sweet, warm in nature; it has the functions of strengthening the spleen and replenishing qi, and drying dampness and promoting diuresis; Arillus Longan: sweet in taste, warm in nature; it has the functions of tonifying the heart and spleen, and nourishing blood and calming the mind; Folium Diospyri: bitter in taste, cold in nature; it has the functions of relieving cough and asthma, promoting the production of body fluid and quenching thirst, and promoting blood circulation and stopping bleeding; Fructus Crataegi: sour, sweet, slightly warm; it has the functions of promoting digestion and strengthening the stomach, promoting qi circulation and removing stasis, and reducing turbidity and lipid-lowering.

[0032] The present invention follows the compatibility principle of "monarch, minister, assistant and messenger", with salvia miltiorrhiza and calcined pearl mother-of-pearl as monarch medicine, zelan, cinnamon twig and prepared rehmannia as minister medicine, and curcuma, atractylodes macrocephala, longan pulp, persimmon leaf and hawthorn as assistant and messenger medicine, and the effect of regulating qi and removing blood stasis is carried out together. Among them, salvia miltiorrhiza has the effects of promoting blood circulation and removing blood stasis, relieving pain by menstruation, and clearing the heart and removing vexation. In the treatment of diseases such as chloasma, qi and blood stasis is an important pathogenesis, and salvia miltiorrhiza can effectively improve blood circulation, eliminate blood stasis blockage, and play a role in the main cause of qi and blood stagnation and blood stasis internal resistance. After calcination, pearl mother-of-pearl has the effects of calming the liver and suppressing yang, clearing the liver and improving eyesight, and calming the heart and tranquilizing the mind. It can regulate the yin and yang balance of the human body, has a better conditioning effect on the qi and blood disorder caused by liver depression and fire transformation and liver yang hyperactivity, and plays a leading therapeutic role with salvia miltiorrhiza for the main cause and pathogenesis. Zelan has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncle, and promoting diuresis and reducing swelling. It can assist Danshen to enhance the effect of promoting blood circulation and removing blood stasis, further promote the circulation of qi and blood, eliminate blood stasis, and strengthen the effect of the main medicine in treating qi and blood stasis. Cinnamon twig can warm and dredge the meridians, assist yang and transform qi, dispel cold and relieve pain, warm and dredge the meridians, promote the circulation of qi and blood, and has a good conditioning effect on cold stagnation and blood stasis or qi and blood stagnation. It assists the main medicine and the ministerial medicine Ze Lan, etc., strengthens the effect of promoting blood circulation and dredge the meridians, and can also play a certain role in dispelling cold, targeting the possible concurrent symptoms of cold evil stagnation. Rehmannia has the effects of nourishing yin and blood, replenishing essence and filling marrow. While regulating qi and removing blood stasis, it can nourish yin and nourish blood, replenish the yin blood that may be lost due to blood stasis and the process of regulating qi and removing blood stasis, make qi and blood sufficient and run normally, assist the main medicine and other ministerial medicines to play a better role, and play a therapeutic role for concurrent symptoms. Curcuma has the effects of promoting blood circulation and relieving pain, promoting qi and relieving depression, clearing the heart and cooling blood, and promoting gallbladder and relieving jaundice. It can assist the main and auxiliary drugs to strengthen the effects of promoting blood circulation and removing blood stasis, promoting qi and relieving depression, and treat various symptoms caused by qi stagnation and blood stasis. At the same time, it can also clear the heart and cool the blood, and prevent the blood heat that may occur in the process of promoting blood circulation and removing blood stasis, and be used as an adjuvant drug. Atractylodes can strengthen the spleen and replenish qi, dry dampness and promote diuresis. The spleen and stomach are the foundation of acquired constitution and the source of qi and blood biochemistry. Atractylodes can strengthen the spleen and replenish qi, promote the transportation and transformation function of the spleen and stomach, make qi and blood biochemistry active, and assist other drugs to play a better role. At the same time, it can also dry dampness and promote diuresis, prevent the endogenous water and dampness caused by poor qi and blood, and play an adjuvant and auxiliary role. Longan meat has the effects of nourishing the heart and spleen, nourishing blood and calming the mind. It can assist cooked rehmannia in nourishing yin and blood, and at the same time, it can nourish the heart and calm the mind. It has a certain conditioning effect on symptoms such as restlessness caused by poor qi and blood, liver depression and qi stagnation. Persimmon leaves have the effects of cooling blood and stopping bleeding, relieving cough and relieving asthma, promoting blood circulation and removing blood stasis. It can guide other drugs to act on the face and other diseased areas, play the role of guiding the meridians, and assist other drugs to enhance the effect of promoting blood circulation and removing blood stasis. Hawthorn has the effect of digesting food and removing accumulation, promoting qi and dispersing blood stasis. It can prevent spleen and stomach stagnation caused by factors such as drugs and diet, and at the same time promote qi and dissipate blood stasis, assist other drugs to enhance the effect of promoting blood circulation and removing blood stasis, and can reconcile various drugs to make the effect of the whole prescription more coordinated.

[0033] The Chinese medicinal materials used in the following embodiments of the present invention are all commercially available products; without special instructions, those skilled in the art can purchase them through conventional channels.

[0034] Example 1

[0035] This example provides a drug for regulating qi and resolving stasis, and its dosage form is oral liquid. The formula is as follows: 180 parts of Salvia miltiorrhiza, 110 parts of calcined margarita, 70 parts of Eupatorium japonicum Thunb., 70 parts of Cinnamomum cassia Presl, 50 parts of Rehmannia glutinosa Libosch., 50 parts of Curcuma aromatica Salisb., 50 parts of Atractylodes macrocephala Koidz., 25 parts of Arillus longan, 10 parts of Folium Diospyri, and 10 parts of Fructus Crataegi.

[0036] The preparation process is as follows:

[0037] (1) After mixing Salvia miltiorrhiza, Eupatorium japonicum Thunb., Cinnamomum cassia Presl, Rehmannia glutinosa Libosch., Curcuma aromatica Salisb., Atractylodes macrocephala Koidz., Arillus longan, Folium Diospyri, and Fructus Crataegi, add 10 times the total mass of the above raw materials of water, decoct for 2.5 h, and filter to obtain a decoction; then add 8 times the water, decoct for 1.5 h, and filter to obtain a decoction; combine the two decoctions to obtain medicinal liquid A.

[0038] (2) After pulverizing calcined margarita, add 6 times the total mass of water, decoct for 3 h, and filter to obtain a decoction; then add 5 times the water, decoct for 2 h, and filter to obtain a decoction; then add 5 times the water, decoct for 1 h, and filter to obtain a decoction; combine the three decoctions to obtain medicinal liquid B.

[0039] (3) After combining medicinal liquid A and medicinal liquid B, concentrate to a clear paste with a relative density of 1.14 - 1.18 (50 °C).

[0040] (4) Add 2 times the volume of ethanol solution (95%) to the clear paste, stir evenly, let stand for 48 h, filter to take the supernatant, recover ethanol and then concentrate to an extract with a relative density of 1.18 - 1.22 (50 °C).

[0041] (5) Mix the extract with refined honey, sorbic acid, and polysorbate - 80 in a ratio of 250 g:100 g:0.8 g:4 mL, stir until dissolved (heating appropriately for easy dissolution), add water to make up the volume to obtain a drug for regulating qi and resolving stasis. The concentration of the extract in the drug is 0.6 kg / L.

[0042] Example 2

[0043] This example provides a drug for regulating qi and resolving stasis, and its dosage form is oral liquid. The formula is as follows: 150 parts of Salvia miltiorrhiza, 120 parts of calcined margarita, 80 parts of Eupatorium japonicum Thunb., 60 parts of Cinnamomum cassia Presl, 40 parts of Rehmannia glutinosa Libosch., 40 parts of Curcuma aromatica Salisb., 60 parts of Atractylodes macrocephala Koidz., 30 parts of Arillus longan, 15 parts of Folium Diospyri, and 15 parts of Fructus Crataegi.

[0044] The preparation process is as follows:

[0045] (1) Mix Salvia miltiorrhiza, Lycopus lucidus, Cinnamomum cassia, Rehmannia glutinosa, Curcuma aromatica, Atractylodes macrocephala, Arillus longan, Folium persimmonis, and Crataegus pinnatifida, add water 10 times the total mass of the above raw materials, decoct for 2.5 h, and filter to obtain a decoction; then add 8 times the water, decoct for 1.5 h, and filter to obtain a decoction; combine the two decoctions to obtain medicinal liquid A.

[0046] (2) After pulverizing calcined nacre, add water 6 times the total mass, decoct for 3 h, and filter to obtain a decoction; then add 5 times the water, decoct for 2 h, and filter to obtain a decoction; then add 5 times the water, decoct for 1 h, and filter to obtain a decoction; combine the three decoctions to obtain medicinal liquid B.

[0047] (3) After combining medicinal liquid A and medicinal liquid B, concentrate to a clear paste with a relative density of 1.14 - 1.18 (50 °C).

[0048] (4) Add an ethanol solution (95%) with a volume 2 times that of the clear paste, stir evenly, let stand for 48 h, filter to obtain the supernatant, recover the ethanol, and concentrate to an extract with a relative density of 1.18 - 1.22 (50 °C).

[0049] (5) Mix the extract, refined honey, sorbic acid, and polysorbate - 80 in a ratio of 250 g:100 g:0.8 g:4 mL, stir until dissolved (heating appropriately can facilitate dissolution), add water to make up the volume to obtain a drug for regulating qi and resolving stasis. The concentration of the extract in the drug is 0.6 kg / L.

[0050] Example 3

[0051] This example provides a drug for regulating qi and resolving stasis, and its dosage form is oral liquid. The formula is as follows: 200 parts of Salvia miltiorrhiza, 100 parts of calcined nacre, 60 parts of Lycopus lucidus, 80 parts of Cinnamomum cassia, 60 parts of Rehmannia glutinosa, 60 parts of Curcuma aromatica, 40 parts of Atractylodes macrocephala, 20 parts of Arillus longan, 10 parts of Folium persimmonis, and 10 parts of Crataegus pinnatifida.

[0052] The preparation process is as follows:

[0053] (1) Mix Salvia miltiorrhiza, Lycopus lucidus, Cinnamomum cassia, Rehmannia glutinosa, Curcuma aromatica, Atractylodes macrocephala, Arillus longan, Folium persimmonis, and Crataegus pinnatifida, add water 10 times the total mass of the above raw materials, decoct for 2.5 h, and filter to obtain a decoction; then add 8 times the water, decoct for 1.5 h, and filter to obtain a decoction; combine the two decoctions to obtain medicinal liquid A.

[0054] (2) After pulverizing calcined nacre, add water 6 times the total mass, decoct for 3 h, and filter to obtain a decoction; then add 5 times the water, decoct for 2 h, and filter to obtain a decoction; then add 5 times the water, decoct for 1 h, and filter to obtain a decoction; combine the three decoctions to obtain medicinal liquid B.

[0055] (3) After combining liquid medicine A and liquid medicine B, concentrate them to a clear extract with a relative density of 1.14 - 1.18 (at 50 °C).

[0056] (4) Add ethanol solution (95%) with a volume 2 times that of the clear extract, stir evenly, let stand for 48 h, filter to obtain the supernatant, recover ethanol, and then concentrate to an extract with a relative density of 1.18 - 1.22 (at 50 °C).

[0057] (5) Mix the extract, refined honey, sorbic acid, and polysorbate - 80 in the ratio of 250 g:100 g:0.8 g:4 mL, stir until dissolved (heating appropriately for easy dissolution), add water to make up the volume to obtain the medicine for regulating qi and promoting blood circulation to remove stasis. The concentration of the extract in the medicine is 0.6 kg / L.

[0058] Comparative Example 1

[0059] The difference between this comparative example and Example 1 is only that Salvia miltiorrhiza and Curcuma aromatica are omitted.

[0060] Comparative Example 2

[0061] The difference between this comparative example and Example 1 is only that Salvia miltiorrhiza is replaced by Panax ginseng.

[0062] Comparative Example 3

[0063] The difference between this comparative example and Example 1 is only that Eupatorium japonicum Thunb. is replaced by Angelica sinensis.

[0064] Comparative Example 4

[0065] The difference between this comparative example and Example 1 is only that Rehmannia glutinosa is replaced by Bupleurum chinense DC.

[0066] Test Example 1

[0067] This test example is for the drug safety test. The test process is as follows:

[0068] Select 40 female Kunming mice with a body weight of 22 ± 2 g, and randomly divide the mice into 8 groups, namely Example 1 - 3 groups, Comparative Example 1 - 4 groups, and blank control group, with 5 mice in each group. Each group of mice is caged and raised according to the group. Under the same natural conditions, feed and drink water conventionally, keep natural light, and start the safety test after raising for 1 week to adapt to the experimental environment.

[0069] The mice in the experimental groups 1-3 were intragastrically administered with 0.1 mL / g (body weight) of the qi-regulating and stasis-resolving drugs of Examples 1-3; the mice in the control groups 1-4 were intragastrically administered with 0.1 mL / g (body weight) of the qi-regulating and stasis-resolving drugs of Comparative Examples 1-4; the blank control group was intragastrically administered with the same dose of normal saline. The gavage was performed once a day for 14 consecutive days. On the 0th, 3rd, 7th, and 14th days of the experiment, the body weights of the mice were measured, and the average body weight of each group of mice was taken. The results of body weight statistics are shown in Table 1. On the 14th day of the experiment, the sera of the mice were collected, and the levels of ALT and AST in the sera of each group of mice were detected using ALT and AST detection kits (Nanjing Jiancheng, Nanjing, China), and the average value of each group of mice was taken. The results of serological index detection are shown in Table 2.

[0070] Table 1 Results of body weight statistics of mice in each group

[0071] Group Day 0 Day 3 Day 7 Day 14 Blank control group 22.1 23.5 23.2 25.1 Example 1 group 24.8 22.6 23.4 26.0 Example 2 group 21.2 23.1 24.3 24.9 Example 3 group 23.5 23.8 24.0 25.3 Comparative example 1 group 22.3 20.6 23.8 25.8 Comparative example 2 group 21.1 24.1 23.4 23.5 Comparative example 3 group 22.9 22.9 24.4 24.7 Comparative example 4 group 21.8 22.6 22.3 22.6

[0072] Table 2 Results of serological index detection of mice in each group

[0073]

[0074]

[0075] It can be seen from the results of Table 1 and Table 2 that compared with the blank control group, there were no significant changes in the body weights, serum ALT, and AST levels of the mice in the experimental groups 1-3 and the control groups 1-4. The changes in serum ALT and AST levels can be used to evaluate whether the mice were affected by drug toxicity and thus caused liver injury. The above results indicate that the qi-regulating and stasis-resolving drugs of Examples 1-3 and Comparative Examples 1-4 have no toxic effects on mice and have high safety.

[0076] Test Example 2

[0077] This test example was a drug efficacy test. The test procedure was as follows:

[0078] Forty-five female Kunming mice with a body weight of 20-25 g were selected and randomly divided into 9 groups, namely the experimental groups 1-3, the control groups 1-4, the model group, and the blank control group, with 5 mice in each group. Each group of mice was caged and raised according to the group. Under the same natural conditions, they were fed and watered routinely, and kept under natural light. After being raised for 1 week to adapt to the experimental environment, the safety test was started.

[0079] The chloasma mouse models were established in the mice of Example Groups 1-3, Comparative Example Groups 1-4 and the Model Group. The construction process of the chloasma mouse model was as follows: A 1.5 cm × 1.5 cm area on the back of the mouse was selected as the test area, the hair was removed to fully expose the skin, and the exposed skin was irradiated with ultraviolet light at a wavelength of 320 nm for 20 minutes every day for 6 consecutive weeks to establish the chloasma mouse model. For the mice in the blank control group, a 1.5 cm × 1.5 cm area on the back was selected as the test area, and the hair was removed to fully expose the skin.

[0080] The mice in Example Groups 1-3 and Comparative Example Groups 1-4 were respectively intragastrically administered with the qi-regulating and stasis-removing drugs of Examples 1-3 and Comparative Examples 1-4 at a dose of 0.1 mL / g (body weight), and the mice in the Model Group and the blank control group were respectively intragastrically administered with the same dose of normal saline. The drugs were administered starting from the day of modeling and continuously administered for 8 weeks. After the administration was completed, the mice were sacrificed, the hair on the back of the mice was removed, and the back skin of the mice was taken. The skin tissue samples were crushed and homogenized for detecting the superoxide dismutase activity (SOD) and malondialdehyde (MDA) content in the skin of each group of mice. The detection results are shown in Table 3.

[0081] Table 3 SOD and MDA content in the skin of each group of mice

[0082]

[0083] It can be seen from the results in Table 3 that compared with the Model Group, the SOD enzyme activity in the skin and liver of the mice in Example Groups 1-3 increased and was close to that of the blank control group, indicating that the qi-regulating and stasis-removing drugs of Examples 1-3 could improve the oxidation degree in the skin of the chloasma mouse model and enhance the antioxidant ability. In contrast, the qi-regulating and stasis-removing drugs of Comparative Examples 1-4 had a lower improvement effect on the chloasma mouse model, and the improvement effect of Comparative Example 1 was the lowest, indicating that the raw material compatibility in the qi-regulating and stasis-removing drugs of the present invention was reasonable and produced a synergistic effect.

[0084] Test Example 3

[0085] In this test example, 320 chloasma volunteer subjects were selected and randomly divided into 8 groups with 40 people in each group. They were respectively administered with the qi-regulating and stasis-removing drugs of Examples 1-3, Comparative Examples 1-4, and the prior art drug (Qi-Regulating and Stasis-Removing Oral Liquid, Yubentang Holding Group Co., Ltd.) to verify the therapeutic efficacy of the qi-regulating and stasis-removing drugs of the present invention on chloasma. The chloasma volunteer subjects were all screened through strict inclusion criteria and exclusion criteria.

[0086] 1. The inclusion criteria for chloasma volunteer subjects were as follows:

[0087] (1) Aged 20-50 years old;

[0088] (2) Have the signs of melasma, meeting the clinical diagnostic criteria of "Melasma" formulated by the Dermatology and Venereology Committee of the Chinese Association of Integrated Traditional Chinese and Western Medicine.

[0089] 2. The exclusion criteria for volunteer subjects with melasma are as follows:

[0090] (1) Allergic constitution, currently suffering from or having suffered from allergic skin diseases;

[0091] (2) Suffering from other types of skin diseases, such as vitiligo, psoriasis, lupus erythematosus, etc.;

[0092] (3) Pregnant or lactating women;

[0093] (4) Those with combined liver and cardiovascular diseases, and patients with malignant tumors;

[0094] (5) Those who have received systematic treatment for melasma within 4 weeks;

[0095] (6) Those who discontinue treatment or change medications or methods during the trial, and those whose curative effects cannot be judged or whose data are incomplete and affect the judgment of curative effects.

[0096] 3. The medication method for volunteer subjects with melasma is as follows: Give the qi-regulating and stasis-removing drugs in Examples 1-3 and Comparative Examples 1-4 to be taken three times a day, morning, noon, and evening, 10 mL each time. Take continuously for 6 weeks. The existing technology group takes according to the instructions of the qi-regulating and stasis-removing oral liquid and takes continuously for 6 weeks.

[0097] 4. The judgment method for treatment effects is as follows: Cured: The area of the pigmented spots regresses by >90% visually with the naked eye and the color basically disappears;

[0098] Effective: The area of the pigmented spots regresses by 30-90% visually with the naked eye and the color becomes significantly lighter or lessened;

[0099] Ineffective: The area of the pigmented spots regresses by <30% visually with the naked eye and the color change is not obvious.

[0100] 5. Treatment effects: As shown in Table 4.

[0101] Table 4 Treatment effects of volunteer subjects with melasma in each group

[0102]

[0103]

[0104] As can be seen from the results in Table 4, the qi-regulating and stasis-removing drugs in Examples 1-3 have the best therapeutic effect on melasma, which is comparable to that of the prior art, while the therapeutic effects of the qi-regulating and stasis-removing drugs in Comparative Examples 1-4 are lower than those in Examples 1-3. Among them, the therapeutic effect of the group in Comparative Example 1 is the worst, which indicates that the compatibility of the raw materials in the qi-regulating and stasis-removing drugs of the present invention is scientific and reasonable, following the compatibility principle of "sovereign, ministerial, adjuvant, and courier", with a rigorous structure, distinct primary and secondary components, and jointly exerting the effects of regulating qi and removing stasis and treating melasma.

[0105] The above-described embodiments are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for regulating qi and removing blood stasis, characterized in that: The invention comprises the following raw materials in parts by weight: 150-200 parts of salvia miltiorrhiza, 100-120 parts of calcined pearl mother-of-pearl, 60-80 parts of zedoaria, 60-80 parts of cassia twig, 40-60 parts of rehmannia glutinosa, 40-60 parts of curcuma aromatica, 40-60 parts of atractylodes macrocephala, 20-30 parts of longan pulp, 10-15 parts of persimmon leaf and 10-15 parts of hawthorn.

2. A medicine for regulating qi and removing blood stasis, characterized in that: The invention comprises the Chinese medicine composition according to claim 1 and pharmaceutically acceptable excipients.

3. The drug according to claim 2, characterized in that The auxiliary materials include one or more of refined honey, polysorbate-80, sorbic acid, stevioside and ethylparaben.

4. The method for preparing the drug according to claim 2 or 3, characterized in that: The steps include: (1) Mix salvia miltiorrhiza, herbaceous angelica root, cinnamon twig, rehmannia root, curcuma, atractylodes macrocephala, longan pulp, persimmon leaf and hawthorn, add water and boil twice, combine the decoctions, filter and obtain liquid A; (2) crushing the calcined pearl mother-of-pearl, adding water and boiling for three times, combining the decoctions, filtering and obtaining liquid B; (3) mixing the medicinal solution A and the medicinal solution B, concentrating them, and obtaining a clear paste; (4) treating the clear paste with an ethanol solution, taking the supernatant, recovering the ethanol and concentrating it into an extract; mixing the extract with excipients, and fixing the volume with water to obtain the drug.

5. The preparation method according to claim 4, characterized in that: In step (1), the decoction process is as follows: for the first decoction, add 10 times the amount of water and decoct for 2.5 hours; for the second decoction, add 8 times the amount of water and decoct for 1.5 hours.

6. The preparation method according to claim 4, characterized in that: In step (2), the decoction process is as follows: for the first decoction, add 6 times the amount of water and decoct for 3 hours; for the second decoction, add 5 times the amount of water and decoct for 2 hours; for the third decoction, add 5 times the amount of water and decoct for 1 hour.

7. The preparation method according to claim 4, characterized in that: In step (3), the relative density of the clear paste is 1.14-1.18 at 50°C; in step (4), the relative density of the extract is 1.18-1.22 at 50°C.

8. The preparation method according to claim 4, characterized in that: The auxiliary materials are refined honey, sorbic acid and polysorbate-80.

9. The preparation method according to claim 8, characterized in that: The mixing ratio of the extract, refined honey, sorbic acid and polysorbate 80 is 200-270 g: 80-120 g: 0.5-1.0 g: 3-5 mL; The concentration of the extract in the medicine is 0.5-0.7kg / L.

10. Use of the Chinese medicine composition according to claim 1 or the medicine according to claim 2 or 3 in the preparation of a medicine for treating chloasma.

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