CN112717084A

CN112717084A - Traditional Chinese medicine composition for treating hyperprolactinemia, preparation method and application

Info

Publication number: CN112717084A
Application number: CN202110211255.2A
Authority: CN
Inventors: 王飞; 徐玲霞; 孙朋; 章莹; 颜冬梅; 唐琍萍; 李斌
Original assignee: Jiangxi University of Traditional Chinese Medicine
Current assignee: Jiangxi University of Traditional Chinese Medicine
Priority date: 2021-02-25
Filing date: 2021-02-25
Publication date: 2021-04-30

Abstract

The invention provides a traditional Chinese medicine composition for treating hyperprolactinemia, a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 5-15 parts of red peony root, 5-15 parts of angelica tail, 10-30 parts of medicinal cyathula root, 5-15 parts of safflower, 15-40 parts of malt, 5-15 parts of ricepaper pith, 10-30 parts of tangerine seed, 5-15 parts of cortex moutan and 5-15 parts of dried orange peel. The traditional Chinese medicine composition provided by the invention has the effects of promoting blood circulation to remove blood stasis, clearing heat and resolving masses, and promoting lactation to remove distension, and can effectively treat hyperprolactinemia; the invention has the advantages of no toxic or side effect, short treatment period and good treatment effect.

Description

Traditional Chinese medicine composition for treating hyperprolactinemia, preparation method and application

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating hyperprolactinemia, a preparation method and application thereof.

Background

Hyperprolactinemia (HPRL) refers to a state that the PRL level of peripheral serum caused by various factors is continuously higher than a normal value, generally, more than two times of PRL detection of the serum is considered, and if the numerical value is more than 25-30 ng/mL, the disease can be diagnosed. However, recent guidelines for HPRL treatment clearly indicate that a diagnosis can be made by one serum PRL test at levels above the upper limit of normal, excluding the influence of drug factors. Hyperprolactinemia is frequently occurred in women, and clinically, amenorrhea, galactorrhea, irregular menstruation, infertility, sexual hypofunction and the like are mainly shown, and male diseases are mainly shown as hyposexuality, sperm quantity reduction, sterility and the like.

The ancient books of traditional Chinese medicine in China have no direct content of the disease, and the ancient books can be classified into the categories of irregular menstruation, amenorrhea, infertility, lactation, impotence, spermatorrhea and the like according to clinical manifestations. The traditional Chinese medicine has unique curative effect on hyperprolactinemia and has no side effects of western medicines.

Disclosure of Invention

The first purpose of the present invention is to provide a Chinese medicine composition for treating hyperprolactinemia, which aims at the defects of the prior art.

The second purpose of the present invention is to provide the application of the above-mentioned Chinese medicinal composition to overcome the disadvantages of the prior art.

The third purpose of the invention is to provide a medicine for treating hyperprolactinemia, which aims at the defects of the prior art.

The fourth purpose of the present invention is to provide a method for preparing the medicine for treating hyperprolactinemia, which is described above, in view of the shortcomings of the prior art.

In order to achieve the first purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine composition for treating hyperprolactinemia is prepared from the following raw material medicines in parts by weight: 5-15 parts of red peony root, 5-15 parts of angelica tail, 10-30 parts of medicinal cyathula root, 5-15 parts of safflower, 15-40 parts of malt, 5-15 parts of ricepaper pith, 5-15 parts of cortex moutan and 5-15 parts of dried orange peel.

As a preferred embodiment of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith, 9 parts of cortex moutan, 9 parts of dried orange peel and 15 parts of tangerine seed.

As a preferred embodiment of the invention, the Chinese medicinal preparation is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

As a preferred embodiment of the present invention, the pharmaceutical preparation is a decoction, a pill, a granule, a powder, a capsule, a tablet, a mixture, a paste, a pellet, or an oral liquid.

In order to achieve the second object, the invention adopts the technical scheme that:

the application of the traditional Chinese medicine composition in preparing the medicine for treating hyperprolactinemia is provided.

In a preferred embodiment of the present invention, the treatment of hyperprolactinemia is a hypothalamic pituitary disease with increased serum prolactin level caused by various reasons, which is frequently occurred in women and clinically manifested by amenorrhea, galactorrhea, irregular menstruation, infertility, sexual hypofunction, etc.

In order to achieve the third object, the invention adopts the technical scheme that:

a medicament for the treatment of hyperprolactinemia, the said medicament is decocted with water and made from any one of the above-mentioned Chinese medicinal composition; the hyperprolactinemia is a hypothalamic pituitary disease with high serum prolactin level caused by various reasons, is frequently generated in women, and mainly shows amenorrhea, galactorrhea, irregular menstruation, infertility, sexual hypofunction and the like clinically.

As a preferred embodiment of the present invention, the preparation method of the medicine is as follows:

taking raw material medicines: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith, 9 parts of cortex moutan, 9 parts of dried tangerine peel and 15 parts of tangerine seed, soaking in water by multiple times, boiling with strong fire, decocting with slow fire, and filtering to obtain decoction.

In order to achieve the fourth object, the invention adopts the technical scheme that:

a preparation method of a medicine for treating hyperprolactinemia comprises the following steps:

(1) taking raw material medicines: taking raw material medicines: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith, 9 parts of cortex moutan, 9 parts of dried orange peel and 15 parts of tangerine seed,

(2) adding 10 times of water for the first time, soaking for 30min, decocting for 20min, and filtering;

(3) adding 8 times of water for the second time, decocting for 15min, and filtering;

(4) the filtrates were combined, concentrated and made up to 500 ml.

Square solution:

radix Cyathulae draws blood and descends, removes stasis and promotes menstruation; the angelica tail promotes blood circulation and unblocks the meridians, and also nourishes blood; radix Paeoniae Rubra has effects of clearing heat and cooling blood, removing blood stasis and relieving pain; the Sichuan safflower has the functions of promoting blood circulation, dredging channels, removing blood stasis and relieving pain. The four medicines are used together to nourish blood, remove blood stasis, dredge meridians and promote lactation. If the breast distention is obvious, fructus Hordei Germinatus and medulla Tetrapanacis can be added for restoring menstrual flow and promoting lactation; for vexation and irritability due to internal disturbance of blood stasis and heat, bupleuri radix and cortex moutan can be added for dispersing stagnated liver qi and clearing heat; for example, pericarpium Citri Reticulatae viride, pericarpium Citri Reticulatae, and semen Citri Reticulatae can be added to treat breast nodule.

The invention has the advantages that:

1. the raw material medicines accord with the compatibility principle of 'monarch, minister, assistant and guide', and the medicinal cyathula root draws blood and descends, removes stasis and dredges the channels; the angelica tail promotes blood circulation and unblocks the meridians, and also nourishes blood; radix Paeoniae Rubra has effects of clearing heat and cooling blood, removing blood stasis and relieving pain; the Sichuan safflower has the functions of promoting blood circulation, dredging channels, removing blood stasis and relieving pain. The four medicines are used together to nourish blood, remove blood stasis, dredge meridians and promote lactation. If the breast distention is obvious, fructus Hordei Germinatus and medulla Tetrapanacis can be added for restoring menstrual flow and promoting lactation; for vexation and irritability due to internal disturbance of blood stasis and heat, bupleuri radix and cortex moutan can be added for dispersing stagnated liver qi and clearing heat; for example, pericarpium Citri Reticulatae viride, pericarpium Citri Reticulatae, and semen Citri Reticulatae can be added to treat breast nodule.

2. The optimal proportion among the raw material medicaments is obtained through test screening, and the curative effect is good.

3. The traditional Chinese medicine composition has the advantages of small number of raw material medicines, synergistic effect among the raw material medicines, no toxic or side effect, simple and convenient preparation method, reduction of economic burden of patients and strong practicability.

The prescription of the invention is a core prescription for treating hyperprolactinemia summarized by the inventor on the basis of years of clinical disease treatment experience, and the prescription is used for conditioning hyperprolactinemia and has good effect. The medicinal material content range claimed by the invention is the prescription amount specially designed for the development of Chinese patent medicines and foods, the change condition of the usage amount of the medicinal materials in the prescription is not disclosed to be leaked, the prescription and the dosage of the prescription are very refined and reasonable, the use is safe, and the prescription is particularly suitable for being developed into the Chinese patent medicines and the related foods for conditioning hyperprolactinemia.

Detailed Description

The present invention will now be described more fully hereinafter with reference to various embodiments for the purpose of facilitating an understanding of the invention, but the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

EXAMPLE 1 Chinese medicinal composition 1

Weighing the following raw material medicines in parts by weight: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt and 9 parts of ricepaperplant pith.

EXAMPLE 2 Chinese medicinal composition (II)

Weighing the following raw material medicines in parts by weight: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith and 15 parts of tangerine seed.

EXAMPLE 3 Chinese medicinal composition (III)

Weighing the following raw material medicines in parts by weight: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith, 9 parts of cortex moutan and 15 parts of tangerine seed.

EXAMPLE 4 Chinese medicinal composition (IV)

Weighing the following raw material medicines in parts by weight: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith, 9 parts of cortex moutan, 9 parts of dried orange peel and 15 parts of tangerine seed.

EXAMPLE 5 Chinese medicinal composition (V)

Weighing the following raw material medicines in parts by weight: 3 parts of red peony root, 3 parts of angelica tail, 9 parts of medicinal cyathula root, 3 parts of safflower, 10 parts of malt, 3 parts of ricepaperplant pith, 3 parts of cortex moutan and 3 parts of dried orange peel.

EXAMPLE 6 Chinese medicinal composition (VI)

Weighing the following raw material medicines in parts by weight: 3 parts of red peony root, 3 parts of angelica tail, 9 parts of medicinal cyathula root, 3 parts of safflower, 10 parts of malt, 3 parts of ricepaperplant pith, 3 parts of cortex moutan, 3 parts of dried orange peel and 9 parts of tangerine seed.

Example 7 preparation of decoction

Taking the traditional Chinese medicine composition described in any one of embodiments 1-6, adding 10 times of water for the first time, soaking for 30min, decocting for 20min, filtering, adding 8 times of water for the second time, decocting for 15min, filtering, combining filtrates, concentrating, and metering to 500 ml.

EXAMPLE 8 preparation of granules

Taking the traditional Chinese medicine composition described in any one of embodiments 1-6, adding 10 times of water for the first time, soaking for 30min, decocting for 20min, filtering, adding 8 times of water for the second time, decocting for 15min, filtering, combining filtrates, concentrating to obtain an extract with a relative density of 1.10-1.19, drying in a vacuum drying oven (60 ℃ and-0.08 Mpa), pulverizing into fine powder, adding a certain amount of auxiliary materials, wherein the ratio of extract powder to auxiliary materials is 3:1, the auxiliary materials are starch and dextrin, and the ratio of starch to dextrin is 1:1, mixing the dry extract powder and the auxiliary materials uniformly, granulating by a dry granulator, grading, and subpackaging to obtain granules.

EXAMPLE 9 preparation of tablets/capsules

Taking the traditional Chinese medicine composition described in any one of embodiments 1-6, adding 10 times of water for the first time, soaking for 30min, decocting for 20min, filtering, adding 8 times of water for the second time, decocting for 15min, filtering, combining filtrates, concentrating to 500mL, transferring 20mL of the water decoction into a penicillin bottle, pre-freezing for 12h in a refrigerator at-20 ℃, placing into a vacuum freeze dryer with-80 ℃ for pre-cooling for 2h, freezing to-80 ℃ and vacuum degree of (5 +/-1) Pa, drying for 72h, taking out a gland and a sealing plug to obtain freeze-dried powder, adding pharmaceutical excipients, vacuum drying, crushing, granulating, filling and encapsulating.

Clinical trial 1

Case 1:

xu certain, female, 27 years old. The mixed feeding is carried out for 7 months after the normal delivery, and then the breast-feeding can not be carried out on time due to the working reason, the emotion is not comfortable, the breast is often swollen, and the patient wants to recover the breast. The following symptoms are marked: distending pain in the chest, milk overflow, restlessness, irritability, slight feeling of tenesmus in the lower abdomen, no rewetting of menstruation, poor appetite, hard stool, and good urination. The tongue is reddish with thin and white coating; the pulse is wiry and slightly astringent. Syndrome differentiation refers to the condition of liver-qi failing to disperse, qi stagnation and blood stasis. For it is suitable to activate qi and blood, dredge meridians and restore milk. Selecting the following components: 15g of angelica tail, 10g of safflower, 15g of red paeony root, 15g of medicinal cyathula root, 30g of roasted malt, 10g of tangerine peel, 15g of ricepaperplant pith and 6g of honey-fried licorice root. After 7 doses of the preparation are taken, the breast distension is relieved, the galactorrhea is eliminated, the vagina is slightly bled, the vexation is reduced, and the lower abdomen still feels drop and swell. The green tangerine peel is removed in the front, 15g of motherwort is added, and after 10 doses are taken continuously, the swelling of the breast gradually gets rid of the damp of the menstruation. So sui Zhi Yao.

Clinical trial 2

Case 2:

bear a certain, female, age 42. In the last two months, because children are uncomfortable in learning emotion and irritable, the menstruation still does not flow for half a month after the menostaxis, the lower abdomen is plumpness and a little amount of milk overflows, the hormone detection in a certain third hospital in province shows that the prolactin is higher than the normal value (the specific numerical value is unknown), and the diagnosis is planned to be hyperprolactinemia. The following symptoms are marked: a small amount of milk overflows, the breasts on both sides are slightly swollen, the inside of the milk is wrapped and the right side is obvious, the edge is clear, the mobility is good, the texture is hard, the pressing pain and the lower abdomen are swollen and the feeling of menstruation is felt. Dry stool, one row in 2-3 days, good urination and yellow urine. Depressed mood, frequent sighing, complaints of irritability and irritability. The tongue is slightly dark red, with a few small ecchymosis on the edge, dark sublingual collaterals and slightly tortuous and thickened; the wiry pulse is slightly astringent and rapid, and the right ulnar pulse is vigorous. Syndrome differentiation refers to stagnation of liver qi, qi stagnation and blood stasis, and internal disturbance of stagnant heat. For it is advisable to soothe the liver, relieve depression, activate blood, resolve stasis, promote qi circulation and dissipate nodulation. Selecting the following components: 20g of angelica tail, 10g of safflower, 15g of red peony root, 15g of medicinal cyathula root, 15g of cortex moutan, 30g of roasted malt, 15g of ricepaperplant pith, 15g of radix bupleuri, 10g of green tangerine orange peel and 6g of honey-fried licorice root. After 7 doses of the medicine are taken, the breast distension is relieved, the lumps in the breast are turned into soft, the galactorrhea is reduced, the stool is turned smooth, the conscious emotional depression is relieved, and the menstruation is still not moist. Continuously taking the first 10 doses, menstruation and menstruation with dark blood color, blood clot, mammary swelling and galactorrhea removed, and little intramammary clot; the tongue with petechia turns pale and the pulse is wiry, astringent and greatly reduced. The medicine is taken 14 times after the administration, and after 2 months, the patient takes out all the symptoms, and the menstruation returns to normal without taking any medicine.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The traditional Chinese medicine composition for treating hyperprolactinemia is characterized by being prepared from the following raw material medicines in parts by weight: 5-15 parts of red peony root, 5-15 parts of angelica tail, 10-30 parts of medicinal cyathula root, 5-15 parts of safflower, 15-40 parts of malt, 5-15 parts of ricepaper pith, 10-30 parts of tangerine seed, 5-15 parts of cortex moutan and 5-15 parts of dried orange peel.

2. The traditional Chinese medicine composition for treating hyperprolactinemia according to claim 1, which is prepared from the following raw material medicines in parts by weight: 9 parts of red peony root, 9 parts of angelica tail, 15 parts of medicinal cyathula root, 9 parts of safflower, 20 parts of malt, 9 parts of ricepaperplant pith, 15 parts of tangerine seed, 9 parts of cortex moutan and 9 parts of dried orange peel.

3. Use of the Chinese medicinal composition for treating hyperprolactinemia according to claim 1 or 2 in the preparation of a medicament for treating hyperprolactinemia.

4. The medicament for treating hyperprolactinemia is characterized in that the Chinese medicinal composition for treating hyperprolactinemia, which is disclosed by claim 1 or 2, is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

5. The medicament for treating hyperprolactinemia according to claim 4, wherein the medicinal preparation is any one of decoction, pills, granules, powder, capsules, tablets, mixture, paste, pellets and oral liquid.

6. The medicament for treating hyperprolactinemia according to claim 4, wherein the medicament is prepared by decocting the Chinese medicinal composition with water.

7. The method of claim 4 for the preparation of a medicament for the treatment of hyperprolactinemia comprising:

taking raw material medicines: soaking radix Paeoniae Rubra, radix Angelicae sinensis, radix Cyathulae, Carthami flos, fructus Hordei Germinatus, medulla Tetrapanacis, cortex moutan, pericarpium Citri Tangerinae, and semen Citri Reticulatae in water several times, boiling with strong fire, decocting with slow fire, and filtering to obtain decoction.