CN112641866B - Pharmaceutical composition for treating postpartum hemorrhage and preparation method thereof - Google Patents

Pharmaceutical composition for treating postpartum hemorrhage and preparation method thereof Download PDF

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CN112641866B
CN112641866B CN202011628769.XA CN202011628769A CN112641866B CN 112641866 B CN112641866 B CN 112641866B CN 202011628769 A CN202011628769 A CN 202011628769A CN 112641866 B CN112641866 B CN 112641866B
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pharmaceutical composition
postpartum hemorrhage
pseudo
ginseng
powder
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CN112641866A (en
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丁雄
刘录
杨竹雅
马晓霞
王晓珍
王钺涵
谭文红
周志宏
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Kunming Laizhang Pharmaceutical Co ltd
Yunnan University of Traditional Chinese Medicine TCM
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Kunming Laizhang Pharmaceutical Co ltd
Yunnan University of Traditional Chinese Medicine TCM
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding

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Abstract

The invention belongs to the technical field of pharmaceutical compositions, and relates to a pharmaceutical composition for treating postpartum hemorrhage, in particular to a pharmaceutical composition consisting of Achillea Wilsoniana and pseudo-ginseng and a preparation method thereof. The pharmaceutical composition has the hemostatic effect by oral administration, can be used for treating clinical postpartum hemorrhage, has obvious curative effect and few toxic and side effects, and has good development and application values.

Description

Pharmaceutical composition for treating postpartum hemorrhage and preparation method thereof
Technical Field
The invention belongs to the technical field of pharmaceutical compositions, and relates to a pharmaceutical composition, in particular to a pharmaceutical composition consisting of Achillea Wilsonii and pseudo-ginseng and a preparation method thereof.
Background
Postpartum Hemorrhage (PPH) is a serious complication of obstetrics, directly affects the quality of life of a surviving woman, and rapid massive blood loss can cause hemorrhagic shock and endanger the life of a parturient. The main causes of postpartum hemorrhage are uterine contraction weakness, placenta factor, soft birth canal injury and blood coagulation dysfunction. Clinically, the postpartum hemorrhage is usually called when the vaginal blood loss of a parturient exceeds 500 ml within 24 hours of delivery. In fact, postpartum hemorrhage time is more common within 2-39 days after delivery, including increased lochia, vaginal persistent hemorrhage, intermittent hemorrhage, paroxysmal hemorrhage accompanied with blood clot and the like, secondary anemia and puerperal infection can occur, hypophysis function is lowered in severe cases, and the like, and the health of a puerpera is seriously affected.
Under the influence of the special physiological state of pregnancy, a series of adaptive changes can occur to body tissues and organs, a neuroendocrine system, a metabolic system and the like, wherein blood components and the blood coagulation function of the body are also changed to a great extent, and the risk of postpartum hemorrhage of the pregnant women is correspondingly increased. Clinical studies have shown that blood coagulation dysfunction is one of the important causes of postpartum hemorrhage. Therefore, on the basis of reducing the toxic and side effects of the medicine as much as possible, the medicine for preventing and treating the postpartum hemorrhage and complications is convenient to develop, safe and efficient, and has positive significance for preventing and treating the postpartum hemorrhage and improving the prognosis of the puerpera.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating postpartum hemorrhage, and aims to solve the technical problem of lack of convenient, safe and efficient medicines for preventing and treating postpartum hemorrhage and complications.
A pharmaceutical composition for the treatment of puerperal hemorrhage comprises herba Berberidis kunmingensis and Notoginseng radix.
The principle and the beneficial effects of the scheme are as follows: the medicine composition for treating and preventing postpartum hemorrhage is prepared by taking the medicinal materials of the parietal barberry and the pseudo-ginseng as raw materials, and has good treatment and prevention effects on postpartum hemorrhage (parturition and artificial abortion).
The first barberry is rhizome of Trillium japonicum (Trillium tschonoskii Maxim.) or Trillium kamtschaticum pall.ex Pursh belonging to Trillium genus of Liliaceae family. Notoginseng radix is dried root of Panax notoginseng (Burk.) F.H.Chen) belonging to Araliaceae. The parietal barberry has certain functions of reducing blood pressure and easing pain, and the pseudo-ginseng has the effects of dissipating blood stasis, stopping bleeding, diminishing swelling, relieving pain and the like. The first pearl is not applied to the medical practice of treating postpartum hemorrhage, and long-term experimental research shows that the medicine effect can be greatly improved by adding a certain amount of the first pearl into the pseudo-ginseng, and the first pearl and the pseudo-ginseng have the synergistic effect. The reasons for postpartum hemorrhage are complex, and factors such as uterine contraction and hypodynamia, placenta factors, soft birth canal injury, blood coagulation dysfunction and the like are all causes of postpartum hemorrhage. Pseudo-ginseng is a conventional medicine for hemostasis, but cannot comprehensively treat postpartum hemorrhage because pseudo-ginseng cannot comprehensively influence the factors causing postpartum hemorrhage. After the parietal radix is added, the composition formed by the pseudo-ginseng and the parietal radix can play a more comprehensive role in treating and preventing postpartum hemorrhage. The most obvious expression is that in a hemostasis experiment, the pharmaceutical composition has better blood coagulation effect than the conventional medicine of GONGXUENING for treating postpartum hemorrhage, and the curative effect of the composition is better than that of the single use of pseudo-ginseng or single bead of capitulum capitatum.
The medicine composition has low toxicity and high safety when being orally administrated. When the daily dose of the mice is 675mg/kg, no obvious toxic reaction of the animals is seen. The mice are subjected to continuous 14-day administration experiments, and toxicity changes related to administration, such as general conditions, liver and kidney functions and main organ coefficients, are not found.
In conclusion, the scheme provides the pharmaceutical composition for treating and preventing the postpartum hemorrhage and the preparation method thereof, and the pharmaceutical composition has the advantages of simple and convenient preparation process, small pharmaceutical dosage, less toxic and side effects, low price and economy, and good development and application values.
Furthermore, the mass ratio of the common cephalanoplos herb to the pseudo-ginseng is 1: 4.
By adopting the technical scheme, the composition formed by the Achillea alpina and the pseudo-ginseng in the mass ratio of 1:4 can effectively treat postpartum hemorrhage and has lower toxic and side effects.
Further, the oral dosage of the pharmaceutical composition is 4.5 g/day.
By adopting the technical scheme, clinical experiments prove that adults can effectively treat or prevent the postpartum hemorrhage caused by artificial abortion or childbirth by taking 4.5g of the pharmaceutical composition in the scheme every day.
Further, the preparation method of the pharmaceutical composition for treating postpartum hemorrhage comprises the following steps: crushing the common cephalanoplos herb and the pseudo-ginseng to obtain common cephalanoplos herb powder and pseudo-ginseng powder, and mixing the common cephalanoplos herb powder and the pseudo-ginseng powder according to the mass ratio of 1:4 to obtain the pharmaceutical composition.
By adopting the technical scheme, the prepared pharmaceutical composition has a good effect of treating postpartum hemorrhage.
Further, the method also comprises the following steps: the pharmaceutical composition is prepared into any pharmaceutically acceptable dosage form.
By adopting the technical scheme, the pharmaceutical composition can be prepared into powder, tablets, capsules and other dosage forms which are beneficial to human body administration.
Furthermore, the mesh number of the first barberry powder and the pseudo-ginseng powder is 80-100 meshes.
By adopting the technical scheme, the medicine is crushed into a certain particle size, which is beneficial to uniformly mixing the medicine powder and is also beneficial to absorbing effective components after being taken by a human body.
Detailed Description
Example 1
Pulverizing herba Achilleae (Trillium tschonoski Maxim.) into fine powder to obtain herba Achilleae powder (80-100 mesh, in this embodiment 100 mesh); pulverizing Notoginseng radix into fine powder to obtain Notoginseng radix powder (80-100 mesh, in this embodiment 100 mesh); respectively taking 9kg of the first berberis bead powder and 36kg of the pseudo-ginseng powder, and uniformly mixing to obtain the pharmaceutical composition.
Example 2
Taking 15kg of the pharmaceutical composition obtained in example 1, and subpackaging into powder, wherein each bag contains 1.5g of the pharmaceutical composition, and 9958 bags are obtained; the patient takes the medicine orally, three times a day, 1 bag each time.
15kg of the pharmaceutical composition obtained in the example 1 is taken and filled into capsules, and each capsule is 0.5g, so that 29780 capsules are obtained; the patient takes the medicine orally three times a day, 3 granules each time.
Experimental example 1: hemostatic effect of pharmaceutical composition
1. Sample (I)
Normal group: physiological saline, 0.3ml daily dose.
Positive control group: GONGXUENING Capsule (Yunnan white drug products, Inc., 0.13 g/capsule, product batch ZMA1402), is prepared into 3.38mg/ml suspension with distilled water, and 0.3ml daily dose.
Composition high dose group: the pharmaceutical composition prepared in example 1 was taken and distilled water was added to make a suspension of 19.5mg/ml, 0.3ml daily dose.
Composition low dose group: the pharmaceutical composition prepared in example 1 was taken and distilled water was added to make a 9.75mg/ml suspension, 0.3ml daily dose.
Group of beads on head top: take Aconitum Carmichaeli powder prepared in example 1, add distilled water to make 19.5mg/ml suspension, 0.3ml daily dose.
Pseudo-ginseng group: the pseudo-ginseng powder prepared in the example 1 is added with distilled water to prepare 19.5mg/ml suspension, and the daily dose is 0.3 ml.
2. Laboratory animal
Healthy Kunming mouse, body weight 19-23 g. Purchased to the laboratory animal center of Kunming medical university.
3. Test methods and procedures
The test was carried out according to the method and operation of the reference "the experimental study of the hemostatic effect of gynecological hemostatic mixture on functional uterine bleeding" (Shanghai: the study of the university of TCM college in Hubei, see pages 9-10 of the study, Exit and blood coagulation time experiments).
4. Test results
The experimental results are detailed in table 1, and the bleeding and blood coagulation time is obviously shortened when the positive control group and each sample group are compared with the normal control group; compared with the positive control group, the bleeding and blood coagulation time of each sample group is obviously shortened, wherein the composition has the best effect in the high-dose group. The experimental tests of using the pseudo-ginseng and the single Achillea alpina herb alone show that the bleeding time and the blood coagulation time of the pseudo-ginseng group and the Achillea alpina herb group are obviously prolonged compared with the high-dose group of the composition, which shows that the proposal combines the two traditional Chinese medicines to generate the synergistic phenomenon, but not the simple superposition of the drug effects.
Table 1: influence of pharmaceutical composition on mouse bleeding and blood coagulation time
Group of Number of samples (N) Bleeding time (min) Blood coagulation time (min)
Normal group 10 20.37±0.39 4.87±0.65
Positive control group 10 16.76±0.52Δ 3.55±0.34Δ
Composition low dose group 10 11.19±0.64Δ* 2.81±0.42Δ*
High dose compositions 10 9.15±0.53Δ* 2.23±0.24Δ*
Notoginseng group 10 16.75±0.44Δ 4.29±0.36Δ
Group of beads on head 10 12.17±0.59Δ* 3.25±0.39Δ*
In table 1, Δ P <0.05 compared to normal group; p <0.05 compared to positive control group.
Experimental example 2: clinical curative effect observation of pharmaceutical composition on postpartum hemorrhage
1. Source of case
1.1 23 cases of full-term cesarean; 26 cases of induced abortion; the number of spontaneous abortion was 16, and 65 cases were total.
1.2 patients' minimum age 20 years, maximum age 42 years, mean age 29.5 years.
1.3 clinical presentation: vaginal bleeding after delivery is not clear (7-40 days after delivery).
1.4 past treatment history: oxytocin treatment was not significant (some patients were treated with antibiotics).
2. The treatment method comprises the following steps: the capsules in example 2 are taken, and all patients are treated in an outpatient way, and are taken three times a day, and 3 granules are taken each time. Three days are one treatment course, and the maximum three treatment courses are adopted. The treatment criteria were as follows:
and (3) healing: bleeding stops and subjective symptoms disappear.
The method has the following advantages: the bleeding is obviously reduced, and the subjective symptoms are relieved.
And (4) invalidation: bleeding remained after three treatment courses.
3. Therapeutic results
The results of the experiment are shown in table 2, and it can be seen from table 2 that 65 patients had: the cure rate is 43.1 percent, and the effective rate is 56.9 percent; after 37 cases enter the second course of treatment, the cure rate is 51.4 percent, and the effective rate is 48.6 percent; the third course of treatment is carried out on 18 cases, the cure rate is 55.6%, the effective rate is 27.7%, and the ineffective rate is 16.7%. The total effective rate is 95.4%, the total cure rate is 87.7%, and the ineffective rate is 4.6%.
Table 2: results of clinical studies
Serial number Recovery method Is effective Invalidation
The first course of treatment 28 37 N/A
The second course of treatment 19 18 N/A
The third course of treatment 10 5 3
Total up to 62 N/A 3
Experimental example 3: safety test of pharmaceutical compositions
The pharmaceutical composition of example 1 was suspended in water (45mg/ml suspension), and the ICR mice were gavaged 1 time a day at 675mg/kg/day for 14 consecutive days without toxicity changes associated with administration, general conditions, liver and kidney functions, and major organ coefficients.
The foregoing is merely an example of the present invention and common general knowledge in the art of designing and/or characterizing particular aspects and/or features is not described in any greater detail herein. It should be noted that, for those skilled in the art, without departing from the technical solution of the present invention, several variations and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.

Claims (5)

1. A pharmaceutical composition for treating postpartum hemorrhage is characterized by comprising Achillea alpina and pseudo-ginseng in a mass ratio of 1: 4.
2. The pharmaceutical composition for treating postpartum hemorrhage according to claim 1, wherein the pharmaceutical composition is orally administered in an amount of 4.5 g/day.
3. The method for preparing a pharmaceutical composition for treating postpartum hemorrhage according to claim 2, comprising the steps of: crushing the common cephalanoplos herb and the pseudo-ginseng to obtain common cephalanoplos herb powder and pseudo-ginseng powder, and mixing the common cephalanoplos herb powder and the pseudo-ginseng powder according to the mass ratio of 1:4 to obtain the pharmaceutical composition.
4. The method for preparing a pharmaceutical composition for treating postpartum hemorrhage according to claim 3, further comprising the steps of: the pharmaceutical composition is prepared into any pharmaceutically acceptable dosage form.
5. The method for preparing a pharmaceutical composition for treating postpartum hemorrhage according to claim 4, wherein the mesh number of the parietal barberry powder and the pseudo-ginseng powder is 80-100 meshes.
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Publication number Priority date Publication date Assignee Title
CN105412625A (en) * 2015-12-31 2016-03-23 苏远安 Traditional Chinese medicine composition for treating internal injury headache
CN105687363A (en) * 2016-02-29 2016-06-22 三峡大学 Special-effect traditional Chinese medicine for treating bleeding wounds and preparation method and application thereof
CN106421255A (en) * 2016-11-28 2017-02-22 杨卫 Topical traditional Chinese composition and its application
CN106967147A (en) * 2017-04-06 2017-07-21 中国科学院昆明植物研究所 C27Spirostan type steroid saponin compounds and its pharmaceutical composition and its application

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Publication number Priority date Publication date Assignee Title
CN110433242A (en) * 2018-05-03 2019-11-12 焦爱芳 Bedsore powder and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105412625A (en) * 2015-12-31 2016-03-23 苏远安 Traditional Chinese medicine composition for treating internal injury headache
CN105687363A (en) * 2016-02-29 2016-06-22 三峡大学 Special-effect traditional Chinese medicine for treating bleeding wounds and preparation method and application thereof
CN106421255A (en) * 2016-11-28 2017-02-22 杨卫 Topical traditional Chinese composition and its application
CN106967147A (en) * 2017-04-06 2017-07-21 中国科学院昆明植物研究所 C27Spirostan type steroid saponin compounds and its pharmaceutical composition and its application

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